The confusion on the delay of the Food and Drug Administration to the granting of total approval to the COVVI-19 vaccine in Novavax has deepened during the weekend when the agency commissioner, Marty Makary, went to social networks to defend the controversial management of the FDA of the submission of the company.
In the process, Makary and a spokesperson for the Ministry of Health and Social Services seemed to raise the spectrum according to which, in the future, the manufacturers of Covid vaccines may have to generate new efficiency data before the release of annual updates of their vaccines – an obstacle, they would be illegal.
“Since the season lasts only in the number of weeks, when they could have the vaccines approved with studies at the start of the season, it would be too late … To get the vaccine. It makes no sense,” said Michael Osterholm, director of the research center and infectious policy of research and the policies of infectious diseases.
“Unfortunately, we have a combination of government and public relations scientists who do not understand what they do not understand. And it is potentially a very dangerous concern,” he said.
Friday, quoting anonymous sources, the Wall Street Journal reported that the FDA asked Novavax to conduct a new randomized controlled trial of its vaccine, a step that would cost the company tens of millions of dollars and a delay in months, if not to a complete approval of the vaccine.
The agency was supposed to decide by April 1 at the request of the company for a complete license for its vaccine, known in regulatory terms as a request for a biology license, or BLA. The vaccine has been used since 2022 in an emergency use authorization. Instead, the agency’s political staff took the unusual measure to decide to delay the decision.
In a statement published on April 23, Novavax said that it had received official FDA communications requesting post-marketing commitment to generate additional clinical data. The company said it was anxious to get involved with the FDA “quickly” to advance the approval process. A randomized controlled trial to determine efficiency is not a typical post-commercialization study.
Commenting on Saturday on the social media site X (formerly Twitter), Makary seemed to confirm the history of the newspaper and justify the demand by describing the company’s vaccine as a new product, and not the same as that tested in the phase 3 trial on which its application is based.
“To be clear, this is a new product that Novavax is trying to present on the market with a study of a different product from 2021. New products require new clinical studies,” said Makary.
Like all vaccine manufacturers coded, Novavax updates the strain that its vaccine targets are targets each year – on FDA instructions. The regulation agency has not seen such adjustments – necessary because the SARS -COV -2 virus continues to evolve to escape the immunity that humans have acquired it – as fundamental changes in the product.
Invited to clarify Makary’s Declaration, Andrew Nixon, Director of HHS communications, seemed to suggest that all annual boost could undergo a regulatory examination more than in the past.
“It has now been years since Covid has not presented the threat it has done, and the urgency to precipitate the approval of boosters without normal supervision no longer exists,” he wrote in an email.
When asked if the other two coated vaccine manufacturers provide the American market – Pfizer and Moderna – could also be requested for updated efficiency data, an HHS manager, speaking under the cover of anonymity, did not close the door to the possibility.
“We will assess the data and take this determination with the FDA examination process when they submit their requests,” said the manager.
Dorit Reiss, professor of law at UC Law San Francisco, said that forcing it to manufacturers of vaccines that have been studied with annual efficiency would be “an unrealistic demand … which would kill vaccines that require annual updates”.
Nixon’s response seemed to exempt the suggestion influenza vaccines that the FDA may require efficiency data in the future. “A four-year trial is not a white check for new vaccines each year without clinical trial data, unlike the flu vaccine that has been judged and tested for over 80 years,” he wrote.
Manufacturers of influenza vaccines and vaccines are faced with a similar biological challenge – the need to regularly update the strains of their vaccine target to arm the beneficiaries with antibodies against the versions of the circulating virus.
For years, influenza vaccines have been updated using what is called the FDA deformation change rule. Most of the policy is as follows: the shots updated are not treated as new vaccines, because they are not. As long as the manufacturers change nothing other than the version of the virus they target, they are not required to conduct modified vaccine effectiveness studies.
“If there has been a program that saved millions of lives during the decades, it is the process of approving constraint changes for flu and more recently covored vaccines,” said Osterholm.
“Going with it is (like) trying to play with games and gasoline at the same time.”
