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* Pfizer, BioNTech request EU conditional approval
* Raises prospect of European launch this month
* Rival Moderna has said it is nearing an EU filing
* Pfizer-BioNTech sought U.S. emergency nod in Nov
(Adds background on pandemic, companies quote)
By Ludwig Burger
FRANKFURT, Dec 1 (Reuters) - Pfizer Inc and
BioNTech's COVID-19 vaccine could be rolled out in
Europe this month, the companies said on Tuesday after they
applied for EU emergency approval for the shot.
The application to the European Medicines Agency (EMA) comes
days after the companies applied for emergency use of their
vaccine in the United States. They said their candidate,
BNT162b2, could be launched in the European Union this month.
"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.
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.
An effective immunization is seen as the main weapon against
the pandemic, which has claimed more than 1.4 million lives and
ravaged economies across the globe. Close to 50 potential
vaccines are being tested on volunteers worldwide.
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.
Any clearance in the EU and United States will be
"conditional" or for "emergency use", respectively, meaning
developers are obliged to continue trials and provide more trial
results as they emerge.
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 Pfizer and BioNTech had reported the data from
their clinical trials to the Medicines and Healthcare products
Regulatory Agency (MHRA).
(Reporting by Ludwig Burger and Josephine Mason; Editing by
Pravin Char)
