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 is marketed as Comirnaty. With this announcement, the Comirnaty vaccination is the first coronavirus vaccine to receive full FDA approval.  On January 31, 2022, the FDA approved Moderna’s Covid-19 vaccination for all individuals 18 years and older.  Moderna’s vaccine will be marketed as Spikevax.

It is anticipated that Johnson&Johnson/Janssen will file for FDA approval .  Johnson&Johnson/Janssen coronavirus vaccine continues to be administered through emergency use authorization only.  For vaccinations administered through the emergency use authorization, none have been approved for individuals under age 5.  Pfizer-BioNTech’s emergency use approval applies for individuals ages 5 through 15 years, and Johnson&Johnson/Janssen 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 all eligible individuals who received the 2-dose Pfizer-BioNTech or Moderna Covid-19 vaccination or the single-dose Johnson&Johnson/Janssen vaccine receive a booster  vaccination.  Though the CDC advised that the Pfizer-BioNTech and Moderna vaccines are preferred over the Johnson&Johnson/Janssen vaccine, the Johnson&Johnson/Janssen booster may be administered in certain situations.  Booster eligibility is as follows:  Any individual 18 years or older may receive any available booster vaccination.  For Moderna vaccine recipients, the booster dose should be administered at least 6 months after completion of your 2-dose vaccine series.  For Pfizer-BioNTech vaccine recipients, the booster dose should be administered at least five months after completion of the 2-dose series.  For Johnson&Johnson/Janssen recipients, the booster dose should be administered at least two months after your first vaccination.  For individuals 12 through 17 years old specifically, the Pfizer-BioNTech is the only available booster vaccine at this time, and the booster dose should be administered at least 5 months after completing the 2-dose series.  There are no approved booster vaccines for individuals under age 12 at this time.  However, for moderately or severely immunocompromised adolescents, ages 5 though 11, the CDC recommends an additional dose to be administered 28 days after the second shot.

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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