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Susan Monarez is fighting back against an attempt to remove her as head of the US Centers for Disease Control and Prevention (CDC). On Wednesday afternoon, the US Department of Health and Human Services (HHS) announced in a post on X that Monarez "is no longer director" of the CDC, with the Washington Post reporting that her ouster was due to her refusal to support COVID-19 vaccination policy changes pushed by health secretary Robert F. Kennedy Jr. Now, lawyers for Monarez have confirmed that she was "targeted" for not backing Kennedy's agenda — and that she "has neither resigned nor received notification from the White House that she has been fired." In a post on X, Mark Zaid said he and fellow attorney Abbe Lowell are representing Monarez. He shared a statement asserting that "as a person of integrity and devoted to science, she will not resign."  "When CDC Director Susan Monarez refused to rubber stamp unscientific, reckless directives and fire dedicated health experts she chose protecting the public over serving a public agenda," according to the statement.  Earlier on Wednesday, the FDA announced new regulations on COVID-19 vaccines. The agency rescinded emergency-use authorisations for Pfizer and BioNTech's Comirnaty, as well as Moderna's Spikevax — both of which allowed all individuals aged six months and older to receive the mRNA vaccines. Now, the jabs are limited to all adults 65 and older and certain at-risk populations; Comirnaty is available to those between the ages 5 and 64 with at least one underlying risk factor, while Spikevax is cleared for individuals six months and older at risk for severe disease.  The statement from Monarez's lawyers seemed to describe the attempt to oust her as yet another action by Kennedy aimed at undermining the CDC.  "First it was independent advisory committees and career experts," they wrote, seeming to refer to the abrupt firing of all 17 sitting members of the CDC's Advisory Committee for Immunization Practices (ACIP) — and their hastily named replacements, several of whom had previously spread vaccine misinformation.  "Then it was the dismissal of seasoned scientists," it continued. Earlier this year, HHS announced plans to fire 2400 workers at the CDC, though a recent court ruling seems to have limited the mass layoffs to about 600 employees. "Now, Secretary Kennedy and HHS have set their sights on weaponizing public health for political gain and putting millions of American lives at risk," the statement concluded.It's the second time in less than a week that a CDC employee has described Kennedy as posing a threat to the health of Americans. Hundreds of current and former agency staffers penned an open letter to the health secretary last week accusing Kennedy of being "complicit in dismantling America’s public health infrastructure and endangering the nation’s health by repeatedly spreading inaccurate health information."

iStock, Yulia Sutyagina The American Academy of Pediatrics called the decision to limit children’s access to COVID-19 vaccines “deeply troubling.” The FDA has approved updated COVID-19 vaccines from Pfizer, Moderna and Novavax, but with key limitations: The shots can only be used in adults 65 years and older and younger people who are at elevated risk of severe outcomes. There are some minor differences across the three Wednesday approvals, particularly as it pertains to use in the at-risk younger population. Novavax’s protein-based vaccine can only be given to individuals aged 12 through 64 years , while Pfizer and BioNTech’s ’s mRNA-based Comirnaty can be given to children as young as 5 years . (This is the first time that Comirnaty will receive full approval for children, for whom the vaccine was only previously under emergency use authorization ). Two of Moderna’s updated vaccines were approved on Wednesday. The first, mNEXSPIKE, is indicated for those 12 through 64 years, while the second, Spikevax, has a broader coverage of 6 months through 64 years. In a statement on Wednesday, American Academy of Pediatrics president Susan Kressly blasted the decisions, noting that limiting children’s access to vaccines is “deeply troubling.” “As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families,” she said. The AAP continues to recommend COVID-19 immunization for “all children ages 6 months through 23 months.” Parents who want their children immunized should also have that option and access to the vaccine, Kressly said. In a note to investors on Wednesday evening, investment analysts at William Blair noted that “Despite rhetoric that [Health Secretary Robert F. Kennedy Jr.'s] HHS could consider terminating COVID-19 vaccine use,” Wednesday’s approvals are largely consistent with previous guidance issued by the FDA in May focused on seniors and high-risk populations. These approvals signal that FDA is “maintaining autonomy” and continuing to uphold “data-driven science decisions on vaccine approvability.” This, the analysts continued, is “important for industry integrity as a whole, regardless of any negative political sentiment.” Wednesday’s approvals are the latest in a spate of vaccine policy changes enacted by Kennedy. In May, for instance, the Secretary removed routine COVID-19 vaccination for healthy children and healthy pregnant women from CDC recommendations. Kennedy’s moves have also engendered controversy within the CDC. Late Wednesday evening, CDC director Susan Monarez was f ired by the White House at Kennedy’s urging, in part because she refused to support rescinding certain approvals for COVID-19 vaccines without first consulting her advisors. It is unclear when the previous formulations of these vaccines will be phased out, and at which point these newly updated shots will become unavailable to those who fall outside the CDC’s guidelines. There also remain uncertainties over payer coverage for these vaccines, and whether doctors will be able—or willing—to prescribe these shots off-label to people who want them. Wednesday’s approvals will now go to the CDC’s Advisory Committee on Immunization Practices, which, according to William Blair, will convene by the end of September to discuss recommendations for COVID-19 vaccination. Kennedy in June purged all 17 members of the committee and replaced them days later with just eight panelists, some of whom have documented histories of vaccine criticism.

The FDA clearances come amid a testing time for mRNA technology in the US. Credit: Mirza Kadic via Shutterstock.com. The US Food and Drug Administration (FDA) has approved updated mRNA vaccines from Moderna and Pfizer/BioNTech that protect against Covid-19, despite a broader policy shift shunning the modality in the US. Moderna has scored approvals for updated formulas to its Spikevax vaccine and new vaccine mNEXSPIKE, while Pfizer and BioNTech have received an updated approval for Comirnaty. The supplemental biologics licence applications (sBLA) cover changes in the vaccines that target the LP.8.1 sublineage of the SARS-CoV-2 virus. The LP.8.1 sublineage is currently a dominant variant of the virus and is the preferred target of vaccines for use beginning in autumn 2025, as per guidance from the FDA. Comirnaty has been licensed for adults aged 65 and above, as well as individuals aged five to 64 years with at least one underlying condition that puts them at high risk for severe outcomes from Covid-19. Moderna’s Spikevax has a broader range. The jab is approved for babies from as young as six months of age. Within the six-month to 64-year age range, individuals must have at least one underlying condition that puts them at high risk for severe outcomes from Covid-19 to take the vaccine. Patients aged 65 and above are eligible. Moderna’s mNEXSPIKE, which was only approved in the US in June 2025, is licensed for patients aged at least 12 years. Those aged 64 years and younger must have at least one underlying condition to be eligible. As with Spikevax, all those aged 65 years and older can be administered with the vaccine. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Pfizer and BioNTech said they will immediately begin shipping their vaccine, with it expected to be available in pharmacies, hospitals, and clinics across the US “in the coming days”. Moderna also said its updated vaccines “are expected to be available in the coming days”. William Blair analysts said in a research note: “We see today’s outcome as the FDA maintaining autonomy and data-driven science decisions on vaccine approvability, important for industry integrity as a whole, regardless of any negative political sentiment.” The FDA approvals come amid a testing time for mRNA technology in the US. US health secretary Robert F Kennedy (RFK) Jr cut $500m worth of mRNA funding earlier this month. This amounted to the termination of 22 mRNA vaccine development initiatives, impacting many big pharma companies and smaller biotechs. RFK Jr has long held a negative opinion of mRNA vaccines, maintaining that they hold more risks than benefits. The cuts to mRNA funding are part of a wider shift in the US away from vaccines more generally, given RFK Jr’s anti-vax views. Regulatory shifts include the overhaul of a committee that licenses vaccines in the US with controversial experts , while another example is the restriction of Covid-19 booster shots to the elderly. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now