DUBLIN – Bowing to public and political pressure, the EMA has brought forward its review of BNT-162b2, the mRNA-based COVID-19 vaccine jointly developed by Pfizer Inc. and Biontech SE, to Dec. 21, more than a week ahead of its originally scheduled date of Dec. 29.
Given that the vaccine has already received conditional approvals or emergency authorizations from four scientifically credible regulatory agencies, the U.K.’s MHRA (Dec. 2), Health Canada (Dec. 9), the FDA (Dec. 11) and Singapore’s Health Sciences Authority (Dec. 14), it would be quite an extraordinary scenario were the EMA’s Committee for Medicinal Products for Human Use (CHMP) to assess the vaccine’s risk-benefit profile any differently. It’s a question that has been raised in numerous settings of late, and the EMA has responded accordingly.
It framed the decision quite differently, however. “Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible,” the EMA stated. It has retained the Dec. 29 meeting as well, should it be needed. It is, however, working toward a full marketing authorization rather than an emergency use approval.
The EMA has also confirmed that the European Commission has all but abolished the usual 67-day lag between a positive CHMP opinion and formal approval: “Once the CHMP recommends a marketing authorization, the European Commission will then fast track its decision-making process with a view to granting a marketing authorization valid in all EU and EEA Member States within days.”
The delay between a CHMP decision and formal European Commission approval is an unavoidable legal nicety, stemming from the fact that the commission does not have exclusive oversight of health across the member states. It is a shared legal competence, and member states are therefore required to sign off on any decision, which they do through the Committee of the Permanent Representatives of the Governments of the Member States to the European Union (Core per), a Brussels-based body comprising senior diplomatic representatives from each member state.
The final rubber stamp on ensuring availability of the vaccine in the European Union will therefore take place in Brussels. That’s less than 20 miles from the town of Pours, in Flanders, one of two European production locations for BNT-162b2. New-York-based Pfizer has a manufacturing facility there, while Biontech will also produce the vaccine at a recently purchased facility in Marburg, Germany, which will come on stream in 2021.
Accelerating roll-out plans
The European Commission has a contract for the supply of 200 million doses of BNT-162b2, as well as an option to order 100 million more. In all, Pfizer and Biontech have forecast that they will produce 50 million vaccine doses in 2020 and 1.3 billion in 2021. That is sufficient to immunize 675 million people, given the two-dose regimen it currently employs, unless clinical trials demonstrate that dose-sparing may be feasible in certain cohorts.
A swifter-than-expected approval will put pressure on national health authorities to accelerate their roll-out plans. Ireland, for example, published its vaccine implementation plan on Dec. 15, which assumed that the first vaccines would become available early in 2021. It is already out of date, therefore, although it has stated from the outset that the plan is, necessarily, “a living document,” given the myriad uncertainties attached to the approval and availability of different vaccines.
The second wave of the pandemic has caught many countries off-guard in Europe. Germany has imposed strict lockdown measures over the holiday period because of rising case numbers. Sweden and parts of Switzerland are already hitting ICU capacity. Croatia, Lithuania, Luxembourg and Slovenia all have 14-day average infection rates of more than 1,000 per 100,000 inhabitants. Given the ramped nature of the vaccine rollout, gaining access to a limited supply one week faster will not dent those figures. But there appears to be nothing to gain in waiting an extra week for a decision that is already all but made.