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FDA approves Pfizer vaccine

Despite COVID-19 cases soaring throughout the Piedmont Health District this week, good news has arrived in the form of the U.S. Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.

While coronavirus cases have been surging locally and throughout the nation for weeks now as a result of the highly transmissible delta variant, case numbers are only getting worse in the Piedmont Health District. The majority of the area’s counties saw huge jumps in their COVID figures this week, none larger than in Prince Edward County, which has reflected one of the smallest vaccination percentages of localities in the commonwealth to date.

According to the Virginia Department of Health (VDH), between Monday, Aug. 16, and Monday, Aug. 23, Lunenburg County saw 19 new cases of the coronavirus compared to 13 new cases the week prior.

Prince Edward saw 58 new virus cases, a huge increase compared to the 32 new cases seen just one week ago.

Buckingham County saw 29 new cases of the virus this week, up from 18 cases last week.

Cumberland County saw 12 new cases of the virus this week compared to 16 new cases the week before, and Charlotte was up 29 cases Monday compared to 20 cases the previous week. On Monday, Acting Piedmont Health District Director Dr. Sulola Adekoya noted most of the health district is currently in a high rate of transmission for the coronavirus. With hospital beds filling up fast across the district and community spread on the rise, Adekoya noted the health district did receive some good news Monday morning after learning the FDA had provided full approval of the Pfizer COVID-19 vaccine.

According to the FDA, the fully-approved vaccine, previously known as the Pfizer-BioNTech COVID-19 vaccine, will now be marketed as “Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older.”

While Comirnaty continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals, the vaccine is now fully approved for those 16 and up.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock, M.D., noted Monday. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Adekoya said Monday local health officials are excited about the news and hope the approval will motivate more residents on the fence to get vaccinated against the coronavirus.

And with data now suggesting close to 80% of the community needs to be vaccinated in order to gain herd immunity against the highly transmissible delta variant of the virus, getting more people on board with vaccination is perhaps more important than ever.

“Today we’ve hit another milestone, a key milestone, in the nation’s fight against COVID,” President Joe Biden said Monday, Aug. 23 during remarks from the South Court Auditorium of the White House. “After a strict process, the FDA has reaffirmed its finding that the Pfizer COVID-19 vaccine is safe and effective, and the FDA has given its full and final approval. If you’re one of the millions of Americans who said that they will not get the shot until it was fully approved, it’s time for you to go get your vaccination. Get it today.”

Vaccination rates continue to slowly rise in the health district.

As of Monday, Aug. 16, the percentage of fully vaccinated people in each county was as follows:

Lunenburg – 42.2%

Prince Edward – 36.4%

Buckingham – 41.9%

Cumberland – 39.1%

Charlotte – 40.7%

Along with ramping up efforts to get folks off the fence when it comes to immunization, the health department is also preparing to follow Biden’s plans to begin offering a third vaccine dose to Americans who had their last shot of the Pfizer or Moderna vaccines more than eight months ago in order to boost citizens’ immunity against the virus.

Adekoya said while booster shots, per the Biden Administration’s plan, should be available in the health district beginning Sept. 20, third doses are already available at Piedmont clinics to immunocompromised residents.

Adekoya ended Monday’s interview with a common message — one officials are hoping more people will now take into consideration.

“Please,” she said, “get vaccinated.”