FDA, CDC recommend additional COVID-19 boosters for immunocompromised individuals, people over 50The CDC Roybal Campus. Source: CDC.gov
Atlanta, GA — The United States Food and Drug Administration, on March 29, authorized a second booster dose of either the Pfizer or Moderna COVID-19 vaccines for individuals ages 50 and older and certain immunocompromised individuals. The Centers for Disease Control and Prevention updated its guidance today to reflect the action from the FDA.
The agencies recommend that certain immunocompromised individuals and people over the age of 50 who received an initial booster dose of the COVID-19 vaccine at least four months ago are eligible for another booster dose to increase their protection against severe disease from COVID-19, according to a press release from the CDC.
The FDA also authorized a second Pfizer booster dose for immunocompromised children 12 and older, at least four months after they received the first booster dose. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise, according to a press release from the FDA.
A second Moderna booster dose was authorized as well for immunocompromised individuals who are 18 and older at least four months after their first booster dose.
Also, adults who received a primary vaccine and booster dose of the Johnson and Johnson COVID-19 vaccine at least four months ago may now receive a second booster dose of the Pfizer or Moderna vaccines.
Today’s action from the FDA applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines, and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” said Dr, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”
The updated recommendations from the CDC acknowledge the increased risk of severe disease in certain populations, including those who are elderly or over the age of 50 with multiple underlying conditions, along with the currently available data on vaccine and booster effectiveness.
“Today, CDC expanded eligibility for an additional booster dose for certain individuals who may be at higher risk of severe outcomes from COVID-19,” Dr. Rochelle P. Walensky, director of the CDC. “Boosters are safe, and people over the age of 50 can now get an additional booster 4 months after their prior dose to increase their protection further. This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19, as they are the most likely to benefit from receiving an additional booster dose at this time. CDC, in collaboration with FDA and our public health partners, will continue to evaluate the need for additional booster doses for all Americans.”
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