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The US Food and Drug Administration took a major pharmaceutical initiative on Monday, announcing that the agency has fully approved one of the three available COVID-19 vaccines for use. Although people around the world have been vaccinated for the past eight months, these vaccines have only been approved under emergency use authorization, and it seems that this no longer applies to Pfizer BioNTech.
The U.S. Food and Drug Administration announced that Pfizer vaccines have reached the government’s very “strict” emergency use standards, as well as overall safety and effectiveness.
“The public can be very confident that this vaccine meets the FDA’s high standards for the safety, effectiveness, and manufacturing quality of approved products,” said Dr. Janet Woodcock, Acting Commissioner of the FDA.
The Pfizer vaccine will be available to individuals 16 years and older from December 11, 2020, and Commissioner Woodcock hopes that the new approval will encourage more people to get the vaccine.
“Although millions of people have been safely vaccinated against COVID-19, we recognize that for some people, FDA-approved vaccines may now inject additional confidence in vaccinations. Today’s milestone takes us away from changing the United States. The course of an epidemic is one step closer”
Pfizer’s vaccine uses mRNA, a genetic material used in the body. mRNA is used for vaccination to “simulate” a protein in the virus that causes COVID-19. The FDA pointed out that messenger RNA only exists in the body for a short time and “will not change an individual’s genetic material.”
Moderna and Johnson & Johnson vaccines are still available for personal use, but have not yet received full FDA approval.
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