FRANKFURT, Dec 1 (Reuters) - Pfizer Inc and
BioNTech have applied to the European drugs regulator
for conditional authorization of their COVID-19 vaccine,
following similar steps in the United States and Britain, the
companies said on Tuesday.
The application to the European Medicines Agency (EMA) comes
after the companies applied for U.S. approval on Nov. 20, taking
them a step closer to launching their vaccine.
In their pursuit of a European launch, potentially this
year, 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.
U.S. drugmaker Pfizer and Germany's BioNTech reported final
trial results on Nov. 18 that showed their vaccine candidate was
95% effective in preventing COVID-19, with no major safety
concerns, raising the prospect of U.S. and European approval as
early as December.
The European filing completes the so-called rolling review
process, which was initiated with the EMA on Oct. 6.
The British government said https://www.gov.uk/government/news/government-welcomes-the-mhra-review-into-pfizer-and-biontech-vaccine
last week that the U.S.-German partners had reported the data
from their clinical trials to the UK Medicines and Healthcare
products Regulatory Agency (MHRA).
(Reporting by Ludwig Burger; Editing by Pravin Char)
Astrazeneca (AZN)
