Sputnik V Vaccine Update in India

Sputnik V Vaccine Update in India

The Russian vaccine Sputnik V is an adenovirus-based vaccine developed against coronavirus developed by Gamaleya National Research Centre and manufactured by the Russian Direct Investment Fund (RDIF). 

The vaccine is named after the first artificial Earth Satellite called Sputnik-I launched by the Soviet Union and is the first vaccine that is approved for use in the population.

The vaccine is approved by the Russian government for use by soldiers of the People's Liberation Army.

In Early 2014 Gamaleya National Research Centre developed the Ebola vaccine followed by the development of the Middle East Respiratory Syndrome (MERS) vaccine in 2018.

In February 2020 Gamaleya National research center started work on the SARS-COV-2 vaccine called Sputnik V.

By the 3rd of August Phase 1 and Phase 2 clinical trials were completed on human subjects and the vaccine was registered in Russia on 11 august 2020. By the end of the august post-registration multinational Phase, 3 clinical trials were conducted on over 44,000 volunteers.

After the completion of phase 3 clinical trials by September mass production of the vaccine was started and by the end of the year 2020, the vaccine was supplied around the world.


Ingredients
The main active ingredient of the Sputnik V vaccine is modified replication-defective adenovirus of different serotypes like Serotype 26 for the first component and serotype 5 for the second, which has been modified by including the protein S-expressing gene of SARS-CoV-2.

The other active components of the vaccine are:
1. Tris-(hydroxymethyl)-aminomethane
2. Sodium chloride
3. Sucrose
4. Magnesium chloride hexahydrate 
5. Disodium EDTA dihydrate
6. Polysorbate 80
7. Ethanol
8. Water

Mode of Action

The vaccines do not contain live human adenovirus it contains dead or weak adenovirus that cannot multiply in the body. The vaccine contains two different adenoviruses called rAd26 and rAd5.

The vaccine produces an immune response against the virus by producing antigen-specific cells that are T-lymphocytes: T-helper (CD4+) and T-killer (CD8+) which in turn generates  IgG antibodies in the body against SARS-COV-2.

Efficacy of vaccine 

Initially, either rAd26 or rAd5 adenovector of the vaccine is administered to the individual followed by administration of rAd5 after 21 days or rAd26 after 5 days respectively and then the polymerase chain reaction is completed for determination of the efficacy of the vaccine on the test group and placebo group

. It was seen that the vaccine was 91.4% efficacious in the treatment of the SARS-COV-2 virus but not in the serious condition of the patient.

Sputnik V Cost

One-Dose of Sputnik V costs 10 dollars and it is a 2 dose vaccine costing 20 dollars to an individual.


Dose and Mode of Administration

Sputnik V is a two-dose vaccine in which initially either rAd26 or rAd5 adenovector is administered followed by administration of the second dose of the adenovectors that is rAd5 after 21 days and rAd26 after 5 days. The vaccine is administered intramuscularly.

Pharmaceutical Form
The vaccine has two types of formulations:
1. Frozen that is storage temperature must be −18 °C or 0 °F or lower
2. Lyophilized form
The frozen form is the have large-scale production as it is cheap and is easy to manufacture while the production of lyophilized form is expensive and time-consuming but its transportation is easy as compared to frozen form. 

Side Effects of vaccine 

Sputnik V produces following side effects: 

For Frozen vaccine 
1. Grade 1-2
Headache in 55% population
Fever in 100% population 
Muscle or joint pain in 25% population
2. Grade 1-3
Fatigue is not reported 
3. Severe Adverse effects in 0% population       
  
For Lipophilized vaccine 
1. Grade 1-2
Headache in 25% population
Fever in 35% of population 
Muscle or joint pain in 30% population
2. Grade 1-3
Fatigue is not reported 
3. Severe Adverse effects in 0% population            

Indications

It is approved for emergency use on the population >= 18 years of age to prevent them against the SARS-COV-2 virus.


Contraindications

4. If the patient experienced allergy due to the initial dose of the vaccine.
5. If the patient experienced any kind of allergy due to any ingredient of the vaccine.

Special Population

1. Thrombocytopenia and coagulation disorders
Patients suffering from thrombocytopenia, coagulation disorder, and are on anticoagulant therapy should avoid getting the vaccine as it can lead to bleeding after the intramuscular administration as appropriate data is not available.

2. Immunocompromised individuals
The patients who are who have low immunity or weak immune system or the patients who are on any immunosuppressant therapy like in organ transplantation should avoid getting vaccinated as the safety and efficacy of the patients are not established yet.

3. Pregnancy and Breastfeeding
Pregnant or breastfeeding females should not be vaccinated as the effect of the vaccine on newborn babies and the fetus is not established.

4. Concomitant vaccines
The individuals who are administering Sputnik V should not get vaccinated with another vaccine as data on concomitant use of other vaccines is not known.

5. Elderly and Pediatric Population
The safety and efficacy of the vaccine are studied in the older and younger population so they should avoid being vaccinated as they have a weak immune system.
             

Case Report

A systematic cohort study was performed on health care professionals at Italiano de Buenos Aires Hospital by vaccinating them with the Sputnik V vaccine to determine its safety, efficacy, and Local or systemic side effects on health care workers. They calculated the Incident rates per 1000 person-hours b based on age groups and gender.

The study concluded that 707 health care workers were vaccinated with a response rate of 96.6%. Out of these 707 health care workers, 71.3% reported at least one Events Supposedly Attributed to Vaccines and Immunizations (ESAVI) with the rate of 6.3 per 1000 person/ hour. Amid local side effects, 40% reported fever, 5% diarrhea, and 68% new or worsened muscle pain while 5% of health care workers had serious adverse events that required immediate attention.

Amid Systematic adverse events, 40% reported fever, 5% diarrhea, and 68% new or worsened muscle pain. Females (65.4%) and younger (72.8%) health care workers that are below 55 years of age reported higher Events Supposedly Attributed to Vaccines and Immunizations (ESAVI).

Effect of Sputnik V on SARS-COV-2 Variants

Due to the emergence of SARS COV-2 variants, the safety and efficacy of the vaccine are being affected. This is due to the continuous spread of the virus in a large population that there is mutation or changes in the DNA or genetic makeup of the virus. Due to changes in the DNA of the virus, there is an increased chance that the efficacy of the Sputnik V vaccine on the virus decreases. This can also lead to a decrease in the immunity or immune response against SARS COV-2. This is the reason different vaccines are needed to be developed for every variant of the virus.

Sputnik V in India

Many countries are interested in the Sputnik V vaccine and India is also included in these countries. India has partnered with the US for the production of the Sputnik V vaccine and the approval is given by Central Drug Standard Control Organization (CDSCO) hence CDSCO can approve of Russia for the phase 2 and phase 3 clinical trials on the Indian population.
CDSCO can also give authorization for vaccine use in emergencies without late-phase trials. Serum Institute of India which is the world's largest vaccine manufacturer has a partnership with Russia for mass production of the vaccine on large scale.

Concluding note 

This can be concluded at the end that Sputnik V is the first authorized by the Russian government for emergency use in COVID-19 treatment. It has various indications, contraindications, and side effects which are to be kept in mind before administering vaccines. Over 44,000 people were involved in Sputnik V clinical trials worldwide, it is also seen that countries that have over 50% of the population have an interest in the Sputnik V vaccine and over 1 billion people are vaccinated by Sputnik V in 2020- 2021.