The former government health officials fear that the Trump administration will move to the approvals of slow -off vaccines, even imposing new regulatory obstacles to medication manufacturers, such as changing the requirements for approval or search for additional clinical trial data.
The Food and Medicines Administration confirmed on Monday that it required that the NOVAVAX drug manufacturer execute another clinical trial as part of the approval process for its Covid vaccine, which has been available under the authorization of emergency use since 2022. Dr. Marty Makary, FDA Commissioner, said the company is asking the agency that exceeds “a new product” based on old data.
Novavax’s shot uses traditional protein -based vaccine technology and is the only alternative to Pfizer and Modern RNM shots. The application of the FDA drug manufacturer was based on a randomized clinical trial of 30,000 people made in 2021 in the United States and Mexico.
The agency lost a deadline decision of April 1, which caused concerns among investors. that would not be approved.
On Saturday, Makary suggested in an X post that Novavax was looking for the approval of a “new” vaccine because the strain used in its test has been updated to aim at a more recent COVID variant called Jn.1.
“Under this administration, we are prioritizing the gold standard of science, not what saves the dozens of millions of dollars from pharmaceutical companies,” Makary said.
Novavax declined to comment on Makary’s comment. In a statement issued on Monday, Novavax said he responded to an previous FDA request to commit to providing more data on the vaccine if approved, a standard practice.
Dr. Paul Offit, director of the Vaccine Education Center of the Children’s Hospital in Philadelphia, criticized the administration movement, noting that seasonal flu vaccines are updated every year with new strains without the need for new clinical trials. COVID MRNA vaccines have been updated similarly every year to aim at the most current tension.
“I mean, how exactly do you propose that they do this?” This Offit, who is also a member of an independent vaccine advisory committee for the FDA. “I simply worry that it will be part of a general general strategy to weaken vaccine efforts.”
The FDA directs all media consultations to the Department of Health and Human Services. In a written statement, an HHS spokesman said that the Biden administration renounced the clinical trial requirements for new Covid vaccines “using Covid pandemic as an eternal justification for blankets.”
According to Makary, said the spokesman, the trials of four years “are no longer enough.”
“With Novavax seeking authorization for a new formulation aimed at the Jn.1 variant, the public deserves clear answers about its effectiveness and if its benefits exceed the risks,” said the spokesman.
The Wall Street Journal first reported the FDA request for a new clinical trial.
Other vaccine approvals possibly at risk
Novavax’s shot is not the only Covid vaccine that officials say it may be at risk.
Dr. Tracy Beth Høeg, who was announced as a special advisor to Makary at the beginning of this month, has requested a greater scrutiny of vaccines, telling the FDA staff and high -ranking officials in a meeting that describes the priorities that the agency would make less vaccine approvals in the future, according to three government officials familiar with the matter, who gave the condition of the condition of the condition of the condition of the condition of the condition of the condition of the condition of the condition of the condition of Fear of compensation.
Høeg, a sports medicine doctor, jumped to fame during the pandemic as a vocal critic of Covid vaccines, particularly for children.
His appointment added another anti-Covid-Vaccine voice to the Trump administration. In 2021, HHS Secretary Robert F. Kennedy Jr. described the Covid vaccine as the “most fatal vaccine ever made.” In 2023, Makary and Høeg co -written an editorial for the New York Post criticizing the recommendation of the Biden administration of the Covid session in children.
It is not clear what role, if anyone played Høeg in the FDA that imposed an additional requirement for the approval of the Novavax Covid vaccine. Høeg did not respond to multiple requests for comments.
There are also concerns about several FDA deadlines related to the Arna Covid de Pfizer vaccine, including A decision for the full approval of the shot in children under 11, according to two of the former officials. The vaccine currently has an emergency use authorization for ages of 11 years or less.
RNM vaccines are a particular objective among vaccine activists. Pfizer and Modern vaccines are the first approved using RNM technology, which has led some to affirm that they represent a unique threat. Florida’s general surgeon Joseph Ladapo has criticized RNM vaccines, claiming that they could possibly alter a person’s DNA. Several states have introduced legislation that would prohibit RNM vaccines. CDCs say that Arnm Covid vaccines are safe and do not alter the DNA; Technology had been studied for decades before its first approval in the United States at the end of 2020.
Last week, Politico reported, citing two people familiar with discussions, which Kennedy is considering extracting the Covid vaccine from the list of recommended immunizations for children in the centers for disease control and prevention, a measure that could affect insurance coverage and influence the consideration of some pediatricians to administer them. NBC News has not independently confirmed the report.
Dorit Reiss, an expert in vaccine policies in the Law of the University of California, San Francisco, said that although the absorption of Covid vaccines in children is low, it is important that parents have the option available.
That is especially true for children with underlying health conditions that make them more vulnerable to serious disease and death from the virus, he said.
Experts are also worried that a possible avian flu vaccine for people can be at risk. One of the former officials said that the FDA previously planned to use an emergency use authorization in case health officials need to quickly turn on a shot, but now it is not clear if the Trump administration would do the same.
Dr. Offer Levy, director of the Precision Vaccine Program at the Boston Children’s Hospital, who has advised the FDA, said it will be important that public health experts advocate vaccines, including COVID shooting.
“It will be important to have some kind of antiviral vaccine and updated covid this autumn available, and that is particularly important for the most vulnerable people,” Levy said.
Levy, who said he would not prejudge the potential examination of the administration’s vaccines, also said that common respiratory viruses such as flu and covid still spread widely, and the public will need vaccines.
“Winter viruses, respiratory viruses are killing tens of thousands of Americans a year, still,” he said. “I hope the FDA continues to consider RNM vaccines as one of the platforms.”
