The Food and Drug Administration said on Monday that vaccine developers would not be required to conduct long-term randomized controlled trials for vaccines that have been adapted to protect against them. Concerning the coronovirus variants.
Recommendations, Which call for more like the small tests required for the annual flu vaccine, will greatly speed up the review process at a time when scientists are concerned about how slow or reverse progress can be made against the virus. .
Together, they gave the federal government the most detailed acknowledgment of the risk of variance for current vaccines, treatments, and trials for coronovirus, and FDA acting commissioner Dr. Janet came weeks after Woodcock. Agency was developing a scheme.
“The emergence of virus variants gives rise to new concerns about the performance of these products,” Woodcock said in a statement on Monday. “We want the American public to know that we are using every tool in our toolbox to fight this epidemic, including adapting viruses.”
Most vaccine manufacturers are candidates for authorized vaccines or late-stage trials Already announced plans To adjust their products to address vaccine variants. Modern and Pfizer-BioNotech vaccines use mRNA technology that companies have said can be used to replace existing vaccines within six weeks, although testing and manufacturing will take longer.
Modern has already started developing a new version of its vaccine that can be used as a booster shot against a virus variant originating in South Africa, known as B.1.351 , Which reduces the effectiveness of existing vaccines.
A fast-spreading coronavirus variant first seen in Britain has also acquired a worrying mutation that may have caused it Difficult to control with vaccines. This variant with the mutation was found in the United States last week.
Nevertheless, the guidance is not written with the assumption that new vaccines were imminent, or would be needed. Despite recent indications that some variants – and B.1.351 in particular – make currently authorized vaccines less effective, shots still provide protection and appear to reduce the severity of the disease, leading to hospitalizations Recruitment and death can be prevented.
At a news briefing Monday afternoon, asking how much the variants would have to spread before the updated vaccine was necessary, Drs. Woodcock did not provide any specific criteria. “We need to anticipate and work on it so that we have something on our back before we are on it,” she said.
An updated Kovid-19 vaccine may skip the months-long process of a randomized clinical trial that will compare with a placebo. But a vaccine containing a vaccine will still have to undergo some testing. In tests proposed by the FDA, researchers will draw blood A relatively small group of Volunteers who have been given customized vaccines. Scientists will then observe how many percent of samples of volunteers produce an immune response to variants in the laboratory, and how large this response is. Vaccines will be considered acceptable if they produce an immune response that is close to the one induced by the original vaccines.
The FDA’s top vaccine regulator, Dr. Peter Marks said at the news briefing that the study would include “a few hundred” people and the last several months.
Volunteers will also be carefully monitored for side effects. The agency stated that the test could be done in the same age group and then additional to other age groups.
The guidance encouraged animal studies to support the case of modified vaccines, in which case immune response studies came up with unclear conclusions.
The FDA acknowledged that many questions remained unanswered, such as what kind of data would trigger the need for a customized vaccine and who would make the decision. The agency also noted that the scientist Not yet determined The minimum level of antibodies in the blood of a vaccinated person that will protect someone from the virus.
Some other vaccines are regularly updated in a similar way. Because the influenza virus develops rapidly from one year to the next, vaccine developers have to come up with new recipes annually.
Regulators said the newly created Kovid-19 vaccines would be authorized under the amendment of the emergency authority given for the original vaccine.