New COVID Boosters To Be Released , Before They’re Tested on Humans.
According to a 'Wall Street Journal' report, the FDA is set to approve the new booster shots that target Omicron and its subvariants this week.
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According to a 'Wall Street Journal' report, the FDA is set to approve the new booster shots that target Omicron and its subvariants this week.
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Since the new boosters are reported to only be slightly modified compared to current COVID vaccines, .
FDA Commissioner Dr. Robert Califf said the agency will utilize "real world evidence" in tandem with data from trials in mice to determine safety and efficacy.
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FDA Commissioner Dr. Robert Califf said the agency will utilize "real world evidence" in tandem with data from trials in mice to determine safety and efficacy.
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However, 'New York Post' reports that in June, two experts, including Paul Offit, an FDA adviser, , spoke in opposition of rolling out new shots without testing them on humans.
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I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data, Paul Offit, FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, to 'The Wall Street Journal'.
Offit contends that flu shots and COVID shots can't be compared when considering the safety of slight modifications without human testing because of the different mutations and protection levels.
Proponents of skipping human trials say it will prevent unnecessarily prolonging accessibility to the public.
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If we waited for clinical-trial results, thank you very much, we’d get them in the spring.
It takes time to do clinical trials.
This is just an updating of the previous vaccine that we used, William Schaffner, professor of medicine at Vanderbilt University Medical Center, to 'The Wall Street Journal'
