‘I would ask people to be patient with us as we do this the proper scientific way,’ Dr. Marty Makary said.
The commissioner of the Food and Drug Administration is responding to critics of the agency’s recent approvals of COVID-19 vaccines, saying the FDA is involved in a process that takes time.
Dr. Marty Makary urged patience after disclosing that he was aware of research indicating COVID-19 vaccines may cause immune system deregulation and described databases with self-reported adverse events as inadequate to determine harms from vaccines.
“I don’t want people to think that we’re blowing off the safety signal[s] that many people have described,” said Makary, who was speaking on July 14 on EpochTV’s “American Thought Leaders” in an interview that will be released soon.
“I personally know of people who have been injured by the vaccine. I personally know of friends who have lost a loved one from the mRNA COVID vaccine. So I think it is reasonable at this time to say we want good, solid, definitive data, and the conditional, limited approval of the COVID vaccines is in that framework that we want to see a proper dataset come to us so we can take a good look at that data.”
The Moderna and Pfizer-BioNTech vaccines utilize messenger ribonucleic acid (mRNA) technology.
The FDA has, for years, cleared updated COVID-19 vaccines on an annual basis despite there being scant or no clinical trial data demonstrating the effectiveness of the shots. Makary and another top FDA official, Dr. Vinay Prasad, announced in May that regulators would not be issuing new licenses for the vaccines for many Americans unless manufacturers ran trials based on clinical endpoints, such as the prevention of symptomatic COVID-19.
They also said that testing showing the vaccines trigger antibodies would be sufficient for the elderly, as well as young people with at least one condition the government says places them at higher risk of severe COVID-19 outcomes.
The FDA subsequently approved, in addition to Novavax’s vaccine, a new next-generation vaccine from Moderna and an updated version of Moderna’s existing vaccine, Spikevax, for the elderly and people with at least one risk factor. The latter approval also came for those at least 6 months of age who have at least one risk factor; previously, the vaccine was available under emergency authorization for younger children.
By Zachary Stieber and Jan Jekielek
