In a statement, the UK government said the Medicines and Healthcare Products Regulatory Agency (MHRA) had authorized Oxford University/AstraZeneca’s Covid-19 vaccine following “rigorous clinical trials and a thorough analysis of the data by experts at the MHRA.”
The UK is the first country to approve the Oxford University/AstraZeneca vaccine. The news represents a glimmer of hope for the country at a time when its health services are struggling to cope with soaring infection rates.
AstraZeneca said the first doses were being released Wednesday, so that vaccinations could begin early in the New Year. The company recommends that two doses are administered with an interval of between four and 12 weeks.
“This regimen was shown in clinical trials to be safe and effective at preventing symptomatic Covid-19, with no severe cases and no hospitalisations more than 14 days after the second dose,” it said in a statement.
England’s Oxford University, where the vaccine was developed, said the UK’s Joint Committee on Vaccination and Immunisation (JCVI) was expected to advise that the priority should be to give a first dose to as many people in at-risk groups as possible, rather than providing the required two doses in as short a time as possible.
“The second dose completes the course and is important for longer term protection, and everyone will still receive their second dose within 12 weeks of their first, an approach the JCVI believes will maximise the benefits of this vaccine, ensuring at-risk people are able to get meaningful protection and ease the pressure on the UK National Health Service,” an Oxford University statement said.
The Oxford University/AstraZeneca vaccine has the potential swiftly to protect millions more people around the world as and when other nations’ regulators grant approval.
The vaccine is significantly cheaper than others which have been approved and, crucially, it would be far easier to transport and distribute in developing countries than its rivals since it does not need to be stored at freezing temperatures.
“I think it’s the only vaccine that can be used in those settings at the current time,” Azra Ghani, chair in infectious disease epidemiology at Imperial College London, told CNN. “Pfizer and Moderna require freezer storage, and that just isn’t in place in many settings.”
Minister: ‘Fantastic news’
UK health services are coming under increasing pressure as Covid-19 cases soar in many regions.
The UK recorded a further 53,135 coronavirus cases on Tuesday, breaking its daily record since the pandemic began for a second day in a row.
Dr. Susan Hopkins, senior medical adviser for Public Health England, said in a statement: “We are continuing to see unprecedented levels of Covid-19 infection across the UK, which is of extreme concern particularly as our hospitals are at their most vulnerable.”
UK Health Secretary Matt Hancock welcomed the approval of the Oxford/AstraZeneca vaccine in an interview with Sky News, describing it as “fantastic news.”
The country’s National Health Service (NHS) is “standing ready to deploy, at the sort of pace that is needed to be able to help us to get out of this pandemic by the spring,” he said.
The UK government said the Oxford University/AstraZeneca vaccine met “strict standards of safety, quality and effectiveness” as it announced its approval.
“The NHS has a clear vaccine delivery plan and decades of experience in delivering large scale vaccination programmes,” the statement said. “It has already vaccinated hundreds of thousands of patients with the Pfizer/BioNTech vaccine and its roll out will continue. Now the NHS will begin putting their extensive preparations into action to roll out the Oxford University/AstraZeneca vaccine.”
“Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply,” Andrew Pollard, chief investigator of the Oxford Vaccine Trial, said in November.
The Oxford/AstraZeneca vaccine can be kept at refrigerator temperatures of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) for at least six months. Moderna’s vaccine has to be stored at minus 20 degrees Celsius (minus 4 degrees Fahrenheit) — or at refrigerator temperatures for up to 30 days — and the Pfizer/BioNTech vaccine has to be stored at minus 75 degrees Celsius (minus 103 degrees Fahrenheit), and used within five days once refrigerated at higher temperatures.
“Cold chain” refrigeration is the standard storage used globally to deliver vaccines from central locations to local health clinics. AstraZeneca’s vaccine is so far “the only one that can definitely be delivered to those systems,” added Ghani.
The vaccines are based on different technology. AstraZeneca’s offering — like Johnson & Johnson’s vaccine and Russia’s Sputnik V — uses an adenovirus to carry genetic fragments of coronavirus into the body.