C O V I D -19 Vaccines

Evaluation and Selection

Nina G. Gloriani, MD, PhD

Chair, DOST Vaccine Expert Panel for COVID19
Member, WHO Scientific Steering Committee for COVID19 Solidarity Vaccines Trials
Former Dean, College of Public Health, UP Manila

Townhalls - April 2021

OUTLINE of Presentation
• Vaccine Development, Evaluation, Selection and Approval Processes
• COVID19 Vaccine Platforms
• The Vaccination Process
- Evaluation of SAFETY, IMMUNOGENICITY, EFFICACY
- Implications of virus variants
• FDA Clinical Trial and EUA Approvals
• Key Messages  BIDA + Bakuna
 COVID19 Vaccine Development, Evaluation, Selection
and Approval Processes

FDA

Whole virus vaccine or subunit vaccine based on spike antigen Assurance of safety, immunogenicity, efficacy
 COVID19 VACCINE TYPES/ PLATFORMS
SPIKE- BASED VACCINES:
1. Viruses used as vectors or
WHOLE VIRUS carriers of genetic sequence
vaccine: coding for SPIKE antigens
- Adenov carrying DNA
1. Inactivated or killed virus sequence of SPIKE:
via physical (UV) or chemical Astra Zeneca, Janssen,
Means : Sinovac, Sinopharma, Gamaleya or Sputnik V
Bharat Biotech
2. DNA Vaccine- sequence
DNA codes for SPIKE antigen:
Inovio and Anges-Osaka
2. Live attenuated or
Weakened virus
3. mRNA vaccine – sequence
codes for SPIKE antigen:
Pfizer and Moderna
RNA

5. Synthetic peptides
corresponding to
4. Spike protein antigen produced by
sequences of SPIKE recombinant DNA technology:
antigen Novavax, Clover, Anhui-Zhifei
The Vaccination Process: How do we react to the
vaccines? The body reacts to the
vaccine and produces an
Choose a vaccine Inject the vaccine immune response
into a healthy person

 Safety
 Immunity
 Efficacy
(Protection)
How do we determine which vaccine is SAFE?
Safety: side effects, adverse events, reactogenicity
• Pain at injection site
Local side effects
• Redness or inflammation at
injection site
• Rashes, itchiness
• Fever
Systemic side effects
• Headache
• Fatigue
* Mild, moderate, severe • Nausea/ vomiting
* Expected vs Unexpected side effects • Dizziness
* Common or rare side effects (Rare: severe allergy) • Muscle aches
* Serious adverse events, Adverse events of special interest • Other SEs

 Determine Causality:
Are side effects due to the vaccine?
or caused by other conditions NOT related to vaccine?

 BENEFITS of Vaccine must outweigh risks/ side effects

 HOST
CELL

Antibodies against spike

neutralize the virus,
 Virus not able to bind cell,
therefore, no infection
Dosage requirements for Vaccines
• Number of doses required for primary immunization:
- One dose may provide enough immunity and afford up to 70%
protection
- Two doses used in most clinical trials yielded higher levels of binding
and neutralizing antibodies
• Spacing between doses:
- Could be 2, 3, 4 weeks up to 12 weeks apart: different vaccines used
different schedules; usually, the best interval is at least 4 weeks apart to give
more B cells time to produce more antibodies

• Need for booster doses after primary series:

- depends on duration of immunity –months or years; if short-lived
immunity…will need boosters like flu vaccines
 VARIANTS of CONCERN as of April 9, 2021 P.3 currently Not a Variant of Concern

Mutations in
other parts of
the virus may
also have
some
biological
effects
Nag babagong anyo ang virus  variants   

Resulta ng mutation or variants: Philippine data as of April 9, 2021:

 Mas madaling makahawa (mutation at N501Y)
 Or Mas mababang proteksiyon sa bakuna :
Vaccine efficacy against original virus: 70-95%
South African variant ~ 50-60% (mutation at E484K)
UK variants: 392 cases, South African variants: 344 cases
Brazil variant P.1: 2 cases
P.3 variant from the Philippines: 123 (not VOC)
FDA Approved Vaccines in the Philippines
• As of February 3, 2021 three independent Phase III Clinical Trials have
been approved by FDA: Janssen Clover Sinovac

• FDA approved EUA applications [Only Vaccines with EUA from other countries (SRAs)
with interim Phase III CT results are evaluated for EUA in the Philippines]
Pfizer (January 14, 2021) Astra Zeneca (January 28, 2021) SINOVAC (February 22, 2021) Gamaleya–Sputnik V(March 19, 2021)

Under Evaluation as of April 8, 2021: Bharat Biotech inactivated Vaccine and Janssen adenovirus26-spike vaccine
 Key Messages
• We now have 4 FDA approved COVID19 Vaccines under EUA.
• These vaccines passed the stringent process of evaluation for safety, efficacy,
immunogenicity and other data from various phases of vaccine development, using WHO
Criteria and international standards.
• In addition to the original SARS-CoV-2 virus, we also now have its variants, causing the
current surge in COVID19 cases
• We could control the spread of COVID19 cases and infection if enough people (70-80% of
the population) are immune to the virus  HERD or COMMUNITY IMMUNITY
 The emergence of virus variants will require updating of the vaccine antigens
 Second generation vaccines to include prevalent SARS-CoV-2 variants
 Possibility of multivalent COVID19 vaccines will be needed in the future
 But more importantly, we need to keep COVID19 transmission DOWN: practice
Minimum Public Health Standards * STOPPING THE SPREAD at the SOURCE IS KEY!
 COVID19 : Let’s help end the Pandemic !

Tamang pagsunod
sa public health
standards

Protect yourself, your family, your neighbors, the whole community