F.D.A. gives the nod to Pfizer’s vaccine for older adults

Why It Matters: Older adults are at a higher risk.

According to the FDA, around 60,000 Americans who are aged 65 or more get hospitalized with R.S.V. every year. Further, it estimated that about 6,000 to 10,000 people in that same age group die from the virus each year. The Centers for Disease Control and Prevention (CDC) believes that more than 21,000 people aged over 65 would have to take GSK’s vaccine to prevent one R.S.V. death, while the number was nearly 25,000 for Pfizer’s vaccine. The virus was responsible for driving the “tripledemic” of Covid, flu, and R.S.V. which was particularly deadly for young children and led to overwhelmed hospitals during last winter.

Infants and toddlers are also particularly vulnerable to R.S.V. which is considered to be a major killer of infants globally. In this regard, several treatments, including a maternal vaccine and a monoclonal antibody for infants against R.S.V., are under review by the FDA.

Background: Advisers aired safety concerns.

At an advisory meeting on March 1 about both vaccines, doctors reviewed detailed data provided by the drug-makers. Pfizer’s product, called Abrysvo, proved to be nearly 67 percent effective against cases of the virus with two symptoms and 86 percent effective against cases with three or more symptoms, according to data submitted to the FDA. GSK’s vaccine, Arexvy, was reported to be almost 83 percent effective against R.S.V.

However, the advisory panel also raised concerns about a few cases in which vaccine recipients developed autoimmune syndromes shortly after receiving the shots. In a Pfizer study of about 34,000 patients who received the R.S.V. vaccine, one patient developed a life-threatening case of Guillain-Barré syndrome, which is a condition where the immune system attacks the nervous system, while another patient developed a subtype of that condition called Miller Fisher syndrome 8 days after receiving the shot. Though such cases are usually seen at a rate of about one in 100,000 people in the general population, the incidence rate of the condition was about one in 9,000 among Pfizer’s study population. Some advisers, seeing the low incidence of severe R.S.V. in the patient pool, found those numbers troubling. The final vote of the FDA’s advisory panel in favor of the safety and efficacy of Pfizer’s vaccine was 7 to 4. The panel also gave 10 to 2 votes of approval for GSK’s vaccine which was linked to one case of Guillain-Barré syndrome and two others of a possibly related disorder.

What’s Next: When will the shots be available?

CDC advisers plan to discuss recommendations to healthcare providers about the shots in a meeting next month. So far, they have hinted that the data from the GSK and Pfizer trials support use of the vaccines in people aged 65 or older.

According to a Pfizer spokeswoman, Jerica Pitts, the company is ready to ship the vaccine. However, she did not know the vaccine’s price but said that there would be no co-pay for vaccines deemed medically necessary under Medicaid and Medicare. GSK had earlier said that its vaccine would be available in the fall.