The First COVID-19 Vaccine Has Been Approved by the FDA—Now What?

Despite billions of dollars being invested in COVID-19 vaccines and government agencies aggressively encouraging everyone who qualifies to get vaccinated, all COVID-19 vaccines administered in the United States have only been approved under an Emergency Use Authorization (EUA). On August 23, the U.S. Food and Drug Administration (FDA) authorized Pfizer’s vaccination for anyone aged 16 and up.

Pfizer COVID-19 Vaccine Approved

Previously known as Pfizer-BioNTech COVID-19 Vaccine, the vaccine will now be sold as Comirnaty. The authorized formulation is the same as that used under the EUA, and it will be administered in the same manner: two doses separated by three weeks. This vaccination has already been approved by the EUA for children aged 12 to 15.

COVID-19 vaccines have a variety of methods. Comirnaty contains mRNA, or messenger RNA, which is the genetic material. The mRNA is only present in the body for a short period, but it instructs cells on how to produce a protein identical to the spike protein seen on the top of the coronavirus that causes COVID-19.

The protein is recognized as foreign by the immune system, and antibodies are produced to eliminate it. If a coronavirus infection happens, the body will recognize the spike proteins on the virus in the same way, and it will know what antibodies to generate to kill it. Vaccines based on mRNA cannot cause COVID-19 because they do not contain the virus and are not produced from it.

FDA Approval vs. EUA Approval

Because rigorous testing is conducted before any drug is approved by the FDA, a EUA is only permitted during public health emergencies. The goal is to “provide access to medicinal items that may be useful in avoiding, diagnosing, or treating disease.” Before granting a EUA, the FDA must evaluate that the benefits (including future benefits) outweigh the known and potential hazards of the product’s usage.

To be licensed by the FDA, a vaccination must go through the agency’s regular process, which includes an evaluation of the product’s effectiveness, quality, and safety. In the case of vaccines, the manufacturer must send a biologics license application (BLA), which includes additional preclinical and clinical data, as well as details on the manufacturing process and testing findings, to document the product’s quality. The FDA also conducted its tests to ensure the vaccine’s safety and efficacy.

Acting FDA Commissioner Janet Woodcock, M.D. stated in a press release announcing the approval, “…the public may be very sure that this vaccine satisfies the high requirements for safety, effectiveness, and manufacturing quality that the FDA requires of an approved product.”

Only Use The Third Dose For Immunocompromised

With the current increase in COVID-19 cases, mostly due to the Delta variation, there has been some enthusiasm about the possibility of a third dose of the vaccines. The FDA did allow the third dose under the EUA for certain persons, but these are highly limited. The third dose is only for highly immunocompromised people: solid organ transplant recipients and others with an equal level of immunocompromise. This application was also listed in the vaccine’s FDA approval.

Children Require Approval

While children and teenagers aged 12 to 17 can continue to receive the vaccine under the EUA, no vaccine is allowed for youngsters under the age of 12. Pfizer and Moderna (the other developer of an mRNA vaccine) are researching to assess the vaccine’s safety and optimal dosage for children aged 5 to 11.

The CEO of Pfizer has stated that he anticipates trials on children aged 5 to 11 to be finished in September. The FDA has vowed to act quickly once the data is received, as there is critical concern about children contracting COVID-19 now that they have returned to school, and the number of cases among children has increased.

Pfizer is also undertaking toddler trials and expects to have results by early winter.

Expect To See Advertisements

Manufacturers are not permitted to commercialize products that have only been approved through a EUA. Pfizer and BioNTech can now offer the vaccine to customers after receiving FDA approval.

TMB offers medical billing as well as a full suite of revenue cycle management (RCM) services. With over a decade of experience, we have the procedures in place to efficiently charge small and big practices and companies. Because every company is unique, we provide personalized programs and services to meet the needs of each client.

Categories : Blog