By Pamela Cruz. Peninsula 360 Press [P360P]
This Thursday, the U.S. Food and Drug Administration (FDA) authorized the emergency use of a third dose of Pfizer-BioNTech and Moderna's COVID-19 vaccine (FDA) authorized the emergency use of a third dose of Pfizer-BioNTech and Moderna's COVID-19 vaccine for immunosuppressed individuals, specifically, organ transplant recipients or those with immunosuppressive conditions.
The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices is scheduled to meet today, August 13, to discuss specific clinical recommendations for immunosuppressed individuals.
"The country has entered into another wave of the COVID-19 pandemic, and the FDA is especially aware that immunocompromised individuals are at particular risk for serious disease. After a thorough review of the available data, FDA determined that this small and vulnerable group may benefit from a third dose of Pfizer-BioNTech or Moderna vaccines," said FDA Acting Commissioner Janet Woodcock.
He added that Thursday's action allows physicians to increase immunity in these types of patients, who need additional protection against COVID-19.
"As we said previously, other fully vaccinated individuals are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. FDA is actively engaged in a rigorous, science-based process with our federal partners to consider whether an additional dose may be needed in the future," he added.
Immunosuppressed individuals similar to those who have undergone organ transplantation have a reduced ability to fight infections and other diseases, and are especially vulnerable to infections, including COVID-19.
Woodcock advised these patients to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated, as appropriate to their health status, to provide added protection for their loved ones.
He recommended that immunocompromised individuals discuss monoclonal antibody treatment options with their health care provider in the event of infection or exposure to COVID-19.
The FDA has authorized monoclonal antibody treatments for emergency use during this public health emergency for adults and pediatric patients - aged 12 years or older weighing at least 40 kilograms or about 88 pounds - with positive SARS-CoV-2 direct viral test results, and who are at high risk for progression to severe COVID-19 and/or hospitalization.
Notably, the Pfizer-BioNTech COVID-19 vaccine is currently licensed for emergency use in persons 12 years of age and older, while the Modern COVID-19 vaccine is licensed in persons 18 years of age and older.
Both vaccines are given as a series of two injections: Pfizer-BioNTech COVID-19 three weeks apart and Moderna COVID-19 one month apart.
The licenses for these vaccines have been modified to allow an additional, or third, dose to be given at least 28 days after the two-dose regimen of the same vaccine to persons 18 years of age or older - 12 years of age or older for Pfizer-BioNTech - who have undergone an organ transplant or who are diagnosed with conditions considered to have an equivalent level of immunosuppression.
