Emerging Life Sciences Series

Defining Your Target Product Profile: Therapeutics

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1. Indications and usage

Target Annotations

Most methicillin-resistant staph aureus

Methicillin-resistant staph aureus vaccine. (MRSA) infections are healthcare-associated,

They are used to prevent methicillin-resistant almost 60 percent on community-onset and

staph aureus bacteria from progressing into about 25 percent hospital-based. MRSA in

chronic infection stages in the body. the USA, for instance, has become a major

This vaccine targets patients infected with health concern remaining the primary

Staphylococcus aureus bacteria. nosocomial infection in most hospitals (Lee et

Target patients are those with serious al., 2018). Recently, the bacteria are shown to

underlying infections like persons suffering be very lethal in correlation with covid 19

from underlying disorders and are more disorders.

frequently hospitalized and those participating

in a contact sport. These groups are known to

be in the frontline in acquiring staph aureus

bacteria. Unfortunately, they are prone to the

methicillin-resistant species of bacteria.

Comments:

The drugs presented for treatment of the methicillin-resistant staph aureus include;

vancomycin, daptomycin,telavancin, and ceftaroline. These drugs, however, prove to

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be quite expensive than our vaccine product. Moreover, the vaccine is a one-time

injection, whereas the drugs are continual uptakes and may impact the body system.

2. Dosage and administration

The proposed dosage of the vaccine is

The vaccine is administered through approved for the immune system's normal

intravenous injection. attention (Jabaal et al.,2021). Intravenous

0.5ml of the vaccine is required for an injection is the tested safest method deployed

effective vaccination pact. by the health community in administering

It takes 3-4 months for a subsequent vaccine vaccines. For instance, the Covid 19 vaccine is

injection following the first vaccine administered through intravenous injection,

administered. where it interacts with the T cells and raise

Three subsequent dosages are effective for the immunity against possible attack.

mitigation of the bacteria.

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Comments:

Current vaccine admittance and acceptance rates require most vaccines to follow the intravenous

injection method. Many vaccines prefer the vaccine mode since it is absorbed and takes action

immediately due to direct interactions with the immune cells.

3. Contraindications

Target Annotations

Expectant are leveraged for taking this vaccine. Supply a summary of completed or planned

This is due to possible autoimmune reactions studies that support the target. Alternatively,

that may occur with the unborn children hence include literature references describing

becoming congenitally lethal. contraindications for the drug class.

Vaccines are weakened forms of pathogens.

For staph aureus, once the vaccines get into

the body system, they are recognized as

unique antigens; hence the body immunity

produces antibodies against the intruding

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antigens; in an unborn child, this can set a

cascade of trans-placental reactions that can

harm the unborn child.

Comments:

The counter-indications have been seen more often in the health community. Certain cancer

therapies have been congenitally harmful to the unborn in patients undergoing chemotherapy.

The therapies have led to deaths and immunological reactions that lead to children with

disorders.

4. Adverse reactions

Target Annotations

The vaccine may cause immunological According to an article by Moorlag et al.,2019

reactions in the body, leading to the death major side effects of vaccines include soreness,

of unborn whose immunity is still low. swelling, rash, fever, achiness, or even life-

The drug class is associated with chronic threatening allergic reactions within 2-4 days

immunological reactions and death in administration. Encephalitis, serious eye

severe cases. infections, and ultimate deaths result from a

In clinical studies, vaccines' adverse vaccination as well.

effects include tiredness, headaches,

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anxiety, muscle pains, and nausea.

Comments:

The virus has resisted current drugs for ages; due to more antibiotics uptake, severe liver

diseases have been observed due to the overwhelming detoxification role. Moreover, the

body immunity does not respond well to other treatments after it is exposed to several

intakes of antibiotics rendering the immune system compromised.

5. Clinical pharmacology

Target Annotations

The vaccine works by generating memory Vaccines are weakened forms of the pathogen

B-cells which recognizes the pathogen that create an immunity awareness of an

antigen in the next reaction. An antibody impending intruder (Vetter et al.,2018). They

clearing mechanism is hence created for a wake the and prepare the fight cells for an

future attack. impending pathogenic intruder.

The drug would require 12-24 hours to

integrate into the body systems and organs.

The first vaccine receptors are the cell

membrane, where careers infuse the

vaccine inside the body. The vaccine

moves to the lymphatic vessel, setting the

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memory B- cells active by producing an

antibody against the virus. The vaccine is

distributed in all body parts by the lymph

fluids plus the communication channels

found between the cells.

Once the drag is in uptake, it takes an

amount of 3-4 months of activity. After

that, a new dosage is taken.

The liver does the detoxification role by

clearing the drug. Drug debris constituting

the weak form of the pathogen is liberated

by phagocytic actions and lysis. It is

afterward removed along with uric acid or

fecal matter.

Comments:

Current treatment is bond to internal damage of the liver. They are not very supportive in

clearing the methicillin-resistant strain of the virus. Creating an immune awareness is the

ultimate choice in dealing with the bacteria since it prepares the body for current and next
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attacks.

6. Nonclinical toxicology

Target Annotations

Most of the drug constituents are plant The drug has involved the incorporation of

phytochemicals and are less expected to certain phytochemicals with no harmful

cause any bodily harm. Moreover, the drug effect on the body system. The

has complied with the drug acts and phytochemicals are usually part of the human

regulations to ensure that it can implicate no vegetative diet, and the only difference is the

cytocidal damage on humans. concentration purposefully for eradicating

The maximum allowed dosage in humans is the bacteria.

about 7mm to 10 mm in one injection. These

are the ranges with no negative effects.

In human beings, a safer starting dosage is

set to be 5mm for a single dosage.

Just like other drugs, the long-term effects

include paralysis and serious brain

encephalitis. The long-term effects, however,

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only arises from misuse.

Comments:

Nonclinical toxicology may arise from the bacteria's uptake from food substances or any

community mode of infection. In a hospital setup, however, the bacteria is a nosocomial

infection acquired due to hospitalization. In the hospital setup, however, the methicillin-

resistant strain is dominant.

7. Clinical studies

Target Annotations

The drug has undergone several clinical In any selected population, the drug's

trials and has been tested and proved to be significance has been tested and proved to be

efficient. at 0.01 fail probability. With more research

At all levels of significance of about 99%, in the study, the drug will be established as

the drug is regarded as significant in killing the most preferred in its common side

the pathogen. effects.

The drug has a higher safety profile of one

harm in a population of hundred successes.

The endpoint of the research study reveals

that continual uptake of antibiotics has

caused liver damage; furthermore, increased

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uptake of the antibiotics has created

resistivity. This vaccine, therefore, comes in

the service the two major challenges.

Comments

This drug proves more efficient because apart from dealing with bacteria causing the health

menace, it provides healthy bodily interactions. It has no many side effects especially related

to the liver. Finally, it targets the body's immune system's primary role by using its network

to generate a shield.

Reference

Lee, A. S., de Lencastre, H., Garau, J., Kluytmans, J., Malhotra-Kumar, S., Peschel, A., & Harbarth,

S. (2018). Methicillin-resistant Staphylococcus aureus. Nature reviews Disease

primers, 4(1), 1-23.

Jabal, K. A., Ben-Amram, H., Beiruti, K., Batheesh, Y., Sussan, C., Zarka, S., & Edelstein, M.

(2021). Impact of age, ethnicity, sex, and prior infection status on immunogenicity

following a single dose of the BNT162b2 mRNA COVID-19 vaccine: real-world

evidence from healthcare workers, Israel, December 2020 January 2021.

Eurosurveillance, 26(6), 2100096.
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Moorlag, S. J. C. F. M., Arts, R. J. W., Van Crevel, R., & Netea, M. G. (2019). Non-specific effects

of BCG vaccine on viral infections. Clinical microbiology and disease, 25(12), 1473-

1478

Vetter, V., Denizer, G., Friedland, L. R., Krishnan, J., & Shapiro, M. (2018). Understanding modern-

day vaccines: what you need to know. Annals of medicine, 50(2), 110-120.