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Jared Polis blasts FDA delay on coronavirus vaccine booster approval: “They have blood on their hands”

Polis also urged federal regulators to quickly approve coronavirus vaccines for younger children

Dr. Steve Groshong administers the Pfizer-BioNTech COVID-19 vaccine to Robert Webber during a drive-through vaccine clinic in the parking lot at National Jewish Health on January 29, 2021, in Denver, Colorado. (Kathryn Scott, Special to The Colorado Sun)
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Using uncharacteristically incendiary rhetoric, Gov. Jared Polis on Monday criticized federal regulatory delays in rolling out coronavirus vaccine booster shots, dismissing concerns that the vaccine doses are unnecessary and could be better used elsewhere.

“At the very least, the FDA should get out of the way and allow people to make this choice to protect themselves,” Polis said during a news conference.

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His comments came as the debate over boosters hit high gear.

Following a relatively uneventful news conference in which Polis and others laid out the state’s plans to distribute booster shots to nursing homes — it will look a lot like the initial vaccine rollout — Polis was asked for his opinion on a piece published Monday in the medical journal The Lancet. The piece was co-signed by two departing, high-profile vaccine regulators with the Food and Drug Administration, and it argued that booster shots are unneeded and that vaccine supplies could be better spent on providing protection to unvaccinated parts of the world.

“Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated,” the FDA’s Marion Gruber and Philip Krause, as well several other co-authors from around the world, wrote.

Asked for his thoughts, Polis referred to Gruber and Krause by name, saying that “we can all celebrate” that the two longtime vaccine regulators are leaving the FDA.

“They have blood on their hands and there are thousands of Americans that are dead today because of their delays on the booster shot,” Polis said.

Vaccine drop-in during the grand opening of the St. Vincent Health hospital on September 8, 2021, in Leadville, Colorado. (Hugh Carey, The Colorado Sun)

Gruber and Krause will leave their posts this fall after clashing with the Biden administration over its plans to offer booster shots to all Americans. Their argument, as spelled out in The Lancet piece, is that the COVID-19 vaccines continue to offer strong protection against serious illness, hospitalization and death long after their second dose is administered. The incremental gains that booster shots can provide are not worth prioritizing when so many Americans — and so much of the world — remain unvaccinated and have no protection from the virus at all.

Polis strongly disagreed with this argument, saying that doing a better job of preventing even mild illness among vaccinated people could help slow the spread of the coronavirus in Colorado and across the country. And he said booster shots could prevent hospitalization and death for some small percentage of people who are already vaccinated.

“The benefits outweigh the costs overwhelmingly,” Polis said. “The FDA needs to get out of their ivory tower and realize there is a real-life pandemic with 900 hospitalizations in Colorado, tens of thousands across the country. We have the ability to end it. We need to show the will to end it.”

Polis’ office said the governor’s strong words — which clashed with the more even-keel approach he typically takes in news conferences — were an indication of how urgently he wants to end the pandemic.

“The Governor is distressed as we continue to see Coloradans needlessly suffer from a case of COVID they could have prevented through the safe and effective vaccine or suffer from a breakthrough case that the booster could have prevented,” a spokesman for the governor wrote in an email.

Federal officials have already approved booster shots for people with weakened immune systems, and Polis has been actively encouraging Coloradans to get boosters. There is no need for a doctor’s note to verify health status; people in Colorado will be taken at their word if they show up to a vaccine provider to ask for a booster shot.

Polis said about 2.4% of Colorado adults — including his parents — have already received a booster shot. His administration plans to roll out booster shots to nursing homes later this month. It is also planning for drive-thru events and other clinics when booster shots of the Pfizer vaccine are expected to be approved for everyone on Sept. 20. It’s still not entirely clear how the more widespread booster campaign will work, but the federal government has previously suggested that people who received a two-dose vaccine, like the Pfizer or Moderna vaccines, get a booster eight months after their last shot.

State officials said Monday they expect Colorado to have enough doses to handle the demand for boosters while continuing to make the vaccines widely available for those who are unvaccinated. The state’s vaccine providers can administer more than 600,000 shots per week. At the peak of the booster campaign, the state is expecting to need about 575,000 doses per week, including doses for the unvaccinated.

“Colorado is ready,” said Colorado National Guard Lt. Col. Jamie Pieper, who is helping oversee the vaccination campaign.

By the end of the news conference, though, Polis again returned to criticize the FDA — praising former President Donald Trump’s Operation Warp Speed and saying that, without it, “the FDA would have sat on or delayed the life-saving vaccine for many more months.”

He called on federal regulators to approve vaccines for kids under 12 and also to develop guidance for booster shots for people who received the one-dose vaccine from Johnson & Johnson.

“They need to get off their rear ends and provide that guidance,” Polis said.

Staff writer Jesse Paul contributed to this report.


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