UK Government Asks Regulator to Clear “Temporary Supply” of AstraZeneca’s COVID-19 Vaccine
The UK government on Friday said that it formally asked the Medicines and Healthcare products Regulatory Agency (MHRA) to assess the suitability of AstraZeneca’s COVID-19 vaccine candidate AZD1222 for “temporary supply.” Health and Social Care Secretary Matt Hancock noted that the MHRA will review the vaccine in order “to understand the data and determine whether it meets rigorous safety standards.”
According to the government, the assessment will begin as soon as AstraZeneca, along with partner the University of Oxford, submits the necessary safety, quality and efficacy data. The MHRA recently initiated an accelerated rolling review of AZD1222. June Raine, chief executive of the agency, explained “we will seek advice from the government’s independent advisory body, the Commission on Human Medicines,” which “will critically assess the data too, before advising the UK government on the safety, quality and effectiveness of any potential vaccine.”
May speed access in UK
The government indicated that the move would mean “potentially faster access” to AZD1222, if approved, for people in the UK, versus the EU, where the European Medicines Agency (EMA) said it began a rolling review of the vaccine in early October. Until the end of the year, and as part of the BREXIT transition period, vaccines must be approved via the EMA, with the authorisation automatically valid in the UK. However, the government has asked the MHRA to determine whether AZD1222 can be authorised under Regulation 174 of the Human Medicines Regulations, which allows the temporary supply of medicines or vaccines in response to a public health need.
The UK has an agreement in place with AstraZeneca and the University of Oxford for the supply of up to 100 million doses of AZD1222, with up to 4 million doses ready by the end of the year and 40 million by the end of March 2021. The UK’s Joint Committee on Vaccination and Immunisation, which advises the government on immunisation programmes, has provisionally said that a COVID-19 vaccine should first be given to care home residents and staff, followed by people over 80 and health and social workers, then to the rest of the population in order of age and risk.
Review despite questions over data
The MHRA review comes shortly after the release of a combined interim analysis from two late-stage studies showing that AZD1222 had an average efficacy of 70%, increasing to 90% for a regimen that included initial immunisation with a half dose. However, the data have come under scrutiny amid questions over a dosing error that led to the higher efficacy results, as well differences in age groups between the regimens. Subsequently, AstraZeneca CEO Pascal Soriot said that the company is likely to conduct a further global study of AZD1222 to address the issues.
Commenting on the MHRA review, England’s chief medical officer Chris Whitty said “they will make an assessment with lots of data that is not currently public domain on efficacy and on safety.” Whitty added “I think it’s always a mistake to make too many judgements early before we have the full information and particularly before the regulator…has had their chance to look at the data and make an assessment.”
Earlier in November, the UK government formally asked the MHRA to assess Pfizer and BioNTech’s COVID-19 vaccine BNT162b2, while the companies have also submitted an emergency-use authorisation request to the FDA for the mRNA-based candidate against SARS-CoV-2.