- The Washington Times - Friday, September 17, 2021

The Biden administration said Friday it announced a COVID-19 booster program ahead of regulatory approval to be transparent about how the shots were performing and help states and vaccine providers plan for the effort.

U.S. Surgeon General Vivek Murthy said officials promised to tell Americans if there were signals the shots’ power started to wane and that additional shots were required, so they spoke up in August. He also said vaccine administrators needed a heads up that boosters would be part of the operation.

“You can’t flip a switch and make that happen overnight, there is important planning that has to take place with localities, with state governments, with community organizations,” Dr. Murthy told reporters on a White House COVID-19 briefing. “So we laid out an initial plan for that purpose, to allow the time that we’ve now been using over the past few weeks, to do that all-important coordination.”

Dr. Murthy defended President Biden’s plan in response to criticism the president squeezed Food and Drug Administration regulators and the CDC’s Advisory Committee on Immunization Practices (ACIP) by announcing a Sept. 20 start date for boosters, though the agencies had not signed off on the need for boosters.

FDA advisers debated Pfizer-BioNTech’s request to offer a third dose on Friday and ACIP will convene next week to address the thornier question of whether everyone should get a booster eight months after the second dose — or if boosters should be limited to certain populations, such as the elderly or medically frail.

The government already approved boosters for immunocompromised persons.

The surgeon general said the program was always subject to regulatory review, but top officials felt they needed to give people a sense of the plan.

That didn’t stave off controversy.

Scientists disagree on whether the data supports extra doses for the general population — the vaccines remain generally effective against severe illness — and two senior FDA officials are retiring this fall after they reportedly objected to the president getting ahead of the agency on boosters.

White House COVID-19 Coordinator Jeff Zients said the government will be ready to stock pharmacies and other sites if boosters are approved.

A third dose of the Moderna shot will likely be reviewed in the coming weeks, while Johnson & Johnson recipients will have to wait longer to find out if they should second dose of the company’s one-shot version.

“We have plenty of supply of all three vaccines for boosters pending obviously the FDA and CDC recommendations. We have supply in inventory and supply on-order,” Mr. Zients said. “Supply is in good shape for all Americans to get booster as recommended.”

Roughly 54% of the U.S. population is fully vaccinated and about three-quarters of those aged 12 or older have come forward for at least one dose.

Biden officials are pushing employer-based mandates to get the quarter who are holding out to come forward.

“It’s really important that people get their first and second shot,” Mr. Zients said.

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