Last checked at 
* Pfizer and BioNTech first to release large trial results
* Experts say results show vaccines can halt pandemic
* Markets surge on hopes of light at the end of the tunnel
(Adds Biden, Trump, more expert comment)
By Michael Erman and Julie Steenhuysen
Nov 9 (Reuters) - Pfizer Inc said on Monday its
experimental COVID-19 vaccine was more than 90% effective, a
major victory in the fight against a pandemic that has killed
more than a million people, battered the world's economy and
upended daily life.
Pfizer and German partner BioNTech SE are the first
drugmakers to release successful data from a large-scale
clinical trial of a coronavirus vaccine. The companies said they
have so far found no serious safety concerns and expect to seek
U.S. authorization this month for emergency use of the vaccine.
Health experts said Pfizer's results were positive for all
COVID-19 vaccines currently in development since they show the
shots are going after the right target and are a proof of
concept that the disease can be halted with vaccination.
"Today is a great day for science and humanity," Albert
Bourla, Pfizer's chairman and chief executive, said.
"We are reaching this critical milestone in our vaccine
development program at a time when the world needs it most with
infection rates setting new records, hospitals nearing
over-capacity and economies struggling to reopen."
If Pfizer's vaccine is authorized, the number of doses will
initially be limited and many questions remain, including how
long the vaccine will provide protection.
BioNTech Chief Executive Ugur Sahin told Reuters he was
optimistic the immunisation effect of the vaccine would last for
a year although that was not certain yet.
"This news made me smile from ear to ear. It is a relief to
see such positive results on this vaccine and bodes well for
COVID-19 vaccines in general," said Peter Horby, professor of
emerging infectious diseases at the University of Oxford.
MARKETS SURGE
The prospect of a vaccine electrified world markets with S&P
500 futures hitting a record high and tourism and travel shares
surging. Shares of companies that have benefited from
pandemic-related lockdowns dropped including conferencing
platform Zoom Video Communications which was down 12% in
premarket trading.
Pfizer shares were indicated 14.2% higher in pre-market
trading in New York, while BioNTech's stock was up nearly 23% in
Frankfurt.
"Light at the end of the tunnel. Let's just hope the vaccine
deniers won't get in the way, but 2021 just got a lot brighter,"
said Neil Wilson, chief market analyst at Markets.com
Shares of other vaccine developers in the final stage of
testing also rose with Johnson & Johnson up 4% in
pre-market trading and Moderna 7.4% stronger. Britain's
AstraZeneca was down 0.5%.
"The efficacy data are really impressive. This is better
than most of us anticipated," said William Schaffner, infectious
diseases expert at Vanderbilt University School of Medicine,
Nashville, Tennessee. "The study isn't completed yet, but
nonetheless the data look very solid."
U.S. President Donald Trump welcomed the test results, and
the market boost: "STOCK MARKET UP BIG, VACCINE COMING SOON.
REPORT 90% EFFECTIVE. SUCH GREAT NEWS!" he said on Twitter.
President-elect Joe Biden said the news was excellent but
did not change the fact that face masks, social distancing and
other health measures would be needed well into next year.
1.3 BILLION DOSES
Pfizer expects to seek broad U.S. authorization for
emergency use of the vaccine for people aged 16 to 85. To do so,
it will need two months of safety data from about half the
study's 44,000 participants, which is expected late this month.
"I'm near ecstatic," Bill Gruber, one of Pfizer's top
vaccine scientists, said in an interview. "This is a great day
for public health and for the potential to get us all out of the
circumstances we're now in."
Pfizer and BioNTech have a $1.95 billion contract with the
U.S. government to deliver 100 million vaccine doses beginning
this year. They have also reached supply agreements with the
European Union, the United Kingdom, Canada and Japan.
To save time, the companies began manufacturing the vaccine
before they knew whether it would be effective. They now expect
to produce up to 50 million doses, or enough to protect 25
million people this year.
Pfizer said it expects to produce up to 1.3 billion doses of
the vaccine in 2021.
The U.S. pharmaceutical giant said the interim analysis was
conducted after 94 participants in the trial developed COVID-19,
examining how many of them had received the vaccine versus a
placebo.
The company did not break down exactly how many of those who
fell ill received the vaccine. Still, over 90% effectiveness
implies that no more than 8 of the 94 people who caught COVID-19
had been given the vaccine, which was administered in two shots
about three weeks apart.
The efficacy rate is well above the 50% effectiveness
required by the U.S. Food and Drug Administration for a
coronavirus vaccine.
MORE DATA NEEDED
To confirm the efficacy rate, Pfizer said it would continue
the trial until there are 164 COVID-19 cases among participants.
Bourla told CNBC on Monday that based on rising infection rates,
the trial could be completed before the end of November.
The data have yet to be peer-reviewed or published in a
medical journal. Pfizer said it would do so once it has results
from the entire trial.
"These are interesting first signals, but again they are
only communicated in press releases," said Marylyn Addo, head of
tropical medicine at the University Medical Center
Hamburg-Eppendorf in Germany.
"Primary data are not yet available and a peer-reviewed
publication is still pending. We still have to wait for the
exact data before we can make a final assessment."
The global race for a vaccine has seen wealthier countries
forge multibillion-dollar supply deals with drugmakers like
Pfizer, AstraZeneca Plc and Johnson & Johnson, raising questions
over when middle income and poorer nations will get access to
inoculations.
The U.S. quest for a vaccine has been the Trump
administration's central response to the pandemic. The United
States has the world's highest known number of COVID-19 cases
and deaths with more than 10 million infections and over 237,000
fatalities.
Trump repeatedly assured the public that his administration
would likely identify a successful vaccine in time for the
presidential election, held last Tuesday. On Saturday,
Democratic rival Biden was declared the winner.
ESSENTIAL TOOLS
Vaccines are seen as essential tools to help end the health
crisis that has shuttered businesses and left millions out of
work. Millions of children whose schools were closed in March
remain in remote learning programs.
Dozens of drugmakers and research groups around the globe
have been racing to develop vaccines against COVID-19, which on
Sunday exceeded 50 million infections since the new coronavirus
first emerged late last year in China.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA)
technology, which relies on synthetic genes that can be
generated and manufactured in weeks, and produced at scale more
rapidly than conventional vaccines.
Moderna Inc, whose vaccine candidate employs similar
technology, is expected to report results from its large-scale
trial later this month.
The mRNA technology is designed to trigger an immune
response without using pathogens, such as actual virus
particles.
Pfizer alone will not have the capacity to immediately
provide enough vaccines for the United States. The Trump
administration has said it will have enough supply for all of
the 330 million U.S. residents who wish to be vaccinated by the
middle of 2021.
The U.S. government has said the vaccines will be provided
free to Americans, including the insured, uninsured and those in
government health programs such as Medicare.
(Reporting by Michael Erman and Julie Steenhuysen; Additional
reporting by Michele Gershberg in New York and Ludwig Burger and
Patricia Weiss in Frankfurt; Editing by Bill Berkrot, Caroline
Humer, Edwina Gibbs and David Clarke)
