UK Authorizes Emergency Use of AstraZeneca’s COVID-19 Vaccine

AstraZeneca recently announced that its COVID-19 vaccine has been approved for emergency supply in the United Kingdom (UK). 

This is the first emergency authorization for COVID-19 Vaccine AstraZeneca, formerly known as AZD1222. AstraZeneca  released the first doses last week to prepare for vaccinations early this year. 

“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,” Pascal Soriot, chief executive officer at AstraZeneca, said in the announcement.

“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 continued. 

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) provided authorization for the vaccine to be administered in two doses to individuals 18 years of age and older, with an interval of between four and 12 weeks between the doses, AstraZeneca explained.

The two-dose regimen of COVID-19 Vaccine AstraZeneca was shown to be safe and effective in preventing symptomatic coronavirus in clinical trials at the end of November.

One dosing regimen showed a 90 percent efficacy when the vaccine was given as a half dose, followed by a full dose at least one month apart, while the second dosing regimen showed 62 percent efficacy when given as two full doses at least one month apart.

There were no severe cases and no hospitalizations reported more than 14 days after the second dose. 

Overall, researchers highlighted that the combined analysis found that the candidate was well-tolerated across both dosing regimens, generating an average efficacy of 70 percent.

“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,” Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford Vaccine Trial said in the recent announcement. 

“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 possible,” Pollard continued. 

AstraZeneca noted that it will continue to collect additional safety and efficacy data for COVID-19 Vaccine AstraZeneca from ongoing clinical trials.

Additionally, the company will work with regulatory authorities globally to gain emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries.

The company expects to manufacture and deliver up to 3 billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. 

“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 UK scientists at Oxford University and AstraZeneca whose breakthrough will help to save lives around the world,” said Matt Hancock, UK Secretary of State for Health and Social Care.

COVID-19 Vaccine AstraZeneca can be stored, transported, and handled at normal refrigerated conditions for at least six months and administered within existing healthcare settings, the company said.

In contrast, Pfizer’s 95 percent effective, FDA-approved mRNA COVID-19 vaccine, BNT162b2, must be stored at -112 degrees Fahrenheit to remain effective and can only be stored in the refrigerator for five days. 

This temperature requires special freezers usually found in research labs and hospitals. 

And while the company is developing deep freeze “suitcases” that can be sealed and are safe for shipment in non-refrigerated trucks, these suitcases could create challenges for hospitals, pharmacies, and outpatient clinics that have to administer the vaccines to US citizens.