[UPDATE] FDA approves Pfizer, COVID weekend average slightly dips

Published 9:03 am Monday, August 23, 2021

The U.S. Food and Drug Administration has approved their first COVID-19 vaccine as the Mississippi State Department of Health’s latest data report shows a slight dip in the weekend averages of COVID-19 cases.

In the MSDH’s latest data report, there are 7,249 new COVID-19 cases in the state, 56 deaths, and 178 ongoing outbreaks in long-term care facilities from August 20 to August 22. This is a lower three day total in comparison to the MSDH last weekend report of 7,839 cases.

The states totals rack up to 413,498 cases and 8,047 deaths. The MSDH also reports that 1,104,918 persons fully vaccinated in Mississippi.

Lafayette County has 52 more cases of COVID-19 and one death. There have been no new LTC facility cases or deaths. The county has a overall total of 7243 cases, 129 deaths and 190 LTC outbreaks.

The city of Oxford released numbers showing Baptist Memorial Hospital of North Mississippi has 43 confirmed COVID-19 patients and 14 COVID-19 patients in the intensive care unit.

The Acting FDA Commissioner Janet Woodcock, M.D., hopes the FDA approval instills more confidence in the public to get the vaccine.

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

The vaccine, previously known as Pfizer-BioNTech COVID-19 Vaccine, will now be marketed as Comirnaty and only administered those 16 years and older.

The vaccine is still allowed for children 12 years to 15 years in age under emergency use authorization and administered in a third dose for immunocompromised individuals.

Since December 11, 2020, the Pfizer has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.

EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product outweigh the known and potential risks of the product.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

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.

The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

Commonly reported side effects by the clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

As of today, the MSDH reports 1,104,918 persons fully vaccinated individuals in Mississippi.

For more information on the U.S. Food and Drug Administration’s approval of their first vaccine, visit www.fda.gov.