Moderna (NASDAQ: MRNA) shares have tumbled 31% since January 28, capped by a 7% decline Thursday and a 2% dip Friday in the messenger RNA (mRNA) vaccine developer’s stock following a news report that the U.S. Department of Health and Human Services (HHS) was reviewing a $590 million contract for bird flu vaccines approved in the last days of Joe Biden’s presidency.
The review is the latest in a series of actions by the administration of President Donald Trump focused on vaccines, especially mRNA shots most famously applied in the development of COVID-19 vaccines. The actions follow the confirmation of Robert F. Kennedy Jr., a sharp critic of mRNA vaccines like the COVID-19 jabs, as HHS secretary.
During his U.S. Senate confirmation hearing, Kennedy testified that he was “pro-safety” rather than anti-vaccine: “I believe vaccines have a critical role in healthcare; all of my kids are vaccinated.” But he added: “In my advocacy, I have often disturbed the status quo by asking uncomfortable questions, and I’m not going to apologize for that.” Since his confirmation, Trump signed an executive order creating a “Make America Healthy Again” commission to be chaired by Kennedy, who has promised to “reverse the chronic disease epidemic in America” as HHS Secretary.
“We’re going to make chronic disease our top priority. We will examine our food, our water, our lifestyles, and our environment—everything that goes into Americans’ bodies,” Kennedy vowed in remarks posted February 21 on his official page on X. The posted remarks omitted the word “vaccines” but used visual images that included a few seconds of vials on a conveyor belt at a vaccine production line. “I promise you that I will enter this inquiry with an open mind and a willingness to be wrong.”
In a video excerpt of Kennedy’s remarks to HHS employees posted on X, he included “the childhood vaccine schedule” among potential causes of chronic disease to be investigated: “Whatever belief or suspicion I have expressed in the past, I’m willing to subject them all to the scrutiny of unbiased science.”
The inquiry appeared to veer from an assurance cited publicly by Sen. Bill Cassidy (R-LA): “Mr. Kennedy and the administration reached out seeking to reassure me regarding their commitment to protecting the public health benefit of vaccination.” But in a February 19 post on X, Cassidy wrote: “The commitments I received from RFK Jr. and the administration never precluded him from conducting sound scientific research. I’m confident any reputable review will further confirm settled science of the safety and efficacy of the childhood vaccine schedule.”
The heightened scrutiny of vaccines and vaccine policy has raised concerns among public health stakeholders that Washington will, as a result, respond more slowly than needed to address diseases, including the H5 bird flu outbreak that has catapulted the price of eggs to all-time highs. The CDC’s bird flu webpage listed 70 confirmed cases, seven probable cases, and one death in the United States as of deadline Saturday.
In a commentary published Sunday by Fox News, Kennedy urged parents to “consult with their healthcare providers to understand their options to get the MMR vaccine” in response to the South Plains, Texas, measles outbreak that has seen 146 confirmed cases since late January. “The decision to vaccinate is a personal one,” Kennedy wrote, adding: “Vaccines not only protect individual children from measles, but also contribute to community immunity, protecting those who are unable to be vaccinated due to medical reasons.”
“Failed oversight”
“While it is crucial that the U.S. Department of Health and Human Services support pandemic preparedness, four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production,” a spokesperson for HHS contended in a statement to Bloomberg News, which first reported the review.
In January, under Biden, HHS awarded Moderna the $590 million contract, designed “to accelerate the development of mRNA-based pandemic influenza vaccines and enhance mRNA platform capabilities so that the U.S. is better prepared to respond to other emerging infectious diseases,” the agency stated at the time.
Moderna said the effort was intended to support late-stage development and licensure of pre-pandemic mRNA-based vaccines, as well as the expansion of clinical studies for up to five additional subtypes of pandemic influenza. Moderna said last month it plans to advance its pandemic influenza vaccine candidate mRNA-1018 into a Phase III trial after generating positive preliminary data in a Phase I/II study (NCT05972174) assessing the jab’s safety and immunogenicity in healthy adults aged 18 years and older—a trial that included vaccine candidates against H5 and H7 avian influenza viruses (H5N8, H7N9, H5 only, and H7 only in part A; H5 only-CG in part B). Moderna said it plans to share the Phase I/II results at an upcoming scientific meeting.
News of the HHS contract sparked a 14% surge in Moderna’s stock over three trading days, from $33.76 the day before the January 17 announcement to $38.50 on January 22.
HHS made the contract award through the Rapid Response Partnership Vehicle (RRPV) Consortium with funding from the Biomedical Advanced Research and Development Authority (BARDA), part of HHS’s Administration for Strategic Preparedness and Response (ASPR). The award was part of the medical countermeasures portfolio of the BARDA Influenza and Emerging Infectious Diseases Division and was made under Other Transaction Number: 75A50123D00005.
Moderna shares began Thursday slipping 8% during the first half hour of trading, to a low of $31.01 at 10:01 a.m. ET, before the stock finished the day at $31.09. Shares dipped another 0.4% Friday, to $30.96.
Advisory meeting postponed
The selloff capped a month in which Moderna shares fell from $44.94 on January 28, as the company weathered mixed fourth quarter and full-year 2024 results, and another regulatory action: On February 20, the scheduled February 26–28 meeting of the Advisory Committee on Immunization Practices (ACIP) was postponed. ACIP advises the U.S. Centers for Disease Control and Prevention (CDC) on how vaccines designed to prevent disease should be used.
The agenda for that ACIP meeting, which has yet to be rescheduled, included three items concerning vaccines developed by Moderna:
• A presentation of immunogencity data for its respiratory syncytial virus (RSV) vaccine mRNA-1345 in adults ages 18–59 at increased risk of the disease following 24-month re-vaccination.
• Discussion of data from the company’s COVID-19 vaccine SpikeVax (mRNA-1283)
• A presentation of safety and immunogenicity data for the company’s cytomegalovirus (CMV) vaccine.
The CMV data presentation was “likely from the Phase II [trial] and not the Phase III,” Jefferies equity analyst Michael J. Yee wrote February 20 in a research note.
Moderna anticipates efficacy data later this year from the Phase III trial, which is assessing Moderna’s CMV candidate mRNA-1647 for efficacy, safety, and immunogenicity in the prevention of primary infection in women of childbearing age. While fully enrolled and accruing cases, Moderna acknowledged on February 14 that the trial did not meet the criterion for early efficacy when reviewed by the study’s Data Safety Monitoring Board (DSMB), which recommended instead that the study continue as planned.
While HHS said the ACIP meeting was postponed to accommodate public comments, Yee countered: “This is odd given the agenda already ha[d] public comments scheduled for RSV and flu which are two indications and discussions being voted on at the February meeting.” HHS told Politico the federal public comment portal for the meeting was never activated, which contributed to the postponement decision. The portal was supposed to have been open from February 3 through February 17.
Infectious Diseases Society of America president Tina Tan, MD, criticized the postponement in a statement: “Postponing a meeting of the Advisory Committee on Immunization Practices delays vital discussions and needed decisions on a variety of vaccines by trusted and well-vetted experts.”
Tan also cited the CDC’s removal of images for its Biden-era “Wild to Mild” campaign designed to promote flu vaccination, the subject of an NPR report attributed to two unnamed CDC staffers: “Taken together, these actions run completely counter to the spirit of the commitments Secretary Kennedy made to uphold ACIP and continue disseminating credible, scientifically-based vaccine information through federal government websites and communications. Congress must hold Secretary Kennedy accountable for these actions.”
Report: ACIP members face replacement
More speculation about the reason for the cancellation emerged last week, after Politico reported that Kennedy planned to replace members of ACIP who are considered to have conflicts of interest with vaccine developers, citing an unnamed source. The news outlet said HHS had not responded before publication while the CDC declined comment.
ACIP’s other two meetings planned for this year are still scheduled to take place on June 25–26 and October 22–23.
Also this month, the scheduled March 13 meeting of its Vaccine and Related Biological Products Advisory Committee (VRBPAC) has been canceled without explanation, a member of the committee, Paul A. Offit, MD, of the Children’s Hospital of Philadelphia, told CNBC: “Why did they cancel the meeting? Will manufacturers now turn to the World Health Organization to determine strains for this year’s influenza vaccines?”
Moderna’s February stock slide was reversed mid-month when the company reported mixed fourth-quarter and 2024 results. The company finished Q4 with a net loss of $1.12 billion, down from $217 million in net income a year earlier, on revenue that plummeted by two-thirds (66%) year-over-year to $966 million from $2.811 billion in Q4 2023. For all of last year, Moderna reported a net loss of $3.561, a 25% improvement over its $4.714 billion net loss in 2023.
Moderna CEO Stéphane Bancel cited as Q4 positives the company’s filing of three biologics license applications (BLAs) and reducing costs by 27% year-over-year.
“In 2025, we remain focused on driving sales, delivering up to 10 product approvals through 2027, and expanding cost efficiencies across our business,” Bancel said in a statement. “By the end of 2025, we aim to remove nearly $1 billion in costs. With strong momentum in our late-stage pipeline, we anticipate multiple approvals starting this year, along with key Phase [III] readouts that will support our long-term growth.”
Moderna’s earnings report sparked a 12.5% jump over three days in the stock price, from $31.92 the day before the February 14 release to $35.90 on February 19.
For 2025, Moderna projected its revenue will range from $1.5 to $2.5 billion—of which only approximately $0.2 billion is expected to be generated in the first half of the year, which according to the company reflected the seasonality of its respiratory business.
“We are pleased that MRNA is taking an increasingly conservative approach to its financial guidance with the high end of the ’25 top-line guidance assuming the business is flat ex[cluding] one-timers and the low end contemplating decreased vax rates, share loss, etc.,” J.P. Morgan analyst Jessica Fye wrote February 14 in a research note.
Leaders and laggards
• AEON Biopharma (NYSE American: AEON) shares cratered 84% over two trading days, from $8.64 to $1.42 Wednesday after the developer of therapeutic neurotoxins based on its botulinum toxin complex announced a 1-for-72 reverse stock split that took effect Wednesday. AEON said the reverse stock split was primarily intended to bring it into compliance with NYSE American’s requirements and policies. CNS shares will continue to trade on NYSE American under the symbol AEON, but under a new CUSIP number, 00791X 209. Shares plunged 43% from $8.64 at the close on February 21 to $4.90 on February 24, stayed unchanged the following day, then plummeted another 71% to $1.42 Wednesday.
• Invivyd (NASDAQ: IVVD) shares nosedived 30% from $1.77 to $1.24 on February 24 after the FDA rejected the company’s request to expand the Pemgarda™ (pemivibart) emergency use authorization (EUA) granted last year for pre-exposure prophylaxis of COVID-19. Invivyd asserted that expansion would provide a treatment option for mild-to-moderate COVID-19 in adults and adolescents with moderate-to-severe immune compromise due to conditions such as cancer and organ transplant, and for whom alternative treatments were not accessible or clinically appropriate. “FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs in a bridging analysis of sVNA [serum virus neutralizing antibody] titer levels,” Invivyd stated. The company quoted the FDA in adding that absent such analysis, the agency is “unable to reasonably conclude that the known and potential benefits of pemivibart…outweigh the known and potential risks.”
• Organovo Holdings (NASDAQ: ONVO) shares more than tripled, rocketing 244% from 37 cents to $1.27 Tuesday after the company announced that it had sold its FXR program including its lead asset, the Phase II-ready FXR314, to Eli Lilly (NYSE: LLY) for up to $60 million, according to a regulatory filing—$9 million upfront, another $1 million after 15 months, plus up to $50 million in payments tied to Lilly achieving key regulatory and commercial milestones. Lilly is also acquiring all commercial and intellectual property rights to the FXR program for worldwide development. “This is a significant milestone for our efforts to advance medicines for IBD [inflammatory bowel disease] using insights from our proprietary 3D human tissue models,” Organovo executive chairman Keith Murphy stated. Shares sank 33% Wednesday to 85 cents and dropped another 23.5% to 65 cents Thursday on apparent profit-taking.
• Praxis Precision Medicines (NASDAQ: PRAX) shares skidded 41% from $65.03 to $38.60 Friday after the company said it would continue to completion Study 1 and Study 2 of its Essential3 program to develop ulixacaltamide in essential tremor (ET). The company acted against a recommendation from Study 1’s Independent Data Monitoring Committee (IDMC) which recommended stopping the study for futility, concluding that ulixacaltamide was unlikely to meet the primary efficacy endpoint. Praxis cited the advanced state of enrollment for both Study 1 and Study 2 in deciding to continue both to completion, with topline data expected in the third quarter. Praxis said it will analyze the data to determine whether it supports submission of a New Drug Application (NDA) to the FDA.
• Tempus AI (NASDAQ: TEM) shares slid 15% from $69.57 to $59.10 Tuesday after the artificial intelligence (AI)-based precision medicine company released fourth quarter 2024 results that missed analysts’ expectations. Tempus reported a non-GAAP loss of 18 cents a share (a $13.014 million net loss), on revenue of $200.68 million, compared with the consensus forecast of a 15 cent a share net loss on $202.8 million in revenue. “[Tempus’] core business growth is slowing, raising doubts about its AI-led narrative and long-term sustainable growth rates,” analyst Michael Wiggins De Oliveira wrote at Seeking Alpha. On Wednesday, shares rebounded 5%, to $62.26, after two electronic transfer funds of ARK Investment Management bought a combined 445,958 Tempus shares. Ark Innovation ETF (NYSE Arca: ARKK) snapped up 367,388 shares while ARK Genomic Revolution ETF (NYSE Arca: ARKG) purchased 78,570 shares.
