Regulatory ACIP Panel Set to Vote For Use of New...

ACIP Panel Set to Vote For Use of New GSK and Pfizer RSV Shots


The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC will vote on suggestions for the application of new respiratory syncytial virus (RSV) vaccines from GSK and Pfizer.

Arexvy, manufactured by GSK, and Abrysvo, produced by Pfizer, both received authorization last month to become the first vaccines ever developed for the disorder, which normally causes symptoms similar to a cold but can advance to severe disease and be deadly. Specifically, the vaccinations were successful in garnering approval for preventing diseases of the lower respiratory tract caused by RSV in persons aged 60 and older.

According to the statistics provided by the U.S. government, it is estimated that RSV is responsible for 14,000 fatalities annually among people aged 65 and over in the country.

Both firms gave presentations on Wednesday morning on the data about the effectiveness and safety of their respective vaccinations in the second RSV season following administration

The CDC also presented a cost-effectiveness model for the two injections, which demonstrated that GSK’s vaccination delivered much greater value—even when priced at $270 per dosage versus $200 for the Pfizer dose.

The two firms stated on Wednesday that they had not settled on a final price for their injections. This prompted an appeal from a committee member at Vanderbilt University, Helen Keipp Talbot, M.D., who remarked, “We are voting today at around 4:30. If you could please come up with a price before that it would be incredibly helpful. None of us buy a car unless we know how much it costs.”

The experts from the ACIP will provide recommendations on who ought to receive the new vaccines and how frequently. Both firms have indicated that their respective vaccines will be available for distribution this coming fall.

With a median follow-up period of 14 months after injection, the GSK vaccine has shown an efficacy of nearly 83% in preventing RSV in the first year and over 94% in preventing severe sickness. However, those values declined to 77.3% and 84.6%, respectively, in the subsequent RSV season. This is attributed to the fact that the vaccine’s efficacy decreases with time.

Furthermore, a different subset of the research found that individuals who received a second injection one year following the original administration did not obtain any boost in second season efficacy. This indicates that revaccination after a year doesn’t seem to provide extra benefit, the company stated.

Pfizer’s vaccine, on the other hand, has shown a 66.7% effectiveness rate against RSV in the first year, with an 85.7% protection rate against severe sickness. According to the corporation, the levels of effectiveness dropped to 49% and 78.6%, respectively, during the following season at month 18 of the study.

On Wednesday, both companies announced that they would do additional testing on a subgroup of the trial subjects with a booster dose two years following the original administration of the treatment.

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