Moderna and Pfizer have submitted requests for their Covid-19 boosters, FDA commissioner Dr. Robert Califf announced in a series of tweets.
The boosters are being pushed for release in September by the Biden Administration- which means that the reformulated shots have only been able to be tested on mice, not people.
“The FDA is working tirelessly to evaluate the submissions to ensure the data meet FDA’s rigorous standards for safety, effectiveness and manufacturing quality so that these new boosters are available as soon as possible,” said Dr. Califf.
The tweets suggest that the new boosters are expected to provide greater protection against current mutated strains. The initial versions of the vaccines by the two companies were FDA authorized in December 2020 with decisions made from data based on thousands of trial volunteers.
Having a vast number of the population immunized through prior vaccinations and immunity from Covid recovery itself, makes it difficult to conduct the new booster trial on as many new people as they originally did.
Dr. Califf stated that there will be three decision making factors “Clinical trial data from other bivalent mRNA COVID-19 boosters, RWE from current COVID-19 vaccines administered to millions of people and non-clinical data for the bivalent BA.4/5 vaccines,”
Experts in the field have varying opinions regarding this potential approval, some positive and some not, however, debatable opinions are likely to continue until certain results are observed once human trials are conducted.
Dr. Califf in his series of tweets placed emphasis on the fact that vaccines are the best preventative measure against Covid-19 and its devastating consequences and that getting vaccinated and appropriately boosted prevents death and severe hospitalization requiring illness.
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