The Food and Drug Administration is expected to approve a fourth dose of Pfizer and Moderna's Wuhan coronavirus vaccine this week, despite a lack of clinical data showing they are effective or necessary.
"Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults," CBS News reported late last week. "The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors."
Doctors truly focused on following the science, not political science, are blasting the decision.
"The FDA’s vaccine regulation is sliding further into the abyss. Last week, Pfizer announced that it would seek emergency-use authorization for a fourth dose of its mRNA vaccine, based on the original Wuhan strain of Covid-19, in people over 65. Meantime, Moderna announced that it was seeking an even larger market share: a fourth dose in anyone over 18, based on its original mRNA vaccine. If the FDA moves forward on authorizing either product, it will cement a dangerous precedent: inadequate evidence being used to justify widespread vaccination for years to come," Dr. Vinay Prasad writes for City Journal. "The data supporting fourth doses aren’t up to medicine’s gold standard: a randomized trial. Instead, we have two observational studies comparing people who rushed to be boosted with those who didn’t."
There is zero clinical data that a 4th dose reduces hospitalization risk. There isn't even any evidence that a 3rd dose reduces hospitalization risk in young people.
— Marty Makary MD, MPH (@MartyMakary) March 29, 2022
Political interference over boosters was the issue behind 2 high-level FDA departures in the fall. There is no greater slap in the face of science than bypassing the customary FDA external expert voting process over an authorization with insufficient supporting clinical data.
— Marty Makary MD, MPH (@MartyMakary) March 29, 2022
Biden & his new FDA commiss @DrCaliff_FDA (under pressure from Pharma) should insist on a vote by FDA's external experts before authorizing 4th doses. Public health confidence has been signif eroded. Bypassing the expert vote to push 4th doses will make it worse. Science>politics
— Marty Makary MD, MPH (@MartyMakary) March 29, 2022
As noted, a number of longtime FDA officials resigned last fall due to the approval process being rushed and concerns about side effects -- specifically enlargement of the heart in young people -- being ignored. Not to mention the CDC is just now getting around to studying side effects for women who have experienced serious changes in their menstruation cycles.
The only thing I've seen about it said "yes, it seems the vaccine affects menstruation but it's minor" but I'm telling you- what I'm experiencing and what other people have shared with me is that this is not minor. Excruciating symptoms, and delayed periods of up to two weeks.
— Katy Stoll (@katystoll) March 26, 2022
I'm stunned and furious by the responses to this tweet. I have thousands of messages and DMs to go through. Some of your stories are heartbreaking. So many people have been carrying valid fears but haven't felt comfortable speaking up because it has all been so politicized.
— Katy Stoll (@katystoll) March 28, 2022