The U.S. Food and Drug Administration announced late Thursday night that the Pfizer and Moderna COVID-19 vaccines would both be authorized for an additional dose for certain immunocompromised persons.
According to an FDA news release, those who are solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise could receive additional doses.
The CDC’s Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations on immunocompromised persons.
According to the FDA, their action does not apply to people who are not immunocompromised.
“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” said acting FDA Commissioner Janet Woodcock. “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”
It is recommended that immunocompromised individuals discuss monoclonal antibody treatment options with their health care provider should they contract or be exposed to COVID-19, according to the FDA. The FDA has authorized monoclonal antibody treatments for emergency use during this public health emergency for adults and pediatric patients (ages 12 and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 or hospitalization. One authorized product includes use for preventative (prophylaxis) treatment after being exposed to SARS-CoV-2; however, this product is not a substitute for vaccination, according to the FDA.
The Pfizer-BioNTech COVID-19 Vaccine is currently authorized for emergency use in individuals ages 12 and older, and the Moderna COVID-19 Vaccine is authorized for emergency use in individuals ages 18 and older. Both vaccines are administered as a series of two shots: the Pfizer-BioNTech COVID-19 Vaccine is administered three weeks apart, and the Moderna COVID-19 Vaccine is administered one month apart.
The authorizations for these vaccines have been amended to allow for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine to individuals 18 years of age or older (ages 12 or older for Pfizer-BioNTech) who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromised, according to the FDA.
At the Friday morning medical update at the University of Kansas Health System, Dr. Kevin Ault, a member of the federal advisory panel for vaccine distribution, said the CDC’s Advisory Committee on Immunization Practices was meeting at 10 a.m. Friday to discuss these booster shots for immunocompromised people.
Dr. Ault is an obstetrician and gynecologist at the KU Health System, as well as a member of the ACIP.
The ACIP is expected to make a clinical recommendation after discussing the issues, he said.