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GENEVA: The emergency authorization of COVID-19 vaccines requires “a lot of seriousness and thought,” the World Health Organization said on Monday (Aug 31) after the United States announced that it was considering fast-track candidate drugs.
Although all countries have the right to approve drugs without completing full trials, “it is not something that is done lightly,” WHO chief scientist Soumya Swaminathan told a news conference.
The head of the US Food and Drug Administration said he would be willing to bypass the normal approval process to authorize a COVID-19 vaccine as long as officials were convinced that the benefits outweighed the risks.
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Russia already granted regulatory approval to a COVID-19 vaccine this month after less than two months of human testing, prompting some Western experts to question its safety and efficacy.
The WHO’s preferred approach would be to have a complete set of data that could be used for prequalification of vaccines, Swaminathan said. The WHO would then consider the efficacy and safety of each drug on a case-by-case basis, he added.
The WHO has used experimental drugs to combat Ebola in Africa, a move that proved successful, said Mike Ryan, director of the organization’s emergency program.
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But he emphasized that a fast-track approach without full trials required intensive safety monitoring and tracking work, and should be stopped immediately if problems arise.
“If you move too fast to vaccinate … millions of people, you can miss certain adverse effects,” Ryan said.
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