ROCKINGHAM — The first COVID-19 vaccine has now been given emergency use authorization by the U.S. Food and Drug Administration.
American pharmaceutical company Pfizer, along with its German partner, BioNTech, received FDA authorization for their new COVID-19 vaccine on Dec. 11, 2020.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Dr. Commissioner Stephen M. Hahn said in a press release.
According to the same press release, the FDA concluded that “The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19” and that “…the known and potential benefits outweigh the known and potential risks…”
The Pfizer/BioNTech vaccine uses mRNA, a type of biological instruction manual, to instruct the body’s cells to build SARS-CoV-2 proteins. These viral proteins are non-pathogenic, meaning that they themselves can not cause COVID-19 but are instead used by the body’s immune system for “target practice.” Once the immune system has been exposed to these proteins, it can recognize these viral proteins in a real infection and begin attacking the virus.
Pfizer, in a Nov. 18 press release, announced that its COVID-19 vaccine candidate, BNT162b2, has an efficacy of 95%. Pfizer developed its vaccine candidate in collaboration with the German biotech company BioNTech.
During a press conference earlier this month, Health and Human Services Secretary Dr. Mandy Cohen said North Carolina is slated to receive nearly 85,000 doses of a COVID-19 vaccine, with frontline healthcare workers slated to receive the first shots, which require two doses 21 days apart.
Media outlets report that an ICU nurse in New York was among the first Americans to receive the vaccine on Monday Dec. 14.
In addition to the Pfizer/BioNTech partnership, two other companies have released promising results from late-stage clinical trials. Maderna reported 95% efficacy in its vaccine and AstraZeneca/Oxford has shown 90% efficacy in its vaccine clinical trials.
Maderna developed its vaccine candidate in collaboration with the United States’ National Institute of Allergy and Infectious Diseases and released its data on Nov. 16.
Preliminary data released on the National Institutes of Health website indicates that Maderna’s vaccine, known as mRNA-1273, was shown to have an efficacy rate of 94.5%. The Data and Safety Monitoring Board determined the vaccine to be safe.
AstraZeneca, in partnership with Oxford University, has developed the vaccine candidate AZD1222. According to AstraZeneca’s website, AZD1222 delivers SARS-CoV-2 genetic material for the virus’ spike protein through a viral vector.
According to the FDA website, a meeting to discuss the EUA for Maderna’s vaccine candidate will take place on Dec. 17. Possibly resulting in the second EUA for the COVID-19 vaccine in a week’s time.
COVID-19 is a disease resulting from the SARS-CoV-2 virus that first appeared in late 2019 in the Chinese Hubei province.
Since first appearing in the United States, the SARS-CoV-2 virus has infected more than 15 million Americans, killing 299,000 as of Dec. 14, according to Johns Hopkins University’s COVID-19 tracker.
Richmond County has had 2,208 cases of COVID-19 since the first case of COVID-19 appeared in the county back in April. As of Monday morning, 45 residents of Richmond County have died due to complications of COVID-19.
The Richmond Observer will continue to update the community as plans for distribution of the COVID-19 vaccine are released.
William R. Toler contributed to this story.
