FDA COVID-19 Vaccine Approval and Authorization Updates — August ‘21
In case you have not noticed, it’s been a busy month for the Food and Drug Administration (FDA). Below, I run down some of the biggest highlights around COVID-19 and FDA’s approval and authorization of vaccines for the US population.
FDA Approves First COVID-19 Vaccine
Get ready to learn how to say Comirnaty (koe-mir’-na-tee). Today, the FDA approved the first COVID-19 vaccine. Formally known as the Pfizer-BioNTech SE COVID-19 Vaccine, it will now be marketed as Comirnaty, which shows 91% effective in preventing COVID-19 disease.
The vaccine approval for individuals 16 years of age and older signifies that the vaccine meets the high standards for safety, effectiveness, and manufacturing quality the drug.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19.
The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19.
“The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into — nor does it alter — an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.”
In the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose.
Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots
This month, the FDA concluded that a booster shot will be needed to “maximize vaccine-induced protection and prolong its durability” — acknowledging that many vaccines are associated with a reduction in protection over time, as well as reduced protection against mild and moderate disease brought on by the Delta variant.
This follows this month’s earlier update where the FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech SE and the Moderna #COVID19 vaccines. The amendment allowed for the use of an additional dose in certain immunocompromised individuals who have a reduced ability to fight infections and other diseases.
The latest joint statement from HHS Public Health and Medical Experts sets the threshold at 8 months after an individuals second dose at which the FDA recommends getting the booster shot.
The first groups who can receive the booster: health care providers, nursing home residents, and other seniors who were among the first individuals getting the vaccine.
The FDA also anticipates booster shots for the Johnson & Johnson vaccine but is still reviewing the data.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Disclaimer: With new scientific advances in medicine, the information in this article is subject to change. Always speak with your doctor, or visit www.FDA.gov for an official account on making informed decisions on your health.
