FDA describes the strict covid vaccine approval standards

Food and medication administration described a new regulatory orientation for future COVID-19 vaccines reinforcements on Tuesday, establishing more strict approval standards for healthy Americans.

The agency said it wants to see the new clinical trials that show that COVID shots are still safe and effective before approved for adults and healthy children, a new expensive requirement for pharmaceutical companies that could limit who obtains new soap every year. Previously, the FDA typically approved the updated COVID shots for all Americans every year based on simple tests that show that they trigger an antibody response strong enough.

“The truth is that for most of that, for many Americans, we simply do not know the answer to whether or not they should obtain or not the seven or eight or nine, as the current politics would do,” said Vinay Prasad, an open critic of the pharmaceutical industry that was named to lead the agency's division that surveys the vaccines, during a city in the city on Tuesday.

The FDA recommended different standards of approval evidence based on the risk of patients to seriously ill from COVID, according to an article published on Tuesday at the New England Journal of Medicine. The authors of the newspaper are the FDA Commissioner Marty Makary and Prasad.

“The new COVID-19 philosophy of the FDA represents a balance of regulatory flexibility and a commitment to standard gold science,” said the agency in the newspaper. “The FDA will approve vaccines for high -risk people and, at the same time, will require robust and gold standard data on people with low risk.

COVID Vaccine Manufacturers as PfizerYour partner BIONTECH and Modern You can see slightly lower income if the new guidelines are implemented widely, said BMO Analyst Capital Markets Evan Seigman in a note on Tuesday. But in general, Seigerman said that he considers that the guidelines are “fair and considered” of the benefits and risks that healthy people can obtain from additional vaccines.

“We appreciate that the new named do not seem to exaggerate in their generalizations about the effectiveness of the COVID-19 vaccine,” he said.

Jefferies analyst Michael Yee, who covers modern, said the new regulatory guidelines “seem to be fine for now.” The frame is “generally expected” and in line with the comments of the advisors to the control and prevention of diseases of the centers that are inclined towards the recommendations of risk based on the risk instead of a universal.

“Then, in the general scenario, this really facilitates concern for investors for the orientation of 2025 to some extent,” Yee said.

But Yee said that it is not clear if the clinical trial requirement will apply to the next -generation COVID shots or combined vaccines directed to Covid and other viruses, such as the flu.

The new guide occurs when the Secretary of Health and Human Services, Robert F. Kennedy Jr., an outstanding vaccine skeptic, reviews the nation's health agencies and the United States immunization policy.

For adults 65 years of age or older, and for people of up to 6 months who have certain underlying health conditions, the FDA said that it will accept immunogenicity data, which shows that a vaccine generates a strong immune response, since the benefits of a shot exceed their risks. FDA estimates that 100 to 200 million Americans have conditions that put them at high risk of serious diseases, including obesity and mental health conditions, such as depression.

“There will be a rapid regulatory path for such products to go to the market” for that age group, Prasad said during the City Council.

But for healthy people between 6 months and 64 who have no risk factors, the FDA plans to require stronger randomized and controlled test vaccines with placebo. That means that some people would receive the real shot, while others get an inactive substance as a saline shot, to compare the results.

The main objective of the trials should be to show that the shots help prevent symptomatic COVID, with data that show at least 30% effectiveness, according to the document. People who have had Covid in the past should still be included in the trial to better reflect the general population, the document said.

Drug manufacturers must track participants for at least six months “to ensure that early reinforcement profits persist,” they added.

“Our policy also balances the need for evidence,” Makary and Prasad wrote in the document. “We simply do not know if a 52-year-old healthy woman with a normal BMI that Covid-19 has had three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose.”

The FDA said that when it approves a COVID vaccine for high -risk people, it will encourage manufacturers to perform random and controlled clinical trials in healthy adults as part of their commitment after commercialization for the shot.

During the City Council, Prasad suggested annual updates to vaccines that may not be necessary, saying that the virus is “mutating at a slower pace” than influenza. He said that the FDA requires random clinical trials for covid reinforcements every few years or “for a long time” instead of studies every year.

“The virus does not have a calendar,” he said, and added, “Why don't we let science tell us when we should change” to adapt to an important change in the virus?

The article argued that the COVID vaccine policy approach of “unique size” of the nation, which recommends annual shots for all Americans over six months, is outdated and is no longer in line with other countries. All other nations of high income limit vaccine recommendations to older adults or those with high risk of serious diseases due to COVID, the document said.

The document said that the benefit of repeated vaccines is “uncertain”, particularly among low -risk patients who have developed some immune protection through previous shots, infections or both. The document said that many Americans and medical care suppliers “remain unvolved” of that benefit, pointing out the data of the centers for the control and prevention of diseases on the fall of vaccination rates in the US. UU. For the annual reinforcements of COVID.

The document cited CDC data that indicates that during the last two seasons, less than 25% of Americans have received a COVID-19 shot, including less than 10% of children and less than 50% of adults over 75.

The document also suggested that the wide covid vaccine recommendations have contributed to the decrease in vaccination confidence, even in the measles-backllage vaccine. Even so, the document called MMR vaccines “clearly established as safe and highly effective.”