WASHINGTON (AP) — The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had blocked the company’s application for the first-of-its-kind shot.
Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.
The dispute centered over a 40,000-person clinical trial that concluded Moderna’s new vaccine was more effective in adults aged 50 and older than one of the standard flu shots used today. In the FDA’s rare “refusal to file” letter, vaccine director Dr. Vinay Prasad faulted the trial for not including another brand specifically recommended for people 65 and older.
Moderna publicly objected. It said that while the FDA had recommended that approach, the agency ultimately agreed to the study's design — and that the company shared additional comparison data from a separate trial that used a high-dose shot for older people. Nor did the FDA identify any safety concerns.
Still, Moderna said Wednesday that in a compromise, it is seeking full approval for the vaccine’s use in adults 50 to 64 and accelerated approval for those 65 and older, with an additional study once the shot is on the market. Shares of Moderna Inc. closed up 6% Wednesday.
The FDA is targeting a decision on the application by Aug. 5, and Moderna said it hoped to make the vaccine available later this year. It also has applied for the vaccine’s approval in Europe, Canada and Australia.
“FDA will maintain its high standards during review and potential licensure stages as it does with all products,” HHS spokesman Andrew Nixon said.
The highly unusual public dispute was the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation’s top health official.
In the past year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccines — which are made with mRNA technology — and removed critics of the administration’s approach from an FDA advisory panel.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
FILE - Robert F. Kennedy Jr., President Donald Trump's choice to be Secretary of Health and Human Services, appears before the Senate Finance Committee for his confirmation hearing, at the Capitol in Washington, Jan. 29, 2025. (AP Photo/Ben Curtis, file)
FILE - A sign marks an entrance to a Moderna building in Cambridge, Mass., May 18, 2020. (AP Photo/Bill Sikes, File)
UNITED NATIONS (AP) — The U.N. Security Council is holding a high-level meeting Wednesday on the Gaza ceasefire deal and Israel's efforts to expand control in the West Bank before world leaders head to Washington to discuss the future of the Palestinian territories at the first gathering of President Donald Trump's Board of Peace.
The U.N. session in New York was originally scheduled for Thursday but was moved up after Trump announced the board's meeting for that same date and it became clear that it would complicate travel plans for diplomats planning to attend both. It is a sign of the potential for overlapping and conflicting agendas between the United Nations’ most powerful body and Trump’s new initiative, whose broader ambitions to broker global conflicts have raised concerns in some countries that it may attempt to rival the U.N. Security Council.
Asked what he hopes to see from the back-to-back meetings this week, Palestinian U.N. Ambassador Riyad Mansour told reporters Tuesday, “We expect from the international community to stop Israel and end their illegal effort against annexation, whether in Washington or in New York.”
Ahead of the session, Israeli Foreign Minister Gideon Saar accused the Security Council of being “infected with an anti-Israeli obsession” and insisted that no nation has a stronger right than its “historical and documented right to the land of the Bible.”
In addition to Israel, the foreign ministers of the United Kingdom, Jordan, Egypt and Indonesia are in attendance at the monthly Mideast meeting of the 15-member council after many Arab and Islamic countries requested last week that it discuss Gaza and Israel's contentious West Bank settlement project before some of them head to Washington.
The board to be chaired by Trump was originally envisioned as a small group of world leaders overseeing his 20-point plan for Gaza’s future. But the Republican president's ambitious new vision for the board to be a mediator of worldwide conflicts has led to skepticism from major allies.
While more than 20 countries have so far accepted an invitation to join the board, close U.S. partners, including France, Germany and others, have opted not to join yet and renewed support for the U.N., which also is in the throes of major reforms and funding cuts.
During his statement Wednesday, Mike Waltz, the U.S. ambassador to the U.N., appeared to criticize countries that had not yet signed on to the Board of Peace, saying that unlike the Security Council, the board is “not talking, it is doing.”
“We are hearing the chattering class criticizing the structure of the board, that it's unconventional, that it's unprecedented,” Waltz said. “Again, the old ways were not working.”
The Security Council is meeting a day after nearly all of its 15 members — minus the United States — and dozens of other diplomats joined Palestinian ambassador Mansour as he read a statement on behalf of 80 countries and several organizations condemning Israel's latest actions in the West Bank, demanding an immediate reversal and underlining “strong opposition to any form of annexation.”
In the last several weeks, Israel has launched a contentious land regulation process that will deepen its control in the occupied West Bank. Israeli Energy Minister Eli Cohen said it amounts to “de facto sovereignty” that will block the establishment of a Palestinian state.
Outraged Palestinians, Arab countries and human rights groups have called the moves an illegal annexation of the territory, home to roughly 3.4 million Palestinians who seek it for a future state.
The U.N. meeting also is expected to delve into the U.S.-brokered ceasefire deal that took effect Oct. 10 after more than two years of war between Israel and Hamas. Briefings by U.N. political chief Rosemary DiCarlo and by Israeli and Palestinian civil society representatives were heard for the first time since the Hamas-led Oct. 7, 2023, attacks that launched the war.
DiCarlo said this is “a pivotal moment in the Middle East” that opens the possibility for the region to move in a new direction. “But that opening is neither assured nor indefinite,” she said, and whether it will be sustained depends on decisions in the coming weeks.
“Our collective efforts must now consolidate the ceasefire in Gaza and alleviate the suffering of the population,” she said. “We need concrete progress toward stabilization and recovery, consistent with international law, to lay the foundations for lasting peace. The Board of Peace meeting in Washington, D.C., tomorrow is an important step.”
Aspects of the ceasefire deal have moved forward, including Hamas releasing all the hostages it was holding and increased amounts of humanitarian aid getting into Gaza, though the U.N. says the level is insufficient. A new technocratic committee has been appointed to administer Gaza’s daily affairs.
But the most challenging steps lie ahead, including the deployment of an international security force, disarming Hamas and rebuilding Gaza.
Trump said this week that the Board of Peace members have pledged $5 billion toward Gaza reconstruction and will commit thousands of personnel to international stabilization and police forces for the territory. He didn't provide details. Indonesia’s military says up to 8,000 of its troops are expected to be ready by the end of June for a potential deployment to Gaza as part of a humanitarian and peace mission.
President Donald Trump and first lady Melania Trump walk on the South Lawn to the White House after arriving on Marine One Monday evening, Feb. 16, 2026, in Washington. (AP Photo/Allison Robbert)
FILE - The symbol of the United Nations is displayed outside the Secretariat Building, Feb. 28, 2022, at United Nations Headquarters. (AP Photo/John Minchillo, File)
