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 Together with Pfizer Inc's <PFE.N> 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 <.SPX> rose 1%, while the pan-European STOXX 600 <.STOXX>
climbed 1.3%. [MKTS/GLOB]
Shares in Pfizer and its partner BioNTech <BNTX.O>, whose vaccine
must be transported at far colder temperatures, fell 4.3% and 16.4%
respectively, while Britain's AstraZeneca <AZN.L>, which has yet to
release any results from its late-stage vaccine trials, was down 1%.
(For graphic on U.S. biotech shares:
https://fingfx.thomsonreuters.com/
gfx/mkt/dgkvlalampb/biotech.PNG)
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.
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"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 <AZN.L>. 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)
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