The U.S. Food and Drug Administration (FDA) released a new regulation Monday on the authorization process for COVID-19 vaccines that are being modified to neutralize new strains of the SARS-VOC-2 virus, DPA reports.
These recommendations, detailed in a 24-page document published on the FDA website, are intended to speed up the vaccine evaluation process in the context of fears that new variants of coronavirus – some more contagious, others more likely to avoid action. vaccine neutralizer – could undermine efforts to limit the spread of the new coronavirus, according to Agerpres.
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The recent emergence of new strains has led to growing concerns about the possibility that the first generation of vaccines – developed based on early variants of the coronavirus – may no longer be well enough equipped to protect people from the mix of strains. currently in circulation.
For example, more vaccines have been less effective in South Africa, where a new strain, B.1.351, is dominant compared to other areas of the world where that variant is less present.
A vaccine developed by Janssen Biotech, a division of the Johnson & Johnson group, reduced the risk of moderate and severe cases of COVID-19 by 72% when tested in the United States, but was only 57% effective in Africa. South. Similarly, a Novavax vaccine was almost 90% effective in reducing the risk of developing all types of COVID-19 in the UK and only 49% effective in South Africa.
Another cause for concern: an anti-COVID-19 vaccine developed by AstraZeneca and Oxford University has been shown to be 75% effective in preventing mild to moderate forms of COVID-19 when tested in South Africa before the spread of variant B. .1.351. Once the variant became dominant, the vaccine was no better than a placebo in preventing mild to moderate forms.
In laboratory tests, antibodies generated by people who received a vaccine developed by Pfizer-BioNTech were more effective in neutralizing the UK variant than in neutralizing the South African variant.
Vaccine manufacturers have responded to the threat posed by the new variants by adjusting the production recipe so that the immune system can recognize new viral strains faster and more efficiently.
The new guide published by the FDA contains a multitude of recommendations for vaccine developers, tests and therapies in the light of these new variants. The guide allows modified vaccines to be authorized subject to an amendment added to the existing authorization for emergency use.
The FDA wants manufacturers to submit clinical data to show that modified versions of vaccines are more effective against new strains than original vaccines. The US agency also requires manufacturers to test modified vaccines on people who have never been vaccinated and on people who have been previously vaccinated.
Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said studies to test the immune response to a modified vaccine could likely involve several hundred people and could take two to three months.
For comparison, a typical phase 3 clinical trial can involve tens of thousands of people and take many months.
Such an acceleration in vaccine licensing is a norm for viruses such as the flu, said Diane E. Griffin, a specialist in viral immunology at the Johns Hopkins Bloomberg School of Public Health.
Modified vaccines may be authorized in the future without the need for additional clinical trials, the FDA notes. But, for the time being, this is not the case for such a procedure.
The FDA stressed that the two vaccines currently authorized in the United States – the one developed by Pfizer-BioNTech and the one produced by Moderna in collaboration with the National Institute of Health – are still effective against the mix of viral variants currently circulating in the United States. .
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