COVID-19 Vaccine Approvals

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On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine in persons aged 16 years and older for prevention of COVID-19. The Pfizer-BioNTech COVID-19 vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2. The CDC and FDA report that the vaccine was safe and highly effective in a randomized controlled clinical trial that included 43,252 participants randomized 1:1 to receive either vaccine or placebo. The only known contraindication to  vaccine is a history of severe allergic reaction (e.g., anaphylaxis) to components of the Pfizer-BioNTech vaccine. 

The vaccination is currently being offered to health care providers and residents of long-term care facilities due to a limited supply. Additional vaccine supplies are currently being manufactured and distributed.

According to the CDC, the Pfizer vaccine is administered in two separate intramuscular (IM) doses, administered 21-days apart. A <4 day grace period is allowed. However, if the second dose is administered earlier than day 17, it does not need to be repeated. If more than 21 days elapse since the first dose, the second dose should be given at the earliest opportunity and the series does not need to be repeated. Patients should not receive other types of vaccines within 14-days of receiving the COVID vaccine. Additionally, the COVID vaccines are not considered interchangeable. Individuals initiating a vaccination series with one brand of vaccine should complete this series with the same brand as the safety and efficacy of a mixed-product series have not been evaluated.

Individuals with a prior history of COVID-19 may safely receive this vaccine, but should not receive the vaccine while actively infected. No data exists to determine the safety or efficacy of the vaccine in individuals who have received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. The individuals should wait 90-days following treatment to receive vaccination.

Vaccination is unlikely to offer post-exposure prophylaxis given that it takes 1-2 weeks following the second dose to become fully vaccinated and the median incubation period following exposure is 4-5 days.

On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the use of Moderna’s COVID-19 vaccine, making it the second available vaccine against the virus. This vaccine is given in two doses over a one-month period. The fact sheet is available here. According to the FDA, “the most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever.”

The CDC’s summary of the ACIP Evidence to Recommendations for Use of Pfizer-BioNTech COVID-19 Vaccine under an Emergency Use Authorization can be found in full here.

The FDA news release regarding the Pfizer-BioNTech COVID-19 vaccine can be found here.

The FDA news release regarding the Moderna COVID-19 vaccine can be found here.

Julie Grishaw, ACNP

Senior Editor, McGraw-Hill Education