The U.S. Food and Drug Administration has authorized additional COVID-19 vaccine dose for individuals with weak immunity, who need extra protection from COVID-19. The drug regulator has now amended the emergency use authorizations or EUAs for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow the third dose.
The immunocompromised individuals include solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
According to the agency, other fully vaccinated individuals at present are adequately protected and do not need an additional vaccine dose.
The Centers for Disease Control and Prevention or CDC’s Advisory Committee on Immunization Practices is meeting on Friday to discuss further clinical recommendations regarding immunocompromised individuals.
The EUA for Pfizer-BioNTech COVID-19 Vaccine is currently for individuals ages 12 and older, and for Moderna COVID-19 Vaccine is for 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.
As per FDA’s amendment, individuals with weaker immunity system will be allowed for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine.
Acting FDA Commissioner Janet Woodcock said, “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.”
The FDA said it is actively engaged in a science-based, rigorous process with federal partners to consider whether an additional dose may be needed in the future.
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