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

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

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According to the FDA, about 60,000 adults over the age of 65 are hospitalized with respiratory syncytial virus each year, and about 6,000 to 10,000 people die from the virus. estimated.Centers for Disease Control and Prevention Estimate More than 21,000 people in that age group would need to be vaccinated with the GSK vaccine in one year to prevent one death from RSV. For the Pfizer vaccine, that number was about 25,000.

The virus was a key contributor to the winter “triple epidemic” of novel coronavirus, influenza and respiratory syncytial virus, which hit young children particularly hard and overwhelmed hospitals.

Infants and young children are also at increased risk. RSV is believed to be the leading cause of death in infants worldwide. Several treatments are under regulatory review, including maternal vaccines against RSV and monoclonal antibodies for infants.

At the March 1 advisory meetings on both vaccines, doctors reviewed detailed data provided by pharmaceutical companies.

According to data submitted to the FDA, a Pfizer product called Abrysvo proved effective in about 67 percent of cases of the virus with two symptoms, and about 67 percent effective in cases with three or more symptoms. Proven 86 Percent Efficacy A GSK vaccine called Alexby was nearly 83 percent effective against severe RSV

However, the Advisory Panel also expressed concern about a few cases in which vaccinees developed an autoimmune syndrome shortly after vaccination.

A Pfizer study of about 34,000 patients vaccinated with the RSV vaccine found that a week after vaccination, one patient developed a life-threatening condition called Guillain-Barré syndrome, a condition in which the immune system attacks the nervous system. developed a case threatening the A second patient developed a subtype of the condition called Miller-Fischer syndrome eight days after vaccination.

The incidence of these cases is about 1 in 9,000, but they are commonly seen in about 1 in 100,000 in the general population. Some advisors also noted the low incidence of severe RSV in the patient population and found these figures problematic. The final vote of an FDA advisory panel in favor of the safety and efficacy of the Pfizer vaccine was 7-4. The committee voted 10 to 2 in favor of the GSK vaccine, which was also linked to one Guillain-Barré case and two other Guillain-Barré cases. Possibly related disorders.

CDC Advisors Expected discuss Recommend immunizations to health care providers at next month’s meeting. So far, GSK and Pfizer’s clinical trial data support the vaccine’s use in people over the age of 65, they suggest.

Pfizer spokeswoman Jerika Pitts said the company is ready to ship the vaccine. She said she didn’t know how much the vaccine would cost, but said she wouldn’t pay out-of-pocket for vaccines deemed medically necessary under Medicaid and Medicare. GSK previously announced that a vaccine would be available in the fall.

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