US FDA Preparing to Vote on these Potential RSV Vaccines

Feb 28, 2023

Investors may want to keep an eye on Pfizer (PFE) and GSK (GSK).

That’s because a US FDA advisory panel its two-day meeting to discuss dueling respiratory syncytial virus (RSV) vaccines from the two companies.  By Wednesday evening, the panel will have voted on whether they believe data from the two companies supports the effectiveness and safety of the vaccines for older adults.  

Right now, there are no RSV vaccines.  

That’s because “Developing RSV vaccines has historically been difficult because the main protein on the outside of the virus, called the F protein, changes shape when it infects cells. The most effective antibodies, either natural or factory-made, target a part of this protein that is only exposed before this shape change,” as noted by New Scientist. 

However, that could soon change – with Wednesday’s vote a key step forward.

Also, “The committee’s votes will inform decisions on approval by the FDA staff, which are due for the Pfizer vaccine on May 31, and for the GSK vaccine on May 3. The CDC’s advisers, whose recommendations guide the usage of vaccines in the U.S., will meet again in June. They could vote on whether to recommend the vaccines at that meeting, or at a meeting in October,” says Barron’s. 

We also know that Pfizer’s Phase 3 study found that the shot was 66.7% efficacious in preventing cases of RSV-associated lower-respiratory-tract infections with two or more symptoms and 85.7% effective at preventing those infections with three or more symptoms with older adults. 

Meanwhile, GSK’s Phase 3 study found that its vaccine was 82.6% effective at preventing RSV-associated lower-respiratory-tract disease. Effectiveness against RSV-associated acute respiratory illness was 71.%.

Positive votes on Wednesday could lead to a big moneymaker for Pfizer, which says its RSV vaccine could bring in more than $2 billion in annual revenue by 2027.  

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