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 Together with Pfizer Inc's vaccine, also shown to be 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 by
the year's end.
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 built using new technology known as messenger RNA
or mRNA, represent powerful new tools to fight a pandemic that has
infected 54 million people worldwide and killed 1.3 million. The
news also comes at 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.
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 standard refrigerator
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 -20 degrees Celsius.
Pfizer’s vaccine must be shipped and stored at minus 70 degrees
Celsius, the sort of temperature typical of an Antarctic winter. At
standard refrigerator temperatures, it can be stored for up to five
days.
The data from Moderna's 30,000 participant-strong trial 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 around 20 million doses of the vaccine for the
United States this year, millions of which the company has already
made, and is ready to ship if it receives 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."
DATA DETAILS
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.
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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, the company said.
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.
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 in the coming weeks.
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 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 have between 500 million and 1 billion doses in 2021, split
between its U.S. and international manufacturing sites and dependent in part on
demand.
The U.S. government has said COVID-19 vaccines will be provided free to
Americans, whether they have health insurance, are uninsured or are covered by
government health programs such as Medicare.
Moderna also said it will use its data to seek authorization in Europe and other
regions.
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; Editing by Bill Berkrot,
Caroline Humer, Peter Henderson and Edwina Gibbs)
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