Britain approves use of AstraZeneca-Oxford COVID-19 vaccine

Britain on Wednesday became the first country to authorize an easy-to-handle COVID-19 vaccine whose developers hope it will become the "vaccine for the world." The approval and a shift in policy that will speed up rollout of the vaccine in the United Kingdom comes as a surge in infections threatens to swamp British hospitals.

The Department of Health said it had accepted a recommendation from the Medicines and Healthcare products Regulatory Agency to authorize emergency use of the vaccine developed by Oxford University and U.K.-based drugmaker AstraZeneca.

"The rollout will start on Jan. 4 and will really accelerate into the first few weeks of next year," British Health Secretary Matt Hancock told Sky News. Britain has bought 100 million doses of the vaccine.

AstraZeneca CEO Pascal Soriot told BBC Radio 4 the company could start shipping the first doses of the vaccine Wednesday or Thursday "and the vaccination will start next week, and we will get to one million — and beyond that — a week, very rapidly."

Hundreds of thousands of people in the U.K. have already received a different vaccine, made by U.S. drugmaker Pfizer and German firm BioNTech.

Soriot said it was "an important day for millions of people in the U.K. who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit."

Coronavirus vaccines have typically been given in two doses, with an initial shot followed by a booster about three weeks later.

But in a change of approach, the British government said that with the AstraZeneca vaccine it would prioritize giving as many people as possible a single dose, which is believed to give a large measure of protection against the virus. It said people at the highest risk would get priority, and everyone would get a second jab within 12 weeks of the first.

Canada, which has signed agreements to procure a range of vaccine candidates, has a deal with AstraZeneca for 20 million doses.

In a statement released Wednesday after the authorization in the U.K., Health Canada said it has been reviewing AstraZeneca's vaccine since Oct. 1 and is assessing data "as it becomes available from the manufacturer."

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"There is still information and data to be provided by AstraZeneca for review," the statement said, adding that the department is "working closely" with international regulators.

Health Canada reiterated that it is working to give Canadians access to vaccines "as quickly as possible without compromising … safety, efficacy and quality standards" but said it can't provide a timeline for the completion of its review of the AstraZeneca-Oxford vaccine.

Health Canada has so far authorized two vaccines, the messenger RNA vaccines from Pfizer-BioNTech and Moderna Inc.

Climbing case numbers

The new strategy comes against a backdrop of soaring infections in the U.K. The number of hospitalized COVID-19 patients has surpassed the first peak of the outbreak in the spring, with authorities blaming a new, more transmissible variant of the virus, first identified in southeast England, for the spike.

Oxford University's Dr. Andrew Pollard, one of the leaders of the development team, offered hope the newly approved vaccine will help.

"At the moment, there's no evidence that the vaccines won't work against the new variant," Pollard told Radio 4. "But that is something which we have to look at. We can't be complacent about this variant or perhaps future variants."

Partial results from studies in almost 24,000 people in Britain, Brazil and South Africa suggest the shots are safe and about 70 per cent effective for preventing illness from coronavirus infection. That's not as good as some other vaccine candidates, but Soriot recently told the Sunday Times newspaper that he was confident the vaccine would prove as effective as its rivals.

The AstraZeneca-Oxford vaccine is expected to be relied on in many countries because of its low cost, availability and ease of use. It can be kept in refrigerators rather than the ultra-cold storage some other vaccines require. The company has said it will sell it for $2.50 a dose and plans to make up to three billion doses by the end of 2021.

"We have a vaccine for the world," said Pollard.

Questions remain

Researchers claim the vaccine protected against disease in 62 per cent of those given two full doses and in 90 per cent of those initially given a half dose because of a manufacturing error. However, the second group included only 2,741 people — too few to be conclusive.

Questions also remain about how well the vaccine protects older people. Only 12 per cent of study participants were over 55 and they were enrolled later, so there hasn't been enough time to see whether they develop infections at a lower rate than those not given the vaccine.

Researchers also were criticized for lack of information in September, when studies were suspended because a participant suffered a serious illness. AstraZeneca initially declined to provide further details due to patient confidentiality.

Ultimately, the trials resumed after regulators reviewed safety data and decided it was safe to continue. Published partial results show no hospitalizations or severe disease among those who received the vaccine. A separate study testing the AstraZeneca vaccine in the United States also is underway.

The vaccine will become the second COVID-19 vaccine in use in Britain. On Dec. 2, regulators gave emergency authorization to the Pfizer-BioNTech vaccine.

Having another vaccine available means that more people can get protection, said Sarah Gilbert, an Oxford scientist involved in the AstraZeneca project. It takes a different approach than the Pfizer-BioNTech one or another developed in the U.S. from Moderna Inc.

The ultra-cold storage those other vaccines need is "very impractical" in developing countries, said Dr. Gillies O'Bryan-Tear, chair of policy and communications for Britain's Faculty of Pharmaceutical Medicine. It means the AstraZeneca one "may reach more parts of the world than the Pfizer one," he said.

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Britain's action likely means the World Health Organization will soon clear the AstraZeneca vaccine for use in a global effort to help poor countries called COVAX. The initiative, led by WHO and the vaccines alliance, GAVI, has secured access to at least 100 million doses of the vaccine, with options and other deals to buy more. But none can be distributed until green-lighted by WHO.

The UN health agency does not licence or regulate vaccines itself but typically evaluates vaccines once they have been approved by an agency, such as the U.K. regulator or the European Medicines Agency. WHO experts conduct their own evaluation of whether or not the risks of a vaccine outweigh its benefits and then make a recommendation for the shots to be "pre-qualified" so they can be bought by donors for developing countries.

Most coronavirus vaccines to be used in poorer countries likely will be made by the Serum Institute of India, which has been contracted by AstraZeneca to make one billion doses. In June, the pharmaceutical company announced that the Serum Institute would produce 400 million doses by the end of 2020, but as of early December, only about 50 million doses had been manufactured after production was halted several times.

In addition to the Serum Institute, AstraZeneca also has deals with vaccine makers in Brazil, South Africa and China to make the Oxford-developed vaccine for use in developing countries.