FDA approves Moderna’s mFLUSIVA, the first mRNA flu shot
The entrance to a Moderna building in Cambridge, Mass., on May 18, 2020. The federal government on Wednesday approved the company’s mRNA-based flu shot even as it has been turning away from related research. Credit:
Associated Press
The Food and Drug Administration on Wednesday gave its first-ever approval to an influenza vaccine based on messenger RNA (mRNA). The drug, called mFLUSIVA, will be available to US adults aged 50 and older for the 2026–27 flu season, according to a statement from Moderna, the vaccine’s manufacturer.
“Modernizing the development and production of influenza vaccines has long been a public health priority, and today’s approval of an mRNA-based flu vaccine marks an important step toward a more modern approach,” Moderna CEO Stéphane Bancel says in the statement.
Typically, the FDA’s approval would be reviewed by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), which would issue recommendations on the shot’s use, says Dorit Reiss, a law professor at the University of California, Hastings College of Law, who specializes in vaccines. Insurance companies are required to cover CDC-recommended shots.
But ACIP has been blocked by a federal judge from meeting until it resolves legal issues with how its members were appointed. That means doctors will need to look outside the CDC for guidance, Reiss says, and insurance companies will have more leeway on covering costs.
Like some COVID-19 vaccines, mFLUSIVA uses mRNA to deliver a protein from the virus into the body, which prompts the immune system to produce antibodies against the virus. mRNA vaccines can be developed and produced faster than traditional vaccines, thus enabling a quicker response to mutating viruses, according to a statement from the Infectious Diseases Society of America (IDSA).
The approval is “welcome news,” IDSA president Ronald Nahass says in the statement. “Demonstrating the success of mRNA for influenza opens the door to broader applications, accelerating our ability to create safe and targeted vaccines for a wider range of preventable diseases.”
The FDA’s approval came exactly one year after the department of Health and Human Services (HHS) announced it would stop funding research into mRNA vaccine development at the agency’s Biomedical Advanced Research and Development Authority.
“HHS supports safe, effective vaccines for every American who wants them,” HHS secretary Robert F. Kennedy Jr. says in the statement. “That’s why we’re moving beyond the limitations of mRNA and investing in better solutions.”
—Laura Dattaro, special to C&EN
Senate stopgap funding bill pauses OMB plan to overhaul US grant system
The Senate today is expected to consider a stopgap funding bill (PDF) that would prevent the White House Office of Management and Budget (OMB) from implementing a proposal to overhaul how federal grants are administered and prevent a federal government shutdown at least through Dec. 11.
In May, the OMB proposed a new regulation that would require political appointees to review and approve all funding before it is awarded and give funding agencies the ability to terminate any grant at any time at their discretion. The proposal has received more than 500,000 comments, most of them opposing the planned changes.
After the release of the continuing resolution (CR) on Aug. 2, Sen. Susan Collins (R-ME), chair of the Senate Appropriations Committee, said in a press release that she had “advocated for significant changes to the proposed [OMB] rule in a July 6 letter to the agency, citing its potential to politicize grants and harm small, rural communities, families, and biomedical research.”
Sen. Patty Murray, vice chair of the Senate Appropriations Committee, says that Democrats pushed to kill the proposed OMB rule outright but that the idea was rejected by Senate Republicans. “I’m going to keep fighting to put a stop to it once and for all, and I will keep pressing my Republican colleagues to do exactly that,” she says in a statement.
If the Senate passes the CR, it will then have to be reconciled with the House’s version, released almost a month ago, which would keep the government funded until Dec. 4. The House version does not contain any provisions that would prevent the OMB proposal from going into effect if it is finalized before the stopgap funding bill expires.
House members are currently on their summer recess and are not expected to consider the Senate’s version of the bill until they return Aug. 31.
In a statement, Research!America president and CEO Russ Paulsen calls for Congress to pass the Senate’s version of the bill. “It would not only keep the government open, but it would safeguard scientific progress,” he says.
—Krystal Vasquez
Cyclospora cases climb as new CDC director is confirmed
The US Senate confirmed Erica Schwartz as the next director of the Centers for Disease Control and Prevention (CDC) on Aug. 5 amid an ongoing cyclosporiasis outbreak that now covers 15 states. The foodborne parasitic infection caused by Cyclospora has led to 517 hospitalizations and 2 deaths, according to the CDC’s webpage on the outbreak.
Since May, the CDC has confirmed 10,468 domestic cases of cyclosporiasis; an additional 12,255 cases require further analysis. Outbreaks in 15 states, including newly added Arkansas, Iowa, Missouri, Nebraska, New Hampshire, and North Carolina, have been linked to now-recalled iceberg lettuce from Taylor Farms de Mexico, according to the US Food and Drug Administration and the CDC. Taylor Farms iceberg lettuce was distributed to Taco Bell locations in at least 13 states, Walmart stores in 15 states, and food service businesses in 28 states during June and July.
“The true number of sick people in this multistate outbreak is likely higher than the number reported, and the outbreak may not be limited to the states with known illnesses,” the FDA writes in an Aug. 5 statement on the outbreak.
Schwartz will lead the CDC through the ongoing outbreak and a host of other challenges. She was confirmed in a 51–44 vote largely along party lines; Sen. Tim Kaine (D-Va) was the sole Democrat to vote to confirm Schwartz.
Jill Waalen, president of the American College of Preventive Medicine, is pleased to see a preventive medicine physician as the new leader of the CDC. “Preventive Medicine physicians are exactly the kind of leaders we need at the forefront of our health and public health infrastructure,” Waalen says in a statement. “We wish Dr. Schwartz well and look forward to working with her to prevent the onset of chronic and infectious disease and promote wellness throughout the nation.”
—Bec Roldan, special to C&EN
