Russian coronavirus vaccine is not well tested, and approving it now risks side effects and false protection

on Tuesday, Vladimir Putin announced Russia was the first country to register a vaccine providing “sustainable immunity” against the virus that causes COVID-19, SARS-CoV-2.

Developed by the Gamaleyea Institute in Moscow, registered with the Ministry of Health of Russia and approved for emergency use only.

However, there is concern that it will soon extend well beyond emergency use to the entire Russian population. This prompted discussion about “competition” for the COVID-19 vaccine.

Speed ​​is important, but ensuring that the vaccine is effective and safe is much more important. The consequences of exhausting a potentially dangerous and ineffective vaccine can be widespread.

No test data available

Gamaleyah Institute Announced Registered the SARS-CoV-2 vaccine with the Russian Ministry of Health, a local regulatory agency that determines the drugs that can be used in Russia. This vaccine is called “Sputnik V” Emergency use approved.. Emergency use approval generally means that you can provide vaccines to people at a very high risk of infection, such as healthcare professionals, but not to the general public.

Lab was formerly Registered this vaccine for Phase I/II trials Initially there were only 38 (to assess human safety and immune response). Russian senior official Said This trial evoked a strong immune response with no “serious complications”. From the data released, this is not so surprising Human clinical trials Other similar vaccines have shown Strong immune response and no serious complications..

However, the data from the Sputnik V trial is not publicly available, and the vaccine is not viable because Phase III trials (thousands of volunteers showing efficacy and need to detect rare side effects) have not been conducted. There is no data that indicates protection against. It was executed.

Institute did Announce Phase III Trial Because Sputnik V will start in Russia and some other countries on August 12. However, many scientists (including Russian researchers) concern Vaccines will soon be used in large commercial vaccination campaigns, but emergency approvals usually do not.

What is the risk

Returning to the “race” analogy, we should stop thinking of vaccine development as a 100-meter sprint. Instead, think of it like a pentathlon. In the Pentathlon, each section completed by a player contributes to the overall score and cannot be overlooked. Trying to run this race against COVID-19 without each section can result in a vaccine that has not been properly tested, which can be unsafe and unethical. And we all lose.

The risk of going on a large-scale vaccination without proper testing is significant. If the vaccine is released but has side effects, the consequences include both health effects and a loss of trust from our community. If a vaccine does not protect an individual from infection, vaccinated people can mistakenly believe that they are protected.

A series of clinical system trial It’s often designed in difficult lessons to avoid oversight and build critical data on vaccine safety, immunity, and protection.

So Said US Secretary of Health and Welfare Alex Hazard: “The important thing is not to get the vaccine first. To get a safe and effective vaccine for Americans and the world.”

Development takes time and you need to realistically address your timelines and expectations.

Vaccine testing is strict

When the country considers introducing a vaccine, Examine the following information:

• How safe is the vaccine?
• How well does the vaccine work?
• How serious is the disease that the vaccine prevents?
• How many people will get sick if we don’t have a vaccine?

This information is Phases of clinical trials (Phase I, II, III), With a particular focus on vaccine safety at each step. The development of this information package can take several years, but the timeline may be condensed.

For example, the Ebola vaccine test Condensed in 5 years Due to the urgent need for vaccines in the midst of the ongoing epidemic. Despite this urgency, each clinical trial phase was still complete.

Phase III clinical trials are particularly important in assessing the safety of a large group of people, as early small trials may not identify certain rare side effects. For example, if only 1 in 10,000 vaccine-related side effects occur, the study Enroll and detect 60,000 volunteers..

Vaccines are generally more thoroughly tested than any other drug. Because we vaccinated healthy people, safety is a top priority, and because we administer vaccines to a large number of people, we need to identify rare side effects.

What’s in this vaccine?

This type of vaccine Virus vector.. Viral vectors trick the immune system with bait and switch. Take a harmless virus, modify it to be non-replicating and include a target from the surface of the SARS-CoV-2 virus. of vaccine The immune response is relatively strong, targeting SARS-CoV-2, because it appears to be a dangerous virus to the immune system, but the virus cannot cause disease.

Sputnik V is unusual because it uses two different viral vectors called “prime boost” one after another. Initially called Ad26, this is COVID-19 vaccine under development by Johnson & Johnson, The second is called Ad5 and this is COVID-19 vaccine under development by CanSino Biologics.. This prime boost is relatively powerful Immune reaction, But we certainly don’t know.

Viral vectors are also a relatively new technology. Although there are numerous large clinical trials with HIV, malaria, tuberculosis and Ebola viral vectors, Only one ebola Until now, it has been approved for use by the general public.

This article is reissued from conversation Under Creative Commons license. Read Original work..