Pfizer’s RSV vaccine just won the support of an FDA panel on safety in the elderly. It’s a market that will be worth up to $10 billion in a decade
Pfizer Inc.’s respiratory syncytial virus vaccine was endorsed by a panel of U.S. advisors for its safety and efficacy in people age 60 and older, a key endorsement that brings the drugmaker closer to the lung infection prevention market.
Members of the panel that advises the Food and Drug Administration voted 7 to 4 with one abstention on Tuesday for data presented by the drugmaker to show the vaccine’s effectiveness in preventing RSV. The same panel had previously approved the vaccine by a vote of 7 to 4, again with one abstention, over safety concerns. The FDA is not required to follow the recommendations of the Vaccines and Related Biological Products Advisory Committee, but usually does.
Pfizer is vying with Britain’s GSK Plc to be the first drugmaker to reach the US market with vaccines for the lung disease. GSK will face its own advisory committee hearing on Wednesday for what infectious disease specialists are calling the last major respiratory virus without a vaccine.
Those with weakened immune systems are particularly at risk along with the elderly, with 177,000 hospital admissions and 14,000 deaths among older Americans each year, according to a 2005 study.
Both Pfizer and GSK have presented strong data showing that the vaccines are effective in adults 60 years and older, although there is relatively little evidence of how much the vaccines reduce RSV hospitalizations.
Several FDA Advisory Committee members raised safety questions about two cases of Guillain-Barré syndrome among nearly 20,000 study participants who received the vaccine, which the FDA said before the hearing was a significant potential risk. GBS is a rare condition in which the body’s immune system attacks nerves, which can eventually lead to paralysis, which is usually temporary. Vaccination can rarely trigger the syndrome.
“One case is a red flag, two cases are of great concern, and I am concerned that Pfizer does not believe there are any safety concerns,” said panel member Marie Griffin, professor of public health policy and medicine at Vanderbilt University.
disruptive factors
Pfizer responded that there were confounding factors such as previous medical events occurring in the same two patients and that the elderly population has a higher incidence of the syndrome. The company said it will conduct a post-marketing study and is in contact with the FDA to design it.
Other committee members said the data was sparse. Hana El Sahly, the committee chair, questioned why Pfizer did not wait for data for a second RSV season before seeking regulatory approval. Pfizer said the data is coming soon. Some members even considered postponing the vote until more data became available, including any interactions with flu vaccines.
The adult RSV vaccine market will be worth up to $10 billion by 2032. Pfizer is also joining forces with partners Sanofi and AstraZeneca Plc to develop prevention of dangerous RSV infections in newborns, a market that could reach $1.5 billion, according to forecasts by Bloomberg Intelligence.
Once the FDA decides whether to support the Advisory Committee vote, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will issue recommendations that could have a major impact on how often the RSV vaccines are used — and at what levels of revenue the two are companies ultimately earn from it.
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