UK approves use of 2nd COVID-19 vaccine with easier storage
LONDON – Britain authorized emergency use of a second COVID-19 vaccine Wednesday, becoming the first country to greenlight an easy-to-handle shot that its developers hope will become the “vaccine for the world.”
The Department of Health accepted a recommendation from the Medicines and Healthcare products Regulatory Agency to authorize the vaccine developed by Oxford University and U.K.based drugmaker Astra Zeneca.
Britain bought 100 million doses of the vaccine and plans to begin injections within days. 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.
Astra Zeneca chief executive Pascal 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 Astra Zeneca at no profit.”
Partial results from studies in almost 24,000 people in Britain, Brazil and South Africa suggest the shots are safe and about 70% effective for preventing illness from coronavirus infection.
That’s not as good as some other vaccine candidates, but Soriot told the Sunday Times newspaper he was confident the vaccine would prove as effective as its rivals.
COVID-19 vaccines typically are given in two doses, an initial shot followed by a booster about three weeks later.
The British government said it would prioritize giving as many people as possible a single dose of the Astra Zeneca vaccine. It said people at the highest risk would get priority, and everyone would get a second jab within 12 weeks of the first.
Many countries are likely to rely on the Oxford-Astra-Zeneca vaccine 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 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,” said Oxford’s Dr. Andrew Pollard, who led one of the studies.
Questions remain about how well the vaccine protects older people. Only 12% 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.
In September, studies were suspended because a participant suffered a serious illness. Astra Zeneca initially declined to provide further details, citing patient confidentiality.
The trials resumed after regulators reviewed safety data and decided it was safe to continue. Published results show no hospitalizations or severe disease among those who received the vaccine.
The results released are only partial ones because the studies are continuing. A separate study testing the AstraZeneca vaccine in the USA is underway.
The COVID-19 vaccine will be the second in use in Britain. On Dec. 2, regulators gave similar 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 Astra Zeneca project.
The Astra Zeneca vaccine differs from Pfizer-BioNTech's and another one developed in the USA from Moderna. The ultra-cold storage those other vaccines need is “very impractical” in developing countries, said Gillies O’Bryan-Tear, chair of policy and communication for Britain’s Faculty of Pharmaceutical Medicine. The Astra-Zeneca one “may reach more parts of the world than the Pfizer one,” he said.
Britain’s action probably means the World Health Organization will soon clear the Astra Zeneca vaccine for use in a global effort to help poor countries, called COVAX. The initiative, led by the WHO and the vaccines alliance GAVI, secured access to at least 100 million doses of the vaccine, with options and other deals to buy more. None can be distributed until greenlighted by the WHO.
The United Nations health agency does not licence or regulate vaccines but typically evaluates them once they have been approved by an agency such as the U.K. regulator or the European Medicines Agency. WHO experts determine whether the risks of a vaccine outweigh its benefits, then make a recommendation on whether the shots can be “pre-qualified” so they can be bought by donors for developing countries.
Most COVID-19 vaccines to be used in poorer countries probably will be made by the Serum Institute of India, which was contracted by Astra Zeneca 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 as of early December, only about 50 million doses had been manufactured after production was halted several times.
Astra Zeneca also has deals with vaccine makers in Brazil, South Africa and China to make the Oxford-developed vaccine for use in developing countries.