FDA Authorizes 2nd Booster For Those Over 50

LONG ISLAND, NY — People aged 50 and over, as well as those who are immunocompromised, are one step closer to rolling up their sleeves for a second booster vaccination against COVID-19.

On Tuesday, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals at higher risk for severe disease, hospitalization and death.

Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns, the FDA said.

The date the vaccinations become available depends upon when the Centers for Disease Control and Prevention weighs in on who is eligible, the Washington Post reported.

New York State Governor Kathy Hochul, on Monday, urged those eligible to get boosted as the new omicron sub-variant BA.2 has led to a slight uptick in new coronavirus cases. On Monday, New York's positivity rate stood at 2.87 percent, with 821 hospitalized and eight deaths.

"The best way to protect ourselves and others from this virus is by using the tools we know work," Hochul said. "The booster dose improves your protection against severe illness and hospitalization, so don't delay in getting one once you are eligible. Let's continue to safely move forward through this pandemic."

The FDA amended the emergency use authorization to allow for a second booster of the Pfizer-BioNTech COVID-19 vaccine or Moderna vaccine for those 50 years of age and older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

A second booster dose of Pfizer or Moderna may be administered to individuals 12 years of age and older with certain kinds of immunocompromise, at least 4 months after a first booster, the FDA said. Those eligible include people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise, the FDA said.

“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 Peter Marks, M.D., Ph.D., 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.”