Despite billions being invested in COVID-19 vaccines and government agencies strongly encouraging everyone who qualifies to get vaccinated, all COVID-19 vaccines being administered in the US have been approved only under an Emergency Use Authorization (EUA). That changed on August 23, when the U.S. Food and Drug Administration (FDA) approved Pfizer’s vaccine for anyone 16 and older.
Pfizer’s Approved COVID-19 Vaccine
Up to this point, the vaccine has been known as Pfizer-BioNTech COVID-19 Vaccine, but it will now be marketed as Comirnaty. The approved formulation is the same as that which has been used under the EUA, and will be administered in the same way: two doses with a three week interval between shots. This vaccine already has EUA approval for youth ages 12 through 15, which remains in place.
There are several different mechanisms used by the various vaccines that have been developed for COVID-19. Comirnaty contains genetic material known as mRNA, or messenger RNA. The mRNA only remains intact in the body for a short time, but shows cells how to make a protein similar to the spike protein on the surface of the coronavirus that causes COVID-19.
The immune system recognizes the protein as being foreign and creates antibodies to get rid of it. If an infection of the coronavirus occurs, the body will see the spike proteins on the virus the same way, and it knows what antibodies to produce to eliminate it. Vaccines using mRNA cannot cause COVID-19 as they do not contain, and are not made from, the virus that causes the disease.
FDA Approval Vs. EUA
Rigorous testing is required before any drug is approved by the FDA, so an EUA is only allowed to shortcut the process during public health emergencies. The purpose is to “provide access to medical products that may be effective in preventing, diagnosing, or treating a disease.” Before an EUA can be granted, the FDA must determine that the benefits (including potential benefits) outweigh the known and potential risks of its use.
For a vaccine to be FDA approved, it must go through the agency’s standard process that reviews the product’s effectiveness, quality and safety. The manufacturer must submit a biologics license application (BLA), which, in the case of the vaccines, included additional preclinical and clinical data, plus information on the manufacturing process and testing results to document the quality of the product. The FDA also conducted its own testing to verify the vaccine’s safety and effectiveness.
In a press release announcing the approval, Acting FDA Commissioner Janet Woodcock, M.D. said, “…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.”
Third Dose Only for Immunocompromised
With the current rise in COVID-19 cases, due largely to the Delta variant, there has been some excitement about talk of a third dose of the vaccines. The FDA did approve a third dose under the EUA for certain people, but they are very limited. The third dose is only for seriously immunocompromised individuals: solid organ transplant recipients and others with an equivalent level of immunocompromise. That usage was also included in the vaccine’s FDA approval.
Approval Needed for Children
While children and teens ages 12-17 can continue to receive the vaccine under the EUA, there is no vaccine approved for children under 12. Research is being conducted by Pfizer and Moderna (the other manufacturer of an mRNA vaccine) to determine the safety and appropriate dosage of the vaccine for children ages 5 to 11.
Pfizer’s CEO has said he expects studies on children ages 5 to 11 to be completed in September. The FDA has committed to taking fast action when the data is submitted as there is widespread concern over children getting COVID-19 now that they have returned to school and the number of cases among children has risen.
Pfizer is also conducting studies on toddlers and expects to have data by early winter.
Expect to See Advertising
Manufacturers are not allowed to market products that are only approved under an EUA. Getting FDA approval means that Pfizer and BioNTEch are now able to market the vaccine to consumers.
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