|
 The company expects results of the Phase III trial by year end or
early next year, Dr. Paul Stoffels, J&J's chief scientific officer,
said in a joint press conference with officials from the National
Institutes of Health and the Trump administration.
Rival vaccines from Moderna Inc, Pfizer Inc and AstraZeneca all
require two shots separated by several weeks, which make them much
more difficult to administer.
"The benefits of a single-shot vaccine are potentially profound in
terms of mass immunization campaigns and global pandemic control,"
Dr. Dan Barouch, a Harvard vaccine researcher who helped design
J&J's COVID-19 vaccine, said in a telephone interview.
Stoffels said J&J would publish a detailed study protocol for its
phase 3 trial Wednesday on the company's website, joining the three
other vaccine makers that have made these study plans available in
recent weeks after calls for increased transparency in the trials.
Stoffels said J&J started the phase 3 trial after seeing positive
results in its phase 1/2 trial in the United States and Belgium. The
company plans to release those results imminently.
Stoffels said the safety and level of protection in the study were
on par with what was seen in the company's animal studies, and said
the results showed a single dose could offer sufficient protection
"for a long time."J&J's late-stage trial will use as many as 215
sites in the United States, South Africa, Argentina, Brazil, Chile,
Colombia, Mexico and Peru. The company plans to manufacture as many
as 1 billion doses in 2021, and more after that, Stoffels said.
The goal of the trial is to test whether the vaccine can prevent
moderate to severe COVID-19 after a single dose, but it will also
look to see if the vaccine can prevent serious disease requiring
medical intervention and whether it can prevent milder cases of the
virus.
Stoffels predicts it will take six weeks to two months to enroll the
trial, and said the company hopes to get an answer on whether the
vaccine works "around the end of the year or early next year."
[to top of second column] |
It is not clear how fast the company could get regulatory approval,
but J&J plans to manufacture doses before approval, so it could
start distribution quickly.
The trial will be overseen by an independent Data and Safety
Monitoring Board (DSMB) that will review vaccine safety and
effectiveness. In the press conference, Dr. Francis Collins,
director of the National Institutes of Health, said all three of the
vaccines being organized and supported by the federal government's
Operation Warp Speed - J&J's, Moderna's and AstraZeneca's - share a
common DSMB. Pfizer is running its own trial and has a separate DSMB,
Collins said.
J&J's trial is designed to test for a vaccine that is 60%effective.
In the study protocol, that could be determined after 154 people
became infected with the virus. Stoffels said the company will start
counting cases of COVID-19 infections within the study population 15
days after individuals are vaccinated.
The DSMB will take its first look at the vaccine's efficacy after 20
people have become infected.
Collins said the DSMB does not include any federal employees and is
made up of "very highly experienced" scientists and statistical
experts.
"Until they are convinced that there's something there that looks
promising, nothing is unblinded and sent to the FDA. So everybody
should feel pretty reassured," Collins said. His comments follow
concerns government scientists may be pressured to rush the vaccine
testing process to boost U.S. President Donald Trump's re-election
bid.
(Reporting by Julie Steenhuysen, editing by Peter Henderson and Tom
Brown)
[© 2020 Thomson Reuters. All rights
reserved.] Copyright 2020 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content. |
