Moderna CEO Expects Covid-19 Vaccine Interim Results in November
By Peter Loftus
Moderna Inc. Chief Executive Stéphane Bancel said the federal
government could authorize emergency use of the company's
experimental Covid-19 vaccine in December, if the company gets
positive interim results in November from a large clinical
Mr. Bancel, speaking during The Wall Street Journal's annual
Tech Live conference Monday, said if sufficient interim results
from the study takes longer to get, government authorization of the
vaccine may not occur until early next year.
Cambridge, Mass.,-based Moderna has one of the leading Covid-19
vaccines in development, along with a vaccine co-developed by
Pfizer Inc. and BioNTech SE. Large U.S. trials for two other
leading Covid-19 vaccines, from Johnson & Johnson and
AstraZeneca PLC, have been paused, while the companies investigate
unexplained illnesses among study subjects.
Mr. Bancel's comments suggest Moderna's timetable isn't far off
from Pfizer's, which said last week it expects to seek U.S.
authorization of emergency use of its vaccine by late November.
In July, Moderna started a 30,000-person study in the U.S. to
test whether the vaccine safely protects people from symptomatic
Covid-19 disease, and enrollment is nearly complete.
In the trial, half of the study subjects receive the vaccine and
half receive a placebo, and researchers then count how many get
The first interim analysis of the vaccine's efficacy will happen
when 53 people in the entire study get symptomatic Covid-19. If
there are significantly fewer vaccinated people than unvaccinated
people among those 53 cases, the company may deem the results
sufficient to seek government authorization of wider use.
That first analysis is likely to occur in November, but "it's
hard to predict exactly which week because it depends on the cases,
the number of people getting sick," Mr. Bancel said.
The company also must monitor the safety of at least half of the
study subjects for two months after vaccination before it can seek
an authorization for emergency use. Mr. Bancel said Moderna was
likely to reach that threshold in late November. If Moderna files
for an emergency use authorization soon after, the Food and Drug
Administration may take a few weeks to review the application
before deciding in December.
If the vaccine doesn't demonstrate sufficient efficacy at the
first interim analysis, the company will conduct a second analysis
when 106 cases of symptomatic Covid-19 occur. Mr. Bancel said that
would likely happen in December, which could push back any FDA
decision to late January or early February.
Moderna codesigned its vaccine with the National Institute of
Allergy and Infectious Diseases and began human testing in March
while also starting to expand production of doses. Initial studies
showed it induced immune responses in study volunteers and was
Mr. Bancel said Monday the company continues to expect to
produce about 20 million doses by the end of this year and at least
500 million doses next year. He said ramping up production is a
"Unlike sometimes when you make a recipe at home, if you miss
one ingredient, you might decide to still go ahead and make your
meal, but in our case we cannot do that," Mr. Bancel said. "We need
all the ingredients to be there on time to be able to make a lot of
vaccine. If one ingredient is missing, we cannot make a
Mr. Bancel said Moderna and its contract-manufacturing partner
Lonza Ltd. expect to produce enough doses in the U.S. to meet U.S.
demand. Lonza also is manufacturing doses in Switzerland to meet
demand outside the U.S., he said.
In August, Moderna signed a $1.5 billion contract with the
federal government to supply 100 million doses of its vaccine for
use in the U.S., with an option to supply more doses.
Factoring in additional federal funding that Moderna has
received, the U.S. government is paying $25 per dose, Mr. Bancel
said Monday. He said that because Moderna has never turned a
profit, it is appropriate to make a reasonable profit but not to
maximize profit from a Covid-19 vaccine.
Write to Peter Loftus at email@example.com
(END) Dow Jones Newswires
October 19, 2020 23:44 ET (03:44 GMT)
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