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A Project Report

On
INDIA ‘s VACCINE DIPLOMACY:
BLUNDER OR ACHIEVEMENT
Submitted in the Partial Fulfillment for the Degree of
Bachelor of Business Administration

S.S. JAIN SUBODH P.G AUTONOMOUS COLLEGE,


JAIPUR
(2021-2022)

Submitted by Submitted to
Tanmay Napit Dr.Payal Goyal
2041210 Assistant Professor

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CERTIFICATE

This is to certify the project report entitled ” INDIA ‘S VACCINE DIPLOMACY:


BLUNDER OR ACHIEVEMENT” in a record of project work done
independently by Mr. Tanmay Napit under my guidance and supervision
and it has not previously formed the basis for the award of degree or
fellowship

Dr. Payal Goyal


Assistant Professor
S.S. Jain Subodh P.G (Autonomous) College
Jaipur

DECLARATION
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I, Tanmay Napit student of BBA semester IV hereby declare that the project
work presented in this report is my own work and has been carried out
under the supervision of Dr. Payal Goyal of S.S. Jain Subodh P.G
(AUTONOMOUS) College.This work has not been previously submitted to
any other university for any examination

Tanmay Napit (2041210)


S.S. Jain Subodh P.G (Autonomous) College
Jaipur

ACKNOWLEDGEMENT
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It is often in life that you get a chance of appreciating and expressing your
feelings in black and white to thank people who have been a crucial part of
your success , your accomplishments, and your being what you are today.

I take this opportunity to first of all thank the faculty at S.S. Jain Subodh
P.G (Autonomous) college, especially Dr.K.B. Sharma, Priciple and Dr. Chitra
Rathore, Head Of Department , BBA for inculcating and instilling me the
knowledge, learning,will-power, values and the competitiveness and
professionalism required by me as a management student
I express my sincere and heartiest thanks to everyone who has contributed
toward the successful completion of the project
Last but not the least , I would like to thank my family ; my parents for
supporting me spiritually throughout my life.

Tanmay Napit

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INDEX

S.NO TOPIC PAGE NO.


1 INTRODUCTION 6-14
2 VACCINES 15-24
3 VACINE MAITRI 25-32
INITIATIVE
4 INDIA’S 33-38
VACCINE
ROLLOUT
5 RESULT AND 39-42
CONCLUSION
6 BIBLOGRAPHY 41

INTRODUCTION

Amidst Coronavirus havoc dur to deadly second wave of fresh infections between March
and May. India’s Vaccine matri has initiated some discussions again but this time its not

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just from the opposition parties bur its own people including pro-government activists ,
with BJP led government at the center which is famous for some of the crucial decision
taken since winning the majority two times in Loksabha elections, Vaccine maitri was
aiming at strengthning diplomatic ties with countries which might present India as one of
the global power, deserving a permanent seat at UN Secutiry Council post COVID
Period.

The COVID-19 Pandemic , also known as the coronavirus pandemic, is an ongoing


global pandemic of coronavirus disease 2019 which is caused by severe acute respiratory
syndrome coronavirus 2 (SARS-COV-2). The virus was first identified in Wuhan, China.
The World Health Organisation declared a public Health Emergency of International
Concern regarding COVID-19 on 30 January 2020 and later declared a pandemic on 11
March 2020. As of 11 June 2021 more than 174 million cases have been confirmed,
with more than 3.77 million confirmed deaths attributed to COVID-19, making it one of
the deadliest pandemic in history

The severity of COVID-19 symptoms is highly variable. Ranging from unnoticeable to


life threatning, severe illness is more likely in elderly COVID-19 patient,as well as
those who have underlying medical conditions. COVID-19 transmits when people
breathe in air contaminated by droplets and small airborne particles. The risk of
breathing these particles are highest when people are in close proximity but they can be
inhaled over longer distances, particularly indoors. Transmission casn also occur if
splashed or sprayed with contaminated fluids, in the eyes, noseor mouth and rarely via
contaminated surfaces. People remain contagious for upto 20 days, and can spread the
virus even if they do not develop and symptoms

Recommended preventive measure include social distancing, wearing face mask in


public, ventilation and air-filtering, hand washing, covering one’s mouth when sneezing
or coughing, disinfecting surfaces and monitoring and self-isolation for people who are
exposed to virus and even if they are asymptomatic. However several vaccines have been
developed and widely distributed since December 2020. Current treatments focus on
addressing the symptoms, but work is underway to develop medications that inhibit the
virus. Authorities worldwide have responded by implementing travel restrictions,
lockdowns and quarantines, workplace hazard controls, and business closures, work from
homes and numerous jurisdictions have also worked to increase the testing capacity and
trace contacts of the infected

The pandemic has resulted in significant global, social and economic


disruption,includinhg the largest global recession since the great depression of 1930s it
has led to widespread supply shortages, complicated by panic buying, agricultural
disruption, and food shortages. However, ther also been decreases emission of pollutants

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and greenhouse gases. Numerous educational institutes and public areas have been
partially or fully closed, and many events have been cancelled or postponed.

The pandemic has raised issues of racial and geographic discrimination, health
infrastructure , and the balance between public health imperatives and individual rights

 ORIGIN OF THE VIRUS


The emergence of SARS-COV-2 was first observed when case of unexplained
pneumonia was noted in the city of wuhan, china. During the first week of epidemic in
wuhan, an association was noted between the early cases and the wuhan seafood
wholesale maket (hereafter referred to as the “Huanan market”); cases was mainly
reported in operating dealers and vendors. The authorities closed the market on 1st
january 2020 for environmental sanitation and disinfection. The market was
predomintely sold aquatic products and seafood as well some farmed wild animal
products, was initially suspected to be the epicentre of the epidemic, suggesting an event
human-animal interface. Retrospective investigations identified additional cases with
onset of disease in December 2019, and not all the early cases reported an association
with Huanan market.

Although the role of civets as intermediate hosts in the outbreak of severe acute
respiratory syndrome (SARS) in 2002-2004 had beeen favoured and a role for pangolins
in outbreak of COVID-19 was initially reported, subsequent epidemiological and
epizootic studies have not substantiated the contribution of these animals in transmission
to humans. The possible intermediate host of SARS-COV-2 remains elusive

Bats have been identified as the hosts of a series of important zoonotic viruses (for
example, Nipah virus, Hendra virus and SARS-COV), including coronavirus with
considerable genetic diversity of particular relevance with regard to COVID-19 are those
coronaviruses that were found to be associated with the outbreaks in humans of SARS in
2002 and the Middle East respiratory syndrome(MERS) in 2013

The causative virus of COVID-19 was rapidly isolated from patients and sequenced with
the results from china subsequently shared and published in january 2020. The findings
showed that it was a positive-stranded RNA virus belonging to the coronaviridae family
(a subgroup B betacoronavirus) and was new to humans. In the early work, analysis of
the genomic sequence of the new virus (SARS-COV-2) showed high homology with
that of the coronavirus that caused SARS in 2002-2004, namely SARS-CoV.

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As with the coronavirus that cause SARS and MERS, human-to-human transmission of
SARS-CoV-2 was established, but the virus demonstrated much greated infectivity than
those other two coronaviruses. SARS-CoV-2 shows a broad tisuue tropism, in particular
binding through its spike protein to angiotensin-converting enzyme 2 (ACE2). It also
directly infects endothelial cells lining the blood vessels, unusually for human
respiratory virus. Other novel pathalogical features of the virus are hypercoagulability
and the excesskive multi-organ immune system response and long term sequelae. People
infected with SARS-CoV-2 appear to be most infectious at the time of onset of
symptoms but were also infectious in the day before onset. Infections can be
asymptomatic, cause a mild illness or result in severe disease and death

 The Lab Leak Theory


Biden’s announcement that US intelligence agencies were divided on the question of
the virus’s origin has given wings and new respectability to the “ Wuhan Lab Leak ”
theory earlier dismissed as aright wing, racist conspiracy theory propagated by prez
donald trump and his fellow followers.

That the theory had been under serious consideration since at least septmber 2020
emerged on 15th january this year, a fortnight before the Trump Administration stepped
down, when US State Department made public a “fact sheet” that disclosed previously
undisclosed information, combined with open source information.

It made three points:

1) That researchers at the wuhan institute of virology (WIV) had fallen ill with
symptoms consistent with both Covid-19 and seasoned illness,well before the first
reported case on December 8, 2019

2) That 2016 researchers at WIV had been conducting experiments with RaTG13, a bat
coronavirus that has a 96.2% match Covid-19 ; RaTG13 was isolated as far back as
2013 from samples taken from bat faeces in a mine in yunan, where six miners had
died in 2012;

3) That WIV carried out classified military research including animal experiments on
behalf of the people’s liberation army.

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However according to a report in CNN, the Biden Administration shut down the State
Department investigation as a waste of time and resources after officials questioned its
legitimacy. But pressure was building on Biden to reconsider his position that Covid-19
had originate in nature, especially after a WHO report failed to come up with the
conclusive answers on the origin of the virus.

On may 23 and 24, the Wall Street Journal published two reports that appear to have
pushed biden into action. One report quoted a US intelligence report as going “beyond
the state department fact sheet” and saying three researchers at WIV had fallen sick in
November 2019. The scond report was about the yunan copper mine where six miners
had fallen ill. ;

The WSJ report said the miners,diagnosed with severe pneumonia, had the same lung
patches seen in Covid patients. Over the next year, WIV scientists studied samples from
276 bats in the mine, among which they identified a coronavirus strain they called
RaBTCoV/4991. The same researchers published a paper in nature, describing RaTG13,
which had a 96.2% genome sequence match with SARS-CoV-2

After this scientists around the world noticed similarities in the sample dates and partial
genetic sequences of RaBTCOV/4991 and RaTG13, WIV researchers said the two
viruses were the same. But they said it was not the virus that had caused the death of
miners back in 2012

At the very least, the late admission by WIV that the two viruses were the same, and
some contradictions in their explanations for this, have raised questions about the
transparency of data from WIV. At the other extreme are those who do not rule out that
WIV was conducting experiments to construct new viruses by combining elements of
different bat viruses, perhaps for finding vaccine and that this could have accidentally led
to the leakage of a harmful virus from the lab

All this led to heightened concers that the WHO report on the origins of the virus did not
present the complete picture

But in view of global pandemic with four million deaths, hundred of millions out of
work, and trillion of dollars in economic damage. I think the world should know the truth.
The truth will be known once the proper investigation take place without the interference
of chinese government

Signs and symptoms

Symptoms of COVID-19 are variable, ranging from mild symptoms to severe illness. Common
symptoms include headache, loss of smell and taste, nasal congestion and runny nose, cough,

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muscle pain, sore throat, fever, diarrhea, and breathing difficulties. People with the same
infection may have different symptoms, and their symptoms may change over time. Three
common clusters of symptoms have been identified: one respiratory symptom cluster with
cough, sputum, shortness of breath, and fever; a musculoskeletal symptom cluster with muscle
and joint pain, headache, and fatigue; a cluster of digestive symptoms with abdominal pain,
vomiting, and diarrhea. In people without prior ear, nose, and throat disorders, loss of taste
combined with loss of smell is associated with COVID-19.

Of people who show symptoms, 81% develop only mild to moderate symptoms (up to mild
pneumonia), while 14% develop severe symptoms (dyspnea, hypoxia, or more than 50% lung
involvement on imaging) and 5% of patients suffer critical symptoms (respiratory failure, shock,
or multiorgan dysfunction). At least a third of the people who are infected with the virus do not
develop noticeable symptoms at any point in time. These asymptomatic carriers tend not to get
tested and can spread the disease. Other infected people will develop symptoms later, called
"pre-symptomatic", or have very mild symptoms and can also spread the virus.

As is common with infections, there is a delay between the moment a person first becomes
infected and the appearance of the first symptoms. The median delay for COVID-19 is four to
five days. Most symptomatic people experience symptoms within two to seven days after
exposure, and almost all will experience at least one symptom within 12 days.

Most people recover from the acute phase of the disease. However, some people continue to
experience a range of effects for months after recovery—named long COVID—and damage to
organs has been observed. Multi-year studies are underway to further investigate the long-term
effects of the disease.

Transmission

The respiratory route of spread of COVID-19, encompassing larger droplets and aerosols.

The disease is mainly transmitted via the respiratory route when people inhale droplets and
particles that infected people release as they breathe, talk, cough, sneeze, or sing. Infected people
are more likely to transmit COVID-19 the longer and closer they interact with others. Infection
can occur over longer distances, particularly indoors.

Infectivity begins as early as three days before symptoms appear; it is at its highest once they
manifest. It declines after the first week, but infected people remain contagious for up to 20 days,
and can spread the disease even if they remain asymptomatic.

The size of the infectious particles range from aerosols that remain suspended in the air for long
periods of time to larger droplets that remain airborne or fall to the ground. The variety in size
has redefined the traditional understanding of how respiratory viruses transmit. The largest
droplets of respiratory fluid do not travel far, and can be inhaled or land on mucous membranes
on the eyes, nose, or mouth to infect. Aerosols are highest in concentration when people are in

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close proximity, which leads to easier viral transmission when people are physically close, but
airborne transmission can occur at longer distances, mainly in locations that are poorly
ventilated; in those conditions small particles can remain suspended in the air for minutes to
hours.

Cause

Illustration of SARS-CoV-2

SARS-CoV-2 belongs to the broad family of viruses known as coronaviruses. It is a positive-


sense single-stranded RNA virus, with a single linear RNA segment. Coronaviruses infect
humans, other mammals, and avian species, including livestock and companion animals. Human
coronaviruses are capable of causing illnesses ranging from the common cold to more severe
diseases such as Middle East respiratory syndrome (MERS, fatality rate ~34%). SARS-CoV-2 is
the seventh known coronavirus to infect people, after 229E, NL63, OC43, HKU1, MERS-CoV,
and the original SARS-CoV.

Viral genetic sequence data can provide critical information about whether viruses separated by
time and space are likely to be epidemiologically linked. With a sufficient number of sequenced
genomes, it is possible to reconstruct a phylogenetic tree of the mutation history of a family of
viruses. By 12 January 2020, five genomes of SARS-CoV-2 had been isolated from Wuhan and
reported by the Chinese Center for Disease Control and Prevention (CCDC) and other
institutions; the number of genomes increased to 42 by 30 January 2020. A phylogenetic analysis
of those samples showed they were "highly related with at most seven mutations relative to a
common ancestor", implying that the first human infection occurred in November or December
2019. As of 7 May 2020, 4,690 SARS-CoV-2 genomes sampled on six continents were publicly
available.

Diagnosis

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The standard methods of testing for presence of SARS-CoV-2 are nucleic acid tests, which
detects the presence of viral RNA fragments. As these tests detect RNA but not infectious virus,
its "ability to determine duration of infectivity of patients is limited." The test is typically done
on respiratory samples obtained by a nasopharyngeal swab; however, a nasal swab or sputum
sample may also be used. Results are generally available within hours. The WHO has published
several testing protocols for the disease.
Chest CT scans may be helpful to diagnose COVID-19 in individuals with a high clinical
suspicion of infection but are not recommended for routine screening.

Prevention

Without pandemic containment measures – such as social distancing, vaccination, and face
masks – pathogens can spread exponentially. This graphic shows how early adoption of
containment measures tends to protect wider swaths of the population.

Preventive measures to reduce the chances of infection include getting vaccinated, staying at
home, wearing a mask in public, avoiding crowded places, keeping distance from others,
ventilating indoor spaces, managing potential exposure durations, washing hands with soap and
water often and for at least twenty seconds, practicing good respiratory hygiene, and avoiding
touching the eyes, nose, or mouth with unwashed hands.

Those diagnosed with COVID-19 or who believe they may be infected are advised by the CDC
to stay home except to get medical care, call ahead before visiting a healthcare provider, wear a
face mask before entering the healthcare provider's office and when in any room or vehicle with
another person, cover coughs and sneezes with a tissue, regularly wash hands with soap and
water and avoid sharing personal household items.

Vaccines

In Phase III trials, several COVID-19 vaccines have demonstrated efficacy as high as 95% in
preventing symptomatic COVID-19 infections. As of April 2021[update], 16 vaccines are
authorized by at least one national regulatory authority for public use: two RNA vaccines
(Pfizer–BioNTech and Moderna), seven conventional inactivated vaccines (BBIBP-CorV,
CoronaVac, Covaxin, WIBP-CorV, CoviVac, Minhai-Kangtai and QazVac), five viral vector
vaccines (Sputnik Light, Sputnik V, Oxford–AstraZeneca, Convidecia, and Johnson & Johnson),
and two protein subunit vaccines (EpiVacCorona and RBD-Dimer). In total, as of
March 2021[update], 308 vaccine candidates are in various stages of development, with 73 in
clinical research, including 24 in Phase I trials, 33 in Phase I–II trials, and 16 in Phase III
development.

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Many countries have implemented phased distribution plans that prioritize those at highest risk
of complications, such as the elderly, and those at high risk of exposure and transmission, such
as healthcare workers. Single dose interim use is under consideration in order to extend
vaccination to as many people as possible until vaccine availability improves.

On 21 December 2020, the European Union approved the Pfizer BioNTech vaccine. Vaccinations
began to be administered on 27 December 2020. The Moderna vaccine was authorized on 6
January 2021 and the AstraZeneca vaccine was authorized on 29 January 2021.

On 4 February 2020, US Secretary of Health and Human Services Alex Azar published a notice of
declaration under the Public Readiness and Emergency Preparedness Act for medical
countermeasures against COVID-19, covering "any vaccine, used to treat, diagnose, cure,
prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating
therefrom", and stating that the declaration precludes "liability claims alleging negligence by a
manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the
wrong dose, absent willful misconduct”. His declaration is effective in the United States through
1 October 2024. On 8 December it was reported that the AstraZeneca vaccine is about 70%
effective, according to a study.

Treatment

There is no specific, effective treatment or cure for coronavirus disease 2019 (COVID-19), the
disease caused by the SARS-CoV-2 virus.[147][148] Thus, the cornerstone of management of
COVID-19 is supportive care, which includes treatment to relieve symptoms, fluid therapy,
oxygen support and prone positioning as needed, and medications or devices to support other
affected vital organs.

Most cases of COVID-19 are mild. In these, supportive care includes medication such as
paracetamol or NSAIDs to relieve symptoms (fever, body aches, cough), proper intake of fluids,
rest, and nasal breathing. Good personal hygiene and a healthy diet are also recommended.
The U.S. Centers for Disease Control and Prevention (CDC) recommend that those who suspect
they are carrying the virus isolate themselves at home and wear a face mask.

People with more severe cases may need treatment in hospital. In those with low oxygen levels,
use of the glucocorticoid dexamethasone is strongly recommended, as it can reduce the risk of
death. Noninvasive ventilation and, ultimately, admission to an intensive care unit for
mechanical ventilation may be required to support breathing. Extracorporeal membrane
oxygenation (ECMO) has been used to address the issue of respiratory failure, but its benefits
are still under consideration.

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Several experimental treatments are being actively studied in clinical trials. Others were
thought to be promising early in the pandemic, such as hydroxychloroquine and
lopinavir/ritonavir, but later research found them to be ineffective or even harmful. Despite
ongoing research, there is still not enough high-quality evidence to recommend so-called early
treatment. Nevertheless, in the United States, two monoclonal antibody-based therapies are
available for early use in cases thought to be at high risk of progression to severe disease. The
antiviral remdesivir is available in the U.S., Canada, Australia, and several other countries, with
varying restrictions; however, it is not recommended for people needing mechanical
ventilation, and is discouraged altogether by the World Health Organization (WHO), due to
limited evidence of its efficacy.

 AFTERMATH
Equitable access to safe and effective vaccines is critical to ending the COVID-19 pandemic, so
it is hugely encouraging to see so many vaccines proving and going into development. As we
know safe and effective vaccines are game changing and will play crucial role in fighting the
pandemic. As the covid is still on a massive surge but the fight against covid is becoming
relatively easier after the arrival of vaccines, but it’s not vaccines that will stop the pandemic,
it’s vaccination, and there must be fair and equitable access to vaccines, and ensure every
country receives them and can roll them out to protect their people, various nations among the
globe has come forward to help.

Moving further we will discuss about the VACCINES and INDIA’s VACCINE MAITRI INITIATIVE

VACCINES

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After publication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) genetic
sequence on January 11, 2020, research and collaboration among scientists and
biopharmaceutical manufacturers quickly followed.

Russia became first country to register its covid vaccine on 11th august 2020 named
SPUTNIK-V it is an adenovirus viral vector vaccine for COVID-19 developed by Gamaleya
Research institute of epidemiology and microbiology with the collaboration of Russian Ministry
of Health  

The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs)
for 3 SARS-CoV-2 vaccines since December 2020. Two are mRNA vaccines – BNT-162b2
(Pfizer) and mRNA-1273 (Moderna), whereas the third is a viral vector vaccine – Ad26.COV2.S
(Johnson & Johnson). Other vaccines are in or nearing phase 3 trials. 

In INDIA two vaccines are granted emergency use authorization by the Central Drugs Standard
Control Organization (CDSCO) in India, Covishield® (Astra-Zeneca’s vaccine manufactured by
Serum Institute of India) and Covaxin® (manufactured by Bharat Biotech Limited). Sputnik-V
has been granted EUA in the month of April 2021 

Vaccination in previously infected individuals

The CDC recommends vaccination for individuals who have already had COVID-19 and
recovered. Vaccinations provide a safer and more reliable way to build antibodies compared with
infection. Patients may receive the vaccine once they have recovered from the acute illness (if
symptomatic) and meet the criteria to discontinue isolation. Patients who received monoclonal
antibodies or convalescent plasma should wait 90 days before receiving the vaccine.

Evidence shows vaccines provide substantially higher protection against COVID-19 infection
compared with immunity from a previous COVID-19 infection. mRNA vaccinees have higher
antibody titers (up to 10 times higher) than convalescent plasmas from donors who recovered
from natural infection.

Early studies found vaccination of patients with prior SARS-CoV-2 infection enhances T-cell
immunity and antibody-secreting memory B-cell response, and neutralizing antibodies effective
against emerging variants. These data emphasize the importance of vaccinating both uninfected
and previously infected persons to elicit cross-variant neutralizing antibodies.

Vaccine Characteristics

In addition to the complexity of finding the most effective vaccine candidates, the production
process is also important for manufacturing the vaccine to the scale needed globally. Other
variables that increase complexity of distribution include storage requirements (eg, frozen vs
refrigerated) and whether more than a single injection is required for optimal immunity. Several
technological methods (eg, DNA, RNA, inactivated, viral vector, protein subunit) are available
for vaccine development. Vaccine attributes (eg, number of doses, speed of development,
scalability) depend on the type of technological method employed.  

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Some methods have been used in the development of previous vaccines, whereas others are
newly developed. For example, mRNA vaccines for influenza, rabies, and Zika virus have been
previously tested in animals.  

Examples of advantages and disadvantages of the various vaccine technologies are included in
Table 1.

Table 1. Vaccine Platform Characteristics

Platform Attributes  Doses Vaccine Candidate (Manufacturer)

Fast development speed; low- to- BNT-162b2 (Pfizer, BioNTech);


Mrna 2
medium manufacturing scale
mRNA-1273 (Moderna)
Fast development speed; medium
DNA 2 INO-4800 (Inova)
manufacturing scale

AZD-1222 Ad5-CoV (AstraZeneca;


Medium development; high
Viral vector 1 or 2 Oxford University);
manufacturing scale
Ad26.COV2. S (Johnson & Johnson)
Medium- to-fast development; high
Protein subunit 2 NVX-CoV2373 (Novavax)
manufacturing scale 

Whole virion Ability to quickly produce large 2 Covaxin; BBV152 (Oncogene, Bharat
inactivated  amounts of vaccine Biotech and Sinovac Biotech)

mRNA Vaccines

BNT-162b2 

Overview

 Rolling BLA submitted May 7, 2021 to FDA for full approval for individuals aged 16
years and older

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 EUA granted in the United States for individuals aged 12 years and older 
 NIH  phase 2 trial of allergic reactions to vaccine in participants with severe allergies
underway
 Phase 3 trials complete in adults and adolescents aged 12 years and older 
 Phase 2/3 trial in pregnant women started in February 2021 
 Phase 1/2/3 trials starting spring 2021 in infants and younger children aged 6 months and
older 
 Phase 3 trial in older adults of BNT-162b2 booster dose followed by 20-valent
pneumococcal conjugate vaccine (20vPnC) 

BNT-152b2 (Pfizer) is a nucleoside-modified messenger RNA (modRNA) vaccine that encodes


an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen. It is a 2-dose series given
21 days apart.

A multinational phase 3 trial randomly assigned 43,448 participants to receive vaccine or


placebo (vaccine group, 21,720; placebo group, 21,728) by injection. Approximately 42% of
global participants and 30% of US participants were of racially and ethnically diverse
backgrounds, and 41% of global and 45% of US participants were 56-85 years of age. 

Vaccine efficacy was 95% against the original SARS-CoV-2 strain at 7 days after dose 2, and no
serious safety concerns were observed. There were 170 confirmed cases (placebo group, 162;
vaccine group, 8); 10 severe cases occurred after the first dose (placebo group, 9; vaccine group,
1). The only grade 3 adverse event with a frequency of greater than 2% was fatigue at 3.8%;
headache occurred in 2% of participants. Short-term mild-to-moderate pain at the injection site
was the most common reaction, and severe pain occurred in less than 1% of participants across
all age groups.

Efficacy data in an ongoing, real-world, phase 3 assessment of 46,307 participants showed


91.3% efficacy against COVID-19, when gauged as cases 7 days to 6 months after the second
vaccine dose. Among 927 confirmed symptomatic COVID-19 cases, 850 were in the placebo
group compared with 77 in the vaccine group. It was 100% effective in preventing severe disease
(Centers for Disease Control and Prevention [CDC] definition). All 32 severe disease cases
occurred in the placebo group.

Results from an observational study of real-world data from healthcare workers (HCWs)
employed in a large medical center in Israel after their first vaccine dose have been published.
Among 9109 eligible staff, 7214 (79%) received a first dose and 6037 (66%) received the second
dose in December 2020 and January 2021. Compared with a symptomatic COVID-19 rate of 5
per 10,000 person-days in unvaccinated HCWs, disease rates were 2.8 and 1.2 per 10,000
person-days on days 1-14 and days 15-28 after the first vaccine dose, respectively. Adjusted rate
reductions of COVID-19 disease were 47% for days 1-14 and 85% for days 15-28 after the first
dose.

mRNA-1273

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Overview

 EUA in the United States for adults aged 18 years and older 
 EUA submitted June 10, 2021 for adolescents based on phase 2/3 Teen COVE trial (n = 3,732)
completed in adolescents aged 12-17 years showing 100% efficacy after 2 doses
 June 1, 2021: Rolling BLA initiated for U.S. licensure in adults
 NIH  phase 2 trial of allergic reactions to vaccine in participants with severe allergies underway
 US phase 3 trial (COVE) in adults complete  
 Phase 2/3 Kid COVE trial children aged 6 months and older began in March 2021 (target
enrollment 6,750) 
 Phase 2 study started for booster vaccine candidates 
 Phase 3 trial in university students planned to assess nasal viral load and shedding 

The mRNA-1273 vaccine (Moderna) encodes the S-2P antigen. It is administered as a 2-dose
series given 28 days apart. The US phase 3 trial (COVE) launched in July 2020. The trial was
conducted in cooperation with the National Institute of Allergy and Infectious Diseases and
included more than 30,000 participants who received two 100-mcg doses or matched placebo on
days 1 and 29. Overall efficacy was 94.1% for the original viral strain. There were 196
confirmed cases (placebo group, 185; vaccine group, 11). Among the 185 cases in the placebo
group, 30 cases were severe, including 1 death.

The COVE study (n = 30,420) included Americans 65 years and older (24.8%), younger
individuals with high-risk chronic diseases (16.7%), individuals who identify as Hispanic or
Latinx (20.5%), and individuals who identify as Black or African American (10.4%).  At 6
months after the second dose, efficacy was greater than 90% against COVID-19 infection and
greater than 95% against severe COVID-19 in identified cases (data adjudicated from over 900
cases, of which over 100 were severe).

In an ongoing phase 1 trial, 33 adult participants in all age groups showed high antibody activity
elicited by mRNA-1273 at 6 months after the second dose.

Booster vaccine

A single booster dose of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against


SARS-CoV-2 and 2 variants of concern (B.1.351, P.1) in previously vaccinated clinical trial
participants. A booster dose of mRNA-1273.351, a strain-matched candidate, achieved higher
titers against B.1.351 than a booster dose of mRNA-1273.

Evaluation of a multivalent vaccine booster, mRNA-1273.211, that combines mRNA-1273


ancestral strains and mRNA-1273.351 in a single vaccine is ongoing. 

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Viral Vector Vaccines

Ad26.COV2.S

Overview

 EUA in the United States for adults aged 18 years and older
 Phase 3 trial (ENSEMBLE) in adults completed  
 Phase 2 trial in pregnant women launched February 2021 
 Phase 2a trial (ENSEMBLE 2) to assess efficacy of 1 or 2 doses began late 2020 
 ENSEMBLE 2 trial expanded to include adolescents April 2021 

Ad26.COV2.S is an adenovirus serotype 26 (Ad26) recombinant vector-based vaccine (JNJ-


78436735, VAC31518; Johnson & Johnson) administered as 1 single injection. 

The phase 3 trial (ENSEMBLE) began in September 2020 in the United States, South Africa,
and South America. In December 2020, it was fully enrolled. Interim results for the phase 1/2a
trial describing neutralizing antibody titers of more than 90% at day 29 and 100% at day 57 were
published in January 2021.

The EMSEMBLE trial randomly assigned more than 40,000 participants worldwide to receive 1
injection of either Ad26.COV2.S (n = 19,630) or placebo (n = 19,691). Ad26.COV2.S protected
against moderate to severe–critical Covid-19 with onset at least 14 days after administration
(vaccine group,116 cases; placebo group, 348; efficacy, 66.9%) and at least 28 days after
administration (66 vs 193 cases; efficacy, 66.1%). The vaccine showed higher efficacy against
severe–critical Covid-19 (76.7% for onset at 14 days and 85.4% for onset at 28 days). The
vaccine was 100% effective against COVID-19–related hospitalization and death at Day 28; 16
hospitalizations occurred in the placebo group.

Ad26.COV2.S showed consistent protection across race; age groups, including older adults
(participants aged 60 years and older were 34.6% of the vaccine arm); and across all variants and
regions studied, including South Africa, where nearly all cases of COVID-19 (95%) were due to
infection with a SARS-CoV-2 variant from the B.1.351 lineage.

The EUA Fact Sheet for Health Care Professionals states the vaccine's safety and efficacy in
older study participants showed no overall differences compared with younger participants. At
least 28 days post vaccination, efficacy against moderate to severe/critical disease at all study
sites (ie, United States, Latin America, South Africa) was 66.2% for those aged 60 years and
older compared with 66.1% for those 18-59 years. In the United States, estimated efficacy was
85.9% at least 28 days after vaccination.  

AZD-1222

Overview

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 Pending EUA submission in the United States; approved for use in United Kingdom and other
countries 
 Phase 3 trials in United States completed March 2021 
 Phase 3 trial in United Kingdom planned to assess safety and immune response in children and
young adults aged 6-17 years 

AZD-1222 (ChAdOx1 nCoV-19; AstraZeneca) is a replication-deficient chimpanzee adenoviral


vector vaccine containing the surface glycoprotein antigen (spike protein) gene. It is
administered as 2-dose series 28 days apart. This vaccine primes the immune system by eliciting
antibodies to attack the SARS-CoV-2 virus if it later infects the body. Owing to the testing of a
different coronavirus vaccine in 2019, development for AZD-1222 was faster than that of other
viral vector vaccines.

Results of an interim analysis of the phase 3 clinical trial in the United Kingdom, Brazil, and
South Africa are as follows:

One dosing regimen (n = 2741) showed vaccine efficacy of 90% when given as a half dose,
followed by a full dose at least 1 month later. Another dosing regimen (n = 8895) showed 62.1%
efficacy when given as 2 full doses at least 1 month apart. The combined analysis from both
dosing regimens (N = 11,636) resulted in an average efficacy of 70.4% (p  < .0001 for all). From
21 days after the first dose, 10 patients in the control arm were hospitalized for COVID-19 (2
severe, 1 death).  Concerns about the clinical trial implementation and data analysis have
emerged because the half-dose regimen was not in the approved study design. These concerns
will be addressed by regulatory agencies and await publication of the trial data. 

In another trial, researchers studied the second vaccine dose administered at 3 months after the
first dose instead of at 1 month. After the initial 21-day exclusion period, there were no
hospitalizations in the vaccine group compared with 15 in the control group. Vaccine efficacy
after a single standard dose of vaccine from day 22 to day 90 was 76%. Modelled analysis
indicated that protection did not wane during the initial 3-month period. Similarly, antibody
levels were maintained during this period with minimal waning by day 90. In the group that
received 2 doses of the standard dose, vaccine efficacy was higher with a longer prime-boost
interval (3 months) compared with an interval less than 6 weeks (82.4% vs 54.9% respectively).

Nasal swabs were obtained from trial participants every week in the UK study, regardless of
symptoms. This allowed assessment of the overall impact of the vaccine on risk for infection,
and thus a surrogate for potential onward transmission. A single standard dose of AZD-1222
reduced PCR positivity by 67%, and after the second dose, reduced PCR positivity by 49.5%
overall. These data indicate that ChAdOx1 nCoV-19, used in the authorized schedules, may have
a substantial impact on transmission by reducing the number of infected individuals in the
population.

Protein Subunit Vaccines

NVX-CoV2373 

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Overview

 Phase 3 trial (PREVENT-19) demonstrated 90.4% overall efficacy and 100% protection against
moderate-to-severe disease 
 Crossover studies initiated in ongoing trials in South Africa, the United Kingdom, and the United
States in March/April 2021 to ensure all participants receive vaccine
 Trial in adolescents aged 12-17 years has enrolled 2,248 participants as of mid-June 2021 with
enrollment goal of 3,000 across 75 US sites 
 Refrigerate (2-8ºC) for shipping and storage; solution for IM injection 

NVX-CoV2373 (Novavax) is engineered using recombinant nanoparticle technology from


SARS-CoV-2 genetic sequence to generate full-length, prefusion spike (S) protein. This is
combined with an adjuvant (Matrix-M). Results of preclinical studies showed that it binds
efficiently with human receptors targeted by the virus. It is administered as a 2-dose series given
21 days apart. 

The PREVENT-19 phase 3 clinical trial demonstrated overall efficacy of 90.4%. Results are
based on 77 cases of symptomatic COVID-19 that investigators observed among trial
participants from January 25 through April 30, 2021. There were 63 cases among the
approximately 10,000 participants who received placebo and 14 cases among the approximately
20,000 participants who received the investigational vaccine. Of the 63 COVID-19 cases in the
placebo group, investigators classified 10 as moderate and 4 as severe. There were no cases of
moderate or severe disease in the investigational vaccine group.

The phase 3 trial in the United Kingdom has completed enrollment and the phase 2b trial in
South Africa has reported final results.  Results of these trials are timely, as new circulating viral
variants in The United Kingdom and South Africa have emerged during the trials. 

 VACCINES IN INDIA

India has ramped up its coronavirus vaccine production amid a deadly second wave of infection.
The government aims to vaccinate all Indians by the end of the year, but the drive has been
stumbled by slow pace, shortage of doses and vaccine hesitancy.

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Only 3.5% of the people have been fully vaccinated and 15% have received one dose since the
beginning of the drive in January
There are currently two homegrown vaccines for the coronavirus: Covishield and Covaxin.
Russia’s Sputnik V has also been approved for use and is being used in some quantities

 Sputnik V

The vaccine, developed by Moscow’s Gamaleya institute, initially rolled out before the final
trial data had been released. But scientists say its benefits have now been demonstrated.
It uses a cold-type, virus, engineered to be harmless, as a carrier to deliver a small fragment
of the coronavirus to the body. After being vaccinated, the body starts to produce antibodies
especially tailored to the virus it can be stored at the temperature of between 2 and 8C
degrees (a standard fridge is roughly3-5C degrees) making it easier to transport and store.
Unlike other vaccines, the Sputnik jab uses two slightly different versions of the vaccine for
the first and the second dose – given 21 days apart
They both target the coronavirus’s distinctive “spike”, but use different vectors –
the neutralized virus that carries the spike to the body.
The idea is that using two different formulas boosts the immune system even more than using
the same version twice and may give longer-lasting protection. India receives its first batch
of doses of the vaccine in May.

 Covaxin

Covaxin is an inactivated vaccine which means that it is made up of killed coronaviruses,


making it safe to be injected into the body
Bharat Biotech, a 24-year-old vaccine maker with a Portfolio of 16 vaccines and exports to
123 countries, used a sample of the coronavirus, isolated by India’s National Institute of
Virology.
When administered, immune cells can still recognize the dead virus, prompting the immune
system to make the antibodies against the virus. The two doses are given four weeks apart.
The vaccine can be stored at 2C to 8C degrees
The vaccine has efficacy rate of 81% preliminary data from its phase 3 trial show

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India’s regulators gave the vaccine an emergency approval in January while the third phase
of the trial was still underway sparking skepticism and question from experts
The Covaxin is approved in January for “restricted use in emergency situation in public
interest, experts wondered how vaccine was cleared for emergency use when its trials were
still underway. The All-India Drug Network at the time said that it was “baffled to
understand the scientific logic” to approve an “an incompletely studied vaccine”
Both the manufacturer and drug regulator had defended Covaxin, “saying it was safe and
provides a robust immune response” Bharat Biotech had said that Indian clinical trial laws
allowed “accelerated” authorization for use of drugs after the second phase of trials for
“unmet medical needs of serious and life-threatening diseases in the country”
It has promised to make available the full data for third phase of trials in July

 Covishield

The Oxford-AstraZeneca vaccine is being manufactured locally by SII.


The vaccine is made from weakened version of common cold virus(adenovirus) from
chimpanzees. It has been modified to look more like coronavirus although it can cause illness
When the vaccine is injected into a patient, it prompts the immune system to start making
antibodies and primes it to attack any coronavirus infection.
The jab is administered in two does given between 4 and 12 weeks apart. It can be safely
stored at temperatures of 2C to 8C degrees
International clinical trials of the Oxford-AstraZeneca vaccine showed that when people
were given a half dose and then full dose, effectiveness hit 90%
However, unpublished data suggests that leaving longer gap between the first and second
doses increase the overall effectiveness of the jab – in a sub-group given the vaccine this way
found to be 70% effective after the first does. The SII, the Indian maker of the vaccine, says
Covishield is “highly effective” and backed by phase III trial data from Brazil and United
Kingdom.

 Other Vaccine Candidates in India

The other candidates which are in different stages of trials in India to test safety and efficacy
include:

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 ZyCov-Di, being developed by Ahmedabad-based Zydus-Cadila
 Hyderabad- based Biological E to produce the vaccine developed by US firm Johnson
& Johnson
 HGCO19, India’s first mRNA vaccine made by Pune-based Genova in collaboration
with Seattle-based HDT Biotech corporation, using bits of genetic code to cause an
immune response
 A nasal vaccine by Bharat Bio Tech
 A local version of Novavax vaccine, which will be produced by Serum Institute of
India (SII)

 India Became Global Pharmacy

India has shipped 66 million doses of vaccines to 95 countries in Latin America, the
Caribbean, Asia and Africa. The recipient countries include UK, Canada, Brazil and Mexico.
Both Covishield and Covaxin have been exported some in the form of “gifts”, others in line
with commercial agreements signed between the vaccine makers and the recipient nations,
and the rest under the COVAX scheme, which is led by the World Health Organization
(WHO) and hopes to deliver more than two billion doses to people in 190 countries in less
than a year.
But in march, India placed a temporary hold on all exports of the Oxford-AstraZeneca
vaccine. The government said rising cases meant domestic demand was expected to pick up
and so the doses were needed to India’s own rollout

Vaccine Maitri Initiative

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As countries scramble to secure Covid-19 vaccines, ugly expressions like “vaccine race”
and “vaccine nationalism” have entered the global lexicon. But, at a time when global
cooperation in sharing vaccines is minimal, and the World Health Organization’s
vaccine-distribution plans are yet to get off the ground, India has taken a different tack,
quietly pursuing “vaccine diplomacy”. Its “Vaccine Maitri” (Vaccine Friendship)
campaign has shipped hundreds of Indian-made Covishield and Covaxin to some 95
countries

India is a global pharmaceutical powerhouse, manufacturing some 20 percent of all


generic medicines and accounting for as much as 62 percent of global vaccine
production, so it was quick off the mark when the pandemic struck. Before Covid-19
vaccines were developed, India supplied some 100 countries with hydroxychloroquine
and paracetamol, and sent pharmaceuticals, test kits, and other equipment to around 90
countries. Later, In June 2020, SII entered into a licensing agreement with AstraZeneca, a
British-Swedish pharmaceutical company, to supply one billion doses of the Oxford
University COVID vaccine to middle- and lower-income countries. Even before the
Oxford-AstraZeneca vaccine was approved, Adar Poonawalla, the 40-year old head of
the privately-owned Serum Institute of India, audaciously decided to manufacture it,
a billion dollar gamble. When approvals came, SII was able to churn out millions of
doses, making them available to the government both for domestic use and export
Indian vaccines have been flown to most of the country’s neighbors, including
Afghanistan, Bangladesh, Bhutan, Sri Lanka, the Maldives, Myanmar, and Nepal, and
also farther afield, to the Seychelles, Cambodia, Mongolia, and Pacific Island, Caribbean,
and African countries. Vaccines have helped mend strained relations with Bangladesh
and cement friendly ties with the Maldives

To be sure, China and Russia are prompting their own vaccines, and western drug
companies are raking in a publicity bonanza (along with a share price windfall). But in
developing vaccines for its own use, the global north overlooked the prohibitive cost of
the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines for poorer countries,
India made vaccines, on the other hand, are reportedly safe, cost-effective, and-unlike
some other-do not require storage and transport at very low temperatures.

At the most crucial time in the pandemic when most countries are criticized for hoarding
vaccine doses, India stands out for having sent 33 million to poorer countries, with
millions more in the pipeline
There is also an unspoken subtext: rivalry with China, with which tensions have
intensified following clashes along the Himalayan frontier. Not only has India
overshadowed China as a provider of cheap and accessible vaccines to the Global South;

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it has been quicker and more effective. For example, China has announced 300,000 doses
for Myanmar but is yet to deliver any, while India quickly supplied 1.7 million. Similarly,
Indian vaccines beat China's into Cambodia and Afghanistan.

When a credibility crisis consumed China's vaccines in pandemic-ravaged Brazil, with


polls showing 50 percent of Brazilians surveyed unwilling to take the Sinovac vaccine,
President Jair Bolsonaro turned to India, which came through promptly. Tweeting his
thanks, Bolsonaro illustrated his gratitude with an image from India's Ramayana epic,
depicting Lord Hanuman carrying an entire mountain to deliver the life-saving herb
Sanjeevani booti to Lanka.

Indian vaccines are arriving even in richer countries. The United Kingdom has ordered
ten million doses from SII. Canada, whose prime minister, Justin Trudeau, has riled his
Indian counterpart, Narendra Modi, more than once, telephoned Modi to ask for two
million vaccines; the first half-million were delivered within days. Trudeau effusively
declared that the world's victory over Covid-19 would be "because of India's tremendous
pharmaceutical capacity

India is using the country's capacity in this sector subtly to advertise an alternative to
China's economic and geopolitical dominance. While China has been secretive in
releasing data about its vaccines, leading to controversies over the efficacy of them, India
organized trips for foreign ambassadors to visit pharmaceutical factories in Pune and
Hyderabad.

The contrast with the behaviour of wealthier countries is no less striking. According to
Duke University's Global Health Institute, developed countries with 16 percent of the
world's population—including Canada, the United States, and the UK, each of whom
have guaranteed enough supplies to vaccinate their populations several times over—have
secured 60 percent of global vaccine supplies for themselves. Other countries
commandeering supplies exceeding their domestic needs include Australia, Chile, and
several European Union members.

The world is paying attention to India as it shares its available vaccine supplies, instead
of choosing the nationalist course of blocking exports. India has also offered 1.1 billion
vaccine doses to the WHO's COVAX programme to distribute Covid-19 vaccines to
poorer countries. As Modi has tweeted, "We are all together in the fight against this
pandemic. India is committed to sharing resources, experiences, and knowledge for
global good."

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If there is a concern, it is that India has exported three times as many doses as it has
administered to its own people (till march). The country is lagging behind its own target
of immunizing 300 million people by August, after vaccinating some three million
health-care workers in a campaign that began on January 16. And mounting concern
about rising case numbers, the emergence of Covid-19 variants that may not respond to
existing vaccines, and an economy that has not yet fully recovered, will intensify the
challenge India confronts in fulfilling its obligations to developing countries while also
meeting domestic demand

In January 2021, India was not only kicking off its vaccination drive, but also sharing
millions of doses with other countries. India was heralded in the news as the nation with
biggest vaccine manufacturing capacity. The country’s foreign minister was busy
tweeting about each shipment of vaccines to another nation, by March, however, that rosy
picture gave way to calamity, overshadowing earlier success. Some believe now that
India’s vaccine diplomacy was a mistake, or at least that it did not yield the desired result
but as we say that everything has two sides

It is true that by April it became obvious that India was being hit by a massive wave of
COVID-19 infections, and that the spike was not confined to specific states, like
Maharashtra, but was quickly on its way to being a national crisis. New Delhi then
blocked all exports of vaccines, promising it would be a temporary two-month measure to
“prioritize” domestic needs. Should we treat the promise literally, that period will end by
the beginnings of June, although it is not so clear exports will recommence then.
Meanwhile, the current of assistance has started to flow the opposite way: The world is
now helping India. As Indian hospitals overflowed with patients, many of them with
severe symptoms and with thousands dying due to insufficient equipment, some countries
starting to send emergency transports of medical aid to India, such as oxygen
concentrators.

Now is a time of reckoning in India. What could have been done differently, who is to
blame, and could the governments — both central and the state — have reacted better and
faster? It certainly looks that they could have, and in many ways, given that experts and
pandemic watchers in the country were sending warning signs early. Another oft-
discussed issues is that of vaccine diplomacy – with hindsight, some question if it made

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sense to share doses with other nations when New Delhi should have focused on
vaccinating its own citizens.

The counterpoint to this is the data: India donated over 10 million doses of vaccines to
other countries, while it administered 187 million doses to its own citizens (both numbers
as of May 21). The number of Indians vaccinated with at least once dose is certainly
small, given the country’s population of 1.4 billion, but the gifted doses would not have
changed the overall picture.

Besides donations, over 35.7 million doses were sold to other countries and these
commercial shipments, presumably, were doses sold by the Serum Institute of India –
a private company which has the biggest COVID-19 vaccine producing capacity in the
world and which produces AstraZeneca’s vaccine on a license. The doses that New Delhi
gifted to other countries were also mostly produced by this company, and then purchased
by the Indian government, which decided to donate a part of them to other countries. It is
true that the government of India could have halted commercial sales earlier and for
longer (it did so briefly in January and in April). Yet, this would have generated legal
problems (as the current blocking of exports is doing) and raise moral questions (most of
the customers are poorer countries). Moreover, although the number of doses sold was
larger than the number of donated doses, and they could have been used to vaccinate
millions in India, on a national scale these doses would not have been able to stop the
second wave.

Finally, the third type of exports were Indian shipments of nearly 20 million doses of
vaccines destined to be used by the COVAX facility for poorer countries. This, however,
was not just a moral obligation but a formal one – international donors had in fact earlier
supplied the Serum Institute of India with funds so that the company could ramp up
manufacturing capacity, provided that a part of the vaccine doses would be later given to
COVAX. Indeed, India’s Ministry of External Affairs data show that while the last
commercial shipment was on April 16 (and was flown to Syria), transports for the sake of
COVAX continued until mid-April, destined for countries such as Zambia, Mauritania,
Syria, Albania, Cameroon.

COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines


directed by Gavi, The vaccine Alliance (formerly the Global Alliance for Vaccines and
Immunization, or Gavi), The Coalition for Epidemic Preparedness innovations (CEPI)
and The World Health Organization (WHO). It is one of the three pillars of the Access to
COVID-19 Tools Accelerator, an initiative begun in April 2020 by the WHO, the
European Commission, and the government of France as a response to the COVID-19

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pandemic COVAX coordinates international resources to enable low-to-middle-income
countries equitable access to COVID-19 test, therapies, and vaccines. And no country to
receive vaccines more than 20% of their population before all countries have vaccinated
at least 20% of their population, By 15th July 2020, 165 countries – representing 60% of
the human population +

Ultimately, India’s vaccine diplomacy was not a mistake in the sense that not undertaking
it would not have stopped the calamity. This is especially true when we conclude that
only the 10 million doses donated by New Delhi to other nations can be really counted as
vaccine diplomacy (rather than commercial sales or other commitments). But the
question remains – did this policy yield any results?

While we can best assess the ultimate results of India’s vaccine diplomacy with a cool
head a few years from now, it cannot be ruled out that the efforts to far — even frozen
and cloudy as they are at present — may still have yielded modest results.

First, the current has put India firmly on the map of global health politics. Two years ago,
if people were asked which countries would be crucial in dealing with a hypothetical
pandemic, I assume many would not have mentioned India. Of course, the Serum
Institute of India was a known entity already because of the other vaccines it produced by
it, such as for measles, but that was not well known outside certain circles.

Second, New Delhi has taken diplomatic first steps on new ground. In its vaccine
diplomacy, India confirmed that it remains focused on its region – with neighbors
receiving the largest donations – and does not have the resources to deeply engage in
distant regions. And yet, shipments to Africa, South America, and various island nations
can certainly be considered first steps on new ground.

Third, should such steps continue, we may yet see India benefit politically. For instance,
small island nations may seem to have little to offer New Delhi, but India has long
attempted to engage them diplomatically, for example seeking support for United Nations
reform. It is similarly too early to tell how much the China-India rivalry has seeped into
global vaccine diplomacy, and whether New Delhi has scored any points in that contest.

29
India’s assistance to Paraguay is illustrative as a case that ticked many political boxes at
the same time. Paraguay is one of the few nations left that recognize Taiwan as a
sovereign country; Beijing reportedly pressed the South American country to derecognize
Taiwan, while offering its vaccines. Paraguay refused and then India sent its vaccines to
the country. Even though the number of doses was small, hardly enough to make a huge
difference, the story made waves in global media and also For instance, India is keen on
mending its ties with Bangladesh. New Delhi’s controversial citizenship law enacted last
year and the news of $40 billion in investments from China to Bangladesh had strained
ties between the two nations. The COVID-19 vaccine can let a little slack back in.
Similarly, vaccine diplomacy provides an opportunity for India to resolve outstanding
issues with Nepal. Relations between the two countries recently hit a new low when they
entered into a heated exchange over the Kalapani territorial dispute—an area situated at
the strategic China-Nepal-India trijunction. In Indian Ocean countries like the Maldives
and Mauritius, India’s vaccine diplomacy can help foster stronger ties in the region, and
offset China’s growing influence attributable to its financial investments and social-
development projects.

Fourth, and on a most general level, while the current crisis has showed New Delhi’s
many mistakes on the domestic front, the earlier circumstances which led to it donating
doses highlighted the country’s strengths. For example, the Serum Institute of India is
able to produce cheap vaccines on a massive scale, and to do so with the use of foreign
technology. This can be grounds for a fruitful international health alliance in the future,
with Western countries sharing the know-how (including licenses) with India, a country
with a massive workforce and cheap manufacturing conditions, in order to supply the
world with affordable vaccines
Additionally Made-In-India drugs are cheaper particularly for low-Income and
developing markets. Pfizer-BioNTech’s and Moderna’s vaccines widely used in the
Global North, are priced at US$19 and US$32-37 per dose, respectively. In India, while
vaccine makers are supplying doses at subsidized rates to the government, they are still
significantly cheaper. India’s Serum Institute will reportedly price Covishield at US$13
per dose commercially
Also made in India vaccines are more suitable for countries with weak cold chain and
infrastructure facilities. Both the Pfizer and Moderna vaccines must be stored at sub-zero
temperatures whereas both Indian-made vaccines can be stored at between 2 and 8C
degrees

Since the early days of the pandemic, India has been vocal about its commitment to
support global recovery efforts and was one of the first countries to provide food,

30
medicines and essential supplies to countries in South Asia, Africa, and the Indo-Pacific.
At the UN General Assembly in September 2020, Prime Minister Modi expressed India’s
commitment to make India’s vaccine production and delivery capacity available to
“humanity” as it combats the virus. A core and foundational principle of Indian foreign
policy is – Vasudeva Katumbakam or the “world as one family”.

Beyond semantics and altruism, India’s vaccine diplomacy serves as an effective tool and
instrument of Indian soft-power and influence, serving to cement and deepen ties in
India’s neighborhood and Indo-Pacific. India has lobbied for years to secure a seat on the
UN Security Council and has been building ties with smaller developing nations
particularly in the Indian and Pacific Ocean regions. India’s vaccine diplomacy could
translate into critical votes at a time when India has secured a non-permanent seat on the
UN Security Council and is scheduled to host the G20 summit in 2023. The goodwill
India earns through its vaccine diplomacy could pay dividends in the future.

India’s vaccine diplomacy also comes against the backdrop of increased geopolitical
tensions with China. In the wake of last year’s protracted border dispute between the two
countries, Prime Minister Modi emphasized the need for India to be “Atmanirbhar” (self-
reliant) in the production of goods and services and play a more critical role in global
value chains. India’s show of strength in the vaccine race is a powerful expression of this
sentiment. And there are signs that the world is paying attention. At the recent QUAD
leaders’ summit held on 12 March 2021, the US, Australia and Japan acknowledged
India’s vaccine contributions and agreed that India would lead production of Johnson &
Johnson’s vaccine as part of a new QUAD-led vaccine initiative.

India played crucial role in providing the vaccines to the poor and low-income countries
at the crucial times when other countries were hoarding vaccines for themselves.
In a analysis it is found that rich countries have bought doses to vaccinate their entire
populations three times over if all the vaccines are approved of use.
Canada, for example has ordered enough vaccines to protect each Canadian five times,
and when most of the global leader countries refused to share their vaccines in order to
vaccinate their own population first, India has played an exemplary role by providing
vaccine to all over world from January to mid-April, even in the many south-east Asian
countries the first vaccine they received was of Indian origin. It is significant victory for
India, as India vaccine diplomacy has helped soothe some prickly relationships with
neighbors in south Asia “where it has been fighting an increasingly sharp diplomatic
battle with China”

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We can say in the initial phase India ‘s vaccine diplomacy was a quite success as because
many of the countries who received vaccines through India’s vaccine maitri initiative are
very small even it is hard to locate such countries on map and are low-income countries
and it is hard for them to procure vaccines for their population but through India s help
they are able to at least roll out vaccination drive in their countries
+The scale of India’s vaccine gifts is unrivaled. No other country has delivered millions
of free vaccines to other nations — not even China, which has pursued its own vaccine
diplomacy in a bid to repair the damage to its global image from the spread of the deadly
coronavirus from Chinese soil. The gifts help to highlight India’s enormous vaccine-
manufacturing capacity.

What stands out the most about India’s humanitarian gesture is that it was launched just
four days after the country began vaccinating its own citizens, starting with health care
workers. On receiving the first shipment of Indian vaccines, the prime minister of the
Himalayan kingdom of Bhutan called it “altruism” that “precious commodities are shared
even before meeting your own needs.” The overseas vaccine shipments extend from
India’s ambitious plan to inoculate its huge 1.3 billion population in one of the world’s
biggest COVID-19 vaccination drives.

India’s free-vaccine diplomacy, however, has been driven by more than altruism. There
are geopolitical considerations at play, including building goodwill and influence and
countering China’s growing strategic footprint in the Indian Ocean region. Supplying free
vaccines to combat a raging pandemic also seems a better choice for New Delhi than
providing direct aid in another form.
But amid the surge in covid case in April, India witnessed a second wave of covid and
vaccine shortage and because of this central government has put a ban on vaccine export
in mid of April and because of this vaccination programme of several countries in Africa
and in has been put on hold but government may start distributing vaccine again.

INDIA’s VACCINE ROLLOUT

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India began administration of COVID-19 vaccines on 16 January 2021. As of 22 June
2021, India has administered 294,639,511 doses overall, including first and second doses
approved vaccines
Two vaccines received approval for emergency use in India at the onset of the
programme, Covishield-a brand of the Oxford-AstraZeneca vaccine manufactured by the
Serum Institute of India, and Covaxin, which was developed by Bharat Biotech. In April
2021, the Indian government approved the Russian Sputnik V vaccine (which is
distributed locally by Dr. Reddy’s Laboratories) as a third vaccine, which began use in
May 2021.
India began its vaccination program on 16 January 2021, operating 3,006 vaccination
centers on the onset. Each vaccination center will offer either Covishield or Covaxin, but
not both.165,714 people were vaccinated on the first day of availability. Difficulties in
uploading beneficiary lists at some sites caused delays. In the first three days, 631,417
people were vaccinated. Of these, 0.18% reported side-effects and nine people (0.002%)
were admitted to hospitals for observation and treatment. Within those first days, there
were concerns about low turnout, due to a combination of vaccine safety concerns,
technical problems with the software used, and misinformation.

The first phase of the rollout involved health workers and frontline workers including
police, paramilitary forces, sanitation workers, and disaster management volunteers. By 1
March, only 14 million healthcare and frontline workers had been vaccinated, falling
short of the original goal of 30 million.

Second phase

The next phase of the vaccine rollout covered all residents over the age of 60, residents
between the ages of 45 and 60 with one or more qualifying comorbidities, and any health
care or frontline worker that did not receive a dose during phase 1. Online registration
began on 1 March via the Aarogya Setu app and Co-WIN ("Winning over COVID-19")
website. Amid the beginnings of a major second wave of infections in the country,
vaccine exports were suspended in March 2021, and the government ordered 110 million
Covishield doses from SII. The company aims to produce 100 million doses per month,
but by May 2021 its production capacity was only 60–70 million doses.Following the
conclusion of its trial, the DCGI issued a standard emergency use authorization to
Covaxin on 11 March 2021.

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From 1 April, eligibility was extended to all residents over the age of 45. On 8 April,
Prime Minister Narendra Modi called for a four-day Teeka Utsav ("Vaccine Festival")
from 11 to 14 April, with a goal to increase the pace of the program by vaccinating as
many eligible residents as possible. By the end of the Utsav, India had reached a total of
over 111 million vaccine doses to-date.

Third phase, Sputnik V approval

On 12 April, the DCGI approved Russia's Sputnik V vaccine for emergency use in India.
A phase 3 trial had been conducted in the country in September 2020, which showed
91.6% efficacy.[38] The local distributor Dr. Reddy's Laboratories stated that it planned
to have the vaccine available in India by late-May 2021.

On 19 April, it was announced that the next phase of the vaccine program would begin on
1 May, extending eligibility to all residents over the age of 18. Under phase 3, individual
stakeholders were also given more flexibility in how they conduct the vaccine program.
As part of this plan, only half of the vaccines supplied by manufacturers to the Central
Drugs Laboratory would be distributed by the central government. This supply would go
to government-run clinics and be offered free-of-charge to residents 45 and over and
priority workers, and siphoned off to states based on factors such as the number of active
cases and how quickly they are administering vaccines. The remainder would be offered
to individual states and purchased on the open market (including private hospitals), which
would be able to serve residents over the age of 18.

Registration for the next phase began on 28 April; a single-day record of nearly 13.3
million people registered. Due to supply issues, several states, including Delhi, Gujarat
and Madhya Pradesh announced that they would delay their wider rollouts of vaccines to
later in the month. The initial shipment of 150,000 Sputnik V doses arrived on 1 May,
and began to be administered on 14 May. An estimated 156 million doses is expected
between August and December; initially, doses will be sourced from Russia, but domestic
production is expected to begin by August 2021
.
India s vaccination program was full of up and downs as it started its vaccine roll out in
January but the country has gone from a daily average of 3.65 million doses being
administered from April 1 to April 10 to an average 1.8 million doses a day in the month
of May (calculated using data from the Ministry of Health and Family Welfare’s
Cumulative Coverage Reports of COVID-19 Vaccination). The drop in the vaccination

34
rate can be directly attributed to the dwindling supply of vaccines and hesitancy for
vaccine among the population
The two main vaccine manufactures, Serum Institute of India (SII), and Bharat Biotech,
have struggled to meet domestic and global. SII currently manufactures 65 million doses
per month while Bharat Biotech manufactures 20 million doses per month. Both
manufacturers had sought grants of approximately $400 million and $210 million
respectively from the Indian government to increase production capabilities. The
government granted these funds in the form of an advance payment for vaccines to be
supplied in the coming months. However, the decision to do so was made in April 2021,
when India had already been hit by the second wave. SII and Bharat Biotech claim that
they will be able to produce 100 million doses per month and 78.2 million doses per
month respectively starting in August 2021. But even if both companies succeed in
meeting their production targets, it is important to remember that a portion of these doses
will be used to fulfil their international commitments as well.
India has recently seen a devastating second wave of the COVID-19 pandemic, with a
record high of over 414,000 daily cases on May 6, 2021. Although this figure has since
declined

In May, the editors of The Lancet suggested this was partly due to complacency from the
Indian national government. For the editors, “the impression from the government was
that India had beaten COVID-19 after several months of low case counts, despite
repeated warnings from Trusted Source of the dangers of a second wave and the
emergence of new strains.”

“Modeling [falsely] suggested that India had reached herd immunity, encouraging
complacency and insufficient preparation, but a serosurvey by the Indian Council of
Medical Research in January suggested that only 21% of the population had antibodies
against SARS-CoV-2.”

Dr. Manju Rahi, of the Indian Council of Medical Research, and Dr. Amit Sharma, of the
ICMR-National Institute of Malaria Research, both in New Delhi, the authors of the
present opinion piece, highlight the key issues surrounding the failure of adequate
planning and deployment of COVID-19 vaccines.

For Dr. Rahi and Dr. Sharma, “inadequate vaccination planning coupled with suboptimal
pandemic management has led to a large burden of cases and deaths.”

35
Despite this, insufficient production of the vaccines and inadequate planning means the
country has a significant shortfall of vaccines. Currently, only around 12.5% of the Indian
population has been fully vaccinated by June 2.

In response, the country has authorized vaccines that have received authorization in other
countries, even if they have not gone through clinical trials in India
India’s vaccine program is being hobbled by supply shortages and an abrupt shift in
procurement policy. Just months ago, public health experts were counting on India to
play a crucial role in supplying coronavirus vaccines to the world. The government was
so confident of its ability that it allowed more than 60 million doses to be exported or
donated to other countries between January and March
Faced with surging infections, India suspended exports at the mid-April and has begun to
importing Russia’s Sputnik V vaccine to try alleviate the shortfall in local production.
Last week the government acknowledge that vaccine shortages in India will persist at
least until July
Experts have said that much more planning should have gone into sustaining the exports
alongside catering to domestic needs. No advance purchase agreements paced with
manufactures has further augmented the issues of shortages of vaccines to immunize the
national population

Vaccine shortage

The government relaxed after the peak of the first wave, and as the graph went down, the
government thought that the pandemic is over and there were successive statement came

36
from the political leaders, , ministers and health beaurocracy more or less declaring the
victory in war against the coronavirus, but COVID-19 is complacent it stuck us when we
were most vulnerable and the only weapon which we can work against this is vaccines

And India is the global hub of vaccine we produce 60% of the world’s vaccine, but still,
we need to find out how shortfall in vaccine rollout so how did we get into it
We always knew that we have population of 138 crore, so how come we didn’t prepare
so one reason white evidently was that everyone thought , government thought that
pandemic is over we have herd immunity and we can take our time and also the other
thing was that there were confusions – who will pay for it, how much to pay for it, what
should be the budget for it, will it be allowed in private sector or not and everywhere we
will find that decision were taken in last moment we have wasted 6 months in our
preparation for vaccine
When we knew that vaccines are coming and our own country is going to manufacture
the bulk of vaccines, we were not able to secure our own supplies
The first orders that government of India made for vaccines were after the 3rd of January
after emergency use approval use is given whereas on the other hand smarter countries
secured their vaccine supplies much earlier in America even when trials were on billions
of dollars were paid to vaccine manufactures so that they would start producing and doses
would be available to public, their government was proactive in placing orders
In India it took so long it was on January that orders were places whatever stockpiled has
been used but no manufacture has money to increase the production, manufactures said
we can scale up the production but we need money to do this and also government cut the
price so low that for us to scale up production is very difficult
The government has imposed the firm price control and because of these manufactures
were not able to compete in global market
India should be sitting on the top of world just like USA but India didn’t do it. If we look
at UK, UK has proactively booked its supply of both Pfizer and Astra-Zeneca it has
enough vaccine to vaccinate its population 5 times over
Even if we look at Israel, Israel is small country with 1 crore population, it has election
coming up, so what Benjamin Netanyahu did is he went again proactively and bought and
booked as many as Pfizer vaccines at twice of the whatever price is going on at that time.
Maybe he did this to increase his vote bank but aftermath of this is 100% of Israelis are
now vaccinated
And another reason for initial slow pace is Government’s covid policy under which half
of all produced in India went to the federal government and the left over 25% went to
state administration and 25% to private hospitals and due to this we got three different

37
rate of single vaccine in a country which was low for central and comparatively high for
state government

Due to this many states failed to procure vaccines and several states suspended
vaccinations for 18-44 age group because central would have a lot more clout in dealing
with multinational rather than individual states or smaller players directly negotiating
with these companies
And as India fail to vaccinate it population in initial phases, the second wave has done
absolute carnage in India at the peak time India was getting 4lakh cases and daily 4
thousand death which is highest ever in world, the health infrastructure has been
collapsed, hospitals run out of bed, there were massive shortage of oxygen and useful
supplies such as remdesivir injection and medicines and many states witnessed cases of
Black Fungus
As on 21 June under new introduced policy the federal government will now buy
vaccines direct from manufactures and supplies them to state authorities based on their
population sizes, the level of disease, vaccination progress and vaccine shortages
The announcement happened just days after the previous policy attracted criticism from
India's top court. It questioned the rationale behind it as it sometimes led to states paying
more for vaccines than the federal government had to.
Hospitals said a uniform policy has eased the burden of procurement and prices and as
result India s vaccination drive Is again getting pace and recently India vaccinated 8.5
million people in a single day that is second highest in world, as for most of May India
struggled to deliver over 2 million doses a day and beginning June, this is a great
achievement
With rapid vaccination rate we are back on track vaccinating people but still it’s a long
way to go…………...

RESULTS & CONCLUSION

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India start its vaccine maitri program in order to aid poor and middle-income countries
because of India s ability to produce vaccines at cheaper price
India provided vaccine to all over the world to about 95 countries, many countries could
able to start their vaccinate drive just because of India’s timely help
The policy received criticism by pro-government activist regarding that India should
cater its own need first rather that distributing it to world
but still it should be considered more of success than failure, as this put India on map of
global health politics, two years ago, if people were asked which countries would be
crucial in dealing with a pandemic, many would not have mentioned India of course, the
Serum Institute of India was a known entity already
we may yet see India benefit politically. For instance, small island nations may seem to
have little to offer New Delhi, but India has long attempted to engage them
diplomatically, for example seeking support for United Nations reforms.

Key points

 Collaborative Effort: It also includes the joint development of life-saving vaccines and
related technologies, with the major actors typically scientists coming together to work
irrespective of the kind of diplomatic relationship between the participating countries.

 Benefit for India: It could provide innovative opportunities to promote India’s foreign
policy and diplomatic relations between nations in its neighborhood and across the globe.

o India had earlier supplied hydroxychloroquine, Remdesivir and paracetamol


tablets, as well as diagnostic kits, ventilators, masks, gloves and other medical
supplies to a large number of countries to help them deal with the pandemic.

o India has also carried out capacity building and training workshops for
neighboring countries.

 Importance of India’s Vaccine Diplomacy:

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o Earning long term goodwill: By financing shipments from India’s assistance
programs for cash-strapped neighboring countries desperately needing such
assistance, India shall earn the long-term goodwill of its immediate neighbors and
across Indian ocean countries

o It is in line with India’s neighborhood first initiative.

o Advantage over Chinese: China recently offered its vaccines to Nepal,


Afghanistan, Sri Lanka and Bangladesh as it held a multilateral dialogue with the
four countries and Pakistan on anti-epidemic prevention.

o Early shipment from India in these countries helped India in countering China’s
vaccine and mask diplomacy in its neighborhood.

o Leverage over western countries: While the affluent western world, notably
the US and Europe, are focused almost exclusively on their own problems, India
is being appreciated for helping its neighbors and developing countries, who
could not afford US and European vaccines.

o Make India global supply center: Beyond India's immediate neighbors,


South Korea, Qatar, Bahrain, Saudi Arabia, Morocco and South Africa have all
shown inclinations to purchase vaccines from India which is estimated to be 60%
of the global supply of inoculants.

o Boost Pharma Manufacturing in India: India can become the pharmacy of


the world. If Indian vaccines help developing countries to meet their urgent needs,
they can become the future long-term destination for market expansion of Indian
pharma.

o Help in reviving the economy: If India becomes the manufacturing hub to


corona vaccines across the world, it shall give a boost to the GDP of India.

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Rescue from cold war over vaccine:

The US-China cold war has been accused of making distribution of vaccines “political
football”, which caused the inordinate delay in commencing the inoculation programmes
by WHO. Thus, early shipment of vaccines by India is seen as a rescue from this bipolar
tussle.

Earning moral right:

India's vaccine distribution comes at a time when WHO director-General has criticized
moral corruption of drug manufacturers from rich countries for delaying distribution of
vaccines and targeting shipments to rich countries only. This could help India have a
moral right to have greater say in international forums.

Disrupts vaccine nationalism:

Vaccine Nationalism is the mechanism through which a country manages to secure doses
of vaccines for its own citizens or residents and prioritizes its own domestic markets
before they are made available in other countries through pre-purchase agreements with a
vaccine manufacturer.

The major drawback of vaccine nationalism is that it puts countries with fewer resources
and bargaining power at a disadvantage. India’s intervention by making vaccines
available to needy countries disrupted the vaccine nationalism.

Facilitating global collaboration:

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An alliance between western technology and Indian manufacturing capabilities may still
be crucial to produce cheap vaccines for the world

Way Forward

India needs to balance its domestic needs with diplomatic commitments. The vaccination
drive in India commenced in January, 2021 is going to be the World's Largest
Vaccination Program. India has the challenge that while it distributes the vaccine to the
world, it should ensure the much-needed vaccine supply to those in India who cannot
afford it.
Indian representative at UN Syed Akbaruddin said “Vaccine diplomacy needs to be
viewed in a broader perspective and in a nuanced manner, “Pursuing international
cooperation in a calibrated manner is the right thing to have done and is the right thing to
do because other countries are waiting for our success in this. Never has there been in
Indian history an opportunity where 90 countries are waiting for you to produce
something”

Meeting that challenge is a vital national interest. India’s vaccine diplomacy has been a
boon to the country’s aspirations to be recognized as a global power. In combating the
pandemic, it has gone well beyond the routine provision of health care or the supply of
generics. To be sure, it is uncertain whether promoting soft power through health-care
exports significantly boosts a country’s position in the global order. But if and when the
permanent seats at the United Nations Security Council are ever rearranged, grateful
governments will know who has done the most to save a world reeling from the
onslaught of a deadly pathogen.
This could be India’s chance to secure a permanent seat at UN security council………….

BIBLOGRAPHY

 www.indianexpress.com

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 www.mohfw.gov.in
 www.mea.gov.in
 www.medscape.com
 www.bbc.com
 www.project-syndicate.org
 www.thediplomat.com
 www.devpolicy.org
 www.orfonline.org
 www.japantimes.co.jp
 www.medicalnewstoday.com
 www.washingtonpost.com
 www.thehindu.com
 www.theprint.com
 www.who.int
 www.Straitstimes.com
 www.wikipedia.org

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