Evidence so far suggests that the two Covid-19 vaccines authorized in the U.S., from Moderna and Pfizer-BioNTech, appear to offer good protection against new variants.But the fact that the virus continues to mutate means drugmakers will need to keep up, adapting quickly if necessary.
The FDA guidance suggests companies may be able to pull back on lengthy clinical trials to prove safety and effectiveness each time a new variant emerges."For influenza, we are so accustomed to doing this," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said on a call with reporters Monday. Because the flu shot is so well studied, human clinical studies are unnecessary each year.
Let us never forget that China killed over 500,000 Americans without firing a single gunshot or tactile nuclear weapon.🇺🇸🙏❤
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