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* Moderna vaccine 94.5% effective in interim trial data
* No severe COVID-19 cases in trial participants with shot
* Moderna vaccine easier to transport than Pfizer's
* Globals stocks hit record high
* Experts encouraged by Moderna results
(Updates shares, adds detail)
By Julie Steenhuysen and Michael Erman
Nov 16 (Reuters) - Moderna Inc's experimental
vaccine is 94.5% effective in preventing COVID-19 based on
interim data from a late-stage trial, the company said on
Monday, becoming the second U.S. drugmaker to report results
that far exceed expectations.
Together with Pfizer Inc's vaccine, which is also
more than 90% effective, and pending more safety data and
regulatory review, the United States could have two vaccines
authorized for emergency use in December with as many as 60
million doses of vaccine available this year.
The vaccines, both developed with new technology known as
messenger RNA (mRNA), represent powerful tools to fight a
pandemic that has infected 54 million people worldwide and
killed 1.3 million.
Unlike Pfizer's vaccine, Moderna's shot can be stored at
normal fridge temperatures, which should make it easier to
distribute, a critical factor as COVID-19 cases are soaring,
hitting new records in the United States and pushing some
European countries back into lockdowns.
"We are going to have a vaccine that can stop COVID-19,"
Moderna President Stephen Hoge said in a telephone interview.
Moderna's interim analysis was based on 95 infections among
trial participants who received the vaccine or a placebo. Only
five infections occurred in volunteers who received the vaccine
mRNA-1273, which is administered in two shots 28 days apart.
"The vaccine is really the light at the end of the tunnel,"
Dr. Anthony Fauci, the top U.S. infectious diseases expert said.
He urged Americans not to let their guard down and to continue
washing hands and being vigilant about social distancing.
Even with fast authorization, the vaccines will not come in
time for most people celebrating the U.S. Thanksgiving and
end-of-year holidays, when families and friends come together -
just the types of gatherings public health officials warn
against.
Moderna expects to have enough safety data required for U.S.
authorization in the next week or so and expects to file for
emergency use authorization (EUA) in the coming weeks.
The company's shares, which have more than quadrupled this
year, jumped 8%, while European and U.S. stocks rose. The
benchmark S&P 500 rose 1%, while the pan-European STOXX
600 climbed 1.3%.
Shares in Pfizer and its partner BioNTech, whose
vaccine must be transported at far colder temperatures, fell
4.3% and 16.4% respectively, while Britain's AstraZeneca
, which has yet to release any results from its
late-stage vaccine trials, was down 1%.
SEVERE CASES
Moderna's data provide further validation of the promising
but previously unproven mRNA platform, which turns the human
body into a vaccine factory by coaxing cells to make virus
proteins that the immune system sees as a threat and attacks.
Moderna expects the vaccine to be stable at normal fridge
temperatures of 2 to 8 degrees Celsius (36 to 48°F) for 30 days
and it can be stored for up to 6 months at -20C.
Pfizer's vaccine must be shipped and stored at -70C, the
sort of temperature typical of an Antarctic winter. It can be
stored for up to five days at standard refrigerator
temperatures, or for up to 15 days in a thermal shipping box.
The data from Moderna's trial involving 30,000 volunteers
also showed the vaccine prevented cases of severe COVID-19, a
question that still remains with the Pfizer vaccine. Of the 95
cases in Moderna's trial, 11 were severe and all 11 occurred
among volunteers who got the placebo.
Moderna, part of the U.S. government's Operation Warp Speed
program, expects to produce about 20 million doses for the
United States this year, millions of which the company has
already made and is ready to ship if it gets FDA authorization.
"Assuming we get an emergency use authorization, we'll be
ready to ship through Warp Speed almost in hours," Hoge said.
"So it could start being distributed instantly."
The 95 cases of COVID-19 included several key groups who are
at increased risk for severe disease, including 15 cases in
adults aged 65 and older and 20 in participants from racially
diverse groups.
"We will need much more data and a full report or
publication to see if the benefit is consistent across all
groups, notably the elderly, but this is definitely encouraging
progress, said Stephen Evans, professor of pharmacoepidemiology,
London School of Hygiene & Tropical Medicine.
The trials were designed to measure whether the vaccines
stop people from getting sick rather than whether they prevent
transmission, which remains to be tested.
"It is likely that vaccines that prevent symptomatic disease
will reduce the duration and level of infectiousness, and thus
reduce transmission, but we don't yet know if this effect will
be large enough to make any meaningful difference to the spread
of the virus within communities," said Eleanor Riley, professor
of immunology and infectious disease at the University of
Edinburgh.
ROLLING REVIEW
Most side effects were mild to moderate. A significant
proportion of volunteers, however, experienced more severe aches
and pains after taking the second dose, including about 10% who
had fatigue severe enough to interfere with daily activities
while another 9% had severe body aches. Most of these complaints
were generally short-lived, Moderna said.
"These effects are what we would expect with a vaccine that
is working and inducing a good immune response," said Peter
Openshaw, professor of experimental medicine at Imperial College
London.
The U.S. government, faced with the world's highest known
number of COVID-19 cases, could have access next year to more
than 1 billion doses from Moderna and Pfizer, more than needed
for the country's 330 million residents.
The Trump Administration has mainly relied on the
development of vaccines and treatments as its response to the
pandemic. Moderna has received nearly $1 billion in research and
development funding from the U.S. government and has a $1.5
billion deal for 100 million doses. The government has an option
for another 400 million doses.
The company hopes to produce between 500 million and 1
billion doses in 2021, split between its U.S. and international
manufacturing sites, depending in part on demand.
Europe's health regulator said on Monday it had launched a
real-time "rolling review" of Moderna's vaccine, as it has done
for vaccines from Pfizer and AstraZeneca. Brussels also
said it was in talks with Moderna about securing doses.
Other countries such as China and Russia have already begun
vaccinations. Russia licensed its Sputnik-V COVID-19 vaccine for
domestic use in August before it started large-scale trials. It
said on Nov. 11 that its vaccine was 92% effective based on 20
infections in its large trial.
(Reporting by Michael Erman and Julie Steenhuysen; Additional
reporting by Josephine Mason and Thyagaraju Adinarayan; Writing
by David Clarke; Editing by Bill Berkrot, Caroline Humer, Peter
Henderson, Edwina Gibbs and Carmel Crimmins)
