mNEXSPIKE

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

The bulk of Moderna’s revenue came from sales of its COVID-19 vaccine Spikevax, which posted a haul of $114 million for the second quarter. As Moderna plows ahead with its multiyear cost-savings scheme, the mRNA specialist delivered a better second quarter than expected despite sales of its vaccines still leaving something to be desired.For the second three months of 2025, Moderna recorded total revenues of $142 million, down roughly 41% versus 2025, against a net loss of $825 million.The bulk of Moderna’s revenue came from sales of its COVID-19 vaccine Spikevax, which posted a haul of $114 million for the quarter. That sum marked (PDF) a 38% decline over the vaccine’s sales in 2024’s second quarter but came out ahead of consensus estimates of $88 million, Myles Minter’s team at William Blair wrote in a note to clients Friday.Moderna’s loss for the period was also less sharp than the $1.16 billion expected by Wall Street, the analysts added.Heading into the third quarter, Moderna now boasts three commercial products with full FDA approvals. Besides Spikevax, the company has secured green lights for its next-generation COVID vaccine, mNEXSPIKE, and the respiratory syncytial virus (RSV) shot mRESVIA.The latter vaccine, which was approved last May, has struggled to catch on amid competition from rival RSV shots produced by Pfizer and GSK.Second-quarter sales of mRESVIA were “negligible,” according to Moderna, and fell well below a consensus sales estimate of $6 million for the period, the William Blair team wrote.Despite the overall decline in commercial product revenue, Moderna was also pleasantly surprised by second-quarter Spikevax sales, which came in above the company’s expectations thanks to a “stronger-than-expected U.S. spring booster season,” Chief Financial Officer Jamey Mock said on an analyst call Friday.Nevertheless, Moderna has lowered its revenue guidance for the year by $300 million. The company now expects to generate total 2025 sales between a range of $1.5 billion to $2.2 billion, which Mock attributed to a “timing shift” in COVID vaccine shipments to the U.K. from the second half of the year into the first quarter of 2026.“This represents the vast majority of the $300 million impact,” the finance chief explained. Moderna’s fortunes have reversed sharply in the transition from a pandemic to an endemic market for COVID-19 vaccines. In an effort to right the ship at the business, Moderna has embarked on a long-term savings drive with the goal of reducing operating costs by about $1.5 billion over the next two years. The company is targeting a cash break-even point sometime in 2028.Looking to its commercial future, the company has also scaled back its work in respiratory vaccines to pivot toward potential launches that are less seasonal in nature than its established COVID and RSV shots.On the R&D front, Moderna has accrued sufficient cases for evaluation of the primary endpoint in the phase 3 study of its cytomegalovirus (CMV) vaccine candidate mRNA-1647 and expects to conduct a final analysis before the year is over. The company has also elected to incorporate additional secondary endpoints into the trial.Regarding the addition of those endpoints, there are “a lot of other data that will help inform the potential value of a CMV vaccine,” Moderna President Stephen Hoge, M.D., said Friday. He noted that the presence of virus in fluid and other measures of infection “could be quite relevant for the use of the CMV vaccine across a wider range of populations, including even in the congenital CMV space.”“We wanted to make sure that we reflected those in the final analysis plan,” Hoge added.As for Moderna’s cost-cutting efforts, realigning R&D expenses has been a major recent focus for the company. In support of those efforts, Moderna lowered R&D expenses for the second quarter by 43% to $700 million, which finance chief Mock attributed to the wind-down of respiratory trials and lower clinical manufacturing costs.“We also had year-over-year reductions in preclinical and external service costs, reflecting ongoing portfolio prioritization and productivity efforts,” the CFO said. Meanwhile, when asked for more color on the 10% head count reduction Moderna unveiled this week, CEO Stéphane Bancel noted that the cuts will largely affect manufacturing and R&D roles, in line with the company’s broader cost-cutting focus. On the research side, Bancel reiterated that Moderna is no longer investing in phase 3 respiratory studies.“So, as those phase out, of course, there is some capacity that we need to kind of resize,” he said.Moderna is still hiring across other areas, Bancel stressed, noting that the company will specifically need additional staff to support new product launches.Under the layoff scheme, Moderna will reduce its global workforce by about 10%, the company announced in a memo to employees Thursday. The mRNA specialist expects to employ “fewer than 5,000 colleagues” by the end of the year, compared to roughly 5,800 staffers at the beginning of 2025.