FDA describes stricter admission standards for the approval of Covid vaccines

Brandon Guerrero from Compton, California, receives both flu and covid vaccine in CVS in Huntington Park, California on August 28, 2024.

Christina House | Los Angeles Times | Getty pictures

On Tuesday, the Food and Drug Administration described new regulatory guidelines for future COVID-19 vaccine boosers and set stricter admission standards for healthy Americans.

The agency said she wanted to see new clinical studies that show that Covid shots are still safe and effective before they are approved for healthy adults and children, a costly new requirement for pharmaceutical companies that could restrict who gets new jabs every year. Previously, the FDA typically updated Covid recordings for all Americans have too approved every year, based on simple tests that show that they trigger a sufficient antibody reaction.

“The truth is that for most of them we simply know the answer for many Americans whether they should get the seven, eight or nine or ten or not,” said Vinay Prasad, a pronounced critic of the pharmaceutical industry who heads the agency's department that the vaccines covered on Tuesday on Tuesday on Tuesday.

The FDA recommended different evidence standards for the approval based on the risk of patients to become severely ill from Covid, according to a work that was published on Tuesday in the New England Journal of Medicine. The authors of the paper are FDA commissioner Marty Makary and Prasad.

“The new Covid 19 philosophy of the FDA is a balance of regulatory flexibility and a commitment to gold standard sciences,” said the agency in the newspaper. “The FDA approves vaccines for high -risk opera and at the same time demands robust, gold standard data on people with little risk.

Covid vaccine manufacturers such as Pfizerhis partner Biontech And Modern The BMO Capital Markets Analyst Evan Seogerman, Evan Seogerman, said the BMO Capital Markets -Analyst Evan Seigerman on Tuesday with somewhat lower sales if the new guidelines are largely implemented. Overall, Seogerman said that he regarded the guidelines as “fair and considerate” for the advantages and risks that healthy people could gain through additional vaccinations.

“We appreciate new appointments in their generalizations about the effectiveness of vaccines from Covid-19,” he said.

The analyst of Jefferies, Michael Yee, who covers Moderna, said that the new regulatory guidelines “seem to be fine for the time being”. The framework is “generally expected” and corresponds to the commentary from consultants for disease control and prevention of centers that tend to be more risk -based vaccine recommendations than a universal vaccine recommendations.

“In the overall picture, this makes some investors easier for the guidance of 2025,” said Yee.

However, Yee said it was unclear whether the requirements for clinical studies for the next generation or combination vaccines for covid and other viruses such as the flu apply.

As Robert F. Kennedy Jr., the new guidance is a prominent skeptic of vaccines, the country's health authorities and the country's health authorities.

For adults aged 65 and over and for people aged 6 and over, the FDA will accept the immunogenicity data – which shows that a vaccine creates a strong immune response – to determine that the advantages of a shot transfer its risks. The FDA estimates that 100 to 200 million Americans have diseases in which they expose a high risk of serious illnesses, including obesity and mental illnesses such as depression.

“There will be a quick regulatory path that such products can bring on the market” for this age group, said Prasad during the town hall.

For healthy people between 6 months and 64 years of age who have no risk factors, the FDA plans to request strong evidence of vaccines from randomized, placebo -controlled studies. This means that some people would receive the actual shot, while others receive an inactive substance like a saline solution to compare the results.

The main objective of the studies should show that the recordings help prevent symptomatic covid, whereby data showed effectiveness according to the work of at least 30%. People who have had Covid in the past should still be included in the process to better reflect the general population, the paper says.

The drug manufacturers have to follow the participants at least six months to ensure that the early earnings gain continues, “they added.

“Our politics is also the same as the need for evidence,” wrote Makary and Prasad in the newspaper. “We just don't know whether a healthy 52-year-old woman with a normal BMI who had Covid-19 three times and received six earlier doses of a Covid 19 vaccine from which seventh dose will benefit.”

The FDA said that if it approved a Covid vaccine for high-risk people, it will encourage the manufacturers to carry out, randomized, randomized, controlled clinical studies in healthy adults as part of their re-marketing engagement for the shot.

During the town hall, Prasad suggested that annual updates for covid vaccinations may not be necessary, and said that the virus is “slower” than the influenza. He said that he expects the FDA to need randomized clinical studies for Covid booster every few years or “so long that this may not be studies every year.

“The virus has no calendar,” he said, adding: “Why do we not let science tell ourselves when we should change” in order to adapt to a great shift in the virus.

The FDA rejects the “unit size” approach

It was argued in the newspaper that the approach of national vaccine policy, which recommends annual recordings for all Americans over six months, is out of date and no longer matches other countries. All other nations with high incomes limit the vaccine recommendations for older adults or people with a high risk of serious diseases due to covid, the paper says.

In the work, the advantage of repetition vaccinations was “uncertain”, especially in patients with low risk, which developed immune protection through previous recordings, infections or both. The newspaper states that many Americans and health service providers “do not remain convinced” and indicate data from the centers for the control and prevention of diseases in the United States for annual covid booster.

In the article, CDC data cited that, in the last two seasons, less than 25% of the Americans have received a COVID 19 shot, including less than 10% of children and less than 50% of adults over 75 years. Less than a third of the healthcare workers received updated covid booster in the 2023 TO 2024 seasons.

The work also presented that wide covid vaccine recommendations have contributed to a declining trust in the vaccination every year, also in the vaccine-micks mump-rubella. Nevertheless, the paper called MMR vaccines as “clearly defined as safe and highly effective”.