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Why the U.K. Regulator Approved Booster Shots—but the U.S. Is Still Deciding - Barron's

Dr. Anthony Fauci has said booster shots could be ready the week of September 20.

(Mandel Ngan/AFP/Getty Images)

The U.K. drug regulator on Thursday gave emergency use authorization for two Covid-19 vaccines to be used as booster shots, paving the way for Brits to receive a third dose as health authorities mull data suggesting immunity wanes over time.

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) said that the vaccines developed by AstraZeneca (ticker: AZN) as well as Pfizer (PFE) and BioNTech (BNTX) could be used safely as a third dose to protect people against Covid-19.

AstraZeneca ‘s U.S.-listed shares fell 0.5% on Thursday, with Pfizer stock down 0.5% along with the wider pharmaceuticals sector. BioNTech shares rose 2.8%.

“We know that a person’s immunity may decline over time after their first vaccine course. I am pleased to confirm that the Covid-19 vaccines made by Pfizer and AstraZeneca can be used as safe and effective booster doses,” said Dr. June Raine, the chief executive of the MHRA. 

In the U.S., the Food and Drug Administration is still determining the suitability of booster shots, and regulatory approval would face a vote from the Centers for Disease Control’s Advisory Committee on Immunization Practices.

Top federal health officials from both bodies have told the White House to scale back its plans to offer booster shots to the general public in September because regulators need more time to review data, the New York Times reported.

So is the U.S. lagging behind? Not necessarily.

Booster shots have received regulatory approval in the U.K., but the decision on whether to roll them out, when, and to whom lies with the Joint Committee on Vaccination and Immunization. The JCVI is a government advisory committee of independent experts, and at least one of its members has warned that it may be “too soon” to start rolling out booster shots, according to a report in the Telegraph.

The logic is that, since levels of the antibodies that offer protection against the virus decline over time, boosting too early or at the wrong time of year could leave people less protected when they need it most.

Raine clarified that the decision lies with the JCVI, noting that MHRA approval is “an important regulatory change as it gives further options for the vaccination programme, which has saved thousands of lives so far.” 

“It will now be for the [JCVI] to advise on whether booster jabs will be given and if so, which vaccines should be used,” she added.

The JCVI is set to meet Thursday to decide on a booster program, so it’s possible a green light could come soon and third doses will be rolled out in the U.K. in short order.

There is political will in both countries to make boosters happen. British ministers are believed to be keen to roll out a mass third shot program as fast as possible for all adults, the Guardian reported.

And Dr. Anthony Fauci, President Joe Biden’s chief medical advisor, said it was likely a Pfizer-BioNTech booster would be approved to meet a September 20 deadline, speaking to CBS’ “Face the Nation” last weekend. “I think it’s going to be at the most a couple of weeks, a few weeks delay, if any,” the top doctor said.

But a slight delay between the U.K. and U.S. in vaccine rollout would not be unprecedented. After all, the U.K. was the first country to give clearance to the Pfizer-BioNTech vaccine, on December 2 last year—with the U.S. following nine days later.

Moves in the U.S., U.K., and other countries to give residents a third shot of a Covid-19 vaccine come as the World Health Organization (WHO) continues to urge a halt to such initiatives—a call that has so far been largely ignored.

Rich countries with large supplies of vaccines should make doses available for poorer countries before offering booster shots this year, WHO Director-General Tedros Adhanom said in a news conference Wednesday, as reported by the Associated Press.

“I will not stay silent when companies and countries that control the global supply of vaccines think the world’s poor should be satisfied with leftovers,” Adhanom said, according to the report. “Because manufacturers have prioritized or been legally obliged to fulfill bilateral deals with rich countries willing to pay top dollar, low income countries have been deprived of the tools to protect their people.”

Write to Jack Denton at jack.denton@dowjones.com

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