The FDA seems to be in the vaccine accessories

Former health officers fear that the Trump administration will change to a slow approval of vaccines in Slow-Walk vaccines, even if drug manufacturers impose new regulatory hurdles, e.g. B. the change in the requirements for admission or the search for additional clinical experimental data.

The Food and Drug Administration confirmed on Monday that the drug maker Novavax carried out another clinical study as part of the admission procedure for his COVID vaccine, which has been available as part of the emergency administration since 2022. Dr. Marty Makary, the FDA commissioner, asks the agency to approved “a new product” based on old data.

The intake of Novavax uses traditional protein-based vaccine technology and is the only alternative to the MRNA recordings of Pfizer and Moderna. The application of the pharmaceutical manufacturer at the FDA was based on a randomized clinical study of 30,000 people, which was carried out in 2021 in the USA and Mexico.

The agency missed a deadline on April 1, which resulted in the investor to consider that it would not be approved.

On Saturday, Makary proposed in a post on X that Novavax was aiming for a “new” vaccine, since the tribe used in his attempt has been updated since then to aim a newer covid variant called JN.1.

“After this administration, we prioritize the gold standard of the scientific-what saves the $ 10 million of pharmaceutical companies,” said Makary.

Novavax refused to comment on Makary’s remark. In a publication published on Monday, Novavax said that she replied to an earlier FDA request to provide more data on the vaccine when approved.

Dr. Paul Offit, the director of the Vaccine Education Center in the Children’s Hospital in Philadelphia, criticized the step of the administration and pointed out that the seasonal flu vaccines are updated every year with new tribes without new clinical studies being necessary. Similarly, the MRNA -Covid vaccines have been updated every year in order to reach the latest tribe.

“I mean, how exactly he suggests doing that?” said Offit, who also works for the FDA in an independent vaccine consulting committee. “It is only worried to me that it is part of a general general strategy to weaken the vaccine efforts.”

The FDA directs all media inquiries to the Ministry of Health and Human Services. In a written declaration, an HHS spokesman said that the bidding disposal of clinical study requirements for new COVID vaccines did not use “Covid pandemic to use as an eternal justification for flat -rate permits”.

Under Makary, according to the spokesman, there were sufficient exams “no longer” four years ago.

“Since Novavax applies for a new wording for the JN.1 variant, the public deserves clear answers to its effectiveness and if its advantages outweigh the risks,” said the spokesman.

The Wall Street Journal reported for the first time about the FDA request for a new clinical study.

Other vaccination moods that may be at risk

Novavax ‘shot is not the only Covid vaccine that officials say that they may be at risk.

Dr. Tracy Beth Høeg, who was announced at the beginning of this month as a special consultant of Makary, has been described in a meeting in which priorities described that the agency has informed the FDA employees and high-ranking civil servants that, according to three former government officials who are familiar with the matter speaks because she was afraid of the disease of anonymity because she speaks of anonymity of the arrival of anonymous ends on fear of taking up recording.

Høeg, a sports medicine doctor, increased as a voice critic of Covid vaccines, especially for children, as a vocal critic.

Their 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 “deadliest vaccine that was ever done”. In 2023, Makary and Høeg wrote a guiding article for the New York Post, in which the recommendation of the bidet management to the covid shot in children was criticized.

It is unclear what role – if at all – played Høeg in the FDA to impose an additional requirement for the approval of Novavax from Covid in the vaccine. Høeg did not respond to several inquiries about comments.

There are also concerns about several upcoming FDA A decision for the full approval for the shot in children under 11 years according to two of the former officials. The vaccine currently has an emergency permit for 11 years and under.

The mRNA vaccines are a special destination for anti-accacine activists. The Pfizer and Moderna vaccines are the first approved with MRNA technology, which caused them to claim that they represent a unique threat. The general surgeon in Florida, Joseph Ladapo, has led against mRNA vaccines and claimed that they could possibly change the DNA of a person. Several states have introduced laws that would ban MRNA vaccines. According to CDC, the MRNA -Covid vaccines are safe and do not change the DNA. The technology was examined for decades before its first approval in the USA at the end of 2020.

Last week, Politico reported on two people familiar with the discussions that Kennedy is considering to draw the Covid vaccine from the centers for the control of the disease and the list of the recommended immunizations of children for children who influence the insurance coverage and the consideration by the children in the pediatric economy could influence them. NBC News did not confirm the reporting independently.

Dorit Reiss, an expert in vaccine policy at the University of California Law San Francisco, said that the inclusion of covid vaccines in children is low, but it is important that the parents have the option available.

This applies in particular to children with underlying health states that make them more vulnerable to serious illnesses and death, she said.

Experts also fear that a possible bird flu could be at risk for people. One of the former officials said that the FDA had previously planned to use an authorization route for necessities if health officials had to be a shot quickly, but it is now unclear whether the Trump government would do the same.

Dr. Ofer Levy, director of the Precision Vaccines program at Boston Children’s Hospital who advised the FDA, said that it will be important for public health experts to work for vaccines, including the COVID shots.

“It will be important that a kind of updated antiviral and covid vaccine is available in autumn, and this is particularly important for the most endangered people,” said Levy.

Levy – He said that he would not prejudice the potential examination of vaccines through the administration, also said that common respiratory viruses such as flu and covid are still widespread, and the public will need vaccines.

“Winter viruses, respiratory viruses, still kill tens of thousands of Americans a year,” he said. “I hope that the FDA will continue to consider the mRNA vaccines as one of the platforms.”