Is It Safe to Get 3 Vaccines at Once? Vaccine Makers Say Yes, But FDA Wants Proof
Is it safe to get a COVID-19, RSV and flu vaccine at the same time?
This article originally appeared on The Defender and was republished with permission.
Guest post by Michael Nevradakis, Ph.D.
According to an Aug. 25 memo, the FDA now says vaccine makers must conduct clinical trials to study the potential adverse effects of simultaneously giving multiple shots for respiratory viruses before they can market the vaccines as “safe and effective” when received at the same time.
Is it safe to get a COVID-19, RSV and flu vaccine at the same time? The answer, according to many medical experts and the CDC and HHS websites, is yes — but that’s about to change.
According to an Aug. 25 memo, the U.S. Food and Drug Administration (FDA) now says vaccine makers must conduct clinical trials to study the potential adverse effects of simultaneously giving multiple shots for respiratory viruses before they can market the vaccines as “safe and effective” when received at the same time.
The FDA said it “cannot affirm that concurrent administration is both safe and effective,” as coadministration has not been thoroughly studied.
Some medical and scientific experts welcomed the new policy, first reported last week by The Washington Post.
Dr. Clayton J. Baker, an internal medicine physician, said:
“There is urgent need for scientifically sound, non-Pharma-conducted studies regarding the safety of all simultaneously administered vaccines.
“This practice is widely used and dangerously under-evaluated. The greatest risk is to young children during co-administration of the many different vaccines listed on the current, bloated Centers for Disease Control and Prevention [CDC] pediatric schedule.”
Last month, two doctors who lost their medical licenses because they questioned the CDC’s vaccine recommendations for children sued the agency for failing to test the cumulative effect of the 72-dose schedule on children’s health.
Research scientist and author James Lyons-Weiler, Ph.D., said, “Properly controlled and sufficiently powered trials are the gold standard,” promised by U.S. Health Secretary Robert F. Kennedy Jr., and that such trials are “the correct approach for any clinical intervention.”
“It’s about time the gold standard of science is applied to vaccines,” he said.
In a statement shared with The Defender, Emily G. Hilliard, press secretary for the U.S. Department of Health and Human Services, said the department “does not comment on future or potential policy decisions.”
Prasad: Past studies ‘incapable of adequately documenting safety signals’
According to Fierce Pharma, the Biden administration “supported vaccine coadministration as a means to increase immunization rates.”
Dr. Vinay Prasad, director of the FDA Center for Biologics Evaluation and Research (CBER), has publicly criticized this strategy due to a lack of evidence supporting it, the Post reported.
The Post cited 2021 guidance from the World Health Organization, which found that coadministration of the COVID-19 and flu vaccines is safe and “has potential advantages.”
A survey of the scientific literature, published in March in the journal Influenza and Other Respiratory Viruses and cited by the Post, found that “Adult vaccine coadministration is safe for all the combinations we assessed,” with adverse events that were “generally mild to moderate and of short duration.”
The Post also cited a 2022 CDC study published in JAMA Network Open, which found that “simultaneous administration of COVID-19 mRNA booster and influenza vaccines may be associated with increased likelihood of systemic reactions.” Yet, according to the Post, “those reactions were mostly mild and went away quickly.”
In the FDA memo, Prasad said past determinations regarding the safety of coadministering respiratory virus vaccines were made on the basis of small randomized studies. “Such small trials are inherently incapable of adequately documenting safety signals,” he said.
Baker agreed:
“At least two of the studies showed statistically significant increases in systemic reactions when the vaccines were coadministered. To dismiss this finding without further evaluation — as was done — is both irresponsible and tendentious in favor of ‘just giving’ the shots.”
Lyons-Weiler said the relevant studies “support convenience and short-term tolerability,” but “do not deliver the decisive evidence needed for label-level claims about clinical benefit or the absence of interaction-driven risk.”
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Giving multiple vaccines at once is convenient, profitable — but not necessarily safe
Dr. Ashish Jha, the White House’s former coronavirus coordinator during the Biden administration and now dean of the Brown University School of Public Health, told the Post that the millions of doses of respiratory virus vaccines coadministered over the years prove they are safe.
“The burden of proof is not on manufacturers to be able to do something that clearly has been done millions of times safely,” Jha said.
Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense, said Jha “is partaking in a fallacy that past actions were safe and warranted,” as “historic data of dubious record does not constitute a safety study.”
Jablonowski said:
“That it has been administered millions of times does not make vaccines safe; it makes them profitable. That we administered vaccines to our most vulnerable — during pregnancy and to 6-month-old infants — doesn’t make them safe, it makes us reckless.”
Baker agreed, saying, “Jha is correct in stating that the coadministration of multiple vaccines for respiratory viruses ‘clearly has been done millions of times.’ But how ‘safely’ has it been done? Jha doesn’t know, because nobody knows.”
Jablonowski said looking at vaccination data retrospectively is problematic because “there is no experimental control.”
He cited the case of a 6-month-old in Iowa who received multiple respiratory virus vaccines concurrently in 2022 and was “found pulseless” in his crib 10 days later, according to a report in the U.S. government-run Vaccine Adverse Event Reporting System or VAERS.
“Which vaccine, if any, likely killed him? We don’t know, because we don’t have the safety studies for combinations,” Jablonowski said.
Jablonowski also referred to a 2023 paper published in The BMJ on the safety of the mRNA COVID-19 booster shots. His analysis of the study’s data found that people who received a flu vaccine along with their fourth COVID-19 booster dose had a 62.5% higher risk of stroke within 28 days of vaccination.
The 2022 CDC study does, in fact, show “a compounding or synergy of adverse reactions,” Jablonowski added.
The study states:
“Compared with administration of COVID-19 mRNA booster vaccines alone, simultaneous administration of COVID-19 mRNA booster and seasonal influenza vaccines was associated with significant increases in reports of systemic reactions during days 0 to 7 following vaccination.”
Jablonowski analyzed the study’s results. He found that people who received Pfizer or Moderna COVID-19 vaccines concurrently with a flu vaccine were more likely to experience a systemic or injection-site reaction or to be unable to work or attend school following vaccination.
FDA policy ‘could have implications’ beyond cold and flu season
CDC guidance, current as of Aug. 18, states, “Flu, COVID-19, and RSV vaccines may be co-administered (given at the same visit)” and “may also be co-administered with other vaccines.”
According to the Post, Prasad’s memo “could have implications that go beyond the fall respiratory vaccination season.”
While the memo “does not prevent pharmacies and doctors from providing coronavirus and flu vaccines in the same visit,” the Post suggested that immunization rates may decline if more than one visit is required to receive multiple respiratory virus vaccines, or longer intervals are required between shots.
The memo comes as national pharmacy chains, including CVS and Walgreens, have begun limiting access to COVID-19 vaccines in response to new federal guidelines enacted last month ending emergency use authorization of the COVID-19 shots and restricting them to people at higher risk for severe illness.
According to the Post, Pfizer responded to Prasad’s memo by sending a letter to healthcare providers stating that some batches of its COVID-19 vaccine contain “unapproved prescribing information inside the cartons,” indicating the company intends to add a warning about coadministration of the vaccine to its product label.
According to the Post, the FDA’s policy change may also lead to new recommendations for respiratory vaccines — potentially stemming from the CDC’s vaccine advisory panel, the Advisory Committee on Immunization Practices (ACIP).
CDC vaccine advisers to meet next week
ACIP is scheduled to meet Sept. 18 to vote on COVID-19 vaccine recommendations for the upcoming cold and flu season.
In June, Kennedy retired all 17 members of ACIP to eliminate conflicts of interest. Shortly after, Kennedy named eight researchers and physicians to the committee, but one nominee declined to participate. Fierce Pharma reported last week that Kennedy plans to nominate seven additional members to the committee.
The new FDA policy is part of a broader series of shakeups at the FDA and CDC.
Prasad resigned from his position on July 29 amid pressure from vocal critics, but returned to his position two weeks later.
In May, Prasad replaced Peter Marks, M.D., Ph.D., as head of CBER. Marks had overseen Operation Warp Speed and the rapid development and approval of the COVID-19 vaccines. He resigned in March under pressure from Kennedy.
On Aug. 27, the White House confirmed the firing of CDC Director Susan Monarez, after she refused to resign amid clashes with Kennedy.
During a contentious U.S. Senate hearing Thursday, Kennedy said Monarez had indicated she would refuse to endorse any ACIP recommendations, even before the committee met to make them.
On Sept. 1, President Donald Trump suggested that the CDC and Big Pharma have not been fully forthcoming about COVID-19 vaccine safety data. Trump demanded they “clear up this mess.”
Related articles in The Defender
Top Vaccine Regulator Returns to FDA Two Weeks After He Was Fired
Dr. Vinay Prasad Replaces Ousted Peter Marks as Chief FDA Vaccine Regulator
Sparks Fly as RFK Jr. Tells Senators CDC Failed Americans During COVID
FDA Restricts Some COVID Vaccines to High-Risk Groups, But HHS Says Everyone Will Have Access
CDC Hit With Lawsuit Over Failure to Test Cumulative Effect of 72-Dose Childhood Vaccine Schedule
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