* Pfizer, BioNTech request EU conditional approval
* Regulator says panel to meet Dec 29 at latest
* Rival Moderna also submits EU filing for its shot
* Both groups have applied for U.S. emergency use
(Adds EMA starting rolling review of J&J candidate)
By Ludwig Burger
FRANKFURT, Dec 1 (Reuters) - Moderna and Pfizer-BioNTech
are in a tight race to launch their COVID-19 vaccines in Europe
after both applied for emergency EU approval on Tuesday, though
there was uncertainty over whether a rollout could begin this
year.
The applications to the European Medicines Agency (EMA) came
a day after Moderna sought emergency use for its shot
in the United States and more than a week after Pfizer
and BioNTech did the same.
U.S. drugmaker Pfizer and its German development partner
BioNTech said their vaccine could be launched in the European
Union as early as this month.
"We can start to deliver within a few hours (of an
approval)," said Sierk Poetting, head of operations and finance
at BioNTech. "We have been stocking up. And everything that is
there can really be distributed within a few hours."
The EMA clouded the timeline, however, when it said it would
complete its review for that vaccine by Dec. 29 at the latest,
and for Moderna's shot by Jan. 12. It added its schedule may be
subject to change as its evaluation proceeds.
The European Commission, the EU executive body, said it
would likely give its final authorization for a vaccine's
rollout days after a recommendation by the EMA.
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.
Both U.S. biotech firm Moderna and Pfizer-BioNTech have
reported preliminary findings of more than 90% effectiveness -
an unexpectedly high rate - in trials of their vaccines, which
are both based on new messenger RNA (mRNA) technology.
CUSTOMISED GENETIC CODE
Their work validates that of several biotech experts, who
for years have been labouring to prove a once-unorthodox idea:
The human body can act as its own vaccine factory.
Both inoculations work by injecting people with customised
genetic code that instructs human cells to make key virus
proteins to induce an immune response.
Pfizer and BioNTech reported final trial results on Nov. 18
that showed their vaccine candidate, known as BNT162b2, was 95%
effective in preventing COVID-19, with no major safety concerns.
Moderna Inc said on Monday that full results from a
late-stage study showed its candidate, mRNA-1273, was 94.1%
effective, also with no serious safety concerns.
Any clearance in the EU and United States for the vaccines
will be "conditional" or for "emergency use", meaning developers
are obliged to continue trials and provide more trial results as
they emerge.
The European filings complete so-called rolling reviews,
initiated by the EMA on Oct. 6 in the case of Pfizer and on Nov.
16 for Moderna, aimed at speeding up the process by doing a
real-time assessment of the data as it lands.
The EMA said on Tuesday it had started a rolling review of
Johnson & Johnson's vaccine candidate after preliminary
results showed it triggered production of antibodies and immune
cells against the virus. The review will go on until enough
evidence ss available for a formal marketing authorisation
application, the regulator added.
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; Additional
reporting by Markus Wacket in Berlin; Editing by Pravin Char)
Astrazeneca (AZN)
