UPDATED: UK authorizes Oxford-AstraZeneca COVID-19 vaccine

Regulatory NewsRegulatory News | 30 December 2020 |  By 

Editor’s note: This article was updated 04 January 2020 to include new information about EMA's review of the Oxford-AstraZeneca COVID-19 vaccine.
The United Kingdom has followed the recommendation of its Medicines and Healthcare products Regulatory Agency (MHRA) to issue temporary authorization for the vaccine against COVID-19 co-developed by Oxford University and AstraZeneca. The UK’s authorization is the first for the vaccine.
The authorization for temporary supply under the UK’s Human Medicines Regulation 174 is the same mechanism the country used earlier in the month for the Pfizer-BioNTech mRNA COVID-19 vaccine.  “As with any new medicine in the UK, this product will be closely monitored to allow quick identification of new safety information,” said MHRA in addressing health care professionals about the new vaccine.  
Speaking of this second vaccine option, UK’s Health and Social Care Secretary Matt Hancock said, “[T]he new Oxford jab will allow us to accelerate our vaccination plan, allowing us to return to normality in the future.”
The Oxford-AstraZeneca vaccine, based on a recombinant chimpanzee adenovirus vector, is kept refrigerated between the range of 2 to 8°C.
The second dose may be given within a window from 4 to 12 weeks after the first dose, with “increased immunogenicity associated with a longer dose interval,” according to MHRA’s healthcare provider information. The best data for efficacy is currently for a second dose administered within the 8 to 12 week window, noted the regulator.
These storage and administration requirements are more forgiving than either the Pfizer-BioNTech vaccine or Moderna’s mRNA vaccine, each of which must be transported and stored frozen, with the Pfizer-BioNTech requiring ultra-cold storage not achievable by most commercial freezers. Sponsor recommendations from Pfizer-BioNTech are to give the two vaccine doses 21 days apart; Moderna’s prime vaccine dose is to be followed by a booster at 28 days.
AstraZeneca said in a press release that it plans to provide the UK with “millions” of doses in the first quarter of 2021, with total UK delivery reaching “up to” 100 million doses.  The UK’s Hancock noted that “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.”
A pooled analysis of over 11,000 participants in the UK and Brazil showed efficacy against symptomatic COVID-19 infections of 70.4%. The vaccine was generally well tolerated, with most adverse events such as injection site pain, myalgias, headache and fever in the mild to moderate range.
The US Food and Drug Administration (FDA) has not yet received an application for emergency use authorization (EUA) of the Oxford-AstraZeneca vaccine, which has been under rolling review by the European Medicines Agency (EMA) since 1 October. However, on 31 December, EMA said that although it had received an additional package of clinical information on 21 December, the regulator still needed "additional scientific information" on certain issues.

Additional data are still needed to support claims of quality, safety and efficacy of the vaccine before EMA can grant conditional marketing organization, according to agency, which is looking to receive more information from ongoing clinical trials in January 2021, as well as interim data from the US clinical trial at some point during the first quarter of the year.

  that EMA authorized the Pfizer-BioNTech COVID-19 vaccine on 21 December after a rolling review. The US has issued EUAs for that vaccine as well as the mRNA vaccine Moderna developed in collaboration with the National Institutes of Health.


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Tags: coronavirus, MHRA, UK

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