|
 It also reported a 100% success rate in preventing severe cases. The
filing sets Moderna's product up to be the second vaccine likely to
receive U.S. emergency use authorization this year.
"We believe that we have a vaccine that is very highly efficacious.
We now have the data to prove it," Moderna Chief Medical Officer Dr.
Tal Zaks said in a telephone interview. "We expect to be playing a
major part in turning around this pandemic."
Zaks said he was emotional after seeing the 94.1% result over the
weekend: "It was the first time I allowed myself to cry. 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."
Moderna's announcement follows news from Pfizer Inc and German
partner BioNTech SE that their vaccine, which also uses a new
technology called synthetic messenger RNA (mRNA), was 95% effective.
Pfizer has applied for emergency use authorization, putting it about
a week ahead of Moderna.
In addition to filing its U.S. application, Moderna said it would
apply for conditional approval from the European Medicines Agency,
which has already begun a rolling review of data, and would continue
to talk with other regulators conducting rolling reviews.
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 is not statistically significant.
Both the Moderna and Pfizer vaccines proved more effective than
anticipated and far superior to the 50% benchmark set by the U.S.
Food and Drug Administration.
Britain's AstraZeneca has announced an average efficacy rate of 70%
for its vaccine and as much as 90% for a subgroup of trial
participants who got a half dose first, followed by a full dose. But
some scientists have expressed doubts about the robustness of the
90% efficacy figure for the smaller group.
Still, the past few weeks of positive vaccine results have ignited
hopes for an end to a pandemic that has battered economies and
claimed more than 1.45 million lives worldwide. It comes as new
infections and COVID-19 hospitalizations are at record levels across
the United States.
Independent advisers to the U.S. Food and Drug Administration 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 designated 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.
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100% SUCCESS RATE FOR SEVERE CASES
Of the 196 volunteers who contracted COVID-19 in the more than 30,000-person
trial, 185 had received a placebo versus 11 who got the vaccine. The company
reported 30 severe cases - all in the placebo group - which means the vaccine
was 100% effective at preventing severe cases. The trial included one
COVID-19-related death in the placebo group.
Moderna said the vaccine's efficacy was consistent across age, race, ethnicity
and gender demographics. The 196 cases included 33 adults over 65 and 42
volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian
Americans and 3 multiracial participants.
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 on Nov. 16.
Based on that analysis, the most common side effects were fatigue, injection
site redness and pain, headache and body aches, which increased 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 trial in even younger volunteers early in
2021. The company hopes to have the vaccine available for adolescents by
September of next year, Zaks said.
Other vaccine makers have said they are studying their vaccines in young people
as well.
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.
(Reporting by Julie Steenhuysen and Michael Erman; Additional reporting by Ankur
Banerjee in Bengaluru; Editing by Bill Berkrot and Edwina Gibbs)
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