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Hundreds of doctors have asked the FDA not to rush—or politicize—a coronavirus vaccine

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Hundreds of doctors have asked the FDA not to rush—or politicize—a coronavirus vaccine

“There’s only one thing more dangerous than a bad virus, and that’s a bad vaccine,” Dr. Mike Ryan, executive director of WHO’s health emergencies programme, said in March. “We have to be very, very, very careful in developing any product that we’re going to inject into potentially most of the world population.”

Since the beginning of the pandemic, experts have said that developing a vaccine and getting it through the necessary safety and efficacy protocols would take, at minimum, 12 to 18 months. Yet here we are, 7 months in, and Vladimir Putin has just announced that Russia has already approved a vaccine for the coronavirus.

According to the BBC, there are more than 100 vaccines in various stages of development and testing. Six of those have reached phase 3 trials, involving more widespread testing in humans. Russia’s vaccine is not among those six.

Meanwhile, hundreds of U.S. doctors have signed a letter urging the FDA not to rush or politicize vaccine trials.


“We are experts in virology, epidemiology, vaccinology, infectious disease, clinical care and public health,” the letter opens, before declaring the “urgent” need for a COVID-19 vaccine. “We are committed to promoting the broad uptake of safe and effective COVID-19 vaccines. The need is urgent but all vaccines must be rigorously studied to determine whether their benefits exceed their risks.”

The letter expresses concern that public confidence in a vaccine will be greatly undermined by rushing the process, and that thorough safety trials must be followed through in order for doctors themselves to confidently recommend and administer one.

For those reasons, the doctors urged transparency in the process of trialing and documenting any potential vaccines:

“The foundation of public confidence in vaccine safety has long been, and must remain, the well-established and trusted FDA approval procedures. The public is typically and rightly able to comment on vaccine approval. It is important that investigators share Phase 3 trial design details. For example, Data Safety Monitoring Boards apply predetermined ‘stopping rules’ to decide whether a study should be terminated early based on the detection of early benefits, the likelihood of no benefit, or the emergence of serious safety problems. These stopping rules should be publicly available. There must also be continuous monitoring for unexpected severe side effects that might only become apparent after large numbers of people are vaccinated.”

Finally, they drove home the point that doctors can only recommend a vaccine if they believe it is safe, and that evaluating safety can only be done with a transparent process unmarred by politics.

“We can only perform as advocates if we ourselves are persuaded that the vaccine(s) truly is safe and effective. We must be able to explain to the public what we know and what we don’t know about these vaccines. For that to happen, we must be able to witness a transparent and rigorous FDA approval process that is devoid of political considerations.”

Russia’s announcement could very well push vaccine makers and the government to rush the development and trialing process, which would be a mistake. Vaccine development usually takes years, not months, and skipping safety steps in the name of competition or expediency could make public health problems worse, not better.

As always, government needs to listen to the health experts on this front. We need a vaccine as soon as possible, but we also need to make sure we utilize the knowledge and processes that will ensure any vaccine will be safe to administer, no matter which company or country gets there first.

“There’s only one thing more dangerous than a bad virus, and that’s a bad vaccine,” Dr. Mike Ryan, executive director of WHO’s health emergencies programme, said in March. “We have to be very, very, very careful in developing any product that we’re going to inject into potentially most of the world population.”

Since the beginning of the pandemic, experts have said that developing a vaccine and getting it through the necessary safety and efficacy protocols would take, at minimum, 12 to 18 months. Yet here we are, 7 months in, and Vladimir Putin has just announced that Russia has already approved a vaccine for the coronavirus.

According to the BBC, there are more than 100 vaccines in various stages of development and testing. Six of those have reached phase 3 trials, involving more widespread testing in humans. Russia’s vaccine is not among those six.

Meanwhile, hundreds of U.S. doctors have signed a letter urging the FDA not to rush or politicize vaccine trials.


“We are experts in virology, epidemiology, vaccinology, infectious disease, clinical care and public health,” the letter opens, before declaring the “urgent” need for a COVID-19 vaccine. “We are committed to promoting the broad uptake of safe and effective COVID-19 vaccines. The need is urgent but all vaccines must be rigorously studied to determine whether their benefits exceed their risks.”

The letter expresses concern that public confidence in a vaccine will be greatly undermined by rushing the process, and that thorough safety trials must be followed through in order for doctors themselves to confidently recommend and administer one.

For those reasons, the doctors urged transparency in the process of trialing and documenting any potential vaccines:

“The foundation of public confidence in vaccine safety has long been, and must remain, the well-established and trusted FDA approval procedures. The public is typically and rightly able to comment on vaccine approval. It is important that investigators share Phase 3 trial design details. For example, Data Safety Monitoring Boards apply predetermined ‘stopping rules’ to decide whether a study should be terminated early based on the detection of early benefits, the likelihood of no benefit, or the emergence of serious safety problems. These stopping rules should be publicly available. There must also be continuous monitoring for unexpected severe side effects that might only become apparent after large numbers of people are vaccinated.”

Finally, they drove home the point that doctors can only recommend a vaccine if they believe it is safe, and that evaluating safety can only be done with a transparent process unmarred by politics.

“We can only perform as advocates if we ourselves are persuaded that the vaccine(s) truly is safe and effective. We must be able to explain to the public what we know and what we don’t know about these vaccines. For that to happen, we must be able to witness a transparent and rigorous FDA approval process that is devoid of political considerations.”

Russia’s announcement could very well push vaccine makers and the government to rush the development and trialing process, which would be a mistake. Vaccine development usually takes years, not months, and skipping safety steps in the name of competition or expediency could make public health problems worse, not better.

As always, government needs to listen to the health experts on this front. We need a vaccine as soon as possible, but we also need to make sure we utilize the knowledge and processes that will ensure any vaccine will be safe to administer, no matter which company or country gets there first.

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