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(Adds comment from expert, Pfizer CEO)
By Michael Erman
Nov 18 (Reuters) - Final results from Pfizer Inc's
COVID-19 vaccine trial showed its shot had a 95% success rate
and two months of safety data, paving the way for the drugmaker
to apply for an emergency U.S. authorization within days, it
said on Wednesday.
The vaccine's efficacy rate, the highest of any candidate in
late-stage clinical trials so far, was welcomed by experts who
had already said that interim results showing Pfizer's shot was
over 90% effective were very encouraging.
Pfizer said there were 170 cases of COVID-19 in its trial of
more than 43,000 volunteers and only eight people with the
disease had been given the shot rather than a placebo, meaning
the vaccine had a 95% efficacy rate. Of the 10 people who
developed severe COVID-19, one had received the vaccine.
"The data is very strong," said Ian Jones, a professor of
virology at Britain's University of Reading. "It's looking like
a real contender."
Pfizer said it expected the U.S. Food and Drug
Administration's vaccine advisory committee to review and
discuss the data in a public meeting that will likely be held in
December.
"We continue to move at the speed of science, and we know
that every day matters in our path to authorization," Pfizer
Chief Executive Albert Bourla said.
The final analysis comes just a week after initial results
from the trial showed the vaccine, developed with German partner
BioNTech SE, was more than 90% effective. Moderna Inc
on Monday released preliminary data for its vaccine,
showing 94.5% effectiveness.
The better-than-expected results from the two vaccines, both
developed with new messenger RNA (mRNA) technology, have raised
hopes for an end to a pandemic that has killed more than 1.3
million people and wreaked havoc upon economies and daily life.
However, while some groups such as healthcare workers will
be prioritized in the United States for vaccinations this year,
it will be months before large-scale rollouts begin.
THE MOST VULNERABLE
Distribution of a Pfizer shot is complicated by the need to
store it at ultra-cold temperatures of -70 degrees Celsius. It
can, however, be kept in a normal fridge for up to five days, or
up to 15 days in a thermal shipping box.
Pfizer said the efficacy of the vaccine was consistent
across different age and ethnic groups, a sign that the
immunization could be employed broadly around the world.
Efficacy in adults over 65 years, who are at particular risk
from the virus, was over 94%.
"The 94% protection for older people is key. This is the
evidence we needed to ensure that the most vulnerable people are
protected," said Andrew Hill, senior visiting research fellow at
the University of Liverpool's department of pharmacology.
Equity markets strengthened slightly on the Pfizer news.
Europe's STOXX 600 and the U.S S&P 500 futures
both rose about 0.3% to hit highs for the day. The moves were
small, however, compared with the jump when Pfizer first
announced the vaccine was more than 90% effective on Nov. 9.
Pfizer shares rose 3% in premarket trade while BioNTech's
U.S.-listed shares jumped 8%.
MILD SIDE EFFECTS
Pfizer said its two-dose vaccine, BNT162b2, was
well-tolerated and that side effects were mostly mild to
moderate, and cleared up quickly.
The only severe adverse event that affected more than 2% of
those vaccinated was fatigue, which affected 3.7% of recipients
after the second dose. Older adults tended to report fewer and
milder adverse events.
Moderna named five categories of severe side effects
experienced by at least 2% of those who received its vaccine. It
listed fatigue at a frequency of 9.7%, muscle pain at 8.9%,
joint pain at 5.2%, headache at 4.5%, pain at 4.1% and redness
around the injection site at 2%.
Pfizer's final results come as the virus is running rampant
around the world, placing an enormous strain on healthcare
systems with record numbers of new cases and hospitalizations.
The approach of winter in the northern hemisphere in tandem
with the holiday season is expected to worsen case numbers as
people spend more time indoors and have family gatherings.
"With hundreds of thousands of people around the globe
infected every day, we urgently need to get a safe and effective
vaccine to the world," Pfizer's Bourla said.
Pfizer and BioNTech also said they plan to submit the data
to other regulatory agencies around the world and submit data
from the study to a peer-reviewed scientific journal.
Pfizer reiterated that it expects to make as many as 50
million vaccine doses this year, enough to protect 25 million
people, and then produce up to 1.3 billion doses in 2021.
Of the dozens of drugmakers and research groups racing to
develop vaccines against COVID-19, the next data release will
likely be from AstraZeneca Plc with the University of
Oxford in November or December. Johnson & Johnson says
it is on track to deliver data this year.
(Reporting by Michael Erman in Maplewood, N.J.; Additional
reporting by Ankur Banerjee in Bengaluru and Elizabeth Howcroft
and Kate Kelland in London; Writing by David Clarke; Editing by
Bill Berkrot, Peter Henderson, Edwina Gibbs and Pravin Char)
