First COVID-19 Vaccine gained FDA approval; What it means for County

Posted 9/1/21

The Pfizer-BioNTech COVID-19 Vaccine has a new name. Readers may now refer to it as “Comirnaty.” This marketing adjustment arrived with an announcement surrounding it on Aug. 23. “Today, the …

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First COVID-19 Vaccine gained FDA approval; What it means for County


The Pfizer-BioNTech COVID-19 Vaccine has a new name. Readers may now refer to it as “Comirnaty.” This marketing adjustment arrived with an announcement surrounding it on Aug. 23. “Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine,” wrote the FDA in a news release entitled, “FDA Approves First COVID-19 Vaccine.”

On Dec. 11, 2020, Comirnaty was granted Emergency Use Authorization (EUA) by the FDA. This was the first COVID-19 vaccine to be authorized for distribution. Anybody aged 16 or above could have the shot administered to them. Five months succeeding that, the EUA began applying to children of 12 through 15 years.

EUAs are initiated by the FDA when a public health crisis is occurring. If they judge that the benefits of a medical item override its potential risks, the agency will authorize it. The advantage of Comirnaty was that it protected humans from the coronavirus. In the same day that this first COVID-19 immunization was authorized, the illness had stolen nearly 300,000 lives.

Many residents of Washington County secured the Pfizer-BioNTech COVID-19 Vaccine while it was under EUA. Data from the State of Minnesota that was updated on Aug. 19 supports this. There are 215,405 people aged 12 and up in the region. Of that total, 168,388 had begun a vaccine series. Over 73 percent were completely inoculated against COVID-19. Among all Minnesotans aged 12 and up, 57.3 percent received Comirnaty.

Comirnaty achieved approval from the FDA after withstanding the “standard process for reviewing the quality, safety and effectiveness of medical products.”



The agency analyzed the immunization’s biologics license application. “For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA,” the FDA wrote, “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.”

Comirnaty met the FDA’s expectations. It has now been defined as “safe” and “effective.” Further backing up this claim was a clinical trial led by the FDA. Approximately 22,000 people were injected with the vaccine and 22,000 people took a placebo. Every participant in this experiment was 16 or more years old. In the end, Comirnaty was proven 91 percent effective in protecting the demographic from COVID-19.

Trials persisted. Six months after the participants secured a second dose, 12,000 of them were checked on. The most common symptoms that they reported were chills, fatigue, fever, headache, pain in joints or muscles, and injection-site redness and swelling. “Most” individuals recovered from these side-effects and “some” entered intensive care support. Still, the FDA concluded that “the vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.”

The FDA’s approval of Comirnaty could result in two different occurrences within Washington County. This is based on the words of Kevin Corbid. The county administrator told The Journal: “One, it may change some minds for people who have not been vaccinated to decide to get vaccinated, which would be a very good thing. And then, secondly, [public health workers] think there’s a possibility that it could lead to additional employers or other groups requiring vaccinations for their staff.”

Corbid voiced these predictions two days after Comirnaty gained FDA approval. He expressed that the effects of this news on Washington County had not been noticed yet. Even so, “there’s speculation that the approval by the FDA might lead to some different types of actions being taken,” Corbid argued, “and so we’re preparing for that possibility. For example, we’re getting ready for maybe a few more people coming to our vaccination clinics, so we’re ready for that if that occurs.”

Free Washington County Vaccine Clinics operate weekly in Forest Lake, Stillwater, and here in Cottage Grove. Walkins are embraced, but one may also schedule an appointment. Further information can be discovered on .

In addition to county officials, people from the state government issued statements regarding the FDA’s recent actions. Jan Malcom, the commissioner of health in Minnesota, remarked, “We welcome today’s announcement because we know full approval from FDA will give a boost of confidence to some who had not yet been vaccinated. Pfizer and the other COVID-19 vaccines are our most important tools for moving past the pandemic and getting back to where we want to be. We encourage everyone who is eligible but unvaccinated to get it done for their own benefit and for the benefit of their family and friends.”

The “other” immunizations for COVID-19 that Malcolm referred to are by Moderna and Johnson & Johnson. Moderna’s is a series of two doses whereas the Janssen COVID-19 Vaccine is one dose. A news update of Aug. 23 by the State of Minnesota reads, “FDA is continuing its review and approval process for these two vaccines as well as for use of Pfizer in people younger than 16.”

Minnesotans have been invited by Governor Tim Walz to “roll up [their] sleeves” and accept their free shot. According to Corbid, there are “lots of options” available to the unvaccinated. Navigating to vaccineconnector. is one. This webpage enables users to attend a walk-in or schedule an appointment. Another resource that is available to Minnesotans is the Vaccine Locator Map. The website, vaccine/find-vaccine/locations/ index.jsp , pinpoints where COVID-19 vaccine providers are. One final step that will lead one in the direction of their shot is phoning their primary health care provider or a local pharmacy.

Corbid and Washington County Public Health are “hopeful” that more individuals aged 12 and up will receive a COVID-19 vaccine. This is in the midst of extra citizens becoming infected with the virus each day. On Aug. 10, the number of average daily cases in the county was 32. Fourteen days later, average daily cases increased to a total of 68. The statewide fatality rate was at 1.23 percent on Aug. 24. This data is based on the reports of the Mayo Clinic.

To The Journal, Corbid concluded, “There may be a number of reasons why [one may get vaccinated]. One of them may be the FDA approval of the Pfizer… Our public health folks seem to have seen a little bit of an uptick in vaccinations because of the Delta variant and some of the surge that we’re seeing and some of the reports of severe illnesses…and regardless of the reason why that’s a good thing.”