UK Government Authorizes AstraZeneca’s COVID-19 Vaccine for Emergency Use

Residents of the United Kingdom now have a second vaccine against the novel coronavirus, even as a more virulent strain of COVID-19 sweeps across its lands. Overnight, U.K. health authorities authorized the COVID-19 vaccine developed by AstraZeneca and Oxford University for emergency use.

The U.K. Medicines and Healthcare products Regulatory Agency’s decision for authorization was based on independent advice from its Commission on Human Medicines following a rolling review of Phase III trial data. This marked the first authorization of AstraZeneca’s vaccine.

Doses are expected to be shipped across the U.K. today and vaccinations with AZD1222, now known as COVID-19 Vaccine AstraZeneca, are expected to begin in the first days of 2021. Like the mRNA vaccine developed by Pfizer and BioNTech, AstraZeneca’s vaccine is a two-shot regimen, with doses administered four to 12 weeks apart. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalizations more than 14 days after the second dose, the company said in its announcement.

U.K. health officials are taking a slightly different approach with their immunization strategy. The government plans to give the first dose to as many people as possible to provide partial protection before administering a second dose, CNN reported.

AstraZeneca has pledged to provide up to 100 million doses of its adenovirus to the U.K. AstraZeneca’s COVID-19 vaccine candidate AZD1222 is a viral vector-based, weakened version of adenovirus containing the genetic material of SARS-CoV-2 spike protein. The AstraZeneca-developed vaccine is expected to ramp up the U.K.’s ability to fight COVID-19 and inoculate a greater number of its citizens.

AstraZeneca Chief Executive Officer Pascal Soriot touted the vaccine’s ability to protect against COVID-19 and said the authorization will benefit millions of people in the U.K.

“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,” Soriot said in a statement.

There has been some confusion over how much protection the AstraZeneca vaccine provides against the virus, particular compared to the Pfizer and BioNTech vaccine, as well as a similar vaccine developed by Boston-based Moderna. Study data shows the vaccine candidate is safe and effective against the novel coronavirus. However, its efficacy is quite a bit lower than the mRNA vaccine developed by Pfizer and BioNTech, which has a 95% efficacy, and one developed by Moderna, which has a 94% efficacy. AstraZeneca’s efficacy is at 70.4%. During Phase III trials, one of the cohorts was administered one and a half doses, as opposed to two full doses. Vaccine efficacy in that cohort was up to 90%. The disparity is under investigation by the researchers. In interviews ahead of the U.K. authorization, Soriot expressed confidence the level of protection provided by his company’s vaccine will be close to that of the mRNA vaccines.

Unlike the mRNA vaccines, COVID-19 Vaccine AstraZeneca does not have to be stored at extremely low temperatures. It is likely the vaccine will be authorized for use in many nations where logistics could prevent widespread use of the mRNA vaccines. The vaccine can be stored, transported and handled at normal refrigerated conditions for at least six months and administered within existing healthcare settings. AstraZeneca is seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries where the vaccine could make a significant impact. Adar Poonawalla, CEO of Serum Institute of India, the world’s largest vaccine producer, has been touting the efficacy of the vaccine, as well as its safety. Earlier this month, he said his company will apply for an emergency-use license in the next couple of weeks.

Published: Dec 30, 2020

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