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FDA Expands Vaccine Booster Eligibility

On October 15, 2021, the Vaccines and Related Biological Products Advisory Committee at the U.S. Food and Drug Administration (FDA) convened to review the results of a federally-funded study that examined how the antibody levels of COVID-19 vaccine recipients responded to additional doses of different vaccines. This study concluded that recipients of the Johnson & Johnson vaccine who received a full dose of the Moderna vaccine experienced a 76-fold increase in their antibody levels compared to a fourfold increase in antibody levels after receiving a second dose of the Johnson & Johnson vaccine. A booster dose of the Pfizer-BioNTech vaccine produced comparable results, though the additional Moderna dose induced the greatest increase in antibody levels. Additionally, the study demonstrated that individuals who received a two-dose primary series of either the Pfizer-BioNTech or Moderna vaccine experienced similar immune responses after receiving a booster dose of either mRNA vaccine.

On October 20, 2021, the FDA amended the Emergency Use Authorization (EUA) for each of the COVID-19 vaccines to expand eligibility for vaccine boosters and to allow the administration of “mix-and-match” boosters. This will allow individuals to receive a booster dose of any vaccine, regardless of the vaccine they originally received. Importantly, this will allow recipients of the Johnson & Johnson vaccine to receive a booster dose of an mRNA vaccine. However, this will not prevent recipients of the Johnson & Johnson vaccine from receiving a booster dose of that vaccine if they wish. The EUAs for the vaccines were updated as follows:

  • A single booster dose of the Moderna COVID-19 vaccine may be administered at least six months after completion of the two-dose primary series. Those eligible for a booster dose of the Moderna COVID-19 vaccine include:

    • Individuals 65 years of age and older;

    • Individuals 18 through 64 years of age at high risk of severe COVID-19; and

    • Individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

  • A single booster dose of the Johnson & Johnson COVID-19 vaccine may be administered at least two months after completion of a single-dose primary regimen to individuals 18 years of age and older.

  • A booster dose of any available COVID-19 vaccine may be administered to eligible individuals following completion of primary vaccination.

  • A single booster dose of Comirnaty may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

Alongside the FDA’s updated guidance, the agency issued the following statement:

“We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.” This indicates that the agency will likely issue updated guidance on COVID-19 boosters for individuals between 18-64 years of age prior to the upcoming holiday season. If studies indicate that booster doses prove are necessary to maintain high levels of immunity in this population, it will be essential for the FDA to allow them to receive booster doses in the next two to three weeks to prevent a spike in COVID-19 cases and hospitalizations similar to the one experienced in November and December 2020.

If you are newly eligible to receive a COVID-19 booster, Pandemic Patients recommends that you consult with your health care provider to discuss receiving a booster dose to maintain strong COVID-19 antibody levels. If you have not yet been vaccinated against COVID-19, Pandemic Patients urges you to consult with your health care provider to discuss getting vaccinated as soon as possible.

FDA Grants EUA to Novavax COVID-19 Vaccine

On July 13, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Novavax’s COVID-19 vaccine. The FDA’s authorization of this vaccine provides an additional option for individuals who wish to get vaccinated against COVID-19.

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FDA Authorizes Pfizer and Moderna COVID-19 Vaccines for Children

On June 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the Pfizer and Moderna vaccines (marketed as Comirnaty and Spikevax) to allow children as young as six months to get vaccinated against COVID-19. In making this decision, the FDA concluded that the vaccines are safe and effective for use in this population and that the benefits of vaccination outweigh the potential risks.

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FDA Authorizes First Vaccine Booster for Children 5-11

On May 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to authorize the use of a single booster dose for children between the ages of five and eleven. The FDA authorized the administration of this booster at least five months after the completion of the primary vaccination series with the same vaccine.

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