Rush for COVID-19 vaccine shouldn’t be a sociopolitical risk
The Russian vaccine Sputnik V by the Gamaleya Research Institute of Epidemiology and Microbiology recently made global headlines as the world’s so-called first COVID-19 vaccine, drawing outrage from the scientific community over its safety.
The World Health Organization (WHO) has responded that it has not received enough information on Sputnik V and that if Russia wants the WHO’s stamp of approval, it must submit a rigorous review of the vaccine’s safety data.
Typically, a vaccine requires 10 to 15 years of research before it is made available to the general public. However, clinical trials and licensing can be accelerated in cases of emergency such as the COVID-19 pandemic.
According to the WHO, only six vaccines are currently in Phase 3 trials, but none has yet completed them. In addition, the Russian vaccine is only at Phase 1, but the website for Sputnik V says that Phases 1 and 2 were completed last Aug. 1. Unlike Phases 1 and 2, Phase 3 involves a larger population of volunteers and has a longer length of study. It is also designed to determine a vaccine’s longer-term effects.
In the US research for new vaccines, Phase 1 uses 20 to 100 healthy volunteers, with the purpose of evaluating the vaccine’s safety, effectiveness, and dose. Phase 2 involves up to several hundred volunteers, evaluating short-term side effects and how the volunteers’ immune systems respond to the vaccine.
Lastly, Phase 3 uses hundreds or thousands of volunteers, focusing on safety and efficacy, including common side effects. Additionally, Phase 3 compares how people who get the vaccine and people who do not get the vaccine respond.
After Phase 3, the Food and Drug Administration licenses the vaccine only if it is safe and effective, and if the benefits outweigh risks. The US FDA and Centers for Disease Control and Prevention closely monitor vaccine safety after the public begins using the vaccine, to help ensure that possible risks associated with the vaccine are identified.
We should acknowledge that any vaccine being researched can have possible unknown harmful effects, and that these effects may not be fully known until large numbers of people have been immunized. We should not ignore the importance of following firmly established procedures for the development of new vaccines.
It has been reported that Phase 3 for Sputnik V in the Philippines will be simultaneous with Russia’s, and that it is expected to be approved by the Philippine FDA by April 2021. If the Philippines pushes through with Phase 3, it is vital that we have a vaccine advisory committee that will provide definite directions to prevent harmful effects.
Our quest to end COVID-19 should not be a sociopolitical risk, because if it backfires, it’s the poor who will be helpless. This should not be the reason for more people to lose faith in science and become anti-vaxxers who renounce the ability of vaccines to save lives.
Teresa May Bandiola
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