The Russian vaccine Sputnik V is an adenovirus-based vaccine developed by Gamaleya National Research Centre and manufactured by the Russian Direct Investment Fund to protect against coronavirus (RDIF).
The vaccine is named after the Soviet Union's first artificial Earth satellite, Sputnik-I, and is the first vaccine to be accepted for use in the general population.
The vaccine has been authorised by the Russian government for use by People's Liberation Army soldiers.
The Ebola vaccine was developed by Gamaleya National Research Centre in early 2014, followed by the Middle East Respiratory Syndrome (MERS) vaccine in 2018.
In February 2020, the Gamaleya National Research Center began developing Sputnik V, a SARS-COV-2 vaccine.
Phase 1 and Phase 2 clinical trials on human subjects were completed by August 3rd, and the vaccine was registered in Russia on August 11th, 2020. Three clinical trials involving over 44,000 participants were completed by the end of the August post-registration multinational Phase.
By September, after phase 3 clinical trials were completed, mass development of the vaccine had begun, and by the end of 2020, the vaccine will be supplied around the world.
Efficacy of vaccine
Initially, the person receives either the rAd26 or rAd5 adenovector of the vaccine, which is accompanied by administration of rAd5 after 21 days or rAd26 after 5 days, respectively, and then the polymerase chain reaction is completed to determine the vaccine's effectiveness in the test and placebo groups.
The vaccine was found to be 91.4 percent effective in treating the SARS-COV-2 virus, but not in treating the patient's serious condition.
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.
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 Lyophilized 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 with thrombocytopenia, coagulation disorders, or who are on anticoagulant medication should stop having the vaccine because there isn't enough evidence to know whether it can cause bleeding after intramuscular administration.
2. People with weakened immune systems
Patients with poor immunity or a compromised immune system, as well as those on immunosuppressive therapy, such as those undergoing organ transplantation, should avoid getting vaccinated because the vaccine's protection and effectiveness have yet to be determined.
3. Breastfeeding and Pregnancy
Females that are pregnant or breastfeeding should not be vaccinated because the vaccine's effect on newborn babies and the foetus is unknown.
4. Vaccines given at the same time
Individuals administering Sputnik V should not get vaccinated with another vaccine since there is no data about the use of other vaccines at the same time.
5. Elderly and Pediatric population.
Since the vaccine's protection and effectiveness are being tested in older and younger people, they should stop getting vaccinated if they have a weak immune system.
Effect of Sputnik V on SARS-COV-2 New & Mutant Variants
The vaccine's safety and effectiveness have been harmed as a result of the development of SARS COV-2 variants. This is due to the virus's ongoing spread in a large population, which has resulted in mutations or changes in the virus's DNA or genetic composition. Due to shifts in the virus's DNA, there is a greater risk that the Sputnik V vaccine's effectiveness against the virus will wane. This may also result in a reduction in SARS COV-2 immunity or immune response. This is why different vaccines must be formulated for each virus variant.
Sputnik V in India
The Sputnik V vaccine has piqued the interest of a number of countries, including India. India has partnered with the United States to produce the Sputnik V vaccine, which has been approved by the Central Drug Standard Control Organization (CDSCO). As a result, CDSCO can approve Russia for phase 2 and phase 3 clinical trials in India.
Without late-phase trials, the CDSCO may also approve vaccine use in an emergency. The world's largest vaccine producer, India's Serum Institute, has partnered with Russia to mass produce the vaccine on a wide scale.
Concluding note
At the end of the day, Sputnik V is the first COVID-19 treatment device authorised by the Russian government for emergency use. There are a variety of warnings, contraindications, and side effects to be aware of when prescribing vaccines. Over 44,000 people took part in Sputnik V clinical trials around the world, and countries with populations of over 50% are showing interest in the vaccine. In 2020-2021, over 1 billion people will be vaccinated with Sputnik V.
More FAQs by Dr. Rashi Bahuguna
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