FDA approves Moderna's new lower-dose COVID-19 vaccine
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option.
The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target.
The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday.
The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus.
That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.
Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials.
Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall.
The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said.
The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.
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Trump posted, using a favorite epithet. The backlash has highlighted the precarious political position Newsom has staked out. When Newsom hosted conservative pundit Charlie Kirk on his podcast in March, Kirk pointedly asked about a transgender girl who was poised to win a track championship and told Newsom he had 'opportunity to run to the middle' by speaking out. By aligning with Kirk, Newsom drew both furious criticism and praise for breaking with progressive orthodoxy as Democrats regrouped from a stinging 2024 election. 'This isn't part of a smart, masterful tack-to-the-middle play — this is sloppy,' said a Democratic consultant with experience in LGBTQ politics granted anonymity to speak candidly. 'Anyone with a few working brain cells left could've seen this was going to lead to the president using his words against him.' The issue has driven conservative media coverage, prompted national Republican attacks on vulnerable California House Democrats, and permeated California's burgeoning race to replace Newsom after he exits next year. Republican candidate Steve Hilton campaigned outside the track meet this weekend in the Fresno suburb of Clovis, vowing to undo the 2013 state law that lets students compete on the teams matching their gender identities. 'One way or another this cruelty, this absurdity, this unfairness will end when I am governor of California,' Hilton said, flanked by supporters hoisting 'save girls sports' signs. Newsom has done little to change the status quo after speaking out against it. He remained on the sidelines earlier this year as Democratic state lawmakers derailed Republican legislation that would have undone that statute. Last week, a Newsom representative praised the California Interscholastic Federation's 'reasonable' 11th-hour rule change that allows more girls to compete in events when a trans opponent is involved. The state regulator tweaked its rules in response to a social media screed by Trump last week after the same trans athlete qualified for state championships. But that change did not mollify federal critics. The Department of Justice sent a letter to the California Interscholastic Federation, which governs high school sports, demanding that school districts break with the state's policy on trans athletes by next week or face legal action. The letter, sent by Harmeet K. Dhillon, the assistant attorney general for civil rights and a former California Republican Party official, claimed California was in violation of the Equal Protection Clause of the Constitution that prohibits discrimination on the basis of sex. 'Knowingly depriving female students of athletic opportunities and benefits on the basis of their sex would constitute unconstitutional sex discrimination under the Equal Protection Clause,' Dhillon wrote. 'Scientific evidence shows that upsetting the historical status quo and forcing girls to compete against males would deprive them of athletic opportunities and benefits because of their sex.' A Newsom official declined to comment further. A representative for California Attorney General Rob Bonta said in a statement the office was 'very concerned with the Trump Administration's ongoing threats to California schools' and vowed to defend 'the rights of students — including transgender students — to be free from discrimination and harassment.' State Superintendent of Public Instruction Tony Thurmond encouraged school districts to hold the line. In an official guidance sent to superintendents on Tuesday, Thurmond cast doubt on the assertion California's policies violated federal law and could endanger funding. 'Let's be clear: sending a letter does not change the law,' Thurmond, who is running for governor, said in a statement. 'The DOJ's letter to school districts does not announce any new federal law, and state law on this issue has remained unchanged since 2013.' Newsom has a long history of supporting LGBTQ rights. He famously defied federal law and issued same-sex marriage licenses when he was mayor of San Francisco. As governor, he has both energized and disappointed advocates for transgender Californians. He signed a law barring schools from requiring parents to be notified about students' gender identities — drawing a threat from Elon Musk — and vetoed a bill that would have let kids' gender identities be factored into custody decisions. Members of the Legislature's LGBTQ caucus were reluctant to criticize Newsom publicly, even if they were not happy with his attention-grabbing comments. 'His podcast career is his podcast career,' said Assemblymember Alex Lee. 'Whatever he wants to do with Steve Bannon and Charlie Kirk, whatever. But he hasn't changed his policies. He's not done anything differently. He said bullshit on a stupid podcast.' Lee said while Newsom has a long history of being 'usually on the right side,' his recent maneuvers are not politically savvy unless he 'wants to run in the Republican primary, I guess, where all they do is talk about culture wars.' LGBTQ Victory Fund President Evan Low, a former California state lawmaker, said Republicans were continuing to hammer trans rights to distract from their unpopular policy positions. He praised Newsom's record on LGBTQ issues and cautioned against playing into Republicans' playbook. 'No one can tear down his track record,' said Low. 'At the same time, I urge caution to many in our ecosystem to not fall into the trap of this false narrative being an issue.'
