It's unprecedented times for the Covid vaccine market, experts say. And, though the Food and Drug Administration signed off on their boosters, Pfizer and Moderna remain under significant pressure.
Pfizer with German partner BioNTech, Moderna and Novavax are launching their updated booster shots, targeting the prevalent LP.8.1 strain.
But these launches come at a time of major uncertainty in the vaccines market. Robert F. Kennedy Jr., a well-known skeptic of vaccines, leads the Department of Health and Human Services, the agency that sits over the FDA and the Centers for Disease Control and Prevention. The CDC, for its part, has yet to weigh in on whether it will actually recommend the already approved shots. Without the CDC's go-ahead, many insurers might opt against covering the costs of these shots.
Meanwhile, the Senate took RFK Jr. to task on Thursday with members on both sides of the political aisle accusing him of trying to deny people vaccines. On Friday, Sen. Edward Markey, D-Mass., will hold a press conference with former CDC Director Rochelle Walensky "slamming RFK Jr.'s reckless and irresponsible anti-vaccine rhetoric." They plan to call for the health secretary's resignation.
All in all, this fall vaccine season is something new entirely, says Alicia Heesen, a consultant with health care technology firm MMIT.
"I do think some (vaccine makers) might be holding their breath and waiting to see," Heesen told Investor's Business Daily. "I think that they are going into the season trying to prepare for something that no one could have ever prepared for."
RFK Jr. Grilled Over Vaccines
The battle with RFK Jr. hit a fever pitch this week. Senators grilled him for over three hours Thursday over the widespread changes to vaccine research and access under his health department.
The CDC remains a key point of contention.
Earlier this year, Kennedy fired the independent advisors in charge of determining if the agency should recommend specific vaccines. He later replaced them with his own handpicked members.
Kennedy also ousted the CDC's new director, Susan Monarez, less than a month into the job. According to NBC News, her lawyers say she "refused to rubber-stamp unscientific, reckless directives." The White House says she was "not aligned with the President's agenda."
"It's been obvious from the start that Robert Kennedy's primary interest is to take vaccines away from Americans," Sen. Ron Wyden, D-Ore., said during the hearing Thursday, according to the New York Times.
"Effectively, we're denying people vaccine," said Sen. Bill Cassidy, a Republican from Louisiana. Cassidy initially had misgivings over Kennedy's appointment to the health secretary role, but ultimately supported the nomination.
Trump Lambastes Covid Vaccine Makers
President Donald Trump is aiming his ire in another direction.
In a high-profile brawl on Sept. 3, Trump and the chief executives of Pfizer and Moderna went tit for tat over Operation Warp Speed. Operation Warp Speed was a public-private partnership announced during Trump's first White House tenure to quickly develop Covid vaccines, treatments and tests. It came during the earliest days of the pandemic.
Trump called on drug companies to justify the success of their various Covid drugs.
"Many people think they are a miracle that saved Millions of lives," Trump said in a post to Truth Social. "Others disagree! With CDC being ripped apart over this question, I want the answer, and I want it NOW. I have been shown information from Pfizer, and others, that is extraordinary, but they never seem to show those results to the public. Why not???"
His claim is not true. The companies have all published study results in news releases and medical journals. A study published in the Journal of the American Medical Association in July shows Covid vaccines averted an estimated 2.5 million deaths between 2020 and 2024.
'Public Health Achievement'
Albert Bourla, Pfizer's CEO, called Operation Warp Speed a "profound public health achievement," helping to save more than 14 million lives across the globe. He stood by Pfizer's Covid vaccine data, sharing a link to the many updates published since March 2020.
"President Trump's call for transparency is welcomed, and we remain deeply committed to that principle," he said in a written statement. "Transparency has always been a cornerstone of trust, and we are dedicated to continuing to provide clear, factual data to the public. To date, data on Pfizer's COVID-19 vaccine have appeared in over 600 peer-reviewed publications."
Similarly, Moderna highlighted the "hundreds of peer-reviewed publications" it has shared with U.S. regulators regarding its Covid vaccines. The company noted it has conducted vaccine effectiveness studies every year in more than 5 million people to date.
"We have also actively monitored the safety of the more than 1 billion doses administered to-date, and have always transparently shared those results with regulators and with the public, including through peer-reviewed publications and presentations," the company said in a written response.
CDC Quagmire Could Rattle Vaccines
Still, there could be some truth to Trump's assertion the CDC is struggling with how to approach the Covid vaccines. The CDC's Advisory Committee on Immunization Practices is expected to meet later this month to determine whether to recommend the already approved Covid vaccines.
Leerink Partners analysts say there's uncertainty heading into that meeting. Key opinion leaders — often including doctors and other medical experts — say Kennedy could further reduce access to Covid vaccines in the future.
"The KOLs see a 'two steps forward, one step back' dynamic at play with this administration, and see fewer 'positive' vaccine updates and 'increasingly negative' vaccine policy over time," they said in an August report to clients.
MMIT's Heesen says CDC recommendations are going to be quite important heading forward.
MMIT conducted a survey of insurance companies. A quarter said they would align their coverage plans with the CDC's recommendations. Four in 10 payers, though, said they wouldn't change reimbursement if the agency limits who should receive Covid vaccines.
Demand For Covid Vaccines Is Waning
The market for Covid vaccines has dwindled for years, but still remains an important contributor to sales for Pfizer, BioNTech, Moderna and Novavax.
For Pfizer, the biggest of the quartet, sales of its Covid vaccine, Comirnaty, brought in $5.35 billion in 2024 sales. Though that's a far cry from its peak of $37.81 billion in 2022 sales, it still accounted for 8% of Pfizer's massive topline last year. For the remaining three, virtually all of their sales came from their Covid vaccines. Moderna also sells a vaccine to prevent respiratory syncytial virus, or RSV.
On Aug. 27, the FDA approved the suite of Covid vaccines for all people age 65 and older, and for younger people who are at risk of developing severe Covid. The approvals line up with FDA guidance issued in May, William Blair analyst Myles Minter said in a report.
But views from on high could rattle the makers of Covid vaccines.
Narrowed Use Of Covid Vaccines
Ultimately, it will be on the companies to advocate for their Covid vaccines, Heesen said.
"This opens up an opportunity for manufacturers to step in and take on that role as one of the key sources for payers and maybe even (health care professionals) as well," she said.
But the Covid vaccine makers should expect an uphill battle. Leerink analysts expect the CDC's board to opt against recommending the boosters. A recent work group estimated 60% to 70% of the U.S. population is at risk of developing severe Covid. But demand for Covid vaccines has declined markedly over the years.
"As such, this narrowing of authorized use, combined with already limited demand from healthy individuals, presents limited near-term risk to COVID-19 manufacturers, in our view," they said.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
