The FDA has delayed the PDUFA date for Moderna’s RSV vaccine, the company announced Friday morning.
The delay likely won’t push the decision past the end of May, according to Moderna’s press release, and regulators have not raised any concerns about “vaccine safety, efficacy or quality” preventing the shot’s approval. Rather, the FDA cited “administrative constraints” for the delay, and the shot is still on track to be reviewed at the CDC’s June ACIP meeting, when the agency will make its recommendations for the upcoming RSV vaccine season.
Moderna shares $MRNA were down about 1% to 2% in Friday premarket trading.
TD Cowen analyst Tyler Van Buren told Endpoints News in an email Friday morning that the delay “does not change the probability of approval in my mind.” William Blair analyst Myles Minter also said he expects the shot to be approved in time for the ACIP meeting.
The PDUFA had originally been scheduled for May 12, which would have given the company its first approved product that falls outside a once-in-a-century public health crisis. An approval is expected to be a formality ahead of the ACIP meeting, Van Buren and other analysts told Endpoints, leaving Moderna with lingering questions for at least another six weeks.
Moderna’s near-term plans hinge on the success of the RSV vaccine. The company laid out a plan to return to growth by 2026, which necessitates reversing the $4.7 billion loss it recorded in 2023 in a two- to three-year span.
“I think everyone unanimously thinks that it will get approval,” Minter said this week before Friday’s delay was announced. “How those [ACIP] recommendations play out, and where Moderna’s product positioning will be, is front of mind for investors.”
With Covid vaccine sales sharply in decline since the peak of the pandemic, Moderna’s RSV shot will need to make up much of the difference in order for the company to reach its goals. Execs have also been slashing costs across the board, although Moderna’s R&D spending this year is still expected to be about $4 billion.
Investor reactions have been mixed: Moderna’s stock price fell 45% in 2023, but is up about 10% for the year, including a 45% rise since a mid-February low.
RSV vaccine competition with GSK and Pfizer will be tough, as the pair combined for $2.5 billion in sales last year, surpassing expectations and invigorating GSK in particular. Most of that revenue came from the 60-and-older population, Van Buren said, and Moderna’s entry is likely to increase the amount of people vaccinated.
As such, key for Moderna will be market share and elbowing GSK and Pfizer out of the way. The total market for elderly RSV vaccine recipients could reach as much as $3 billion, Van Buren said.
“One would reason that in the second season, especially with three companies, that elderly sales would go up,” Van Buren said. “If they’re able to really compete, and at least take an equivalent share of the market, they could do $1 billion [in elderly sales].”
Pharmacy footprint critical
Chief among the questions facing Moderna is how quickly it can secure contracts with big pharmacies like CVS and Walgreens in order to compete with GSK and Pfizer.
Stephen HogeThe “overwhelming majority” of sales will come through retail pharmacies, Moderna president Stephen Hoge said at an investor conference in March. The CDC, at February’s most recent ACIP meeting, estimated that about 82% to 89% of shots were administered at a pharmacy in any given week between mid-November 2023 and early February 2024.
Moderna stayed mum on the contracting issue during its earnings call earlier this month, citing its inability to formally discuss them until the ACIP recommendations come through. The company also declined to comment on this article through a spokesperson. It’s left investors and analysts trying to tease or parse out any hints they can.
Lavina Talukdar, Moderna’s head of investor relations, said at a separate conference in March that based on the company’s experience with Covid, dispensing shots should come quickly after signing those contracts.
“Before the season starts, we should be through contracting,” Talukdar said at the time. “So, as in the case of Covid, we only really needed two months’ notice, if you will, in order to fulfill supply needs in the market, and I think it will be similar for RSV.”
There have also been investor concerns about whether ACIP will recommend once-yearly dosing or once-every-other year dosing, as Moderna’s vaccine efficacy appeared less durable than GSK’s and Pfizer’s, Van Buren said. But he views that as unlikely, since every other seasonal vaccine is dispensed yearly and ACIP is already on the record saying that for maximum protection, one should be dosed at the beginning of every RSV season.
One thing that won’t be a concern is Moderna’s manufacturing capabilities, Minter and Van Buren both said. Although the biotech has reduced its manufacturing costs, it largely resulted in a more streamlined process rather than shutting down plants. Moderna expects to be ready at the beginning of the RSV vaccine season in September.
“Instead of having five managers to do QC at a particular site, you can just have one managing a team, that sort of thing,” Minter said. “But the underlying capacity and footprint from a donor hasn’t really changed.”
Editor’s note: This story and headline have been updated to include the new information Friday morning of the FDA delaying Moderna’s PDUFA.