Andrew Dunn
Biopharma Correspondent
The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.
Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.
RSV, or respiratory syncytial virus, is one of the most common viruses in the world, and these are the first-ever approved vaccines after several decades of attempts. The Pfizer and GSK programs both build on a key research breakthrough about a key viral protein made around a decade ago by National Institutes of Health researchers.
Annaliesa Anderson
“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century,” Annaliesa Anderson, Pfizer’s chief scientific officer of vaccine R&D, said in a statement. “Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults.”
While GSK and Pfizer are the first companies to secure vaccine approvals, they may soon face additional competition. Moderna announced positive Phase III results from its RSV jab in older adults earlier this year, with plans to file for approval in the first half of 2023. Bavarian Nordic also expects a mid-year readout for a late-stage study of its RSV shot.
Commercial battle heats up
All told, Jefferies analysts forecast RSV to be a $17 billion market by 2033, according to a May 30 research note. They forecast Pfizer reaching a 20% market share, with Moderna and GSK having leading shares, as their shots have numerically higher vaccine efficacy than Pfizer’s.
In the months before the launches, Pfizer’s leaders have already started publicly angling for their own edge in what’s expected to be a competitive market.
In a nutshell, Pfizer has highlighted its vaccine as having a milder side effect profile than GSK’s, which uses an adjuvant. GSK reported higher rates of headache, joint and muscle pain, fatigue, and injection site pain than Pfizer did in its vaccine study.
Bill Gruber
“As you look at the marketplace over time, the vaccine is no good if people don’t get it,” Bill Gruber, Pfizer’s SVP of vaccine clinical R&D, told Endpoints News in April. “The tolerability profile can play a big role there.”
GSK’s vaccine, for its part, has shown a higher level of efficacy. Its shot was about 83% effective at preventing lower respiratory tract disease, while Pfizer’s was about 67% effective by a similar, but not identical, metric.
For all the new RSV vaccines, a key unknown is how many older adults will roll up their sleeves. Jefferies estimates about 80 million people in the US could be eligible, with 40 million to 50 million vaccinations translating to about $6 billion. While GSK and Pfizer have not disclosed specific pricing plans, Jefferies forecast prices of $110 to $150 per dose in the US, along with some commercial discounting.
Pfizer also looks to have the maternal immunization market to itself. GSK dropped its program in 2022, citing safety concerns, while an FDA advisory committee voted May 18 in favor of Abrysvo for use in pregnant people to protect newborns. The FDA is expected to make a decision for that population by Aug. 21.
There could also be a non-vaccine option for infants as well. Sanofi and AstraZeneca’s antibody drug, Beyfortus, has shown 83% effectiveness at reducing hospitalizations, with the FDA set to make an approval decision in the third quarter.
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