LONDON (AP) – Britain on Wednesday became the first country to authorize an easy-to-handle COVID-19 vaccine, whose developers hope will become the “vaccine for the world”. Approval and a change in policy that will accelerate the deployment of the vaccine in the UK comes as an increase in infections threatens the wetlands of British hospitals.
The Department of Health said it had accepted a recommendation from the Medicines and Health Products Regulatory Agency to authorize emergency use of the vaccine developed by Oxford University and UK-based drug manufacturer AstraZeneca United.
“The launch will start on January 4 and will really accelerate during the first 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 that the company could start sending the first doses of the vaccine on Wednesday or Thursday “and vaccination will start next week and we will reach a 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 firm 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, easy to administer and is provided by AstraZeneca without any benefit.”
Coronavirus vaccines are usually 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 a maximum number of people a single dose, which is believed to provide great protection against the virus. It was said that the people most at risk would have priority and that everyone would get a second time in the twelve weeks following the first.
The new strategy is set in a context of rising infections in the UK. The number of COVID-19 patients hospitalized has surpassed the first peak of the outbreak in the spring, with authorities guilty of a new, more transmissible variant of the virus, first identified in south-east England, by the tip.
Dr Andrew Pollard of Oxford University, 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 must keep in mind. We cannot be complacent with this variant or perhaps with future variants. “.
Partial results from studies in nearly 24,000 people in Britain, Brazil and South Africa suggest that the traits are safe and around 70% effective in preventing coronary heart disease.
This is not as good as some other vaccine candidates, but Soriot recently told the Sunday Times that he was confident the vaccine would be as effective as its rivals.
The Oxford-AstraZeneca vaccine is expected to be based in many countries due to its low cost, availability and ease of use. It can be stored in refrigerators instead of in ultra-cold storage that some other vaccines require. The company has said it will 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,” Pollard said.
The researchers say the vaccine is protected against the disease in 62% of those who received full doses and in 90% of those who initially received half a dose due to a manufacturing error. However, the second group included only 2,741 people, too few to be conclusive.
There are also questions about vaccine protection for the elderly. Only 12% of study participants were over 55 and enrolled later, so there was not enough time to see if they developed infections at a slower rate than those who had not been given the vaccine.
Researchers were also criticized for the lack of information in September, when studies were suspended because a participant was suffering from a serious illness. AstraZeneca initially declined to provide further details due to patient confidentiality.
Ultimately, trials resumed after regulators reviewed the safety data and decided it was safe to continue. The published partial results show no hospitalizations or serious illnesses among those who received the vaccine. A separate study is also being conducted to test the AstraZeneca vaccine in the US.
The vaccine will become the second COVID-19 vaccine used in Britain. On December 2, regulators gave emergency authorization to the Pfizer-BioNTech vaccine.
Having another vaccine available means more people can get protection, said Sarah Gilbert, an Oxford scientist involved in the AstraZeneca project. It takes a different approach to Pfizer-BioNTech, one or the other developed in the United States from Moderna Inc.
Gillies O’Bryan-Tear, president of policy and communications for Britain’s School of Pharmaceutical Medicine, said the ultra-cold storage these other vaccines need is “very impractical” in developing countries. It means the AstraZeneca “can reach more parts of the world than the Pfizer,” he said.
Britain’s action probably means the World Health Organization will soon eliminate the AstraZeneca vaccine for use in a global effort to help poor countries, called COVAX. The initiative, led by the WHO and the GAVI vaccine alliance, has secured access to at least 100 million doses of the vaccine, with options and other offers to buy more. But none can be distributed until the WHO makes a green light.
The United Nations health agency does not license or regulate vaccines on its own, but usually evaluates vaccines once they have been approved by an agency such as the UK regulator or the European Medicines Agency. WHO experts make their own assessment of whether or not the risks of a vaccine outweigh its benefits and then make a recommendation that the shots be “prequalified” so that donors can buy them in developing countries.
Most of the coronavirus vaccines that will be used in the poorest countries will likely be made by the Serum Institute of India, which AstraZeneca has contracted 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 stopping production several times.
In addition to the Serum Institute, AstraZeneca also has deals with vaccine manufacturers in Brazil, South Africa and China to manufacture the vaccine developed by Oxford for use in developing countries.
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Corder reported from The Hague, the Netherlands. AP medical writer Maria Cheng in Toronto and AP correspondent Jill Lawless in London helped report.