U.S. likely to authorize COVID vaccine booster shots

U.S. likely to authorize COVID vaccine booster shots

After struggling for months to persuade Americans to get the COVID-19 vaccine, U.S. health officials could soon face a fresh challenge: talking vaccinated people into getting booster shots to gain longer-lasting protection as the Delta variant sends infections soaring again.

As early as this week, U.S. health authorities are expected to recommend an extra dose of the vaccine for all Americans eight months after they get their second shot, according to two people who spoke to the Associated Press on condition of anonymity to discuss internal deliberations.

That means the biggest vaccination drive in U.S. history is about to get even more extensive.

The move is being driven by both the highly contagious Delta variant and by preliminary evidence that the vaccine’s protective effect starts dropping within months.

The new urgency from U.S. officials reflects how quickly the variant has knocked the country back on its heels. On the Fourth of July, President Biden proclaimed that the nation was declaring its independence from the virus. But since then, infections, hospitalizations and deaths have increased nationwide, overloading emergency rooms across parts of the South and West.

When Pfizer announced plans in July to apply for approval for boosters, U.S. officials said it was too early to know whether they were needed. Experts worried that a new campaign calling for boosters would muddle the continuing campaign to win over the tens of millions of Americans who are skeptical or hesitant to get even their first shots.

“We have to really make sure that while we’re spending a lot of time and effort on third doses that we don’t undermine our campaign for first vaccinations,” Lawrence Gostin, a public health specialist at Georgetown University, said Tuesday. “That’s truly the existential crisis in the United States.”

Calling for third doses could discourage people who had been skeptical of the shot’s effectiveness in the first place, Gostin warned.

Booster shots would only begin to be administered widely once the Food and Drug Administration formally approves the vaccines, which are being dispensed for now under what is known as emergency use authorization. Full approval of the Pfizer shot is expected in the coming weeks.

Last week, U.S. health officials recommended boosters for some people with weakened immune systems, such as cancer patients and organ transplant recipients.

The director of the National Institutes of Health, Dr. Francis Collins, said Sunday the U.S. could decide in the next couple of weeks whether to offer booster shots this fall to other Americans as well.

Among the first to receive them could be healthcare workers, nursing home residents and other older Americans, who were some of the first to be vaccinated once the shots were authorized last December.

More than 198 million Americans have received at least one dose of a COVID-19 vaccine, or 70% of those who are eligible, according to the Centers for Disease Control and Prevention. Just under 60% of Americans 12 and older are fully vaccinated.

The vaccination drive has been slower than the Biden administration had hoped for. At the same time, the Delta variant is spreading aggressively through unvaccinated communities and also causing an increasing number of “breakthrough infections” of fully inoculated people.

Studies show the vaccine remains highly protective against severe COVID-19, but results from Israel released last month suggest its potency wanes. Its effectiveness against symptomatic infection peaked at 96% two months after study participants got their second dose. Four months later, it was down to 90%. By six months, it was about 84%.

Israel, which exclusively administered the Pfizer shot, has been offering a booster to people over 50 to control its Delta surge. Researchers are still trying to understand to what extent the breakthrough infections are due to waning immunity or vulnerability to the Delta variant.

On Tuesday, European medical regulators said they are talking with vaccine developers about the need for boosters but haven’t made any decisions.

On Monday, Pfizer and its partner BioNTech announced they submitted data to the FDA to support authorizing a booster shot for the general public. Pfizer said a small study showed people who received a third dose had higher levels of antibodies against several versions of the coronavirus, including the Delta variant. The company is working on a larger study.

Americans who received the earliest doses of Pfizer’s vaccine — mainly healthcare workers and nursing home residents — are approaching the eight-month mark from when they received their second dose.

“There is a concern that the vaccine may start to wane in its effectiveness,” the NIH’s Collins said. “And Delta is a nasty one for us to try to deal with. The combination of those two means we may need boosters, maybe beginning first with healthcare providers, as well as people in nursing homes, and then gradually moving forward” with others.

He said because the variant only started hitting the country hard in July, the next couple of weeks of case data will help the U.S. make a decision.

The Pfizer and Moderna vaccines are administered in two doses. Officials are continuing to collect information as well about the one-shot Johnson & Johnson vaccine, which was approved in the U.S. in late February, to determine when to recommend boosters.

The White House has said that even though the U.S. has begun sharing more than 110 million vaccine doses with the rest of the world, the nation has enough to deliver boosters to Americans.

Global health officials, including the World Health Organization, have called on wealthier and more-vaccinated countries to hold off on booster shots for those who are fully vaccinated to ensure the supply of first doses for people in poorer corners of the world.

Gostin said any Biden administration plan to recommend boosters for all Americans would be “a slap in the face” to other nations that haven’t yet been able to vaccinate their most vulnerable people.

“It’s tone-deaf to the rest of the world that can’t even get any doses,” he said.

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