MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline

Regulatory NewsRegulatory News | 02 December 2020 |  By 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted temporary authorization on 2 December to Pfizer and BioNTech’s mRNA-based BNT162b2 COVID-19 vaccine, vaulting ahead of regulators in the US and EU.
The temporary authorization is “batch-specific” and applies only to a single batch of the vaccine. Subsequent batches must be approved by MHRA and must meet the same authorization conditions as the initial batch. MHRA said the decision was made based on advice from its Commission on Human Medicines (CHM) following a rolling review of data submitted by the companies. The agency is currently conducting rolling reviews of vaccine candidates from Moderna and AstraZeneca.
The UK’s quick decision set off a dispute with its EU counterparts over whose review approach is more appropriate and amplified pressure on the US Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for the vaccine.
The UK is set to receive its first 800,000 doses of the vaccine, enough to vaccinate 400,000 people, in the coming days. The country has preordered 40 million doses of the vaccine in total, most of which are expected to be delivered next year. The temporary authorization allows the vaccine to be given to individuals 16 years of age and older under strict conditions set by the regulator.
The agency made the decision to authorize the vaccine under Regulation 174 of the UK’s Human Medicines Regulations 2012, which allows the temporary supply of an unlicensed medicinal product in response to a public health threat.
While the UK has said its “preferred route to enable deployment of a new vaccine for COVID-19 is through the usual marketing authorisation (product licensing) process,” it is still subject to EU rules during the Brexit transition period that expires at the end of the year, which require central marketing authorization for biotechnology products. Beginning next year, the UK will have the authority to fully license COVID-19 vaccines and other products that previously required use of the European Medicines Agency’s (EMA’s) centralized procedure on its own.
To prepare for the potential rollout of a COVID-19 vaccine under Regulation 174, the UK amended its regulations to allow for conditions to be placed on products granted temporary authorization in October.
In a lengthy set of conditions released alongside the announcement, MHRA explains that the vaccine must be supplied and sold in line with its recommended use and that the authorization is void if any conditions of the authorization are breached. The document also specifies quality, labeling, pharmacovigilance and supply chain/distribution conditions for the companies to meet.
EU and US timeline
Both the EU and US have set more conservative timelines for authorizing COVID-19 vaccines, with EMA and the US Food and Drug Administration (FDA) expected to recommend or authorize their first vaccines later this month.
EMA this week announced it has received applications for conditional marketing authorization from Pfizer and Moderna and rolling reviews of AstraZeneca and Janssen vaccines are underway. (RELATED: Pfizer, Moderna apply for EMA authorization; Janssen's candidate begins rolling review, Regulatory Focus 1 December 2020).
The agency’s recently instated Executive Director Emer Cooke told EU health ministers Wednesday it could make a recommendation on Pfizer/BioNTech’s vaccine by 29 December.
“Our scientific committee for human medicines plans to conclude the assessments during an extraordinary meeting scheduled for 29 December at the latest,” Cooke said, adding that a meeting to review Moderna’s vaccine has been tentatively scheduled for 12 January.
Once a recommendation from EMA is made, the European Commission has committed to fast-track its decision-making process with the aim of granting conditional marketing authorization in a matter of days rather than the two months that usually elapse between recommendation and authorization.
European Health Commissioner Stella Kyriakides backed EMA’s approach and contrasted the conditional marketing authorization pathway with the temporary and emergency pathways being used in the UK and US.
“[Conditional marketing authorization] provides for a controlled and robust framework for assessment. This is different to the emergency use authorization which will be issued by other countries. Our authorization ensures that all pharmacovigilance, manufacturing controls including batch controls for vaccines and other postapproval obligations apply in a legally binding manner and are evaluated on a continued basis,” she said.

German Health Minister Jens Spahn noted that Germany and other EU member states could have issued an emergency authorization on their own, but instead opted for a “common European approach” to authorizing COVID-19 vaccines.
In the US, FDA Commissioner Stephen Hahn is facing pressure from the Trump administration to quickly approve a vaccine after being summoned to the White House for a meeting with Chief of Staff Mark Meadows. One of the reasons behind FDA’s slower timeline is that the agency, unlike its European peers, does its own analyses of the raw data included in an application before making its decision. By contrast, most regulators rely more heavily on the analyses conducted by sponsors.
FDA is currently reviewing EUA requests from both Pfizer/BioNTech and Moderna and has committed to holding advisory committee meetings to gain input from outside advisors before issuing an EUA for any COVID-19 vaccine. The first of those meetings will take place on 10 December to review the Pfizer/BioNTech vaccine, followed a week later by another meeting to look at Moderna’s. (RELATED: Pfizer files EUA for COVID vaccine; FDA sets adcomm for 10 December, Regulatory Focus 20 November 2020; Moderna files COVID vaccine EUA; adcomm set for 17 December, Regulatory Focus 30 November 2020).
In an interview with ABC on Monday, Hahn said the agency could issue an EUA “relatively quickly” after the advisory committee meetings—potentially allowing for a mid-December authorization—but declined to give a more specific timeline.


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