Johnson & Johnson's Covid-19 Vaccine Gets Green Light From CDC -- 3rd Update
By Peter Loftus
The U.S. Centers for Disease Control and Prevention signed off
on adding Johnson & Johnson's newly authorized Covid-19 vaccine
to the arsenal of preventive weapons against the coronavirus.
CDC Director Rochelle P. Walensky gave the go-ahead Sunday after
a panel of advisers voted in support of adults in the U.S. getting
the one-dose vaccine. The Advisory Committee on Immunization
Practices voted 12-0 in favor with one recusal.
The steps concluded a review process before the shot reaches
wider use, which is expected this week.
"In the midst of this tragedy we do have some reason for
optimism," said committee member Dr. Matthew Daley, senior
investigator at the Institute for Health Research with Kaiser
Permanente Colorado. "How very grateful I am that we now have three
safe and highly effective vaccines."
The U.S. Food and Drug Administration authorized use of the
single-dose shot on Saturday based on its 66% effectiveness at
preventing moderate to severe Covid-19 disease in a large study
that also showed it was safe.
J&J said after the FDA clearance that it had started to ship
doses of its vaccine for allocation and distribution by the federal
government. The doses are expected to start reaching vaccine
providers in the U.S. in the coming days, with vaccinations
starting soon afterward.
It was the third Covid-19 vaccine cleared by the FDA, after the
agency's clearance in December of shots from Pfizer Inc. with its
partner BioNTech SE and from Moderna Inc.
The addition of the J&J vaccine is expected to boost the
mass vaccination campaign aiming to bring the pandemic under
control. Demand for the previously authorized vaccines has outpaced
supply so far.
More than 75 million of the 96.4 million doses distributed
nationwide have been administered, according to the CDC.
J&J expects to ship about four million doses right away, and
to deliver another 16 million by the end of March. By the end of
June, J&J expects to provide a total of 100 million doses for
use in the U.S.
The federal government has purchased the doses and is making
them available free to people.
The new supplies should help more people get vaccinated,
especially after J&J increases its output. Yet health
authorities don't expect the availability of three shots will mean
that many people will start having a choice among them soon.
Each of the three authorized shots works well, according to the
authorities, who encourage people to get whichever vaccine they can
The CDC's vaccine advisory committee members -- physicians,
public-health officials and infectious-disease specialists --
discussed the clinical evidence for J&J's vaccine during an
Members of the committee generally had favorable comments about
the vaccine, but some expressed concerns.
One concern was that in the large clinical trial, J&J's
vaccine appeared to be less effective among people age 60 and older
who had certain medical conditions such as diabetes and
J&J's Macaya Douoguih, head of clinical development and
medical affairs with J&J's Janssen pharmaceuticals unit, said
those results should be interpreted with caution because they are
based on a relatively small number of Covid-19 cases in that
subgroup. She said it wasn't in line with the rest of the trial
data, which support that the vaccine provides protection.
The efficacy among American Indian and Alaska Natives also was
lower than the overall efficacy in the study.
Committee members also began to wrestle with the potentially
difficult task of comparing the three authorized vaccines and
giving guidance about whether people should choose one over the
others. The question has arisen partly because the overall efficacy
of J&J's vaccine in a large trial was lower than that for
Pfizer's and Moderna's from separate trials.
For now, the committee isn't expressing a preference, with
members saying it is tough to compare and contrast the vaccines
across different trials, and that all three were generally safe and
"We want to make sure the public understands the best vaccine is
the one they can get access to," said Dr. Jason Goldman, a liaison
to the committee from the American College of Physicians.
Write to Peter Loftus at firstname.lastname@example.org
(END) Dow Jones Newswires
February 28, 2021 18:16 ET (23:16 GMT)
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