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Sputnik V Covid vaccine: Sputnik V is safe and effective, but some questions remain

Sydney
Russia was the first country in the world to register a vaccine against the coronavirus. Its Ministry of Health urgently approved the Sputnik V vaccine in August 2020. The Russian vaccine was viewed with skepticism by the international scientific community because it was approved a month before the publication of the results of the phase 1 and 2 trials. A growing body of anecdotal data from clinical trials and vaccinations shows the vaccine to be safe and highly effective.

The Sputnik V vaccine raises many questions, such as whether it is associated with the rare blood clotting disease associated with the AstraZeneca vaccine and how well it works against variants of the coronavirus. So what type of vaccine is Sputnik V, how does it work, and what data do we have on it? How does Sputnik V work? Sputnik V was designed by the Gamalaya National Research Center for Epidemiology and Microbiology. It has its own Twitter account which bills itself as “the world’s first registered COVID-19 vaccine” and is approved in 69 countries, including Russia, South Korea, Argentina and the United Arab Emirates.

Asking cells to make spike protein from SARS-CoV-2
Like the Oxford-AstraZeneca vaccine, the basis of the vaccine is a harmless form of adenovirus, one of the many viruses that can cause the common cold. The adenovirus serves as a DNA packaging system to educate our cells. This DNA instructs cells to make a spike protein from SARS-CoV-2. The immune system is then trained to produce an immune response to the spike protein, which provides protection against the SARS-CoV-2 virus. Unlike other adenovirus vaccines, Sputnik V uses two different adenoviruses for the first and second doses.

This is because people can develop an immune reaction against the adenovirus vector used when the vaccine is first injected, which could potentially reduce the overall effectiveness. Two doses are given three weeks apart, instead of the 8 to 12 weeks usually recommended for the Oxford-AstraZeneca vaccine. Sputnik V does not require ultra-cold temperatures like mRNA-based vaccines, making it a major attraction for many vaccine-desperate countries. Unlike some other vaccines, Gamalea is ready to share its manufacturing platform.

No major adverse effects appeared with regard to the vaccine
How well does Sputnik V work against COVID-19? Data from phase 1 and 2 clinical trials were published in September in the prestigious medical journal The Lancet. These data showed no major adverse reactions to the vaccine, and side effects were also common to other COVID-19 vaccines. These were mainly fever, headache and pain at the injection site. Most impressive were the results of a large Phase 3 trial published in The Lancet in February of this year, which reported 91.6% efficacy against infections symptomatic of the disease. This puts Sputnik on a par with mRNA vaccines from Pfizer and Moderna, where the initial efficacy was 95% and 94.1%, respectively.

The results of the phase 3 trial also suggested that even a single dose of Sputnik was protective, with an effectiveness of 79.4%. After some countries approved “Sputnik Lite”, some issues were resolved with the efficacy of a single dose by making a second dose of Sputnik V. Two different cell cultures are needed to produce the two different adenoviruses used in them. first and second doses of Sputnik V. The production of only one type of adenovirus facilitates the production of the vaccine. Beyond these trials, a press release from Gamalea said that a real-world analysis of the vaccine given to nearly 38 million Russians gave 97.6% efficacy against the infection.

“Sputnik V is the most effective vaccine in the world”
On this basis, Gamalea claimed that Sputnik V is the “most effective vaccine in the world”. Despite the encouraging efficacy results, concerns remain. Phase 1 and 2 safety trials and phase 3 efficacy trials not sharing original data or full details of their nature of study, as well as discrepancies in published data, were the subject of of criticism. Sputnik V has not yet been approved by the European Medicines Agency (EMA) or the World Health Organization, which means it cannot be used by Kovax, a global initiative for a vaccine. COVID. Gamalya has yet to provide the EMA with the vaccine manufacturing and clinical data needed to obtain this approval.

What are the unanswered questions about Sputnik V? There are many problems associated with the vaccine. Of particular importance is whether it is associated with the very rare blood clotting disease that has been linked to the AstraZeneca and Johnson & Johnson vaccines, which use the same adenoviral vectors. Gamalya claims that none of the people who received the Sputnik V vaccine were reported to have this. An analysis after 2.8 million doses of Sputnik V in Argentina confirms this. Results announced by Argentina’s health ministry via a press release reported no vaccine-related deaths and mostly mild side effects. And there was no indication of an association between Sputnik V and the disease, even in clinical trials.

decreased ability of antibodies to prevent infection
However, not enough data relating to the actual situation has been released to be completely sure. It is only when these data are published that researchers will be able to draw a conclusion on this subject. It is also not known how well the Sputnik vaccine works against rapidly spreading forms of the disease such as Delta. Some of these types are able to partially evade the immune response generated by COVID vaccines. Research published in July looked at antibodies in the blood of people vaccinated with Sputnik V to see how it behaves against alpha, beta, gamma and delta forms. The ability of their antibodies to prevent infection was found to be reduced.

It is not known how this reduction will affect the vaccine’s effectiveness against hospitalizations and deaths, as we are still awaiting the release of actual data on this. We need more studies that directly compare blood samples from people vaccinated with different vaccines before Sputnik’s claims to be very effective against the variants can be confirmed. We’ll also have to see a real-world analysis of its effectiveness against variants, such as those done with Pfizer and AstraZeneca.

Screenwriters: Megan Stein and Jamie Trikass, University of Sydney

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