FDA Approves Pfizer’s RSV Vaccine for Adults 60 and Older

Each year, about 60,000 adults 65 and older are hospitalized with RSV and about 6,000 to 10,000 die from the virus, FDA guessD, Centers for Disease Control and Prevention estimated that in one year, more than 21,000 people in that age group would need to get the GSK vaccine to prevent one RSV death; The number for the Pfizer shot was around 25,000.

The virus was a major driver in winter’s “tripledemic” of Covid, flu and RSV, which was particularly hard on young children, resulting in overwhelmed hospitals.

Infants and children are also at high risk; RSV is considered a leading killer of infants globally. Several treatments, including a maternal vaccine and a monoclonal antibody for infants against RSV, are under agency review.

During a consultative meeting on March 1 about both the vaccines, doctors reviewed the detailed data provided by the drug makers.

Pfizer’s product, Abrisvo, proved about 67 percent effective in cases of the virus with two symptoms and 86 percent in cases with three or more symptoms, according to data submitted to the FDA. effective. against severe RSV

But the advisory panel also raised concerns about some cases in which vaccine recipients developed autoimmune syndrome shortly after receiving the shots.

In a Pfizer study of nearly 34,000 patients who received the RSV vaccine, one week after the shot, one patient developed a life-threatening case of Guillain-Barré syndrome, a condition where the immune system attacks the nervous system. A second patient developed a subtype of the condition called Miller Fisher syndrome eight days after receiving the shot.

In those cases the incidence rate of the condition is approximately one in 9,000 – although they are typically seen in the general population at a rate of approximately one in 100,000. Some consultants found those numbers troubling, even taking into account the low incidence of severe RSV in the patient pool. The final vote of the FDA’s advisory panel was 7 to 4 in favor of the safety and efficacy of the Pfizer vaccine. The panel voted 10 to 2 in favor of the GSK vaccine, which was also linked to a Guillain-Barre case and two others. Possible related disorder.

CDC consultants are expected To discuss Recommendations to health care providers about the shots at a meeting next month. So far, they have indicated that data from the GSK and Pfizer trials support the use of the vaccines in people aged 65 and older.

Pfizer spokeswoman Jerrica Pitts said the company is ready to ship the vaccine. He did not know the cost of the vaccine, but said there would be no co-pay for vaccines deemed medically necessary under Medicaid and Medicare. GSK previously said its vaccine would be available in the fall.

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