FDA Approves Vaccine For Pregnant Women

The U.S. Food and Drug Administration (FDA) on Monday approved Abrysvo, the first vaccine approved for use in pregnant women to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.

“Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy. Abrysvo is administered as a single dose injection into the muscle. The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older,” the FDA said in a press release.

“RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

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Pfizer RSV vaccine to protect infants approved by FDA
Source: NBC News (YouTube) pic.twitter.com/9Pj2EgG1X0

— Wittgenstein (@backtolife_2023) August 22, 2023

NBC News reports:

The single-dose shot, made by Pfizer, spurs the production of protective antibodies that transfer from mother to infant through the placenta. It’s the first vaccine that can protect babies from RSV, which causes a lower respiratory illness that can be severe in infants.

However, last month the FDA also approved an injectable RSV drug for infants that delivers a dose of antibodies directly to the bloodstream.

Before Pfizer’s shot can be distributed to the public, an advisory committee to the Centers for Disease Control and Prevention must still recommend who should receive it. After that, it’s up to CDC Director Dr. Mandy Cohen to officially recommend the vaccine.

Pfizer said that the CDC advisory committee will most likely meet by early October and that the company plans to make the vaccine publicly available shortly after it is officially recommended.

“Abrysvo was found to lower the risk of severe disease from RSV among infants by 82% within roughly three months after birth. By around six months, the efficacy was around 69%,” NBC News noted.

“The most common side effects reported among pregnant women who got the shot were fatigue, headache, injection site pain, muscle pain, nausea, joint pain and diarrhea,” the outlet added.

Dr. Peter McCullough criticized an FDA Panel’s approval of the RSV shot for pregnant women in May.

‘Sad Day for Babies and Mums’: FDA Panel Recommends Pfizer’s RSV Vaccine for Pregnant Women • Children's Health Defense. Never risk a pregnancy. Not worth it. #courageousdiscourse ⁦@TXforVaxChoice⁩ ⁦@ChildrensHD⁩ https://t.co/zKWKIEUQ27

— Peter A. McCullough, MD, MPH™ (@P_McCulloughMD) May 20, 2023

From the FDA:

A clinical study evaluated the effectiveness of Abrysvo to prevent LRTD and severe LRTD caused by RSV in infants born to individuals who were vaccinated during pregnancy. Among approximately 3,500 pregnant individuals who received Abrysvo, compared to approximately 3,500 pregnant individuals who received placebo, Abrysvo reduced the risk of severe LRTD by 81.8% within 90 days after birth, and 69.4% within 180 days after birth. In a subgroup of pregnant individuals who were 32 through 36 weeks gestational age, of whom approximately 1,500 received Abrysvo and 1,500 received placebo, Abrysvo reduced the risk of LRTD by 34.7%, and reduced the risk of severe LRTD by 91.1% within 90 days after birth when compared to placebo. Within 180 days after birth, Abrysvo reduced the risk of LRTD by 57.3% and by 76.5% for severe LRTD, when compared to placebo.

The safety of Abrysvo was evaluated in two studies. In one study, approximately 3,600 pregnant individuals received a single dose of Abrysvo and approximately 3,600 pregnant individuals received a placebo. In the second study, approximately 100 pregnant individuals received Abrysvo and approximately 100 pregnant individuals received placebo.

The most commonly reported side effects by pregnant individuals who received Abrysvo were pain at the injection site, headache, muscle pain and nausea.

In addition, although not commonly reported, a dangerous hypertensive disorder, known as pre-eclampsia, occurred in 1.8% of pregnant individuals who received Abrysvo compared to 1.4% of pregnant individuals who received placebo. In the safety studies, low birth weight and jaundice in infants occurred at a higher rate in the pregnant Abrysvo recipients compared to pregnant placebo recipients.

“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,” McCullough told The Defender.

“Pregnancies should not be threatened with novel vaccines for uncommon and low-risk infantile illnesses.”

The Defender reports that the clinical trial for Abrysvo “reported 18 peripartum fetal deaths.”

From The Defender:

According to CNBC, the clinical trial for Abrysvo “reported 18 peripartum fetal deaths.”

However, the FDA said these deaths were “unlikely” to be related to the shot. According to Axios, “The fetal deaths present in the vaccine group (0.3%) were not related to Pfizer’s vaccine … Similarly, 4 out of 5 infant deaths were considered unrelated to the shot, with one being possibly connected to the shot, although that remains unclear.”

Data reported by Pfizer to the CDC indicated that 14% of pregnant women who participated in Pfizer’s trial sustained an adverse event, with 4.2% sustaining a “serious” adverse event, 1.7% experiencing a “severe” adverse event and 0.5% suffering a “life-threatening” adverse event.

Similarly, the same data showed that 37.1% of infants whose mothers received the experimental Pfizer vaccine experienced adverse events within one month of birth — with 15.5% classified as “serious,” 4.5% as “severe” and 1% as “life-threatening,” while efficacy waned within months of vaccination.

According to the National Vaccine Information Center (NVIC), “The RSV clinical trial data also included the death of one pregnant woman, 18 stillbirths (10 in vaccinated pregnant women and eight in unvaccinated pregnant women), and 17 infant deaths (five from the vaccinated pregnancy group and 12 in unvaccinated pregnancy group).”

Attorney, journalist and podcaster Daniel Horowitz, in an article published Monday in the Conservative Review, quoted Phase 2 trial data for Abrysvo. He wrote: “Pfizer reported 3 out of 116 (2.6%) premature births in the placebo group and 6 out of 114 (5.3%) in the group that received the vaccine that was chosen as Pfizer’s final product,” adding that Pfizer “was studying preterm birth as an ‘adverse event of special interest.’”