Pfizer seeks expanded delivery of its boosters

FDA approval sought for anyone 18 and up

Pfizer asked U.S. regulators Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 or older, a step that comes amid concern about increased spread of the coronavirus with holiday travel and gatherings.

Older Americans and other groups particularly vulnerable to the virus have had access to a third dose of the Pfizer-biontech vaccine since September. But the Food and Drug Administration has said it would move quickly to expand boosters to younger ages if warranted.

Pfizer is submitting early results of a booster study in 10,000 people to make its case that it’s time to further expand the booster campaign.

While all three vaccines used in the U.S. continue to offer strong protection against severe COVID-19 illness and death, the effectiveness against milder infection can wane over time.

Pfizer’s new study concluded a booster could restore protection against symptomatic infection to about 95 percent, even as the extra-contagious delta variant was surging. Side effects were similar to those seen with the company’s first two shots.

A median of 11 months after their last Pfizer vaccination, trial participants were given either a third dose or a dummy shot. Researchers tracked any infections that occurred at least a week later and so far have counted five cases of symptomatic COVID-19 among booster recipients compared with 109 cases among people who got dummy shots.

The Biden administration had originally envisioned boosters for all adults but faced a stinging setback in September when the FDA’S scientific advisers rejected extra Pfizer doses for everyone.

The panel wasn’t convinced that young healthy people needed another dose, particularly when most of the world’s population remains unvaccinated. Instead, it recommended boosters just for certain groups — one of a series of decisions about extra doses for the three vaccines used in the U.S.

The current rules: People who initially received Pfizer or Moderna vaccinations are eligible for a booster six months later if they are 65 or older or are at high risk of COVID-19 because of health problems or their job or living conditions.

Because the single-dose Johnson & Johnson vaccine hasn’t proven as effective as its two-dose competitors, any J&J recipient can get a booster at least two months later.

Also, anyone eligible for a booster doesn’t have to stick with their initial vaccination type and can get a different company’s vaccine, what’s called mixing and matching.

In other developments:

■ Colorado has reactivated crisis guidelines for staffing at health care systems across the state as COVID-19 hospitalizations and infections continue to rise, and state health officials said Tuesday that anyone 18 and older qualifies for a booster shot.

■ An Idaho infant died of COVID-19 last month, marking the state’s first pediatric coronavirus death, officials said Tuesday.

■ Florida’s largest school district is dropping all mask mandates, allowing parents in all grades to decide whether their children should wear a face covering, the superintendent announced Tuesday. Miami-dade County School Superintendent Alberto Carvalho made the announcement after a judge ruled last week that Republican Gov. Ron Desantis was within his authority to allow parents to opt out of strict mandates. But rather than cite the decision, Carvalho said coronavirus cases are dropping, adding that protocols could change if cases spike again.

■ After months of negotiations, New York and its two neighboring states have finally agreed on how to divide up billions in federal COVID-19 relief money aimed at public transit. New York will receive about $10.8 billion, New Jersey will get about $2.6 billion and Connecticut will receive about $474 million.