FDA Authorizes 2nd COVID Booster: What To Know In New Jersey

NEW JERSEY — The U.S. Food and Drug Administration granted emergency-use authorization Tuesday for a second COVID booster shot for certain individuals. The FDA authorized the additional dose of the Pfizer and Moderna vaccines for people who are 50 and older and certain immunocompromised individuals, which would significantly widen eligibility for New Jerseyans.

The Centers for Disease Control and Prevention must decide when and how the federal government will offer the second booster. But CDC Director Dr. Rochelle Walensky is expected to release a statement shortly signing off on the additional shot, according to NBC News.

The CDC previously approved of a fourth dose — or third Johnson & Johnson shot — for moderately or severely immunocompromised people. Before Tuesday, the FDA authorized an additional booster for certain immunocompromised patients.

The FDA's decision will allow people 50 years another dose of the Pfizer and Moderna shots at least four months after their initial booster. Certain immunocompromised individuals 12 and older can also get another Pfizer dose four months after their first booster — same with the Moderna shot for certain immunocompromised people 18 and older.

For the second Pfizer dose, immunocompromised people younger than 50 qualify if they "have undergone solid organ transplantation, or ... are living with conditions that are considered to have an equivalent level of immunocompromise." It wasn't immediately clear which immunocompromised people ages 18-49 qualify for the additional Moderna booster.

In its announcement, the FDA cited evidence of waning immunity in older and immunocompromised people, and it urged anyone who has not gotten their initial booster dose to do so.

“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 agency said the benefits of the second booster outweigh any risks among these groups. For anyone else, the authorization of the first booster dose remains unchanged.

COVID-19 case numbers, hospitalizations and deaths are declining nationwide, but health officials are keeping an eye on the worrying omicron subvariant, BA.2, or “stealth omicron,” which has caused new cases to more than double in the United Kingdom in recent weeks, National Public Radio reported.

The CDC estimates that BA.2 became the dominant strain in the New Jersey region mid-March. BA.2 represented 71 percent of surveilled cases in the region — which also includes New York, Puerto Rico and the Virgin Islands — for the week ending for the week ending March 26.

Although BA.2's presence in New Jersey has grown, the state hasn't seen a significant jump in cases yet. The state averaged 1,013 infections per day in the past week, compared to 989 daily new cases the week prior, according to federal data.

The state had 360 patients in hospitals with confirmed or suspected COVID as of Monday — far down from the omicron peak of 6,089 on Jan. 11, according to the New Jersey Department of Health.

Approval of a second booster is a complicated matter, though, because health experts don’t know the timing of the next COVID-19 surge, The Associated Press reported. It is more difficult to predict for a number of reasons, including the use of at-home tests, whose results aren't included in government data; and the government’s shift in data collection to focus on hospitalizations, which occur after a surge has arrived.

Citing real-world data from Israel, among a handful of countries that offer a second booster shot, Pfizer asked the FDA to greenlight the additional booster shot for people 65 and older. The FDA also cited data from Israel, saying the second Pfizer booster revealed no new safety concerns.

Moderna followed suit, asking the FDA to approve a broad emergency use application of an additional vaccine booster to include any adult over 18 who has gotten any authorized or approved vaccine.

For the second Moderna booster, the agency said the decision was informed by experience with the Pfizer shot and data from a study that showed no new safety concerns up to three weeks after the second booster was administered.

Both vaccine makers cited studies that confirmed infections were two times lower and rates of severe illness were four times lower among people who received the second Pfizer booster, compared to people who received only one, according to a news release.