Sept. 22, 2021 – FDA Allows COVID-19 Booster Shots For Certain Populations:

On September 22, 2021, the U.S. Food and Drug Administration (FDA) announced that the agency is amending the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine (labeled as Comirnaty) to allow for a single booster dose of the COVID-19 vaccine for members of certain populations. For those who are eligible to receive the booster, it must be administered at least six months after completion of the primary vaccination series. Those currently eligible to receive the COVID-19 booster dose include:

  • Individuals 65 years of age and older;

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

  • Individuals 18 through 64 years of age whose frequent institutional and occupational exposure to the coronavirus puts them at high risk of serious complications of COVID-19 including severe COVID-19. Examples of such individuals include health care workers, teachers, day care staff, grocery workers, and workers in homeless shelters and prisons.

To support the Emergency Use Authorization for a single booster dose of Comirnaty, the FDA analyzed safety and immune response data from participants of the original Comirnaty clinical trial and incorporated real-world data provided by the U.S. Centers for Disease Control and Prevention (CDC), the United Kingdom, and Israel. This information provided the FDA with longitudinal data about the vaccine’s effectiveness and showed how receiving a booster dose improves antibody response against the coronavirus. Specifically, the antibody response is stronger for those who received a booster dose after completing the two-dose primary series compared to individuals that completed the two-dose primary series and did not receive a booster. Additionally, clinical trial participants who completed the two-dose primary series earlier in the clinical trial period had higher rates of COVID-19 compared to those who completed the two-dose primary series later in the clinical trial, which suggests that the antibody response after completing the two-dose primary series decreases modestly over time.

Among those who received a booster dose of Comirnaty, the most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, and chills. Some participants reported swollen lymph nodes in the underarm, which was reported more frequently following the booster dose compared to the two-dose primary series. If you have completed the two-dose primary series of Comirnaty, Pandemic Patients recommends consulting with your health care provider about whether you should receive a booster dose. If you have not yet been vaccinated against COVID-19, Pandemic Patients recommends consulting with your health care provider about getting vaccinated as soon as possible.

While the FDA has granted EUA to Comirnaty, the Moderna and Johnson & Johnson COVID-19 vaccines have not yet been fully approved by the FDA or granted Emergency Use Authorization for booster doses. Hospital data recently released by the CDC demonstrated that recipients of the Moderna vaccine are less likely to be hospitalized with COVID-19. This data suggests that the immunity provided by the Moderna vaccine could last longer than the immunity provided by Comirnaty and the single-dose Johnson & Johnson vaccine. The CDC and FDA are continuing to collect and study data related to the safety and efficacy of the COVID-19 vaccines and will continue to publish guidance for the public as scientific consensus is reached. Recommendations regarding boosters for recipients of the Moderna and Johnson & Johnson COVID-19 vaccines will be available to the public soon.

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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R.T. Asked: When Can I Get the COVID-19 Booster After Receiving Monoclonal Antibodies?

“When should immunocompromised patients get their second COVID-19 vaccine booster after receiving monoclonal antibodies? We are getting conflicting information from doctors, the news, medical literature, and hospitals on whether it is safe to receive a COVID-19 vaccine or vaccine booster after receiving monoclonal antibodies and whether doing this will reduce the efficacy of the vaccine. We are in a quandary, not knowing what to do.”

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