The Food and Drug Administration says it has decided to continue approval of the COVID-19 vaccine updates for the elderly and others at risk of developing severe diseases, but it will require vaccine makers to conduct new major clinical trials before approving them for wider use. The decision means that many Americans who cannot reach the updated shots this fall.
“I think we must recognize ourselves that America is deeply divided on the issue of the policy of repeating the doses of Covid-19 vaccine or reinforcement,” Dr. Vina BrasadThe new FDA vaccine official said in a video It was sent by the agency that announces the change.
Details of the new rules for Covid-19 vaccine approval have been identified article It was published by New England Medicine magazine, composed by Brasad and FDA Commissioner Dr. Martin Macari.
Vacumen manufacturers will need “random experiments controlled by fake” before the FDA agreed to future applications to give clips “to all healthy people” between the ages of 6 months and 64 years, as they wrote.
Otherwise, companies will not only be able to get the routine Covid-19 vaccine updates for the elderly as well as the people who have them The underlying medical conditionLike pregnancy or diabetes, this increases the risk of severe disease.
They wrote: “The scope of diseases in the definition of CDC of high risk of severe diseases, including obesity and even mental health conditions such as depression. Estimates indicate that 100 million to 200 million Americans can reach vaccines in this way.”
Vacumen makers are urged to conduct new random studies in adults between the ages of 50 and 64, where they believe that the balance of benefits and risks is not certain. Brasad said they also encourage new experiences in children under the age of five.
“I think we have a good balance between vulnerable people, and that people who are still at risk will remain on a highway to reach, but people at average risk and low risk, need evidence,” said Brasad.
Makary and Prasad criticized the United States for adopting a “organizational framework that suits everyone” to grant a wide license for the Covid-19 in the past, and cited the poor absorption of the annual Covid-19 Sector last annual.
They also referred to other developed countries that have already limited the annual Covid-19 vaccine to the older adults and those that increase the risk of severe disease.
They wrote: “The US policy has been justified at times by saying that the American people are not developed enough to understand the recommendations based on age and risk. We reject this opinion.”
The new organizational framework for Covid-19 vaccination “was developed by the New Food and Drug Administration Command under the Minister of Health and Humanitarian Services Robert F. Kennedy Junior It comes before a major meeting of the Agency’s outer vaccine consultants on Thursday, to decide on how to update the strain used in next season’s footage.
In recent years, the FDA has highlighted these updates in a similar process of annual influenza shots, which largely depends on laboratory data that shows that vaccines can lead to pre -adopted antibodies to pre -approved clips.
This is a strip less than requesting new random experiments for the vaccines tested against the imaginary medicine to show it that prevents symptoms – a process is usually required only for new shots when there is no current immunization.
But Makari and Brasad said Covid-19 shots Various criteria should be kept, indicating the differences in how the virus and immunity provided by previous vaccines and infection are mutated.
“Ultimately, these studies can only provide reassurance that the American repetition strategy in the separators depends on evidence,” they wrote.
It is not clear whether vaccine makers are able to conduct these types of experiments, if they want to try again to obtain a broader approval than the FDA. Makary and Prasad put forward the possibility of experiments as soon as the coming months.
They wrote: “Covid-19 has a summer transition that can facilitate the conduct of random studies that still apply in future time periods.”
Brasad said that the temporary results of some studies can be ready “by the next calendar year.”
Pfizer said it is “evaluating joint details today” and is in continuous talks with the FDA. The company said that its shots were managed for more than a billion people, including children, which show favorable safety data.
“We are standing beside the flag behind the Pfizer-Biontech Covid-19 vaccine and we continue to believe that extensive vaccination programs are an essential tool to help prevent hospitals associated with Covid-19 and severe disease, including death,” Stephen Danihi said in a statement.
“They appreciate the clear FDA guidance and remain committed to working with the agency to provide the data they need to ensure access to Americans,” said Moderna spokesman Chris Ridley.
Novavax spokesman rejected the comment. Novavax Get Food and drug administration agreed During the weekend of the Covid-19 vaccine, which was limited to the elderly as well as adults and adolescents with at least one case.
While healthcare providers in the United States are usually allowed to manage vaccine with the approval of the Food and Drug Administration “outside the designation” outside the boundaries set by the agency, the narrower approval can affect access to insurance coverage and restrict it to vaccines.
It comes as centers to control and prevent diseases It was also The weight of narrow recommendations for the shots.
The recommendations of the Center for Disease Control directly affect health insurance companies that health insurance companies must cover under the law.
