Why the UK regulator approved the booster shots, but the US is still deciding

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The UK medicines regulator on Thursday gave emergency use authorization for two Covid-19 vaccines to be used as booster shots, paving the way for Britons to receive a third dose as health authorities examine data suggesting that the immunity wanes over time.

The UK Medicines and Health Products Regulatory Agency (MHRA) said vaccines developed by

AstraZeneca

(ticker: AZN) as well as

Pfizer

(PFE) and

BioNTech

(BNTX) could be safely used as a third dose to protect people from Covid-19.

AstraZeneca

U.S.-listed stocks fell 0.5% on Thursday, with

Pfizer

the share was down 0.5% with the pharmaceutical sector as a whole. BioNTech shares rose 2.8%.

“We know that a person’s immunity can decline over time after their first round of immunization. I am happy to confirm that the Covid-19 vaccines manufactured by Pfizer and AstraZeneca can be used as safe and effective booster doses, ”said Dr June Raine, Chief Executive Officer of MHRA.

In the United States, the Food and Drug Administration is still determining the suitability of booster injections, and regulatory approval would be subject to a vote by the Centers for Disease Control’s Advisory Committee on Immunization Practices.

Senior federal health officials from both agencies have asked the White House to scale back plans to offer booster shots to the general public in September as regulators need more time to review the data, the New reported. York Times.

So, is the United States lagging behind? Not necessarily.

The booster injections have received regulatory approval in the UK, but the decision to roll them out, when and to whom is on 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 early” to start rolling out booster injections, according to a report from the Telegraph.

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

Raine said the decision rests with JCVI, noting that the MHRA’s approval is “an important regulatory change as it offers new options for the vaccination program, which has saved thousands of lives so far.”

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

The JCVI is due to meet on Thursday to decide on a recall schedule, so it is possible that a green light will come soon and the third doses will be rolled out in the UK shortly.

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

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

But a slight delay between the UK and US in vaccine deployment would not be unprecedented. After all, the UK was the first country to authorize the Pfizer-BioNTech vaccine on December 2 last year, with the US following it nine days later.

Steps in the US, UK and other countries to give residents a third injection of a Covid-19 vaccine come as the World Health Organization (WHO) continues to urge halt such initiatives – a call that has so far been largely ignored.

Rich countries with large reserves of vaccines should make doses available to poorer countries before offering booster shots this year, WHO Director-General Tedros Adhanom said on Wednesday during a press conference, as reported by the Associated Press.

“I will not remain silent when the companies and countries that control the global vaccine supply think the world’s poor should be content with leftovers,” Adhanom said, according to the report. “Because manufacturers have prioritized or have been legally compelled to enter into bilateral deals with rich countries willing to pay top dollar, low-income countries have been deprived of the tools to protect their populations. “

Write to Jack Denton at [email protected]