When
Pfizer
and
GSK
rolled out the first vaccines to prevent respiratory syncytial virus in older adults last year, they didn’t say how often seniors might need to take the shots. Would people get the jabs every year, like they do for influenza, or would the process be more like that for GSK’s shingles vaccine, which is good for at least seven years?
As the second respiratory virus season of this new RSV-vaccine era approaches, regulators are working toward a decision. Sales of the RSV vaccines smashed expectations in 2023, so the stakes are high for GSK,
Pfizer,
and
Moderna,
which plans to enter the market this year.
GSK which already dominates the market, stands to gain if public-health officials endorse something less frequent than an annual schedule. A call for annual shots could give Pfizer and
Moderna
a better chance of holding their ground.
A meeting of the Centers for Disease Control and Prevention’s influential vaccines advisory committee this Thursday could offer clues about what the agency will decide. Analysts don’t expect the CDC committee, known as the Advisory Committee on Immunization Practices, to make a decision until June.
But the discussion scheduled for Thursday morning could give investors a sense as to how the advisors are leaning, which could have implications for the drugmakers’ stocks.
CDC staff will provide updates on the rollout of the RSV vaccines, and Moderna will make a presentation on the efficacy of its RSV vaccine, which is currently awaiting Food and Drug Administration approval.
In a note out Sunday, Jefferies analyst Michael Yee says he puts 50% to 70% odds on the committee eventually supporting annual RSV vaccination. “We believe Street consensus is probably c.50/50 for annual vs every-other-year, but we think it would be confusing for ACIP to put out biennial recommendations,” he wrote.
The data the companies have presented so far seem to point to GSK’s shot performing better and lasting longer than the competitors, though it remains difficult to parse.
Moderna shares fell in early February after the company released complex data on the efficacy of its RSV vaccine over time. The interpretation of that data has been controversial. While one analyst from TD Cowen said that the Moderna vaccine looked like it lost efficacy more quickly than the GSK vaccine, another from Barclay’s wrote that the two shots look similar, and that the observed difference was because of a change between seasons.
Moderna could clear up some of this controversy during its Thursday presentation. The company is counting on its RSV vaccine to be its first marketed product after the Covid-19 vaccine that made Moderna a household name. Approval this spring by the Food and Drug Administration would allow time for the CDC to issue a recommendation in June, queuing the shot up for a fall rollout.
GSK, which has presented the strongest efficacy data, has so far dominated the market. The company says that its RSV shots accounted for 68% of those administered this year in the U.S., and that sales were $1.5 billion. A recommendation from the CDC for RSV shots every two or three years would likely solidify that lead.
“A debate on annual vs biennial might present risk for use of MRNA, as GSK has suggested higher durability,” Yee wrote.
The CDC’s advisors have been lukewarm on the RSV shots in the past. Their initial endorsement of the GSK and Pfizer shots last June was more tepid than expected, saying that adults aged 60 and up “may receive” an RSV vaccine if they and their physician agree it’s right for them. They chose not to say the shots “are recommended” for people 60 and older, as a committee working group had suggested.
This year, the committee will be considering both how often the shots should be given, and whether the recommendation should be expanded to adults aged 50 and up.
The presentations about the RSV vaccines will come partway through a two-day meeting that begins Wednesday at which the agency’s advisors will hear data presentations on a long list of vaccines, including vaccines for Covid-19 and influenza. The RSV presentations are scheduled to begin at 8:30 a.m. Eastern on Thursday.
Write to Josh Nathan-Kazis at [email protected]
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