* Moderna vaccine 94.5% effective in interim trial data
* No severe COVID-19 cases in trial participants with shot
* Stocks markets head for record high
* Experts encouraged by Moderna results:
(Adds graphic, bullet points, more comment, updates shares)
By Julie Steenhuysen and Michael Erman
Nov 16 (Reuters) - Moderna Inc's experimental
vaccine was 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.
Next year, the U.S. government could have access to more
than 1 billion doses just from the two vaccine makers, more than
needed for the country's 330 million residents.
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. The news also comes at a time when 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 either a placebo or the vaccine.
Of those, only five infections occurred in those who received
the vaccine, which is administered in two shots 28 days apart.
"Having more than one source of an effective vaccine will
increase the global supply and, with luck, help us all to get
back to something like normal sometime in 2021," said Eleanor
Riley, professor of immunology and infectious disease at the
University of Edinburgh.
Moderna expects to have enough safety data required for U.S.
authorization in the next week or so and the company expects to
file for emergency use authorization (EUA) in the coming weeks.
The company's shares, which have more than quadrupled this
year, rose 15% in premarket trading while European stocks and
Wall Street stock futures jumped on the vaccine update. The
benchmark S&P 500 futures rose 1.3%, stopping just short
of a new record high, while the pan-European STOXX 600
hit late-February highs.
Shares in Pfizer were down 1.7% in premarket trading while
Britain's AstraZeneca, which has yet to release any
results from its late-stage vaccine trials, were 0.7% weaker.
SEVERE CASES
A key advantage of Moderna's vaccine is that it does not
need ultra-cold storage like Pfizer's, making it easier to
distribute. Moderna expects it 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.
One unknown with this vaccine, and all the others currently
being tested, is whether they will stop COVID-19 spreading.
"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 Riley at Edinburgh
University.
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
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 certain
virus proteins that the immune system sees as a threat and
mounts a response against.
The United States has the world's highest known number of
COVID-19 cases and deaths with more than 11 million infections
and nearly 250,000 deaths.
The Trump Administration has primarily 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 U.S. government also 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, dependent in part on demand.
Moderna also said it would use its data to seek
authorization in Europe and other regions.
Europe's health regulator said on Monday it had launched a
real-time "rolling review" of Moderna's vaccine, following
similar reviews of vaccines from Pfizer and AstraZeneca.
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 released data from 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)
Astrazeneca (AZN)
