Pfizer Could Apply for Emergency Use of Covid-19 Vaccine by Late November -- 2nd Update
October 16 2020 - 6:57AM
Dow Jones News
By Bojan Pancevski
Pfizer Inc. said it could be ready to apply for emergency-use
authorization of its Covid-19 vaccine by late November, assuming it
receives positive efficacy and safety data from late-stage human
trials, the first time it or any other leading Western vaccine
developer provided such a specific timeline.
The drug giant, which is developing its vaccine candidate with
German partner BioNTech SE, said it continues to expect to have
data on the vaccine's effectiveness -- whether it protects at least
a majority of vaccinated people from the disease -- later this
month. It then expects to have data on the drug's safety by the
third week of November.
Assuming positive results with both sets of data, Pfizer said it
then plans to file for emergency-use authorization for the vaccine
in the U.S. from the Food and Drug Administration soon after
receiving the safety data. It didn't disclose timing for similar
applications anywhere else in the world.
A third set of data -- to ensure the drug can be manufactured on
a large scale at the right quality and consistency -- will be ready
for submission before Pfizer expects to receive the safety
data.
Pfizer said it laid out the timeline in an effort to clear up
any confusion about the complex process. "To ensure public trust
and clear up a great deal of confusion, I believe it is essential
for the public to understand our estimated timelines," Pfizer Chief
Executive Albert Bourla said in an open letter released early
Friday.
Pfizer has long given a late October timeline for having enough
data to establish whether the vaccine is effective, raising the
likelihood of an emergency use authorization shortly after that --
and possibly even before the presidential election. President Trump
said last month, in a debate with former Vice President Joe Biden,
that a vaccine was weeks away. Pfizer's new timeline puts a
pre-election approval for its candidate definitively out of
reach.
Other Western vaccine development programs, including one by the
University of Oxford and AstraZeneca PLC and another by Moderna
Inc., are in late-stage human trials, too. Trials of the Oxford
vaccine were halted in the U.K. and U.S. after a trial subject in
Britain fell ill. They were resumed in the U.K., but the FDA hasn't
yet authorized them to resume in the U.S.
As the West largely waits out the data from these human trials,
China and Russia have rolled out their own vaccines and authorized
their limited use for some parts of their populations and
beyond.
While the timeline laid out by Pfizer on Friday is limited to
its application for U.S. emergency-use authorization, Europe's top
regulator could act quickly on similar data submissions from Pfizer
and partner BioNTech. BioNTech said Friday a European application
for emergency use would quickly follow one made to the FDA.
Such data would be immediately reviewed by the European
Medicines Agency, a senior EMA official said. The EMA, which
regulates drugs across the European Union, could then issue what it
calls a conditional marketing authorization, similar to
emergency-use authorization in the U.S.
Pfizer and BioNTech have been racing to increase production of
its vaccine candidate to meet the world's needs, assuming the shot
wins a regulatory green light. The two have committed to supplying
over 450 million doses this year and next year, contingent on
late-stage trials showing the vaccine to be safe and effective, and
governments giving the go-ahead for its use.
The U.S. government placed an initial order of 100 million
doses, with the option to purchase 500 million additional doses.
The EU ordered 200 million doses with an option for another 100
million. The government of Japan ordered 120 million doses and
Britain ordered 30 million. All orders are subject to regulatory
approval, and only the price of the U.S. deal -- $1.95 billion --
has been disclosed so far.
BioNTech and Pfizer previously set a target to produce up to 100
million vaccines globally by the end of this year. That initial
batch would only be enough for 50 million people, though, because
the vaccine, known as BNT162, consists of two shots, a so-called
prime vaccination and a booster. The two companies haven't
disclosed how many doses they have already made.
--Drew Hinshaw contributed to this article.
Write to Bojan Pancevski at bojan.pancevski@wsj.com
(END) Dow Jones Newswires
October 16, 2020 07:42 ET (11:42 GMT)
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