U.K. approves emergency use of Oxford-AstraZeneca COVID-19 vaccine

The COVID-19 vaccine developed in Britain by Oxford University and AstraZeneca has been approved by the U.K. government for emergency use, the pharmaceutical company announced early Wednesday morning. Approval of the vaccine, which is cheaper to produce and easier to transport and store than the other vaccines already approved in the U.K. and the U.S., will be a welcome weapon in the fight against the coronavirus as infections surge on both sides of the Atlantic.

The British Department of Health and Social Care confirmed in a statement that it had "accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorize Oxford University/AstraZeneca's Covid-19 vaccine for use. This follows rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness."

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"We'll get going on this from Monday," U.K. Health Secretary Matt Hancock told CBS News partner network BBC News. "The number (of doses) that will be ready for next week is in the hundreds of thousands, and then the numbers increase."

AstraZeneca is still awaiting emergency use authorization from the U.S. Food and Drug Administration. Two other vaccines, made by American pharmaceutical companies Pfizer and Moderna, are already being administered in the U.S. The Pfizer vaccine is also being given to those most at risk of serious COVID-19 infections, and some front-line health care workers, in the U.K.

Advantages of this vaccine

The cost of producing one dose of the Oxford vaccine is about a quarter of what it costs to make a dose of the Pfizer drug, and even less compared to the Moderna vaccine. It also has the advantage of requiring only standard refrigeration, whereas the other two vaccines already approved in the U.S. need to be kept at temperatures well below zero, requiring special equipment for transport and storage.    

"This is a moment to celebrate British innovation," Hancock said in a statement on Wednesday. "This vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease. It is a tribute to the incredible U.K. scientists at Oxford University and AstraZeneca whose breakthrough will help to save lives around the world."

Britain is facing a surge in new infections, blamed in large part on a new variant of the coronavirus first discovered in southeast England, but which has now appeared in the U.S. The variant, called B.1.1.7, is believed to be more easily transmitted from person to person, but officials say there's no evidence it causes more serious disease. 

Scientists with Pfizer, Moderna, and Oxford and AstraZeneca have voiced optimism that their vaccines will be effective against the new variant of the coronavirus, but they are awaiting confirmation through ongoing trials.  

AstraZeneca Chief Executive Pascal Soriot told BBC Radio again on Wednesday that his company's "belief, at this point, is that this vaccine should be effective against the [B.1.1.7] variant." 

Hancock warned that, "while it is a time to be hopeful," it remains "vital" for members of the public to "play their part to drive down infections" by following public health guidelines to socially distance and wear face masks.

Dosing plan

The Oxford vaccine requires two doses, but unlike the other two major vaccines already being administered in the U.S., which need the shots to come about three weeks apart, the second dose of the Oxford vaccine can be given within about 12 weeks. Hancock said that longer time window to give the second dose would be "very helpful" in facilitating mass-vaccination efforts.

Prime Minister Boris Johnson celebrated Britain's second COVID-19 vaccine approval with a tweet, calling it "fantastic news — and a triumph for British science," and vowing to inoculate "as many people as quickly as possible." 

With its statement confirming approval of the Oxford-AstraZeneca vaccine, the British government also announced a change in its approach to achieving mass-immunity, aimed at taking advantage of the efficacy provided by even the first dose of the drug.

The Health department said the official dosing regimen for the Oxford vaccine would be announced later Wednesday, but the U.K.'s independent pharmaceuticals regulator had recommended that the "priority should be to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible."

The government stressed that everyone who got the Oxford injection would still get their second dose within 12 weeks of their first, which it said was "important for longer term protection," but that the National Health Service (NHS) would prioritize, "giving the first dose of the vaccine to those in the most high-risk groups."

"With two vaccines now approved, we will be able to vaccinate a greater number of people who are at highest risk, protecting them from the disease and reducing mortality and hospitalization," the Health department said. "This approach will maximize the benefits of both vaccines. It will ensure that more at-risk people are able to get meaningful protection from a vaccine in the coming weeks and months, reducing deaths and starting to ease pressure on our NHS." 

Large-scale human trials showed the Oxford-AstraZeneca vaccine was 70.4% effective at preventing COVID-19 infection overall, but that was an average of results for trial participants who received both two full doses, and a full dose followed by a half dose. In the sub-group who got the half-dose in their second shot, the efficacy of the vaccine was about 90%, but AstraZeneca said that dosing regimen would require more investigation. 

Munir Pirmohamed, who heads the U.K. government's Commission on Human medicines expert Working Group on COVID-19 vaccines, which made decision to approve the Oxford vaccine, told reporters on Wednesday that data available on the second half-dose regimen wasn't yet considered sufficient for the commission to recommend that plan, indicating that the government would approve a full two-dose regimen.

But the commission found that "effectiveness was high, up to 80%, when there was a three month interval between first and second doses" of the Oxford drug. 

Britain has only approved the Pfizer and Oxford vaccines for use in patients over the age of 18, but given the focus on inoculating people in the highest-risk groups first, the vast majority of those who can expect a shot before or within the first quarter of the new year will be the elderly, front-line health care workers, or those with serious underlying conditions.  

The U.K. government has reserved 100 million doses of the Oxford-AstraZeneca vaccine, and AstraZeneca said Wednesday that it expected the first 20 million of those to be made available within the first quarter of 2021.

"Today is an important day for millions of people in the U.K. who will get access to this new vaccine," AstraZeneca boss Soriot said in a statement. "It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit."

In:
• AstraZeneca
• COVID-19 Vaccine
• COVID-19
• Oxford University
• Vaccines
• United Kingdom