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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
By Michael Erman and Julie Steenhuysen
Nov 9 (Reuters) - Pfizer Inc's experimental COVID-19
vaccine is more than 90% effective based on initial trial
results, the drugmaker said on Monday, a major victory in the
war against a virus that has killed over a million people and
battered the world's economy.
Scientists, public health officials and investors welcomed
the first successful interim data from a large-scale clinical
test as a watershed moment that could help turn the tide of the
pandemic if the full trial results pan out. However, mass
roll-outs, which needs regulatory approval, will not happen this
year and several vaccines are seen as necessary to meet massive
global needs.
Pfizer and German partner BioNTech SE said they
had found no serious safety concerns yet and expected to seek
U.S. emergency use authorization (EUA) this month, raising the
chance 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," said Pfizer
Chief Executive Albert Bourla, noting the data milestone comes
with "infection rates setting new records, hospitals nearing
over-capacity and economies struggling to reopen."
Experts said they wanted to see the full trial data, but the
preliminary results looked encouraging.
"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.
There are still many questions, such as how effective the
vaccine is by ethnicity or age, and how long it will provide
immunity, with social distancing and face covering set to remain
for the foreseeable future.
Pfizer expects to seek U.S. emergency use authorization for
people aged 16 to 85. To do so, it will need two months of
follow-up safety data to assure no side effects crop up. That is
expected to be available in the third week of November.
U.S. Health and Human Services Secretary Alex Azar said it
would take several weeks for U.S. regulators to receive and
process the data before a potential approval.
MARKETS SURGE
The prospect of a vaccine electrified world markets with the
S&P 500 and Dow hitting record highs as shares of theme park and
travel companies battered by the pandemic soared. Movie chain
operator AMC Entertainment Holdings was up 60%.
Shares in companies that have thrived during lockdowns, such
as Netflix Inc and conferencing platform Zoom Video
tumbled.
Pfizer shares jumped more than 8% to their highest since
July last year, while BioNTech's stock hit a record high.
Mizuho Securities analyst Vamil Divan forecast the vaccine
may generate sales in excess of $8.5 billion for Pfizer in
2020-2021 alone.
Shares of other vaccine developers in the final stage of
testing also rose with Johnson & Johnson up nearly 4%
and Moderna Inc, whose vaccine uses a similar
technology as the Pfizer shot, up more than 8%. Britain's
AstraZeneca, however, fell 2%. Moderna is expected to
report results from its large-scale trial later this month.
"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 in
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 tweeted.
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.
The World Health Organization called the results very
positive, but warned there was a funding gap of $4.5 billion
that could slow access to tests, medicines and vaccines in low-
and middle-income countries.
There are other challenges as well that could affect less
affluent countries. The Pfizer vaccine must be shipped and
stored at an extremely cold temperature, which requires
necessary infrastructure. That highlights the need for more
traditional vaccines in development, such as J&J's candidate.
'NEAR ECSTATIC'
Still there was cause for jubilation.
"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."
Between 55% and 65% of the population will need to be
vaccinated to break the dynamic of the spread of COVID-19, said
Germany's health minister Jens Spahn, adding that he did not
expect a shot to be available before the first quarter of 2021.
The European Union said on Monday it would soon sign a
contract for up to 300 million doses of the Pfizer and BioNTech
COVID-19 vaccine.
The companies have a $1.95 billion contract with the U.S.
government to deliver 100 million vaccine doses beginning this
year. They did not receive research funding from the Trump
administration's Operation Warp Speed vaccine program.
The drugmakers have also reached supply agreements with the
United Kingdom, Canada and Japan.
The interim analysis, conducted after 94 participants in the
trial developed COVID-19, examined how many had received the
vaccine versus a placebo.
Pfizer did not provide that detail, but over 90% effective
implies that no more than 8 of the 94 had received the vaccine,
administered in two shots about three weeks apart.
The efficacy rate, which could drop once full results are
available, is well above the 50% effectiveness required by the
U.S. Food and Drug Administration for a coronavirus vaccine.
Shortly after Pfizer's announcement, Russia said its Sputnik
V vaccine was also more than 90% effective, based on data
collated from inoculations of the public. Its preliminary Phase
III trial data is due to be published this month.
MORE DATA NEEDED
To confirm the efficacy rate, Pfizer said it would continue
its trial until there were 164 COVID-19 cases among volunteers.
Bourla told CNBC on Monday that could be 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.
Dozens of drugmakers and research groups around the globe
have been racing to develop vaccines against COVID-19, which on
Sunday exceeded 50 million cases 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. The technology is designed
to trigger an immune response without using pathogens, such as
actual virus particles.
The Trump administration has said it will have enough
vaccine doses for all of the 330 million U.S. residents who want
it by the middle of 2021.
(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; Writing
by David Clarke and Bill Berkrot; editing by Caroline Humer,
Edwina Gibbs, Carmel Crimmins and Edward Tobin)
