FDA Authorizes Second Booster Shot, or Fourth-Jab, for Those 50 and Older

The Food and Drug Administration (FDA) on Tuesday authorized Pfizer-BioNTech’s and Moderna’s second booster shots for the Chinese coronavirus for those 50 and older and “certain” immunocompromised individuals.

The FDA had already authorized an additional booster dose for “certain immunocompromised individuals following completion of a three-dose primary vaccination series,” but Tuesday’s decision opened the door to other individuals who may be “higher risk for severe disease, hospitalization and death” to get the second booster shot as well.

“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’s press release reads.

The amended the emergency use authorizations now cover individuals 50 and older, who have had four months go by since their last booster shot, as well as certain immunocompromised individuals 12 and older:

• A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
• A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. 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.
• A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said that “current evidence” points to ‘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,” he said.

“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,” Marks added.

While the move does not authorize the second booster (or fourth jab) for everyone, the FDA said it 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.”

According to the latest survey from TheEconomist/YouGov,  70 percent of individuals say they have received at lest one coronavirus jab, compared to 30 percent who have not. Of those who have, 62 percent said they received “at least three shots” thus far.