The U.S. Food and Drug Administration said it has decided to continue to approve vaccine updates for older people and other vaccines with higher risk of serious disease, but will require vaccine manufacturers to approve them for major new clinical trials before they are approved for wider use. The decision means many Americans without potential conditions may not be able to get updated footage this fall.
“I think we have to admit we are deeply divided on the policy issues of repeated vaccine doses or boosters,” he said. Dr. Vinay PrasadFDA's new top vaccine official said in a video released by an agency that announced the changes.
A post published by the New England Medicine Journal of New England Medicine Journal, written by Prasad and FDA Commissioner Dr. Martin Makary, also outlines details of the new rules approved by the Covid-19 vaccine.
They wrote that vaccine manufacturers will need to conduct "randomized, placebo-controlled trials" before the FDA approves future applications to shoot at "all healthy people" between six months and 64 years of age.
Otherwise, companies will only get regular Covid-19-19 vaccine updates and approve older people as well as those with underlying medical conditions, such as pregnancy or diabetes, which increases the risk of serious illness.
"The range of diseases defined by the CDC's high risk for serious illnesses is huge, including obesity and even mental health conditions (such as depression). Estimates suggest that 100 million to 200 million Americans will be vaccinated in this way," they wrote.
Vaccine manufacturers are being urged to conduct new randomized studies among adults aged 50 to 64, who believe the balance of benefits and risks is uncertain. Prasad said they also encouraged children under the age of 5 to conduct a new trial.
"I think we have a very good balance between the disadvantaged, and people who are still at high risk will still have a fast path, but people who are at average risk and those who are at low risk need evidence," Prasad said.
Makary and Prasad criticized the U.S. for adopting a “regulatory framework of a certain size” to grant broad mandates for past Covid-19 vaccine promoters, and cited the poorer boosters for Covid-19 this year.
They also noted that other developed countries that have already restricted annual Covid-19-19-19 vaccine boosters to the elderly and vaccine boosters with potential conditions increase their risk of serious illness.
"U.S. policy is sometimes justified, believing that the American people are not complex enough to understand advice based on age and risk. We reject this view," they wrote.
FDA develops a new “regulatory framework” under the Secretary of Health and Human Services Robert Kennedy Jr. On Thursday, a key meeting of the agency's external vaccine consultants, it was decided how to update the pressure to use in shooting next season.
In recent years, the FDA has adjusted these updates in a green way in a process similar to the annual flu lens, which is based primarily on lab data showing that vaccines can trigger antibody levels similar to previously approved photos.
This is more than a new randomized trial for a new vaccine tested against placebo to prove it prevents symptomatic illness—a process that usually requires new lenses only if there is no currently approved immunization.
But Makari and Prasad said Covid-19 lenses Different standards should be maintained with different criteria, citing differences in viral mutations and immunity provided by vaccines and prior infections.
“Ultimately, these studies alone can be assured that the U.S. persistent strategy is evidence-based,” they wrote.
It is unclear whether and when vaccine manufacturers will be able to conduct such trials, and whether they want to try again to obtain the FDA with broader approval. Makary and Prasad immediately raised the possibility of the trial after the next few months.
"Covid-19 has summer transmission and can facilitate the behavior of randomized studies that continue to apply in future time periods," they wrote.
Prasad said temporary results from some studies could be "to the next calendar year."
Pfizer said it is "evaluating the details shared today" and is in an ongoing conversation with the FDA. The company said its footage has shown good safety data for more than a billion people, including children.
"We adhere to the science behind the Pfizer-biontech Covid-19 vaccine and continue to believe that a broad vaccination program is an important tool to help prevent common 199-related hospitalizations and severe diseases, including deaths," Pfizer spokesman Steven Danehy said in a statement.
Hyundai spokesman Chris Ridley said they “thanks to the FDA for its clear guidance and continue to work with the agency to provide the data needed to ensure Americans have access.”
A Novavax spokesman declined to comment. Novavax won Narrow FDA approval Over the weekend, its COVID-19 vaccine is limited to older adults and teenagers with at least one potential condition.
While U.S. healthcare providers are often allowed to use FDA-approved “outside labels” for vaccines outside restrictions prescribed by the agency, narrower approvals may affect access to access and limit the coverage of vaccines.
It is the Centers for Disease Control and Prevention It's already past Critical recommendations for weighing lenses.
The CDC’s recommendations directly affect which vaccination health insurance companies must be covered under the law.