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Home News BEWARE! FDA Advisers Recommend World’s First RSV Vaccine from Pfizer

BEWARE! FDA Advisers Recommend World’s First RSV Vaccine from Pfizer

BEWARE! FDA Advisers Recommend World’s First RSV Vaccine from Pfizer

( – The Food and Drug Administration advisory group voted to authorize Pfizer’s first RSV vaccination on Tuesday for individuals 60 and older.

The independent VRBPAC (Vaccines and Related Biological Products Advisory Committee) of the FDA narrowly voted 7 to 4 in favor of safety and 7 to 4 in favor of efficacy, with one member abstaining.

According to NBC News, several of the doctors who abstained based on the vaccine’s efficacy were worried that there weren’t enough RSV infections throughout the study to accurately assess the injection.

Due to concerns about Guillain-Barré syndrome (GBS), a rare neurological condition that can damage nerve cells and cause muscular weakness or paralysis, specialists opposed the vaccination due to its safety profile.

The FDA advisory committee head, Dr. Hana El Sahly, who voted against the injection based on its safety profile but in favor based on efficacy, noted that the shot had a 1 in 9,000 chance of GBS, which is troubling.

The respiratory syncytial virus (RSV) bivalent vaccine candidate, PF-06928316 or RSVpreF, is safe and productive, according to the VRBPAC, which stated that the evidence is “sufficient to support this assertion.”

Pfizer stated in its news release that the vaccine candidate is now being examined by the FDA to prevent acute respiratory illness and lower respiratory tract disease brought on by RSV in persons 60 years of age and older.

“There is a critical need to safeguard this at-risk group,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development Pfizer.

“RSV can cause serious illness, hospitalization, or even death in older persons. “The conclusion of today’s VRBPAC meeting gives us hope because it demonstrates our science’s power and commitment to bringing this significant vaccine candidate to market. As the FDA completes its application examination, we look forward to collaborating.

The FDA will now make a decision about the vaccine’s approval. Even though the FDA typically approves the recommendations of its advisory committee, this procedure might take months. PDUFA’s accurate date of May 2023 is when the FDA decision is anticipated.

According to Fortune, the adult RSV vaccination industry will be valued at up to $10 billion by 2032.

According to forecasts by Bloomberg Intelligence, the market for developing preventative measures for deadly RSV infections in babies might reach $1.5 billion, the source continued. Pfizer is competing with colleagues Sanofi and AstraZeneca Plc in this regard.

According to The Gateway Pundit, Pfizer is working on a new vaccine that would immunize an unborn child while still in the womb and is intended to be administered to pregnant women alone. After delivery, according to Pfizer, newborns will be protected from the respiratory syncytial virus (RSV).

To assess the effectiveness, safety, and immunogenicity of RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy, Pfizer described MATISSE, an ongoing randomized, double-blinded, placebo-controlled Phase 3 study.

In the Pfizer research, 7,400 expectant mothers were divided into two groups and given either a single dose of RSVpreF or a placebo in the late second to the third trimester of their pregnancies.

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