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The UK on Wednesday became the first country in the world to approve the coronavirus vaccine developed by the University of Oxford and drug maker AstraZeneca.
The government said in its announcement that the green light “follows rigorous clinical trials and extensive data analysis by experts” within the regulator, the Medicines and Health Products Regulatory Agency, “which concluded that the vaccine met its strict standards for safety, quality and efficacy. “
British Health Secretary Matt Hancock told the BBC that “hundreds of thousands” of doses of the new vaccine would be available “from Monday”.
The UK also said in the announcement that it will change the way it prioritizes vaccine administration, on the recommendation of the Joint Committee on Vaccination and Immunization (JCVI).
The JCVI “advised that the priority should be to give as many people in risk groups as possible their first dose, rather than delivering the two required doses as quickly as possible,” the announcement said. “Everyone will always get their second dose and it will be within 12 weeks of their first. The second dose completes the course and is important for long-term protection.”
Vaccination requires two doses. Rather than giving 28 days apart, as was done during clinical trials, the committee recommended that “the priority should be to give so many people in the risk groups their first dose, rather than providing the two doses required in as short a time as possible. », Says the ad.
The second dose will be given within 12 weeks.
“Everyone will always get their second dose,” the government said, adding that the second dose “completes the course and is important for long-term protection.”
Hancock told Times Radio that approval of a second vaccine, after the BioNTech / Pfizer jab, means: “I now have a very high degree of confidence that by the spring, enough of those who are vulnerable will be protected, to allow us to get out of this, this pandemic situation. “
The UK has ordered 100 million doses of the Oxford / AstraZeneca vaccine. Added to the 40 million doses of the BioNTech / Pfizer jab, today’s news means the country has enough vaccines to immunize every eligible UK citizen against the coronavirus.
Oxford / AstraZeneca vaccine can be stored between 2 degrees Celsius and 8 degrees – the same temperature as a refrigerator. This facilitates the distribution of the BioNTech / Pfizer vaccine which should be stored at minus 70.
The news comes amid a winter wave of coronavirus cases in the UK, which recorded more than 53,000 new cases on Tuesday and 414 new deaths. The pandemic has put hospitals under pressure levels that are now above its April peak.
“It is the result of decades of revolutionary vaccinology and hard work by the Jenner team. [Institute] at Oxford, ”said Danny Altmann, professor of immunology at Imperial College London.
He added in email comments that a “rapid and effective vaccination program with good population coverage is our only way out.”
The MHRA issued its opinion after evaluating clinical data which showed that the vaccine was on average 70% effective in preventing the disease.
In trials, the vaccine was 90% effective in over 2,700 people who received a half dose followed by a full dose. It was 62% effective in over 8,800 people who received two full doses.
Some observers had criticized AstraZeneca for the different dosage regimens across the trials. The lower dose was the result of an unintentional manufacturing dilution process.
The vaccine is based on adenovirus viral vector technology, which is also used by Johnson & Johnson, the Russian Sputnik vaccine, and some Chinese coronavirus vaccines.
A government spokesperson said the second dose would be the standard full dose, not a lower dose. It will be accessible to people aged 16 and over.
Scientists, meanwhile, praised the rapid approval of the vaccine, as well as the new plan to prioritize the first dose.
This will “maximize the number of risk groups receiving the vaccine,” Lawrence Young, professor of molecular oncology at Warwick Medical School, said via email.
The UK has used an EU loophole to allow the temporary supply of coronavirus vaccines in an emergency. The country will have free rein to fully authorize other vaccines against the coronavirus from January 1, after the end of the Brexit transition period.
The European Medicines Agency is also reviewing data on the Oxford / AstraZeneca vaccine in a continuous review format. It recommended full conditional marketing authorization for the BioNTech / Pfizer vaccine on December 21.
EMA Deputy Executive Director Noel Wathion told the Het Nieuwsblad newspaper in an interview published Tuesday that for Oxford / AstraZeneca the agency had not yet received enough information “to warrant a marketing license. conditional ”.
This article has been updated.