FDA Approval for First COVID-19 Vaccine

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FDA Approval for First COVID-19 Vaccine

On August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved the first vaccine for active prevention of COVID-19 in individuals 16 years of age and older. First approved under an Emergency Use Authorization (EUA) on December 11, 2020, the Pfizer/BioNTech COVID-19 Vaccine will now be marketed as Comirnaty® (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular (IM) use. It contains the same formulation as the vaccine approved under the EUA. The vaccine still is authorized under EUA for individuals 12 years to 15 years of age and for immunocompromised individuals who require administration of a third dose. Comirnaty should be administered as two IM doses (0.3mL each) three weeks apart. The vaccine approval came early as the FDA had an unofficial target date before Labor Day. Comirnaty now has gone through the FDA’s complete biologics license application (BLA), a typical process for reviewing quality, safety and efficacy that meets the FDA’s standards for approving a product. For full prescribing information see here. For updated EUA fact sheets for healthcare providers, see here. For patients and caregivers, the revised EUA fact sheet can be viewed here.

At A Glance

  • Brand (Generic) Name: Comirnaty (COVID-19 Vaccine, mRNA) suspension for injection, for IM use
  • Manufacturer: Pfizer/BioNTech
  • Date Approved: Aug. 23, 2021
  • Indication: active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older
  • Dosage Form Available: multi-dose vials that must be thawed and diluted, each containing six doses of 0.3mL for IM injection
  • Launch Date: The U.S. government will control distribution until further notice.

Comirnaty works by using messenger RNA (mRNA), to instruct cells to make a harmless “spike” protein that is similar to what is found on the surface of the virus that causes COVID-19. The immune system then elicits an immune response and produces antibodies to protect against COVID-19. The mRNA from the vaccine is then broken down and leaves the body after a short period without altering any genetic material.

The FDA evaluated safety and efficacy data based on placebo-controlled trial data that included about 40,000 participants. Results showed the vaccine was 91% effective at preventing COVID-19. In addition, over 204 million doses of Comirnaty have been administered in the U.S. with safety and efficacy closely monitored by the FDA and the U.S. Centers for Disease Control and Prevention (CDC).

The most common reported adverse events (AEs) are pain at the injection site, fatigue, headache, muscle pain, joint pain, fever, chills and injection site redness or swelling. In addition, post-marketing data indicate a slightly increased risk for myocarditis and pericarditis within seven days of the second dose, particularly in males under 40 years of age.

The vaccine is contraindicated for individuals who have a severe allergic reaction or anaphylaxis to any components of the vaccine. However, the vaccine does not contain preservatives, eggs, latex, gelatin or metals.

Two other vaccines currently offered under EUAs include a similar mRNA vaccine from Moderna that is currently available for individuals 18 years of age and older. The second is Janssen’s COVID-19 vaccine, which utilizes an adenovirus type 26 vector, rather than mRNA, to express the “spike” protein and elicit an immune response.

Comirnaty requires ultra-cold storage. It remains active until the expiration date printed on the label if it is stored between -90ºC and -60ºC (-130ºF to -76ºF), or it can be kept for a total of two weeks at -25°C to -15°C (-13°F to 5°F).

Although many approved drugs are used “off-label” the FDA emphasized that Comirnaty should not be used in any age groups that are not indicated in its EUA or prescribing information.