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* 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 comment, updates shares)
By Michael Erman and Julie Steenhuysen
Nov 9 (Reuters) - Pfizer Inc's experimental COVID-19
vaccine was more than 90% effective based on initial trial
results, the company said on Monday, a major victory in the
fight against a pandemic that has killed over a million people
and battered the world's economy.
Experts welcomed the first successful interim data from a
large-scale clinical test as a watershed moment that showed
vaccines could halt the pandemic though mass roll-outs of the
shot, which needs regulatory approval, won't happen this year.
Pfizer and its German partner BioNTech SE said they
had so far found no serious safety concerns and expected to seek
U.S. authorization this month for emergency use of the vaccine,
raising the possibility of a regulatory decision as soon as
December.
If granted, the companies estimate they can roll out up to
50 million doses this year, enough to protect 25 million people,
and then produce up to 1.3 billion doses in 2021.
"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."
Experts cautioned that they still needed to see the full
trial data, which have yet to be peer-reviewed or published in a
medical journal, but the preliminary results looked encouraging
so far.
There are still many questions around the vaccine, such as
how effective it is for vulnerable groups and how long it will
provide immunity, and the "new normal" of social distancing and
face masks looks set to remain for the foreseeable future.
BioNTech Chief Executive Ugur Sahin told Reuters he was
optimistic the immunisation effect of the vaccine would last for
a year though that was not yet certain.
"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 the
S&P 500 and Dow hitting record highs as shares of banks, oil
majors and travel companies soared. Pfizer shares were 8.6%
higher in New York at 1450 GMT, while BioNTech's stock was up
11%.
Shares of other vaccine developers in the final stage of
testing also rose with Johnson & Johnson up 4.5% and
Moderna 5.5% stronger. Britain's AstraZeneca
was down 3.5%.
"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 in the third week
of November.
"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."
To break the dynamic of the spread of the coronavirus,
between 55% and 65% of the population will need to be
vaccinated, Germany's health minister Jens Spahn told a news
conference on Monday, adding that he doesn't expect a shot to be
available before the first quarter of 2021.
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.
The U.S. drugmaker 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.
Pfizer 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 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.
Pfizer said its data would be peer reviewed 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 such as
Pfizer, AstraZeneca Plc and Johnson & Johnson, raising questions
over when middle income and poorer nations will get access to
inoculations.
The U.S. has spent billions of dollars to spur vaccine
development at six pharma companies including Moderna and
Johnson & Johnson through Operation Warp Speed. Pfizer is not
part of that research and development program and runs its trial
independently, but does have a nearly $2 billion deal to supply
vaccines to the United States.
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, Ludwig Burger and
Patricia Weiss in Frankfurt and Kate Kelland in London; Editing
by Bill Berkrot, Caroline Humer, Edwina Gibbs and David Clarke)
