LONDON (AP) – Britain became the first country to approve an easy-to-handle COVID-19 vaccine on Wednesday, which developers hope will become the “vaccine for the world.” The approval and a policy change that will speed up the vaccine rollout in the UK comes as a wave of infections threatens to engulf UK hospitals.
The Department of Health said it had accepted a recommendation from the Medicines and Healthcare Products Regulatory Agency to allow the emergency use of the vaccine developed by Oxford University and UK-based drug manufacturer AstraZeneca.
“The rollout will begin on January 4 and will really accelerate in the first weeks of next year,” UK Health Minister 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 ship the first doses of the vaccine Wednesday or Thursday, “and the vaccination will start next week and we will get to 1 million very quickly – and beyond – per week.”
Hundreds of thousands of people in the UK have already received a different vaccine, made by the US drug manufacturer 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, easy to administer and is provided by AstraZeneca on a non-profit basis. “
Coronavirus vaccines are usually given in two doses, with a first injection followed by a booster about three weeks later.
But in a different approach, the UK government said that with the AstraZeneca vaccine, it would prioritize giving as many people as possible a single dose, which is believed to provide a high degree of protection against the virus. It said people at highest risk would be given priority and everyone would receive a second shot within 12 weeks of the first shot.
The new strategy comes against the background of rising infections in the UK. England, before the peak.
Dr. Andrew Pollard of the University of Oxford, one of the leaders on the development team, hoped the newly approved vaccine will help.
“At the moment there is no evidence that the vaccines will not work against the new variant,” Pollard told Radio 4. “But that is something we have to look at. We cannot be complacent about this variant or perhaps future variants. . “
Partial results of studies involving nearly 24,000 people in Great Britain, Brazil and South Africa suggest the shots are safe and about 70% effective in preventing disease 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 to be as effective as its rivals.
The Oxford-AstraZeneca vaccine is expected to be used in many countries due to its low cost, availability and ease of use. It can be kept in refrigerators instead of the ultra-cold storage that some other vaccines require. The company has said it will sell it for $ 2.50 per dose and plans to make up to 3 billion doses by the end of 2021.
“We have a vaccine for the world,” said Pollard.
Researchers claim that the vaccine is protected against disease in 62% of those who received two full doses and 90% of those who initially received half a dose due to a manufacturing defect. However, the second group included only 2,741 people – too few to be definitive.
Questions also remain about how well the vaccine protects the elderly. Only 12% of the study participants were over 55 years old and enrolled later, so there was not enough time to see if they were less likely to develop infections than those who did not receive the vaccine.
Researchers also faced criticism for lack of information in September, when studies were suspended because one participant had a serious illness. AstraZeneca initially declined to provide further details due to patient confidentiality.
Ultimately, the trials resumed after regulators reviewed the safety data and decided it was safe to proceed. Published partial results show no hospitalization or serious illness among those who received the vaccine. A separate study is also underway testing the AstraZeneca vaccine in the US.
The vaccine will be the second COVID-19 vaccine in use in Great Britain. On December 2, regulators issued an emergency permit for the Pfizer-BioNTech vaccine.
Having a different vaccine available means 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 developed in the United States by Moderna Inc.
The ultra-cold storage required by those other vaccines is “highly impractical” in developing countries, said Dr. Gillies O’Bryan-Tear, chair of policy and communications at the UK Faculty of Pharmaceutical Medicine. It means the AstraZeneca can “reach more parts of the world than the Pfizer,” he said.
The UK move likely 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 vaccine 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 the WHO gives the green light.
The UN health agency itself does not license or regulate vaccines, but usually evaluates vaccines after they have been approved by an agency such as the UK regulator or the European Medicines Agency. WHO experts themselves assess whether or not a vaccine’s risks outweigh its benefits, then recommend that the injections be “pre-qualified” so that they can be purchased by donors for developing countries.
Most of the coronavirus vaccines used in poorer countries will likely be made by the Serum Institute of India, which has been 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 only about 50 million doses had been produced by the beginning of December after production was shut down several times.
In addition to the Serum Institute, AstraZeneca also has deals with vaccine manufacturers in Brazil, South Africa and China to make the Oxford-developed vaccine 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 contributed to the reporting.