Covid-19 vaccine booster launch could be delayed for many

Federal health officials are asking the White House to push back the start of a planned Covid-19 booster campaign, at least for the Moderna Inc. and Johnson & Johnson vaccines, people familiar with the discussions said.

The Food and Drug Administration needs more time to collect and assess the data on safety and efficacy, the people said.

Centers for Disease Control and Prevention Director Rochelle Wollensky and Acting Food and Drug Commissioner Janet Woodcock made the recommendation on Thursday in a meeting with Jeffrey Zients, the White House coronavirus coordinator, one of the people said.

One official said the process for Pfizer remains on track but Moderna and J&J are likely to be pushed back beyond the week of Sept. 20. Last month, the Biden administration said people who had been vaccinated for eight months or longer should get a booster starting Sept. 20.

The White House said it is awaiting a full review, clearance by the FDA and a recommendation by the CDC’s expert advisory panel.

“We always said we would follow the science, and this is all part of a process that is now underway," said Chris Meagher, a White House spokesman. “When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus."

The New York Times earlier reported the recommendation.

Asked earlier this week about concerns the booster campaign was premature, White House press secretary Jen Psaki said, “This was a recommendation made by our nation’s leading health experts based on mounds and mounds of data."

The Biden administration has sought boosters to counter contagious variants such as Delta and correct signs of waning immunity among the vaccinated, though evidence supporting the need for an extra dose, at least in the general public, isn’t conclusive.

Federal health officials told the White House on Thursday they may not be able by Sept. 20 to make a decision clearing boosters for vaccines other than the one from Pfizer Inc. and its partner BioNTech SE.

The initial Pfizer campaign, if it does start the week of Sept. 20, may also need to be limited to higher risk groups such as nursing home residents, healthcare workers and people over 65, the people said.

A Pfizer spokeswoman directed questions on the Biden administration’s booster discussions to the U.S. government. J&J said it is engaging with the FDA and CDC regarding boosting with its vaccine. Moderna didn’t respond to a request for comment but said on Twitter Friday that it had completed its booster application to the FDA, which it began Wednesday.

One issue stalling the discussions, one of the people said, is trying to figure out whether the Moderna vaccine booster should be a 50 microgram dose or the 100 microgram dose used for the first two shots.

The Wall Street Journal reported that Moderna is advocating for 50 micrograms while some in government favor 100 micrograms amid uncertainty because of durability concerns.

The second issue, the person said, is figuring what the right boosting interval for the single dose J&J shot is.

Federal health officials hope they can make recommendations about Moderna and J&J in October, the person said.

According to CDC data, 94.6 million people have been fully vaccinated with Pfizer’s vaccine, 65.8 million people with Moderna’s vaccine and 14.2 million with J&J’s single-dose vaccine.

Boosters are currently authorized for immunocompromised people who received the Pfizer and Moderna vaccines.

Roughly 955,000 people have received an additional Covid-19 vaccine dose since Aug. 13, according to the CDC. At least 10 million people in the U.S. take immunosuppressants that would likely already make them eligible for boosters, according to Johns Hopkins University School of Medicine.