Dive Brief:
- The Food and Drug Administration on Wednesday said it will consult a group of vaccine and infectious disease experts on its review of two experimental vaccines for infections caused by respiratory syncytial virus, or RSV.
- The agency will convene the first advisory committee meeting on Feb. 28 to discuss an RSV vaccine candidate developed by Pfizer, followed by another on March 1 to assess a competing shot from GSK.
- Both Pfizer and GSK have asked the FDA to approve use of their RSV vaccines in adults over the age of 60, following positive results in Phase 3 testing that they separately disclosed last year. The coming meetings will be one of the final regulatory steps before a decision.
Dive Insight:
After many unsuccessful attempts at creating an RSV vaccine, the biopharmaceutical industry is on the cusp of a breakthrough. Along with Pfizer and GSK, Moderna, Johnson & Johnson, Bavarian Nordic have shots advancing through late-stage testing. (Sanofi, along with its partner AstraZeneca, has a preventive antibody drug under review by the FDA for use in infants, and a vaccine that’s earlier in development.)
The virus causes cold-like symptoms in most adults, but can be deadly in young infants and the elderly. The recent RSV season has been particularly acute, with a higher rate of hospitalizations than in previous years.
In testing, GSK set a high bar with its Phase 3 results in older adults. Its vaccine candidate reduced cases of lower respiratory infection by about 83% compared to a placebo, and was even more effective against cases that were rated more severe. Preliminary data revealed by Pfizer in August showed its vaccine was 86% effective against more severe disease, but somewhat less protective, 67%, against moderate disease.
In a recent earnings call, Pfizer CEO Albert Bourla expressed confidence in his company’s RSV candidate, mentioning it as an important launch that will help drive revenue growth.
While Pfizer and GSK’s vaccines are already being reviewed by regulators, Moderna’s shot is right behind the two. Earlier this month Moderna reported that its experimental RSV vaccine was about 84% effective in a Phase 3 trial involving adults over 60. It expects to ask for approval sometime in the first half of the year.
Background material on Pfizer’s and GSK’s vaccines will be provided by the FDA two days before the first meeting on Feb. 28.
Correction: This story has been updated to note Sanofi is further along in developing a preventive antibody drug for RSV.