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Sputnik V: ‘Approved’ Russian covid-19 vaccine plays health and geo-politics in proportion

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The novel Coronavirus which broke out late 2019 became a global emergency after it was declared a pandemic by the World Health Organisation (WHO) in March, 2020. There have been efforts to provide a cure or vaccine to curb the spread and death rate. One of such efforts is the development of vaccines by various laboratories.

Vaccines reduce the risks of getting a disease by working with the body’s natural defences to build protection. They are tested for safety, immune response, and efficacy by going through different stages of pre-clinical and clinical trials.

Vaccine efforts so far

There are numerous efforts at producing a vaccine for coronavirus. According to the WHO there are 167 vaccine projects underway worldwide. 

The WHO draft document on the landscape of COVID-19 candidate vaccines shows that while 28 of these vaccines are in the clinical stage, 139 are in the preclinical stage

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Credit: World Health Organisation.

Recently, Russian President, Vladimir Putin,  announced that a locally developed vaccine for Covid-19 had been given regulatory approval.

The coronavirus vaccine developed by Moscow-based Gamaleya Research Institute is  being approved for use in less than two months of testing on humans. 

The Economic Times reported that Kirill Dmitriev, head of Russia’s sovereign wealth fund, said the vaccine will be marketed under the name “Sputnik V” in foreign markets.

Russian healthcare minister, Mikhail Murashko, said that the experimental vaccine would be given first to healthcare workers and teachers, and then gradually rolled out to the rest of the population. This announcement has come disregarding the WHO’s caution and experts scepticism.

Vaccine Production procedure

Vaccine development is a long and complex process that takes 10 to 15 years with public and private involvement, but with the urgency of this virus, experts think a vaccine is likely to become widely available by mid-2021.

 The Centre for Disease Control and Prevention listed six stages vaccines go through. These stages are: exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing, and Quality control.

Looking at the history of Vaccines, the first stage in vaccine development and testing is the exploratory stage. This stage involves basic laboratory research followed by Pre-clinical studies where tissue-culture or cell-culture systems and animal testing is done to assess safety and immunogenicity, or ability to provoke an immune response.

This is followed by an Investigational New Drug (IND) application which describes the vaccine, its purpose, and process while seeking approval.

If this is approved, the vaccine goes into clinical studies where it is subjected to three phases of trials. The first trial phase  assesses the candidate vaccine in humans. This is done with a small group of adults, usually from 20-80 subjects.

The second phase is done with more subjects in hundreds to study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.

Phase three trial is done on thousands of subjects to assess vaccine safety in a large group of people.

After these trial phases, the vaccine is turned in for approval and licensing. Even after licensing, there is the post-licensure monitoring of the vaccines. Here we have the phase four trials, the Vaccine Adverse Event Reporting System (VAERS), and the Vaccine Safety Datalink (VSD).

Verification: Has Sputnik V passed all stages?

The Sputnik Vaccine developed by the Moscow-based Gamaleya Institute, with funding from the Russian Direct Investment Fund (RDIF) is referenced to the 1957 Soviet Union satellite.

Although scientists have conducted months of human trials, no data has been released aside from studies shared on the government’s Vaccine site. Russia claims the vaccine has passed through Phase 1 and Phase 2 trials which were completed on August 1.

The vaccine which did not go through Phase 3 (which usually precedes approval) was announced as an approved vaccine on Tuesday, August 11, 2020 by Russia’s president after receiving a registration certificate from the Russian Ministry of Health.

The commencement of phase three trial which involves thousands of subjects commenced Wednesday, August 12, 2020 after the announcement. This phase is being carried out in Russia and several Middle Eastern and Latin American countries. Mass production of the vaccine is expected to start in September 2020.

What are experts saying?

Aside from the caution by the WHO, Dr. Paul Offit, an infectious disease physician and director of the Vaccine Education Center at Children’s Hospital of Philadelphia says scepticism is reasonable.

“I think it’s reasonable to be skeptical about a vaccine that doesn’t exist yet to prevent a virus that has been elusive and difficult to characterize.” 

Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins University observes,

“I think it’s really scary. It’s really risky.” 

The WHO spokesperson, Tarik Jasarevic, during a United Nations briefing in Geneva about clinical trials said prequalification includes rigorous review:

“We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine, but again prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data.”

In summary, although vaccines are developed, tested, and regulated in a similar manner to other drugs, vaccines are more thoroughly tested than non-vaccine drugs because the number of human subjects in vaccine clinical trials is greater. 

Though reports and evidence available from the WHO listed the Gamaleya institution vaccine under the 28 candidate vaccine in clinical evaluation; however, it is currently in stage two and has not gone through phase three trial (large subject testing). Additionally, the statement of Kirill Dmitriev, the head of the Russian Direct Investment Fund, that  “Russia will go ahead with Phase 3 trials”  confirms this.

Conclusion

So far, the Russian vaccine process falls short of the standard procedure for developing and testing a vaccine. The Vaccine has also not received the WHO stamp of approval. The WHO has stated clearly that it will not give its approval to any vaccine until rigorous safety data review is done.

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