Recommendations for Immunocompromised Individuals
On August 12, 2021, the FDA authorized an additional dose of COVID vaccine for moderately to severely immunocompromised people who received immunization with mRNA vaccine. A 3rd dose is recommended at least 28 days after the second dose of the initial series. If possible, the third dose should be the same brand as the first two doses. The current recommendation applies to those who received two doses of Moderna or Pfizer, not to those who received the single dose of J&J. The CDC and FDA are developing recommendations for those who received the J&J vaccine. One of the reasons there is less information available is because the J&J vaccine was rolled out later than the others.
Approximately, 3% of the U.S. adult population is considered immunocompromised. Those who are immunocompromised tend to be more vulnerable to becoming ill from COVID and less capable of mounting an adequate immune response. Additionally, there is an increased risk for prolonged infection and viral shedding which can put others at risk. The third dose is not considered a booster dose; it is an additional dose to increase the immune response in those who might not have mounted enough of a beneficial response after receiving the first two doses.
Individuals who fall into this category include the following:
- Those receiving active treatment for solid tumor and blood malignancies.
- Those with a history of solid organ transplant and use of immunosuppressive therapy.
- Those with stem cell transplants within the past two years.
- Those with known underlying immunodeficiency not related to medications, e.g., low antibody levels, no spleen, some patients undergoing hemodialysis.
- Those with advanced or untreated HIV infection.
- Those under treatment with prednisone at doses of 20 mg or higher, chemotherapy, certain immunosuppressants such as TNF blockers, and other biologics. If you have questions if you fall into this category, please contact your BMA physician.
Chronic medical conditions, such as heart disease, diabetes, etc., would NOT qualify under this new recommendation. Nor would living in a long-term care facility. Nevertheless, even with a third dose, it is important for those with an immune compromise to mask around people not in their household, distance at six feet or more, and avoid crowds and poorly ventilated indoor spaces.
COVID Boosters
On August 18th, The CDC released a statement that said that it was preparing to issue guidance on giving booster doses to fully vaccinated people who received the Pfizer or Moderna vaccines. A booster dose is an additional vaccine dose, given because of concerns of waning immunity. This is different from the third shot given to those who are immunocompromised. The CDC says the number of breakthrough infections with the delta SARS-CoV-2 variant, together with evidence of waning antibody levels in people vaccinated more than eight months ago, may justify offering a third dose more widely. The CDC developed a plan to begin offering COVID booster shots this fall, subject to the FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose.
Beginning the week of September 20, booster shots will be offered to those individuals immunized with Pfizer and Moderna mRNA vaccines possibly 6 months after the second dose, according to the Biden administration’s current recommendations. These individuals generally include those who were vaccinated early in rollout, including many health care providers, nursing home residents, and other seniors. It is anticipated booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Since the administration of the J&J vaccine did not begin in the U.S. until March 2021, more data and recommendations are expected in the coming weeks.
Antibody Testing
None of the antibody tests to check vaccine response is authorized or recommended. A third dose would be given on the basis of a person’s clinical situation such as being at high risk of severe COVID due to a moderate to severe immunocompromised status or those meeting appropriate recommendations for boosters shots as described above.
FDA Approval
On August 23, the FDA granted full approval for the Pfizer vaccine for people 16 years of age and older. This is the first of the COVID vaccines to receive full approval from the FDA. Pfizer was the first to apply for this status. Moderna’s vaccine is under review and full approval may come in the next several weeks. J&J’s request for full approval has not yet been submitted to the FDA.
Full FDA approval is a process that usually requires a review of at least six months of safety data. The approval process was initiated after two months of safety data because of the urgency of the global pandemic. According to some polls, including from the Kaiser Family Foundation, it is estimated that as many as 30% of individuals cite lack of full approval as a primary reason for not getting the vaccine.
COVID Immunization at Bethesda Medical Associates
Currently, BMA has Moderna vaccine in stock/on order for administration to our patients now and into the fall. If you qualify for a third shot or a booster shot this fall, you may call our office and schedule your vaccination appointment. If you received a Pfizer vaccine, please follow up with an outside vaccine clinic. If you received the J&J vaccine, we are continuing to monitor current recommendations and will continue to communicate with our patients.
Your partners in health,
Bethesda Medical Associates