WASHINGTON—The Food and Drug Administration plans to develop speedy means of evaluating possible booster shots for Covid-19 vaccines to ensure that they will work against new variants, the agency’s acting commissioner said Thursday.
Dr. Janet Woodcock wasn’t specific about what standards the FDA will use to assess the possible booster shots but said the agency will address these questions in published guidelines over the next few weeks.
“If variants emerge that the vaccines have poor efficacy against, we will need to go through these quickly,” she told reporters Thursday evening. She said that full clinical studies of 30,000 patients or more—the sort of large clinical trial used to authorize vaccines so far—would be too time-consuming.
Dr. Woodcock said there hasn’t been any determination that boosters will be needed.
“With current vaccines, we feel that, against any variants we have seen we have a fair amount of confidence they will provide good protection,” she said. But, she added, “We must prepare for all eventualities. The situation could change, and it could change pretty rapidly.”
The Link LonkFebruary 05, 2021 at 08:34AM
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FDA Plans Speedy Review of Possible Covid-19 Boosters - The Wall Street Journal
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