Pfizer RSV Vaccine Clears U.S. FDA Advisor Hurdle

The Food and Drug Administration’s vaccine advisors voted to approve Pfizer’s Abrysvo respiratory syncytial virus (RSV) vaccine for older adults as it showed that the vaccine is safe and effective for that demographic.

Photo Insert: The FDA’s decision on the Pfizer RSV vaccine is due May 31 and on GSK’s vaccine on May 3.

Advisors will also decide to recommend approval of GSK’s competing RSV vaccine, Josh Nathan-Kazis and Janet H. Cho reported for Barron’s Daily.

RSV can cause serious illness, especially among adults and newborns. Sanofi, Moderna, and Johnson & Johnson are also working to develop vaccines. Pfizer said last year its RSV vaccines for older adults and expectant mothers could generate $2 billion in annual revenue by 2027.

Some members cited a case of Guillain-Barre syndrome, a rare neurological disorder, in Pfizer’s Abrysvo trial. Dr. Marie Griffin, a professor emerita at Vanderbilt University Medical Center, called the Guillain-Barre issue “very concerning.”

Separately, Novavax shares fell 25% after the biotech firm said there is “substantial doubt” about its ability to continue operating through this year.

The COVID-19 vaccine maker said whether it has enough cash or not to fund operations this year is subject to the uncertainty about its 2023 revenue.

Novavax CEO John Jacobs is prioritizing spending cuts, cash flow management and efficiency. It is working on a COVID-19 shot for fall 2023 vaccinations. Unlike Moderna and Pfizer, Novavax’s vaccine is authorized only as boosters for people who can’t or won’t take other vaccines.

The FDA’s decision on the Pfizer RSV vaccine is due May 31 and on GSK’s vaccine on May 3. If the FDA and the Centers for Disease Control and Prevention (CDC) authorize them, Pfizer and GSK’s vaccines could both be available later this year.

WEEKLY FEATURE : MVP Group Keeps Lights On During Pandemic