Situation Report | August 30, 2021
On August 16, 2021, the state Department of Health (DOH) posted guidance on coverage of an additional COVID-19 vaccine after an initial 2-dose vaccine series for certain immunocompromised people. Meanwhile, the U.S. Department of Health and Human Services (HHS) announced that it has developed a plan to begin offering COVID-19 booster shots to all who have received the vaccine.
The state DOH guidance is available here.
The guidance follows action by the U.S. Food and Drug Administration (FDA) on August 12 in which it amended the Emergency Use Authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to allow for the administration of an additional (third) dose for certain people who are moderately or severely immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments.
The EUA amendment for additional doses is not intended for persons with chronic conditions such as diabetes or heart disease, for which there might be mild associated immunosuppression, nor for residents of long-term care facilities who do not otherwise meet the moderate to severe immunocompromised criteria.
For additional questions about vaccines or immunization recommendations, contact the NYSDOH Bureau of Immunization via email at immunize@health.ny.gov or (518) 473-4437.
Information from the U.S. Centers for Disease Control and Prevention (CDC) is available here.
Additional Booster Shots
On August 18, 2021, the U.S. Department of Health and Human Services (HHS) announced that it has developed a plan to begin offering COVID-19 booster shots this fall, subject to subject to. the FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines, and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence.
HHS is prepared to offer booster shots beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents and other seniors will likely be eligible for a booster. HHS would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.
HHS also anticipates booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine and will release a plan for J&J booster shots sometime soon.
More information is available on the HHS website.
FDA
On August 23, 2021, the FDA granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, making it the first to move beyond emergency use status in the United States.
The Pfizer vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under EUA, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.