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(Adds expert reaction)
By Julie Steenhuysen and Michael Erman
Nov 30 (Reuters) - Moderna Inc will apply for U.S.
and European emergency authorization for its COVID-19 vaccine on
Monday after full results from a late-stage study showed it was
94.1% effective with no serious safety concerns, the company
said.
Moderna also reported that the vaccine's efficacy rate was
consistent across age, race, ethnicity and gender demographics
as well as having a 100% success rate in preventing severe cases
of a disease that has killed nearly 1.5 million people.
The filing sets Moderna's product up to be the second
vaccine likely to receive U.S. emergency use authorization this
year following a shot developed by Pfizer and BioNTech
which had a 95% efficacy rate in trials.
"We believe that we have a vaccine that is very highly
efficacious. We now have the data to prove it," Moderna Chief
Medical Officer Tal Zaks said. "We expect to be playing a major
part in turning around this pandemic."
Of the 196 volunteers who contracted COVID-19 in the trial
with more than 30,000 people, 185 received a placebo while 11
got the vaccine. Moderna reported 30 severe cases - all in the
placebo group - which means the vaccine was 100% effective in
preventing severe cases.
"As the numbers of cases reported grows, confidence grows
that this amazing protection will be maintained in a product
that can be rolled out to protect the public," said Alexander
Edwards, associate professor in biomedical technology at
Britain's University of Reading.
In addition to filing its U.S. application, Moderna said it
would seek conditional approval from the European Medicines
Agency, which has already begun a rolling review of its data,
and would continue to talk with other regulators.
Pfizer has already applied for emergency use authorization
in the United States and Europe, putting it about a week ahead
of Moderna.
Moderna said it was on track to have about 20 million doses
of its vaccine ready to ship in the United States by the end of
2020, enough to inoculate 10 million people.
'JUST OVERWHELMING'
Both of the vaccines use a new technology called synthetic
messenger RNA (mRNA) whereas others, such as Britain's
AstraZeneca, are using more traditional methods to
develop their vaccines.
AstraZeneca has announced an average efficacy rate of 70%
for its shot and as much as 90% for a subgroup of trial
participants who got a half dose, followed by a full dose. But
some scientists have expressed doubts about the robustness of
the 90% efficacy figure for the smaller group.
Moderna's latest efficacy result is slightly lower than an
interim analysis released on Nov. 16 of 94.5% effectiveness, a
difference that Zaks said was not statistically significant.
"At this level of effectiveness, when you just do the math
of what it means for the pandemic that's raging around us, it's
just overwhelming," said Zaks, who said he cried when he saw the
final results over the weekend.
Both the Moderna and Pfizer vaccines proved more effective
than anticipated and were far superior to the 50% benchmark set
by the U.S. Food and Drug Administration (FDA).
The past few weeks of positive vaccine results have ignited
hopes for an end to a pandemic that has battered economies and
comes as new infections and COVID-19 hospitalizations are at
record levels across the United States.
Independent advisers to the FDA are scheduled to meet on
Dec. 17 to review Moderna's trial data and make a recommendation
to the FDA. They will meet on Dec. 10 to review Pfizer's data.
Shortly after gaining emergency use authorization, Moderna
expects the vaccine to be shipped to distribution points
throughout the United States by the government's Operation Warp
Speed program and McKesson Corp, a drug distributor
contracted by the U.S. government.
Its distribution is expected to be easier than Pfizer's
because while it needs to be stored in a freezer, it does not
require the ultra-cold temperature needed by Pfizer's vaccine.
CONSISTENT ACROSS AGE AND ETHNICITY
Moderna said the 196 COVID-19 cases in its trial included 33
adults over 65 years old and 42 volunteers from racially diverse
groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3
multiracial participants. There was one death related to
COVID-19 in the placebo group.
Azra Ghani, chair in infectious disease epidemiology at
Imperial College London, said Monday's details from Moderna
confirmed the vaccine was highly efficient, including against
severe cases.
"Whilst this does not exclude some risk of severe disease
after vaccination given the relatively small number of severe
cases, these results suggest very high efficacy," she said.
Zaks said the vaccine has been developed during a period of
"political acrimony" and having a highly effective vaccine may
go a long way toward erasing some of that distrust.
"This is as black and white as an effect on a population
will be. Your chances of actually being sick if you've been
vaccinated are decreased 20-fold," he said.
Moderna reported no new side effects since its interim
analysis. Based on that analysis, the most common side effects
were fatigue, injection site redness and pain, headache and body
aches, which rose after the second dose and were short-lived.
Zaks said the vaccine caused significant flu-like symptoms
in some participants, which, he said, "goes hand-in-hand with
having such a potent vaccine." But it has not caused any
significant safety concerns so far.
Moderna plans to start a new trial to test the vaccine in
adolescents before the end of the year, followed by another in
even younger volunteers early in 2021. It hopes to have the
vaccine available for adolescents by September, Zaks said.
Other vaccine makers have said they are studying their
vaccines in young people as well.
(Reporting by Julie Steenhuysen and Michael Erman; Additional
reporting by Ankur Banerjee in Bengaluru and Kate Kelland in
London; Editing by Bill Berkrot, Edwina Gibbs and David Clarke)
