An editorial headlined “COVID-19 vaccine trials beyond Nigeria’s rhetoric”, in the August 17, 2020 of a national newspaper gushed, “Russia has taken everyone by surprise with its SARS-CoV-2 virus vaccine, already named Sputnik-V. Just after two months, the vaccine has scaled phase three hurdle and President Putin plans a roll out for January 1, 2021.” The article further enthused, “In other countries, it takes as much as five to 10 years to get a vaccine ready.”
First of all it’s misleading to say Russia’s vaccine scaled phase three hurdle. Secondly, vaccines can take between two to 10 years to be approved for use. Russia has no track record of producing vaccines at a supersonic speed.
Since the coronavirus pandemic, emotions have continued to go haywire and clouding reasoning, especially as regards the treatment of the disease. Unfortunately, the media that should report truth are also caught by the coronavirus pandemic emotion bug.
The truth is that Russia breached a major scientific protocol. It prematurely approved a vaccine for use without completing the normal process vaccines undergo before they are considered safe for public use.
There are three phases of a vaccine or drug trial. The vaccine has undergone the first two phases but has not yet undergone the third phase. Yet, President Vladimir Putin has thumped his chest that his country is the “first” to produce a vaccine against the coronavirus.
The vaccine race is now what political leaders want to use for grandstanding, and for some maybe to save their presidency. For one, Americans are not happy with the way President Donald Trump has handled the coronavirus in the US, with elections just around the corner. So, to help his reelection bid Trump has pushed with Operation Warp Speed, to fast track the development of a COVID-19 vaccine. Like Trump, Russians are not also happy with Putin’s handling of the coronavirus. So, he latched on the vaccine to score a political point. It’s like writing an exam with other candidates and telling everyone there that you have finished, while you are still at it.
Russia has not published any paper on the vaccine. The evidence is limited because the scope of usage is small. It could make other countries that are in various stages of development of vaccines to say “If Russia is doing it, we too will do it.” And this could spell doom for the rigorous safety checks vaccines and drugs have to go through before they are used by the general population. According to Reuters, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, Peter Marks, said he will resign if because of the upcoming elections Trump approves a COVID-19 vaccine before it is proven to be effective and safe.
There have been examples of where vaccines went awry. For instance, in 1976, following an outbreak of swine flu in the US, President Gerald Ford said everyone in the country would be vaccinated. But some of those who got the vaccine came down with Guillain-Barre syndrome, which can lead to temporary paralysis.
Similarly, in 2016 the Philippines wanted to vaccinate children against dengue. But it was stopped when they found that the vaccine, Dengvaxia, was associated with a risk of severe disease in some people who were not previously exposed to the disease.
Even for drugs, we can still recall in 1996 when Pfizer tested an unlicensed drug, trovafloxacin (Trovan) to treat children who had meningitis in Kano. Some of the children who took the experimental drug died, some became deaf and mute, and some developed brain damage. Pfizer was sued. After a 15-year legal battle it settled out-of-court, paying out $75m.
A body in Moscow called Association of Clinical Trials Organizations (ACTO), which speaks for the world’s top drugmakers in Russia, advised postponing the approval of the Russian vaccine until the final phase is concluded.
The initial stage of developing a vaccine, involves identification of candidate vaccines. Next is the Pre-Clinical studies stage where animals are used to test the vaccine to see if the vaccine can stimulate immunogenicity, that is, being able to produce an immune response. Many vaccine candidates don’t make it past this stage.
If a candidate vaccine scales this hurdle, an application for investigational new drug is made to the country’s food and drug agency.
If the application is approved the vaccine undergoes three phases of testing with humans. In Phase one, a small group of people is given the vaccine, usually between 20-80. This stage could be non-blinded, that means those getting the vaccine and those giving the vaccine know the vaccine or the placebo.
Phase two involves a larger group of people. They are randomized controlled trials, with a placebo group, usually single-blinded. This means those recruited for the study don’t know whether they are getting the vaccine or the placebo, which could just be saline water. But the researchers know which one they are giving. This is to reduce bias with the study.
If a candidate vaccine scales the second stage, it moves to phase three. Here, tens of thousands of people are recruited for the study. The more people used the better. So that side effects will not be missed. It’s again randomized controlled trial, with placebo, and double-blinded. This means that both the participants and the researchers don’t know who got the placebo and who got the vaccine.
Then there is the Phase four, which is optional. Here the manufacturer can do trials to find out more about the vaccine. Drugs also go through these stages.
To be sure, in the US, FDA in certain cases can issue emergency use authorization which allows unapproved medical products to be used, usually in life-threatening situations. But that has not been the case with Russia’s vaccine. Instead, it went wholesale with the approval of the vaccine as if it has passed through all the safety checks. Less than 100 people have officially received this vaccine.
Some Russians are scandalized by this unsavoury action by the Russian government. For ACTO Executive Director Svetlana Zavidova “The rules for conducting clinical trials are written in blood. They can’t be violated.”
There is an urgent need to find a lasting solution to the coronavirus scourge. But putting politics over health could undermine confidence in the whole process. The media should not make themselves willing agents of propaganda by politicians.
–Dr Cosmas Odoemena, medical practitioner, Lagos