Nevertheless, at the end of the day there is a question: How do the licensing authorities deal with the modified funds? If manufacturers have to submit extensive clinical studies again, a lot of valuable time will pass before they can be used.
The Food and Drug Administration (FDA), which is responsible for drug approval, announced that vaccine developers do not need to conduct lengthy, randomized studies for vaccines that have been adapted to protect against the coronavirus variants concerned.
On Monday the FDA presented several documents on the subject. This also involved adapting diagnostic tests to the new variants. Researchers are currently worried about three mutations: one appeared for the first time in Great Britain, one in South Africa and another in Brazil.
The appearance of these virus variants raises questions about the performance of these products,” said Janet Woodcock of the FDA. Pharmaceutical manufacturers should not wait until a mutated virus can no longer be fought sufficiently well by the vaccines, but should start developing new drugs now. “We have to work on it so that we have something up our sleeve before the threshold is reached,” she said at a press conference.
The y are specially developed for the South African variant, which has also reached the USA.
AstraZeneca President Ruud Dobber said an adjustment would “take eight to nine months from launch to finished product.” In addition, it is important to test the effectiveness of the new vaccine against the new variants in a clinical study.
Allow two to three months
As part of the updated guidance, the FDA recommended that vaccine manufacturers test all modified vaccines in both unvaccinated and vaccinated individuals. Manufacturers should compare the immune response of an adapted vaccine with both the new variant and the original virus.
The FDA also recommended monitoring subjects’ health for at least seven days to support emergency approval for modified vaccines.
The agency is trying to enable drug manufacturers to make the changes with a minimal amount of additional data, according to FDA expert Peter Marks. But he restricted that these studies could also take two or three months.
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Corona mutations USA quickly adapted vaccines