LONDON (AP) – 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”. Approval and a change in policy that will speed up the vaccine’s launch in the UK comes as an increase in infections threatens to flood British hospitals.
The Health Department said it accepted a recommendation from the Medicines and Health Products Regulatory Agency to authorize the emergency use of the vaccine developed by the University of Oxford and by the UK-based pharmaceutical company AstraZeneca.
“The launch will start on January 4 and will really accelerate in the first weeks of next year,” British Health Secretary Matt Hancock told Sky News. Britain bought 100 million doses of the vaccine.
AstraZeneca’s chief executive, Pascal Soriot, told BBC Radio 4 that the company could start sending the first doses of the vaccine on Wednesday or Thursday “and the vaccination will start next week and we will reach 1 million – and beyond that – a week, very quickly ”.
Hundreds of thousands of people in the UK have already received a different vaccine, made by the American pharmaceutical company Pfizer and the German company BioNTech.
Soriot said it was “an important day for millions of people in the UK who will have access to this new vaccine. It has been shown to be effective, well tolerated, simple to administer and is provided by non-profit AstraZeneca. “
Coronavirus vaccines are typically administered in two doses, with an initial injection 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 a single dose to as many people as possible, which is believed to give a great measure of protection against the virus. He said that those most at risk would have priority and everyone would receive a second jab 12 weeks after the first.
The new strategy appears against a backdrop of growing infections in the UK. The number of hospitalized COVID-19 patients exceeded the first peak of the outbreak in the spring, with authorities blaming a new, more transmissible variant of the virus, first identified in southeastern England, for the peak.
Dr. Andrew Pollard of the University of Oxford, one of the leaders of the development team, offered hope that the newly approved vaccine will help.
“At the moment, there is no evidence that vaccines do not work against the new variant,” Pollard told Radio 4. “But this is something we have to look at. We cannot be complacent with this variant or perhaps with future variants. “
Partial results from studies on nearly 24,000 people in Britain, Brazil and South Africa suggest that vaccines are safe and about 70% effective in preventing coronavirus infection.
This is not as good as some other vaccine candidates, but Soriot recently told the Sunday Times that he was confident that the vaccine would be as effective as its rivals.
The Oxford-AstraZeneca vaccine is expected to be reliable in many countries due to its low cost, availability and ease of use. It can be kept in refrigerators, instead of the ultra-cool storage that some other vaccines require. The company said it would sell it for $ 2.50 a dose and plans to make up to 3 billion doses by the end of 2021.
“We have a vaccine for the world,” said Pollard.
The researchers say the vaccine protected against disease in 62% of those who received two full doses and in 90% of those who received half a dose initially due to a manufacturing error. However, the second group included only 2,741 people – too few to be conclusive.
Doubts also remain about how well the vaccine protects the elderly. Only 12% of study participants were over 55 and were enrolled later, so there was not enough time to see if they developed infections at a lower rate than those who did not receive the vaccine.
The researchers were also 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 the patient’s confidentiality.
Finally, testing was resumed after regulators analyzed the safety data and decided it was safe to continue. The published partial results show no hospitalization or serious illness among those who received the vaccine. A separate study testing the AstraZeneca vaccine in the USA is also underway.
The vaccine will become the second COVID-19 vaccine in use in Britain. On December 2, regulators gave emergency clearance for 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 is a different approach from Pfizer-BioNTech, one or the other developed in the United States by Moderna Inc.
The deep-frozen storage these other vaccines need is “very impractical” in developing countries, said Dr. Gillies O’Bryan-Tear, president of policy and communications at the College of Pharmaceutical Medicine in Britain. This means that AstraZeneca “can reach more parts of the world than Pfizer,” he said.
Britain’s action probably means that the World Health Organization will soon release the AstraZeneca vaccine for use in a global effort to help poor countries, called COVAX. The initiative, led by WHO and the GAVI vaccine alliance, 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 it receives the green light from WHO.
The UN health agency does not license or regulate vaccines per se, but usually evaluates vaccines after being approved by an agency such as the UK regulator or the European Medicines Agency. WHO experts carry out their own assessment of whether a vaccine’s risks outweigh its benefits and then recommend that vaccines be “prequalified” so that they can be purchased by donors for developing countries.
Most coronavirus vaccines to be used in poorer countries are likely to be made by the Serum Institute of India, which was contracted by AstraZeneca to make 1 billion doses. In June, the pharmaceutical company announced that the Serum Institute would produce 400 million doses by the end of 2020, but by early December, only about 50 million doses had been manufactured after production was stopped several times.
In addition to the Serum Institute, AstraZeneca also does business with vaccine manufacturers in Brazil, South Africa and China to make the vaccine developed in Oxford for use in developing countries.
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Corder reported from The Hague, Holland. AP medical writer Maria Cheng in Toronto and AP correspondent Jill Lawless in London contributed to the report.