1/31/2021 Johnson & Johnson Covid-19 vaccine is 66% effective in global trial, but 85% effective against severe

inst severe disease, company says - CNN

Johnson & Johnson Covid-19 vaccine is 66% effective in

global trial, but 85% effective against severe disease, company
says
By Maggie Fox, Amanda Sealy and Michael Nedelman, CNN
 Updated 0246 GMT (1046 HKT) January 30, 2021

(CNN) — Johnson & Johnson's Covid-19 single-shot vaccine was shown to be 66% e ective in preventing
moderate and severe disease in a global Phase 3 trial, but 85% e ective against severe disease, the company
announced Friday.

The vaccine was 72% e ective against moderate and severe disease in the US, the company said.

It's a striking di erence from vaccines from Pfizer/BioNTech and Moderna, and it may give pause to people
uncertain about which vaccine to get or when they can get one. The vaccines already on the market in the US are
about 95% e ective overall against symptomatic Covid-19, with perhaps even higher e cacy against severe cases.

But experts say the Johnson & Johnson vaccine will still be useful against the pandemic in the United States and
around the world.

Dr. Anthony Fauci said on Friday the Johnson & Johnson

vaccine and others will help alleviate stress on the US health
care system.

"If we can alleviate that, that is really important -- not only with
this candidate, but the others that have already gotten the
EUA," Fauci, director of the National Institute of Allergy and
Infectious Diseases, said during a call with reporters on Friday
morning.

"If you can prevent severe disease in a high percentage of

Related Article: Novavax says Covid-19
vaccine is 89% e ective in UK trial, but
less so in South Africa
individuals, that will alleviate so much of the stress and human
su ering and death."
The vaccine's e cacy against moderate and severe disease
ranged from one country to another: 72% in the US, 66% in
Latin America and 57% in South Africa. This was measured
starting one month after the shot.

In South Africa, 95% of cases in the trial were due to a variant known as B.1.351, which is known to be more
contagious and carries mutations that may make the virus less susceptible to the antibody immune response --
including antibodies prompted by vaccination.

With that variant, "we have a lower protection against milder forms of Covid than we did in the United States,
where there were more typical circulating variants," Dr. Mathai Mammen, the company's global head of research
and development, told CNN Chief Medical Correspondent, Dr. Sanjay Gupta.

However, even those who got moderate cases of Covid-19 in

the trial tended to develop a milder course and fewer
symptoms, he added.

But for Mammen, the key result was how e ective the vaccine
was at preventing severe disease -- regardless of variant or
age group.

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1/31/2021 Johnson & Johnson Covid-19 vaccine is 66% effective in global trial, but 85% effective against severe disease, company says - CNN

"Across all geographies, across all variants, we see 85%

protection" against severe disease, he said. That trend
increased over time, with no severe cases in the vaccinated
group after day 49, according to the company.

From one month after the shot, all hospitalizations and deaths
occurred in the placebo group.

The results are based on an analysis of more than 44,000

participants in eight countries, with 468 total cases of Covid-
19 split between those receiving the vaccine or placebo. The
results have not been published in a peer-reviewed journal,
Related Article: A pandemic playbook but the company said it plans to do so "in the coming weeks."
for a new year
Johnson & Johnson is expected to apply to the US Food and
Drug Administration next week for emergency use
authorization, which Mammen said could come by late
February.

It will be the third company to seek EUA from the FDA for a coronavirus vaccine. Vaccines made by Moderna and
by Pfizer/BioNTech were authorized in December and are now being given to millions of Americans.

'Pretty good' for single-dose, a ordable vaccine

Dr. Paul O t, a vaccine expert at the University of Pennsylvania and a member of the FDA's Vaccines and Related
Biological Products Advisory Committee, said that under normal circumstances, there might not be much of a
market for a vaccine that is significantly less e ective than two others already on the market. But he added that
these are not normal times, with a pandemic raging and shortage of vaccines.

Pfizer and Moderna both use genetic technology called messenger RNA, or mRNA technology. Johnson &
Johnson uses a weakened common cold virus, known as adenovirus, to carry genetic instructions into the body to
prompt an immune response.

"In a better world, we would have abundant quantities of this

messenger RNA vaccine, Pfizer and Moderna, and that would
be damning for a vaccine that's clearly less e ective. But that
said, we have limited quantities of mRNA vaccine," O t said.

O t has been vaccinated, but said if he had not, he would

first search out a Pfizer or Moderna vaccine, and then if he
couldn't find one in reasonable period of time, he would take
a Johnson & Johnson vaccine if it was available.O t said
getting one brand of vaccine and later on getting a di erent
vaccine should not pose safety issues.

"I would make an e ort to get an mRNA vaccine first," O t

Related Article: CNN analysis suggests
12% -- and as much as a third -- of the
US population might currently have some
protection against Covid-19
said. "Not being able to get it, and knowing I might not be
able to get Pfizer or Moderna for many months, and knowing
this virus is still ranging across the country, I would take J&J in
the secure knowledge that I could get Pfizer or Moderna
later."

The Johnson & Johnson vaccine has advantages, Fauci said.

"A vaccine that's inexpensive, that's a single dose, and that has no cold chain requirements -- that's pretty good,"
Fauci told CNN.

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1/31/2021 Johnson & Johnson Covid-19 vaccine is 66% effective in global trial, but 85% effective against severe disease, company says - CNN

Mammen said the vaccine was well-tolerated, with a "vanilla, even boring, safety data set" that included no cases
of a severe allergic response known as anaphylaxis. About one in 11 had a fever, but only 0.2% were considered
"Grade 3."

Fauci said the results would look even better if Janssen did not have to compete against the 94% and 95%
e cacy seen in trials of the Pfizer and Moderna vaccines — even though the latter are calculated from overall
symptomatic disease, while Johnson & Johnson's figures reference only moderate and severe cases.

"You know what the problem is? If this were out there and we didn't have the Moderna 94-95% .... We would have
said wow, a 72% e ective vaccine that's even more e ective against severe disease is really terrific," he said in a
telephone interview.

"But now we're always judging it against 94 to 95%. Having said that, this is a vaccine that could have use
particularly in developing countries to keep people out of the hospital. It has a very good e cacy against severe
disease," Fauci added.

Trial di erences
Johnson & Johnson's Mammen pushed back against comparing its vaccine with those from Moderna and Pfizer.

"It's really hard to compare numbers head-to-head right now without running a study with two vaccines," he said.

Mammen said there were key di erences between the trials; for example, Johnson & Johnson's vaccine was
tested later, when cases were surging even higher in many parts of the world and new variants of coronavirus were
already circulating. One in particular, called B.351, was dominant in South Africa when the vaccine was tested
there. This variant has mutations that might be expected to weaken the vaccine's e ects somewhat.

But it still protected people, Mammen said.

"I'm looking at that South African variant, and I'm seeing that
we're able to completely protect against concerning levels of
illness, where one might go to a hospital," he said.

Plus, people do not have to worry about coming back for a

second dose.

"We really wanted it to be a single dose. So we optimized our

antigen so that we get enough immunogenicity after one
dose, as opposed to two," he said.

Related Article: White people are getting And, unlike the Pfizer and Moderna vaccines, it does not have
vaccinated at higher rates than Black and to be stored in freezers. It can be stored for three months at
Latino Americans refrigerator temperatures of 36 degrees to 46 degrees
Fahrenheit.

Janssen is already testing a two-dose regimen of the vaccine

and that could increase the e cacy, Fauci said.

"Let's see what that shows. It could possibly bring it up to 90%," he said. "Heck if you got 72 with a single dose,
you would think you would do pretty good with a boost."

100 million dose US contract

The US federal government has contracted to buy 100 million doses of the vaccine, expected to be delivered by
June.

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1/31/2021 Johnson & Johnson Covid-19 vaccine is 66% effective in global trial, but 85% effective against severe disease, company says - CNN

Johnson & Johnson has said it's on track to produce a billion doses worldwide.

And the company has been manufacturing doses for months in anticipation that it would get emergency
authorization from the FDA. The company hopes to begin shipping its product the day after it gets that
authorization.

"We've been manufacturing at risk for a long time -- for more

Get CNN Health's weekly than nine months," Mammen said. "My expectation ... is,
towards the end of February, we should have an emergency
newsletter use authorization."

Sign up here to get The Results Are In with
Dr. Sanjay Gupta every Tuesday from the
CNN Health team.
A fourth vaccine is also jostling to join the mix in the US
market. Maryland-based Novavax released preliminary data
Thursday showing its candidate vaccine had an e cacy of
89% in UK trials. And AstraZeneca is working to finish up
Phase 3 clinical trials of its vaccine, as well.

The Johnson & Johnson vaccine is made di erently from the

Pfizer and Moderna vaccines, which use raw genetic material called messenger RNA. Johnson & Johnson's uses a
common cold virus called adenovirus 26, which has been weakened so that it does not replicate in the body. It's
engineered to carry genetic material from the spike protein of the virus -- that's the part the virus uses to grab onto
the cells it targets.

The vaccine prompts the muscle cells in the arm to produce these pieces of spike protein. The immune system
recognizes them as foreign and builds a defense, so when a real virus tries to infect cells, the body is ready to fight
it o .

Dr. Sanjay Gupta, Elizabeth Cohen and Keri Enriquez contributed to this story.

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