From the WebMD Archives

Dec. 30, 2020 -- The United Kingdom’s regulatory board has has approved the Oxford/AstraZeneca COVID-19 vaccine for use.

Prime Minister Boris Johnson said it was "truly fantastic news - and a triumph for British science."

The rollout begins Jan. 4 for those 18 and older with two standard doses, 4 to 12 weeks apart.

The first batch was released Tuesday. Health Secretary Matt Hanock told member sof Parliament: "We already have 530,000 doses available to the UK from Monday with millions due from AstraZeneca by the beginning of February."

Last month the UK was first to approve the Pfizer/BioNTech vaccine and rollout of that began earlier this month.

AstraZeneca has yet to ask the U.S. FDA to consider the vaccine for use.

'Landmark Moment'

In a news release, Andrew Pollard, professor and director of the Oxford Vaccine Group and chief investigator of the Oxford Vaccine Trial, said: "The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants. Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon as possible."

Pascal Soriot, AstraZeneca chief executive officer, added: "Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants."

First Dose Priority

The Joint Committee on Vaccination and Immunisation also announced prioritization of the first dose of both vaccines: "Having studied evidence on both the Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, the JCVI has advised 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.

"Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer term protection."

'No Corners Cut'

June Raine, the head of the country’s regulatory agency, told reporters: "Our teams of scientists and clinicians have very carefully and methodically and rigorously reviewed all the data on safety, on effectiveness, and on quality, as soon as they have become available, and have done so round the clock, looking at all the tests and trials, even over holiday periods, no corners whatsoever, have been cut."

Munir Pirmohamed, chair of the Commission on Human Medicines Expert Working Group, said the initial half dose, full dose regimen results "were not borne out by the full analysis".

On pregnancy and breastfeeding, he said: "There is limited data on the use of this vaccine in pregnant or breastfeeding women. Women should discuss the benefits and risks of having the vaccine, with a health care professional based on their own individual circumstances and reach a decision together."

On allergic reactions: "We've come to the recommendation people with a known history of reacting to any specific ingredients of vaccine should not have it. But people with allergies to other medicines or food can have the vaccine."

On a possible reduction in virus transmission after vaccination, "we felt that the data was not mature enough to make any recommendations with regard to transmission," he said.

Vaccine Results

Overall, the Oxford vaccine demonstrated 70.4% protection against SARS-CoV-2, according to interim results released Dec. 8 in The Lancet.

For participants who received two standard doses, vaccine efficacy was 62.1%.

In participants who received a low dose followed by a standard dose, efficacy was 90.0%.

Last weekend, AstraZeneca's Pascal Soriot told the Sunday Times: "We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else.

"I can't tell you more because we will publish at some point."

Vaccine Details

The UK has ordered 100 million doses.

Unlike the Pfizer/BioNTech vaccine that requires -70C storage, the Oxford vaccine will be easier to deliver as it can be stored at between 2C and 8C.