COVID-19 Vaccine Update – February 2022 | Robinson+Cole Healthcare Law Diagnosis


[co-author: Erin Howard]

The Food and Drug Administration (FDA) has recently taken a number of notable actions regarding vaccines in response to the ongoing COVID-19 pandemic. Below is an overview of these actions and information related to the COVID-19 vaccine:

Full approval of Moderna COVID-19 vaccine for ages 18+

On January 31, 2022, the FDA announcement its full approval (licensing) of the Moderna COVID-19 vaccine for people 18 years of age and older. The Moderna vaccine had been administered under an Emergency Use Authorization (EUA) from the FDA since December 18, 2020. It is the second COVID-19 vaccine to be approved by the FDA following approval of the Pfizer-BioNTech COVID-19 vaccine on August 23. , 2021. Notably, the approved Moderna COVID-19 vaccine will be marketed and known as “Spikevax”.

FDA review of EUA for COVID-19 vaccine for 6 months to 4 years

The FDA has scheduled a virtual tour Meet of its Advisory Committee on Vaccines and Related Biologicals on February 15, 2022, to discuss a request to amend the EUA of the Pfizer-BioNTech vaccine to allow its use in children 6 months to 4 years of age.

Availability of vaccines for people aged 5 to 15

On October 29, 2021, the FDA authorized the Pfizer-BioNTech vaccine for emergency use in children aged 5 to 11 years. Press release the FDA noted that the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 to 11 years old.

On January 3, 2022, the FDA amended the EUA for the Pfizer-BioNTech vaccine to authorize the use of a single booster dose in persons aged 12 to 15 years and older (this follows the initial EUA for this age group published on 10 May 2021). This recent amendment also allowed a third primary series dose for certain immunocompromised children aged 5 to 11 years.

* Legal intern at Robinson+Cole. Erin is not yet admitted to practice law.

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