AstraZeneca/Oxford score first vote of confidence as UK authorizes their Covid-19 vaccine
AstraZeneca and Oxford have landed the first authorization for their Covid-19 vaccine. And with this particular shot, the UK may be much further ahead than the rest of the world.
The MHRA recommended an emergency OK to the UK government almost two months after it started a rolling review — although the developers only submitted the full application last week. Regulators have determined that “the vaccine has met its strict standards of safety, quality and effectiveness,” according to a statement, even though experts in other countries have raised questions.
While data from a subgroup suggested that a regimen in which people first receive a half dose, followed by a full dose has a higher efficacy figure at 90%, the MHRA gave the thumbs up to the 62% effective full-full dose regimen, which is supported by more evidence from two trials conducted in the UK and South Africa.
Having become the first country to authorize and start administering the Pfizer/BioNTech vaccine, the UK has ordered enough of that mRNA jab for 20 million people. Its deal with AstraZeneca now gives it access to another 50 million adenovirus-based vaccines, more than enough to vaccinate a population of 66 million-plus.
The OK triggers an immediate release of its batches, AstraZeneca said, and millions of doses will be ready for vaccination early in the new year.
Notably, the two doses of its vaccine — dubbed ChAdOx1 nCoV-19 and AZD1222 at various points of its short life — can be given four to 12 weeks apart. According to earlier comments by Adar Poonawalla, CEO of the Serum Institute of India, giving them 2 to 3 months apart boosts the efficacy to 95% (his company is mass-manufacturing the vaccine). By comparison, doctors are recommended to give the second dose of Pfizer/BioNTech’s BNT162b2, now christened Comirnaty, 21 days after the first.
UK authorities made no reference to that claim but said that means they can prioritize giving one, partially protective AstraZeneca/Oxford vaccine to as many people as possible, without having to rush to the next shot.
Matt Hancock, the Secretary of State for Health and Social Care, called it “a moment to celebrate British innovation.”
Other countries, though, haven’t been as enthusiastic. Moncef Slaoui, the scientific chief of Operation Warp Speed, has remarked that AstraZeneca would likely need the results from its US trial to file for an emergency use authorization with the FDA. India had passed on granting an early OK to AstraZeneca. Earlier this week, a top EMA official noted that European authorities have yet to receive the non-clinical data necessary to confirm vaccine “quality” for authorization, meaning they likely can’t make a decision any time soon.
For its part, AstraZeneca has been touting the stability — it can be stored, transported and handled at normal refrigerator temperatures of 2-8 degrees Celsius — and the low cost of its vaccine as it makes plans to supply billions of vaccines to less developed regions.