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The U.S. Food and Drug Administration (FDA) on Monday approved Pfizer’s Abrysvo vaccine, a maternal vaccine meant to protect infants against respiratory syncytial virus, or RSV, through 6 months of age.

The agency approved the vaccine despite concerns raised by members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) about premature births identified during Pfizer’s clinical trials.

VRBPAC panelist Dr. Paul Offit, a pediatrician at Children’s Hospital of Philadelphia and a frequently cited vaccine advocate, said he doesn’t believe there is enough data to indicate the safety of the vaccine is “reassuring.”

In its statement to investors, however, Pfizer was enthusiastic about the prospect of the vaccine.

“ABRYSVO’s approval as the first and only maternal immunization to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health,” said Annaliesa Anderson, Ph.D., Pfizer’s senior vice president and chief scientific officer, Vaccine Research and Development.

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RSV generally causes only mild, cold-like symptoms in infants and young children, most of whom get the illness by age 2 and typically don’t require medical attention. The Centers for Disease Control and Prevention (CDC) estimates 58,0000-80,0000 children younger than age 5 are hospitalized and 100-300 children die from RSV overall in any given year.

Commenting on the vaccine after VRBPAC endorsed it in May, Dr. Peter McCullough told The Defender:

“This product represents an unprecedented attempt to vaccinate mothers for no benefit to them and only theoretical efficacy in babies. In the trial, less than 2% of infants at any time point contracted RSV, which is easily treatable with nebulizers.”

Before the drug can be prescribed to pregnant women, the CDC’s Advisory Committee on Immunization Practices (ACIP) must recommend the vaccine and CDC Director Mandy Cohen must accept the recommendation. She is widely expected to do so, STAT News reported.

The next ACIP meeting is scheduled for October, but STAT said a special meeting might be called in the coming days, given “last year’s early start to the RSV season.”

Earlier this month, the CDC recommended the first-ever monoclonal antibody — Sanofi and AstraZeneca’s Beyfortus — to protect all newborns against RSV after the FDA approved the drug.

It made that recommendation despite 12 infant deaths during the clinical trials and criticism from medical experts who said the move was unnecessary and not worth the known risks.

In late May, the FDA approved the same Pfizer Abrysvo vaccine approved Monday for pregnant women for use in adults over 60.

And earlier in May the agency approved GSK’s Arexvy, the first vaccine authorized for RSV, for adults over 60.

20% higher rate of premature birth among vaccinated mothers in clinical trials

According to the FDA, Abrysvo will be administered to pregnant women between 32 and 36 weeks of pregnancy as a single-dose injection into the muscle.

It said the “safety and effectiveness” of the shots were determined through “ongoing, randomized, placebo-controlled international clinical studies.”

Pfizer reported that in its Phase 3 clinical trial — MATISSE (MATernal Immunization Study for Safety and Efficacy), published in the New England Journal of Medicine — the shot was nearly 82% effective at preventing severe disease from RSV in newborns during the first 90 days of life. There were about 7,000 participants in the clinical trial.

The vaccine was also reported to be about 70% effective during the first six months of the baby’s life, CNBC reported.

But experts, including four members of the VRBPAC committee who voted against recommending the vaccine for pregnant women, said they had concerns about the study.

Tracy Høeg, M.D., Ph.D., reported there was a 20% higher rate of preterm birth in the vaccinated group than in the unvaccinated group.

“Most of VRBPAC shrugged off the signal as ‘non significant’ but study underpowered,” she tweeted — meaning there were not enough participants in the study to confirm whether the safety signal was statistically significant.

Høeg shared more details on Twitter:

Offit voted against approving the vaccine because of the safety signal.

The FDA, following Monday’s approval, said the available data “are insufficient to establish or exclude a causal relationship between preterm birth” and Pfizer’s vaccine, CNBC reported.

It also reported that Pfizer’s VP of Vaccine Research and Development Alejandra Gurtman said the difference in premature birth rates was “not statistically significant.”

Gurtman noted that most premature births occurred 30 days after vaccination, which she said means “a very close causal relationship between the vaccine and preterm birth couldn’t be identified.”

“We couldn’t find any reason why this really happened,” Gurtman said.

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GSK stopped development of the same type of maternal RSV vaccine earlier this year when it detected a similar increase in the number of preterm births among pregnant mothers.

Other commonly reported side effects from Abrysvo included pain at the injection site, headache, muscle pain and nausea.

Pre-eclampsia also occurred in 1.8% of pregnant women who took the drug, relative to 1.4% of women in the placebo group.

The company said it will continue to examine risks in a post-marketing vaccine study, and as part of that, it will create a registry for adverse event reporting.

McCullough wrote on his Substack that this vaccine is more evidence that “Vaccine ideology or hubris appears everywhere! Never had we heard so much about vaccines in our day to day life as laypersons or as healthcare professionals.”

He added:

“Pfizer has aggressively advanced RCTs into the pregnant population with no assurances on long term outcomes. There is no direct benefit to the mothers.

“Furthermore, the sponsors moved the goalposts to make it easier to have a successful trial. We should demand long-term safety, high efficacy … and at least one year of durability, for such a rare and easy-to-treat condition in babies.”