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Variant-matched vaccines do not require long tests, FDA says

The Food and Drug Administration said on Monday that vaccine developers do not need to conduct long-term randomized controlled trials of vaccines adapted to prevent. About coronavirus mutants..

The· RecommendationsThe need for small trials similar to those required for the annual flu vaccine significantly increases the review process when scientists are increasingly concerned about how to slow or reverse the progression to the virus. Accelerate.

Guidance is part of a new document slate released by the agency on Monday. Antibody treatment And Diagnostic test You may need to change your tools to accommodate virus variants.

Together, they came weeks after Dr. Janet Woodcock, FDA’s deputy commissioner, reached the federal government’s most detailed approval of the threat that variants pose to existing vaccines, treatments and trials of coronavirus. It was. Said that the agency is developing plan.

“The emergence of viral variants raises new concerns about the performance of these products,” Dr. Woodcock said in a statement Monday. “We want the American people to know that we are using all the tools in the toolbox to combat this pandemic, including pivoting as the virus adapts.”

Most vaccine manufacturers with licensed vaccines or late-stage study candidates Already announced the plan Adjust the product to address the vaccine variants. The Moderna and Pfizer-BioNTech vaccines use mRNA technology, which both companies have stated that they can be used to modify existing vaccines within 6 weeks, although they are time consuming to test and manufacture.

Moderna has already begun developing a new version of the vaccine that can be used as a booster shot against a viral variant known as B.1.351 that originated in South Africa, which may undermine the effectiveness of existing vaccines.

The first observed rapidly spreading coronavirus mutant in the United Kingdom also acquired an interesting mutation that could make it. Difficult to manage with vaccines.. The mutant with the mutation was discovered in the United States last week.

Still, the guidance did not appear to be written on the assumption that a new vaccine was imminent or needed at all. Despite recent signs that some variants, especially B.1.351, reduce the effectiveness of currently licensed vaccines, Shot still provides protection, significantly reducing the severity of the disease, and hospitalization. It seems to prevent death.

At a press conference on Monday afternoon, Dr. Woodcock did not give specific criteria when asked how much the mutant needed to spread before the updated vaccine was needed. “We need to anticipate this and work on it, so that something will be in our back pocket before the threshold hits us,” she says. I did.

Authorities said the updated Covid-19 vaccine could skip the multi-month process of randomized clinical trials comparing it to placebo. However, fine-tuned vaccines still need to undergo some testing. In a study proposed by the FDA, researchers draw blood from Relatively small group of Volunteers given an adaptive vaccine. Scientists then observe what percentage of the volunteer sample provokes an immune response against the mutant in the laboratory and how large the response is. A vaccine is considered acceptable if it produces an immune response that is relatively close to that stimulated by the original vaccine.

Dr. Peter Marks, the FDA’s top vaccine regulator, said at a news conference that the study would include “hundreds” of people and would last for months.

Volunteers are also carefully monitored for side effects. Authorities said the test could be performed in a single age group and then extrapolated to other age groups.

Guidance also encouraged the use of animal studies to support cases of modified vaccines in case immune response studies draw ambiguous conclusions.

The FDA acknowledged that many questions remain unanswered, such as which type of data raises the need for an indicated vaccine and who makes that decision.Institutions are also scientists It is not yet decided The minimum level of antibody in the blood of a vaccinated person that protects someone from the virus.

Several other vaccines are updated regularly in a similar manner. Vaccine developers need to come up with new recipes each year as the influenza virus evolves rapidly from one year to the next.

According to regulators, the newly adjusted Covid-19 vaccine will be approved under amendments to the emergency permit granted to the original vaccine.

Variant-matched vaccines do not require long tests, FDA says

Source link Variant-matched vaccines do not require long tests, FDA says

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