On Wednesday, Eastern Time, American vaccine manufacturer Moderna announced that it had withdrawn its vaccine for COVID-19 and influenza.The company is considering filing a marketing authorization application for its combined vaccine, pending more efficacy data for its vaccine. Affected by the news, its stock price fell more than 6% during the session.

Moderna said it will resubmit its application later this year with effectiveness data from its standalone flu vaccine in a large-scale trial, which is expected to be released this summer.

Earlier this month, Moderna claimed, largely as expected, that it did not expect regulators to approve the vaccine until 2026 because more data on its flu vaccine was needed.

It is worth noting that the day before Moderna made this decision, the United States tightened the approval requirements for the new crown vaccine.

The U.S. Food and Drug Administration (FDA) said that the approval of new crown vaccines for people over 65 years old or over 6 months old with health problems will continue to use the existing approval process. However, for vaccines planned for people aged 6 months to 64 years old without health problems, pharmaceutical companies need to submit randomized controlled clinical trial results for approval.

Regarding the FDA's new policy, a Moderna spokesperson said: "We appreciate the FDA's clear guidance and remain committed to working with the agency to provide the data they need to ensure Americans have access to vaccines."

Moderna has previously said it does not expect the FDA to delay a decision on its next-generation COVID-19 vaccine, which is expected to be available by the end of this month.

Moderna's shares have fallen more than 30% this year amid declining revenue from its coronavirus vaccine business and investor concerns about John F. Kennedy as health secretary.

The withdrawal is a setback for Moderna, disrupting its overall strategy to expand demand for its vaccine, which was developed because it believes that combining the two vaccines will increase vaccination rates for the coronavirus, which is far less popular than the flu shot.

The FDA recently approved Novavax's COVID-19 vaccine for use in older adults and high-risk groups, but required the company to conduct an additional clinical trial after approval.

Analysts point out that Kennedy Jr. himself has strong anti-vaccine tendencies, which may bring risks to the use and promotion of vaccines as he pushes for a series of medical system reforms.

"I think you have to assume that JFK's intention was to make it harder for vaccines to get to market," said Dr. Amesh Adalja, a vaccine expert at Johns Hopkins University. "He has not been a big believer in the benefits of vaccines in the past."

The FDA’s credibility has long relied on the independence of its scientific decision-making. Although the agency is led by a handful of government appointees, approval decisions are almost always handled by career scientists.

But that standard appears to be changing. FDA staff were ready to approve Novavax's vaccine early last month, but the decision was delayed by administration officials, including the FDA commissioner, according to people familiar with the matter.

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