The FDA and vaccine producers assert their confidence in the safety of doses designed to target Omicron subvariants. Now, the new Covid boosters are set to roll out without human testing.
This week, the Food and Drug Administration is anticipated to approve new Covid-19 booster shots without using data from a study demonstrating whether the shots were safe and effective in patients, a necessary component of its typical decision-making process.
The FDA will not have finished testing the vaccines in humans when it announces its decisions since they have been updated to target the most recent iterations of the Omicron variant.
The agency instead intends to evaluate the doses using information from other sources, including that of mice research, the characteristics of the original vaccines, and the effectiveness of earlier generations of boosters that were designed to target older strains of Omicron.
FDA Commissioner Robert Califf recently tweeted, "Real world evidence fro...
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