The U.S. Food and Drug Administration said on Monday that vaccine developers do not need to conduct lengthy randomized controlled trials on vaccines that have been modified to prevent coronavirus mutations.
These recommendations call for recommendations for small-scale trials that are more like the annual flu vaccine, which will greatly speed up the review process as scientists are increasingly concerned about how these variants will slow or reverse the virus’s progress.
The guidelines are part of a series of new documents released by the agency on Monday, including other documents that modify antibody treatments and diagnostic tests in response to virus variants.
Dr. Woodcock said in a statement on Monday: “The emergence of virus variants has created new concerns about the performance of these products.” “We want the American public to know that we are using all the tools in our toolbox to fight against This pandemic includes the development of the virus as it adapts.”
Most vaccine manufacturers with licensed vaccines or candidate vaccine manufacturers in the later stages of testing have already announced plans to adjust their products to deal with vaccine variants. The two companies said that Moderna and Pfizer-BioNTech vaccines use mRNA technology, which can be used to change existing vaccines within six weeks, although testing and production will take longer.
Moderna has started to develop a new version of its vaccine, which can be used as a booster against the virus variant B.1.351 originating from South Africa, which seems to weaken the effectiveness of the existing vaccine.
A fast-spreading variant of the coronavirus that was first observed in the UK has also acquired worrying mutations that may make it difficult to control the vaccine. A variant with this mutation was discovered in the United States last week.
Nevertheless, the guidelines do not seem to be premised on the imminent or complete need for new vaccines. Although there are recent signs that certain variants (especially B.1.351) invalidate currently approved vaccines, injections still provide protection and seem to greatly reduce the severity of the disease, preventing hospitalization and death.
Asked at a press conference on Monday afternoon how many variants need to be transmitted before the vaccine needs to be updated, Dr. Woodcock did not give any specific criteria. She said: “We need to foresee this and continue to work hard so that we can have a back pocket before the threshold is coming.”
The agency said that an updated Covid-19 vaccine could skip the months of randomized clinical trials that would compare it to a placebo. But the adjusted vaccine still needs some testing.In the trial proposed by the FDA, researchers will Relatively small group Volunteers who have received modified vaccines. The scientists will then observe what percentage of the volunteer samples in the laboratory produce an immune response to the variant, and how big the response is. If the immune response generated by the vaccine is relatively close to that triggered by the original vaccine, it will be judged as acceptable.
Dr. Peter Marks, the FDA’s top vaccine regulatory agency, said at a press conference that the study will include “hundreds of people” and will continue for several months.
Volunteers will also be carefully monitored for side effects. The agency said that the test can be conducted in a single age group and then extrapolated to other age groups.
The guidelines also encourage the use of animal studies to support improved vaccines, in case immune response studies reach vague conclusions.
The FDA acknowledges that many issues remain unresolved, such as which type of data will trigger the demand for adaptive vaccines and who makes the decision. The agency also pointed out that scientists have not yet determined the minimum level of antibodies in the blood of vaccinators that can protect someone from the virus.
Some other vaccines are updated regularly in a similar manner. Because the influenza virus will develop rapidly from one year to the second year, vaccine developers must propose new formulations every year.
The regulator said that the newly adjusted Covid-19 vaccine will be authorized under an amendment to the emergency authorization of the original vaccine.