FRANKFURT (Reuters) – Biotech firm BioNTech said on Monday it widened an ongoing pivotal global study of its COVID-19 vaccine candidate to include testing in its home country of Germany.
Germany’s vaccines regulator, the Paul Ehrlich Institute, gave the approval for the Phase 2/3 trial of the experimental vaccine known as BNT162b2, BioNTech and its partner Pfizer said in a statement.
The global trial was initiated in July, with a view to including about 120 sites globally and seeking up to 30,000 participants in total.
More than 25,000 participants have been enrolled, BioNTech said, adding it remained on track to seek approval for BNT162b2 as early as next month.
(Reporting by Ludwig Burger; editing by Thomas Seythal)