THE SAFEGURDS THAT HELPED ENSURE POLITICES DIDN’T INFLUENCE THE VACCINE PROCESS
By: Fox Parvin
Tags: Health, Coronavirus, Public Health, Covid 19, Vaccines

Tocoincide with the U.S. vaccine rollout, Elemental has published an extremely thorough guide to Covid-19 vaccines, answering every question we could think of. Elemental will continue to update and add to this FAQ as the rollout and FDA authorization process continues. If you would like to submit a question, leave a response at the end of the story. Here’s a peek at one of the questions inside.

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Q: How can I be sure that the process of the vaccine’s development and approval wasn’t inappropriately influenced by political interests?

After evidence surfaced of the Trump administration’s meddling at the CDC, and given the criticism of the administration pressuring the FDA to grant an EUA to hydroxychloroquine (which was later revoked), it’s reasonable to have concerns about political influence in the Covid vaccine development process. Fortunately, several safeguards in the vaccine approval process — even for an EUA — are reassuring.

“One of the things that I point out is that yes, there have been instances [in the history of vaccine development] where scientists have been unethical, and these safeguards are in place to really limit the ability of any one scientist in being unethical,” said [Michele] Andrasik [PhD, director of social and behavioral sciences and community engagement at the Covid-19 Prevention Network at the Fred Hutchinson Cancer Research Center].

Two of the biggest safeguards are the VRBPAC [Vaccines and Related Biological Products Advisory Committee] and ACIP [Advisory Committee on Immunization Practices] committees, both of which are made up of independent experts who are not employees of the FDA or the CDC and both of which hold open meetings available to the public. For example, President Trump issued an ultimatum to the FDA on December 11, demanding that the agency approve the Pfizer vaccine or he would fire FDA Commissioner Stephen Hahn, a move hardly reassuring to those who want the agency to make its decisions without political pressure. However, by that point, the vaccine had already been approved by the U.K.’s regulatory agency and had been reviewed by VRBPAC, which found its data on safety and effectiveness strong enough to recommend the FDA issue an EUA. The FDA nearly always follows VRBPAC recommendations, and the president has no ability to influence VRBPAC’s independent members.

In addition, every vaccine trial has an independent safety monitoring board responsible for overseeing the safety of the trial. You may have heard of some vaccine trials that were paused while an adverse event was investigated. That means the process is working: If someone has a heart attack, the trial stops vaccinating new participants until the study leaders can determine if the heart attack could have been related to the vaccine. Once it’s determined that a serious medical event is not related to the vaccine, the trials resume.

Finally, look to regulatory agencies outside the U.S., [Devon] Greyson [PhD, assistant professor of communication at University of Massachusetts, Amherst], said. “I think something that we in the United States lose sight of is that many, many other countries around the world are also assessing Covid-19 vaccines, and if you’re worried about whether you can trust your own country’s institutions, you can look at other countries to see if they’re also approving those vaccines,” she said. “If they are, you can have more confidence that the approval wasn’t made inappropriately or under political pressure.”