MHRA okays third COVID-19 vaccine

Regulatory NewsRegulatory News
| 08 January 2021 | By Kari Oakes 

As the first week of the new year winds down, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a third vaccine against COVID-19. On Friday, MHRA announced its regulatory approval of the messenger RNA (mRNA) vaccine jointly developed by Moderna and the US National Institutes of Health.
“Having a third COVID-19 vaccine approved for supply following a robust and thorough assessment of all the available data is an important goal to have achieved and I am proud that the agency has helped to make this a reality,” said MHRA chief executive June Raine, CBE, in a press release announcing the approval.
“The progress we are now making for vaccines on the regulatory front, whilst not cutting any corners, is helping in our global fight against this disease and ultimately helping to save lives,” added Raine. Under the UK vaccine approval scheme, independent batch release testing of all COVID-19 vaccines is being carried out by MHRA’s National Institute for Biological Standards and Control.
The regulator’s action comes after a rolling review that began at the end of October 2020 and follows prior greenlighting of the Pfizer-BioNTech mRNA vaccine and the chimpanzee adenovirus vector vaccine co-developed by AstraZeneca and Oxford University. The approval is the first MHRA decision on a COVID-19-related vaccine or therapeutic to fall after the Brexit date of 1 January 2021.
Though MHRA says that for the Moderna vaccine, “It is recommended to administer the second dose 28 days after the first,” the agency has also signaled that the UK may see considerable leeway in administration intervals for the vaccines, all of which require two doses in a prime-boost schedule.
In a 30 December statement, the UK’s chief medical officers announced they agreed with the position of the UK’s Joint Committee on Vaccination and Immunization (JCVI), which is prioritizing administration of a first vaccine dose to high-risk recipients.
In practical terms for the Pfizer-BioNTech vaccine, JCVI has advised a dosing interval that may range from the 21 days specified in the clinical trials (and in FDA’s emergency use authorization for that vaccine) up to 12 weeks after the prime dose has been administered. For the AstraZeneca-Oxford vaccine, MHRA permits an interval ranging from the 3 weeks of that vaccine’s clinical trials up to 12 weeks as well.
“For both vaccines, data provided to MHRA demonstrate that while efficacy is optimized when a second dose is administered, both offer considerable protection after a single dose, at least in the short term,” wrote the medical officers in their 30 December press release. “For both vaccines the second dose completes the course and is likely to be important for longer term protection.”
The JCVI position was updated in a 6 January report that cited modeling indicating that deaths and hospitalizations would be fewer with a scheme that maximized the numbers of people who receive an initial vaccine dose, compared with fully vaccinating fewer people. One consideration, said JCVI, was the blossoming of the newer, more transmissible strain of SARS-CoV-2 in the UK population.
“The committee advises initially prioritizing delivery of the first vaccine dose as this is highly likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19,” according to the report.
Pfizer and BioNTech have advised that the dosing schedule examined in the Phase 3 clinical trial be adhered to, while the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have also advised hewing to recommended administration intervals.
For its part, EMA has now followed FDA in acknowledging that with proper syringes and needles, a sixth dose may be drawn from vials of the Pfizer-BioNTech vaccine. EMA now recommends that product information for the vaccine be updated to reflect that equipment that minimizes dead volume may allow for a full sixth dose.


© 2022 Regulatory Affairs Professionals Society.

Tags: coronavirus, MHRA, UK

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