Monday, 23 August 2021 17:51

FDA grants approval for Pfizer vaccine; 64 new COVID cases reported in Richmond County over weekend

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FDA grants approval for Pfizer vaccine; 64 new COVID cases reported in Richmond County over weekend Pixabay

ROCKINGHAM — More than eight months after being granted emergency use authorization, one of the two vaccines currently available in Richmond County has full approval by the U.S. Food and Drug Administration.

The FDA announced Monday that it has granted approval of the COVID-19 vaccine manufactured by Pfizer and BioNTech, which will now be marked as Comirnaty, for those 16 or older.

That two-dose vaccine also still has emergency use authorization for 12-15 year olds, and a third dose is available for some immunocompromised individuals, according to the FDA.

The Pfizer-BioNTech vaccine first was granted EUA on Dec. 11, 2020.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic, said Acting FDA Commissioner Dr. Janet Woodcock. “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.”

According to the FDA:

“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.”

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Dr. Peter Marks, director of the FDA’s Center for Biologics and Research. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.

“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines,” Marks continued. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

The Moderna vaccine was granted EUA on Dec. 18, 2020 and Johnson & Johnson’s single-dose shot got the green light Feb. 27, 2021.

"Vaccines are our most important tool in the fight against COVID-19," said Dr. Mandy Cohen, secretary of the N.C. Department of Health and Human Services. "All authorized vaccines have met rigorous testing and scientific standards. Millions of North Carolinians have been safely vaccinated, but for some people full FDA approval provides additional confidence. If you are not vaccinated, we urge you: please don’t wait to vaccinate."

As of Monday, 16,268 Richmond County residents had been vaccinated, according to the Health Department. Forty-three of those were since Friday.

The state is offering $100 prepaid Mastercards at “participating locations” while they last, until Aug. 31.

Those Richmond County locations and dates are:

  • Aug. 28 - Dobbins Heights Community Center - 10 a.m.-3 p.m.
  • Aug. 23-27, 30-31 - Richmond County Health Department - 8 a.m.-5 p.m.

Drivers taking patients to get a vaccine can also receive a $25 card — only one per trip and as long as they don’t accept payment for rides, such as a taxi or Uber service.

Because of limited supplies of the Pfizer vaccine, which is the only one authorized for kids aged 12-17, Interim Health Director Cheryl Speight said the Health Department is limiting it to the younger population and giving the Moderna shot to adults. The Johnson & Johnson vaccine is no longer available through the Health Department.

Also on Monday, the Health Department reported 64 new cases of COVID-19, averaging out to around 21 per day over the weekend. There were 174 new cases reported last week.

New daily cases statewide have been around 5,000 or higher since Aug. 18, topping out at 7,020 on Aug. 19, according to NCDHHS.

Within the past month, statewide COVID-related hospitalizations have risen from 817 (July 22) to 3,197 (Aug. 22).

While the Health Department appears to only update hospitalizations on Wednesdays, FirstHealth reported Monday that 87 of its 365 patients (24%) were COVID-positive. Of those:

  • 76 are unvaccinated, 11 are vaccinated
  • All 17 patients in ICU are unvaccinated
  • All six patients on ventilators are unvaccinated

As of Monday morning, Scotland Memorial Hospital had 35 patients isolated with COVID-19.

Of all the patients hospitalized with the coronavirus from April 1-Aug. 18,, 12 were vaccinated and 211 were unvaccinated.

Earlier on Monday, the Health Department reported two more COVID-related deaths, bringing the county's total to 119.

Vaccines are available at the Health Department Monday-Thursday 8 a.m.-5 p.m. and Fridays from 8-11 a.m. There is no charge and no appointment necessary.