COVID-19 Vaccinations: FDA Approval and Updates

On August 23, 2021, the U.S. Food and Drug Administration announced that the coronavirus vaccine manufactured by Pfizer-BioNTech received full approval for individuals 16 years and older.  The fully authorized vaccine will be marketed as Comirnaty. With this announcement, the Comirnaty vaccination is the first coronavirus vaccine to receive full FDA approval.

At this time, Moderna’s application for FDA approval is pending, and it is anticipated that Johnson&Johnson/Janssen will file for FDA approval later this year.  Moderna and Johnson&Johnson/Janssen coronavirus vaccines continue to be administered through emergency use authorization only.  For vaccinations administered through the emergency use authorization, none have been approved for individuals under age 12.  Pfizer-BioNTech’s emergency use approval continues for individuals 12 through 15, Johnson&Johnson/Janssen and Moderna emergency approval is for individuals 18 years and older.

Also under the emergency use provision, the Centers for Disease Control and Prevention are now recommending immunocompromised individuals who received the 2-dose Pfizer-BioNTech or Moderna Covid-19 vaccination receive a 3rd dose of the vaccination.  The 3rd dose should be administered at least 28 days after the 2nd dose.  At this time, the CDC is not recommending that individuals who received the Johnson&Johnson/Janssen vaccination receive an additional or booster dose of the vaccine.

To date, all COVID-19 vaccines are currently covered under the Countermeasures Injury Compensation Program (CICP) only.  A countermeasure is a vaccination, medication, device or other item recommended to diagnose, prevent or treat a declared pandemic, epidemic or security threat.  Federal declarations issued by the Secretary of the U.S. Department of Health and Human Services (HHS) specify the countermeasures covered by the CICP, which currently includes all COVID-19 vaccinations administered in the U.S.  As of the date of our correspondence, the CICP is the only federal compensation program that covers injury claims arising or resulting from a COVID-19 vaccination.  Additional information regarding the CICP can be found at the Health Resources & Services Administration’s (HRSA) website.

Our firm works solely within the confines of the National Vaccine Injury Compensation Program (NVICP), and therefore, cannot assist with COVID-19 vaccine injury claims in the CICP.

If you suffered an injury following administration of any COVID-19 vaccination, you may wish to explore your option to file a request for benefits in the CICP without the assistance of an attorney.  Please note that the deadline to file a claim in the CICP runs one (1) year from the date of vaccination.

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