Not to be one-upped by Moderna once again, Pfizer and BioNTech – which initially announced their decision to file for an emergency-use approval in the US late last week – just teased their plans for a European rollout of their vaccine while announcing that they have filed all the requisite paperwork with the European Medicines Agency, the EU parallel to the FDA.
The companies said their candidate, BNT162b2, could be launched in the EU this month, leaving the EU with an expedited vaccination timeline on par with the US.
“If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA (conditional marketing authorization)that could potentially enable use of BNT162b2 in Europe before the end of 2020,” they said in a joint statement.
Pfizer, in partnership with Germany’s BioNTech, reported “final” trial results on Nov. 18 which showed their vaccine candidate was 95% effective in preventing the virus (preliminary results released a week earlier had a slightly lower headline number, though that was before Moderna came out with its results showing its vaccine was nearly 95% effective), with no major safety concerns, raising the prospect of US and European approval as early as December.
In their pursuit of a European launch, the partners are neck-and-neck with rival Moderna, which said on Monday it would ask the EU regulator to recommend conditional approval for its shot. Any clearance in the EU and US will of course be “conditional” or for “emergency use” only. A more comprehensive review is expected later this month, when the FDA convenes a panel to evaluate the vaccines.
That means the vaccine developers are obliged to continue trials – which are handled by an independent government body – and provide more trial results as they emerge. The application to the EMA comes days after Pfizer applied for emergency use of their vaccine in the US. They said their candidate, BNT162b2, could be launched in the European Union this month.
Meanwhile, following yesterday’s revelation that it had applied for emergency use in the US, Moderna jumped as much as 17% in Tuesday’s premarket trading, leaving it on track to break another intraday record at the open, what would be its fourth straight session of record losses.
If the European filing completes the so-called rolling review process, which was initiated with the EMA on Oct. 6.