Finally…FDA to Test Safety and Effectiveness of Co-Administering Vaccines

Dr. Vinay Prasad is a national treasure. 

Amidst all the controversy over the safety and effectiveness of certain vaccines and the timing of their administration, he has chosen a path not often taken: to collect and examine evidence through randomized controlled trials. 

FDA to take harder look at coadministration of certain vaccines https://t.co/xvjTAIcny0

— Robert W Malone, MD (@RWMaloneMD) October 6, 2025

This approach is, unfortunately, a radical idea and a move that will inspire tremendous opposition among the members of the vaccine cult, who can abide no questioning at all of the current, rather laissez-faire approach to approving and administering vaccines. 

At issue with this particular policy move is the common practice of administering multiple vaccines for respiratory viruses simultaneously. Each of the vaccines has been individually tested for safety and effectiveness, although even Dr. Anthony Fauci has written that vaccines against respiratory viruses are not particularly effective due to the nature of the viruses’ infection route, there is scant evidence that administering them all at the same time is similarly safe and effective. 

Citing a “new evidenced based philosophy,” the FDA’s Center for Biologics Evaluation and Research (CBER) is preparing to take a hard line against the common practice of administering certain respiratory virus vaccines at the same time.

The leadership at CBER—which oversees vaccines and other biologic products like cell and gene therapies at the FDA—will now require randomized, controlled trials in people eligible for multiple vaccines before drugmakers can promote coadministration of the shots or “some sequence of the vaccines,” CBER Director Vinay Prasad, M.D., wrote in a memo posted on the FDA’s website.

“The trial could be performed with a hierarchical statistical design, testing first noninferiority and then superiority,” Prasad said in the communique, which was issued in relation to the FDA’s restricted approval of Pfizer’s updated COVID-19 shot last week.

We already know that side effects experienced by people who get multiple vaccines are more severe than those who get the vaccines individually, but we really have no great evidence that the effectiveness of the vaccines given simultaneously is as great or that there aren’t unanticipated complications that stem from co-administration. Small tests are conducted, but the evidence generated is of very low quality. They are too small and unable to detect any but the largest possible signals. 

Although the new requirement was laid out in communications on Pfizer’s coronavirus vaccine Comirnaty, it will likely affect any company manufacturing vaccines for COVID-19, influenza or respiratory syncytial virus.

Apparently reading the writing on the wall, Pfizer last month sent a letter to healthcare providers warning that certain lots of its 2025-26 COVID vaccine “contain unapproved prescribing information inside the cartons.”

That language related to “concomitant administration of Pfizer-BioNTech COVID-19 vaccine, bivalent with a respiratory syncytial virus (RSV) vaccine or with an RSV vaccine and an influenza vaccine in individuals 65 years of age and older,” according to the letter, which the FDA has posted on its Comirnaty information page.

Pfizer did not provide a statement in response to Prasad’s communications, though a company spokesperson directed Fierce toward its physician letter on the FDA’s website.

In the memo, CBER’s Prasad took issue with the fact that past company claims about concomitant vaccine administration were “made on the basis of small randomized studies showing non-inferior antibody titers.” But the CBER is “unsure” whether those titers correspond to clinical protection and holds concerns that “such small trials are inherently incapable of adequately documenting safety signals,” according to Prasad.

“The studies are simply too small to identify potential increases in adverse events, which Americans may wish to know,” he wrote.

You bet we want to know. Many people who are not particularly skeptical about the safety and/or effectiveness of any particular vaccine are indeed worried that the concentration of so many vaccines given at once, or in sessions separated by small amounts of time, may have unintended side effects. Any one vaccine be both safe and effective, but many all at once? Maybe not. We don’t know because nobody has really looked into the question deeply. 

Unfortunately, vaccine policies have become intensely political, especially since the “experts” lied repeatedly about the COVID vaccine, which was neither as safe as advertised nor as effective. Many of us have concluded that we cannot trust the experts because, well, they are proven liars. 

Yet people on the leftward side of the political aisle, who still fool themselves into believing that even cloth masks are an effective preventive measure, are vehemently against even doing gold-standard studies. Their claim is that even questioning the “Science™” is dangerous. 

Ironically, their solution is to do no science at all. Even doing studies will undermine faith in Science™. Better to believe proven liars, or pretend to, than find out the truth. 

Our recent faith in vaccines was earned through decades of experience, and as with all trust, it was destroyed all at once by arrogance and incompetence. 

It will take years or decades for that trust to be built up again, and the first step is to do gold-standard studies on everything that people question. Yes, that will remind people that no medical treatment is perfectly safe or 100% effective–we used to warn people of both the risks and benefits without lying to people–and that will lay the groundwork for most skeptics to regain some measure of trust and to make informed decisions, not ones based solely on well-earned distrust. 

I never used to question the safety or effectiveness of vaccines–I didn’t expect them to be risk-free or to be 100% effective, but I trusted the people who approved them that the risks were worth the benefits. 

Now, frankly, I don’t. Because I know that these people are perfectly willing to lie. They act like cult leaders, and I treat them as such. Not everything a cult leader says is a lie, but I have plenty of reason to doubt them and their motives. 

Prasad does not have a history of hostility to vaccines or most medical treatments; he does have a history of demanding solid evidence. 

That’s comforting to me, and his approach will ensure that the first step to restoring trust in public health is being taken. 

Editor’s Note: The Schumer Shutdown is here. Rather than put the American people first, Chuck Schumer and the radical Democrats forced a government shutdown for healthcare for illegals. They own this.

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