FDA fully approves Pfizer COVID-19 vaccineFeatured News, Featured Stories, News, Press Release August 23, 2021
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine 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, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
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. 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,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “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. 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.”
FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
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.
Specifically, 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. 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 Pfizer 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.
The most commonly reported side effects by those 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.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.
Gilmer returns to high transmission designation with COVIDFeatured News, Featured Stories, News August 10, 2021
GILMER COUNTY, Ga. – Gilmer, like most all of North Georgia, is seeing resurgence in the COVID-19 virus, whether from the original virus or some variant.
According to reports from the Georgia Department of Public Health, Gilmer saw 15 new cases yesterday alone. In the last two weeks, it has seen 61 new cases. Along with this, the Georgia DPH has once again put Gilmer on the High Transmission counties list.
According to documentation on the GDPH website, they classify High Transmission with the following criteria; “14-day cases rate is >100 cases/100,000 county residents (>5 cases during this period) AND 14-day average % positive PCR tests >10% (>20 total tests performed during this period).”
The Georgia DPH also reports that Gilmer has had 2,663 total cases as of August 9, 2021. Gilmer is among the vast majority of counties in Georgia with this classification, now, as only eight counties in the entire state still remain outside of that criteria. Last week, there were nearly 30 counties not classified as High Transmission.
Further breaking down their statistics, the Department reclassified the counties into three classifications of Green, Yellow, and Red based on their positivity rates in testing. Gilmer received a Yellow Classification. Yellow means “5-10% PCR positivity during previous 14 days.”
Gilmer has seen a 9.7% Positivity of the 432 tests performed in the last 14 days.
Along with the increasing numbers within the county, discussion is increasing at state and federal levels about pushing further with mandates than what has been previously seen.
On August 3, 2021, the North Georgia Health District published an article that stated, “In areas with substantial and high transmission, the CDC recommends that everyone (including fully vaccinated individuals) wear a mask in public indoor settings to help prevent spread of COVID-19 and the Delta variant.”
FYN has confirmed with some local public safety authorities in nearby counties that local discussions have already started for reinstating suggested preventative measures and restrictions in some areas.
Gilmer Schools have also been monitoring the numbers consistently as Superintendent Dr. Brian Ridley said they look at several reports from the daily numbers to specifically school age children from the Department of Health. Dr. Ridley noted that the schools are, again, working closely with the Department of Public Health as these numbers trend upward. From webinars to communicating with the local branch of the Georgia Department of Health, the system is continuing to stay connected with both medical experts and surrounding counties and their BOEs according the Ridley.
He also noted that some steps are already being taken as suggested mask usage and separation in the cafeteria are just some of the small steps they have taken so far. While he said that the virtual academy is available as a back-up, they have no immediate plans for usage as a response to the numbers. He also stated that mask usage is suggested to students. The school mandate was lifted towards the final few weeks on the last school year.
Board of Commissioners Chairman Charlie Paris has also commented saying he monitors the county’s numbers. With the county’s regular meetings starting tomorrow morning at 9 a.m. and Thursday at 6 p.m., there is no planned discussion nor any immediate response in how the meeting will be held.
Gilmer has seen a one day spike of 15 cases, but it barely compares to January as cases peaked on July 15, 2020, with 49 new cases. Both July 2020 and January 2021 say 7 day averages topping 15 to 20 new cases. Comparatively, August 9, 2021, saw a 7 day average of 6.9 cases.
The Department of Health has put the majority of counties into the High Transmission category while local boards are opting for caution and analyzation to see if this is simply a small spike, or a trend towards something more.
First COVID-19 Vaccine for Healthcare Workers Delivered to Public Health in North GeorgiaFeatured, Featured Stories, News, Press Release December 21, 2020
DALTON, Ga – The North Georgia Health District announced that Whitfield County Health Department received an initial shipment of Pfizer COVID-19 vaccine and began administrating the vaccine to healthcare workers from a variety of medical offices on Friday.
This first shipment of Pfizer vaccine contained 1,950 doses and is being kept in an ultracold freezer required for storage and temperature control of the vaccine.
Moderna vaccine should begin arriving in Georgia next week and will be distributed to health departments for administration to healthcare workers in Cherokee, Fannin, Gilmer, Murray, Pickens, and Whitfield counties.
Both Pfizer and Moderna COVID-19 vaccine requires the administration of two doses to be fully effective.
Because initial COVID-19 vaccine supplies are limited, the Georgia Department of Public Health (DPH) at the state and local level is following the recommendations of Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) by prioritizing the vaccine for healthcare personnel and residents of long-term care facilities. The North Georgia Health District will also make vaccine available to local hospitals as those facilities await their own deliveries.
Additional information about distribution and administration of vaccine in North Georgia will be coming soon.
COVID-19 vaccine information in Georgia is available on the DPH website at https://dph.georgia.gov/covid-vaccine.