CHMP recommendation based on data showing a booster (second
shot) of the Johnson & Johnson COVID-19 vaccine increased
protection to 75 percent against symptomatic COVID-19
Data also demonstrated 100 percent protection against severe
COVID-19, at least 14 days post-booster vaccination
The Johnson & Johnson COVID-19 vaccine, when given as a
booster or primary shot, was generally well-tolerated
NEW BRUNSWICK, N.J.,
Dec. 15, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) issued a Positive
Opinion for use of the Company's COVID-19 vaccine as a booster for
adults aged 18 and older at least two months after primary
vaccination with a single-shot of the Johnson & Johnson
COVID-19 vaccine, and as a 'mix and match' booster following
primary vaccination with an approved two-shot mRNA COVID-19 vaccine
regimen (known as heterologous boosting).
"We are pleased with today's Positive Opinion from the CHMP
supporting the use of our COVID-19 vaccine as a booster for
eligible individuals in Europe,"
said Mathai Mammen, M.D., Ph.D.,
Global Head, Janssen Research & Development, Johnson &
Johnson. "There is a growing body of data showing that the Johnson
& Johnson COVID-19 vaccine induces broad and durable humoral
and cellular immune responses, whether administered as a single
shot for an efficient response to the pandemic, or as a booster
shot after at least two months to strengthen protection against
symptomatic COVID-19. Cellular immune responses are showing
potential to be important for both breadth of protection and
The CHMP Opinion was based on a comprehensive data package
that included results from the Phase 3 ENSEMBLE 2 study, which
found a booster of the Johnson & Johnson COVID-19 vaccine
given two months after the primary shot provided 75 percent
protection against symptomatic (moderate to severe) COVID-19
globally (CI, 55%-87%) and 94 percent protection against
symptomatic (moderate to severe) COVID-19 in the U.S. (CI,
59%-100%). It also demonstrated 100 percent protection against
severe COVID-19, at least 14 days post-booster vaccination (CI,
33%-100%). The vaccine, when given as a booster or primary shot,
was generally well-tolerated, with no new safety signals observed
in the two-shot ENSEMBLE 2 trial compared with single-shot
Also included in the data package reviewed by the CHMP were
results from multiple real-world evidence (RWE) studies, including
the Company's previously announced RWE study that demonstrated
similar estimates of single-shot vaccine effectiveness as observed
in our randomized clinical trials. The effectiveness estimates
remained stable with no evidence of reduced effectiveness over time
before the Delta variant emerged and after it became the dominant
strain in the U.S. from March through August (sequencing data were
not available for analysis).
The CHMP recommendation is supported by latest data for
heterologous boosting with the Johnson & Johnson COVID-19
vaccine. Interim data from the National Institute of Allergy and
Infectious Disease (NIAID) "MixNMatch" study demonstrated that a
booster of the Johnson & Johnson COVID-19
vaccine increases immune response regardless of a person's
primary vaccination. A second study by the Beth Israel Deaconess
Medical Center (BIDMC), including a subset of participants from the
Janssen-sponsored COV2008 study, demonstrated the potential
benefits of heterologous boosting: a booster shot of the Johnson
& Johnson vaccine administered at six months after a two-shot
primary regimen of the Pfizer/BioNTech vaccine, increased both
antibody and T-cell responses. In these participants, antibodies
continued to increase for at least four weeks whereas in
individuals who received a homologous boost with the BNT162b2
vaccine, antibodies declined from week two to week four post-boost,
resulting in similar antibody levels in both groups.
The Company's single-shot COVID-19 vaccine, developed by its
Janssen Pharmaceutical Companies of Johnson & Johnson, received
an Emergency Use Authorization in the United States on
27 February 2021 and Conditional
Marketing Authorisation (CMA) by the European Commission on 11
March. On 21 October 2021, the
U.S. Centers for Disease Control and Prevention (CDC) Advisory
Committee on Immunization Practices (ACIP) authorized for emergency
use a booster shot of the Johnson & Johnson COVID-19 vaccine
for adults aged 18 and older. On 9 December
2021, the Strategic Advisory Group of Experts (SAGE) on
Immunization for the World Health Organization (WHO) supported the
use of the Johnson & Johnson COVID-19 vaccine as a heterologous
booster shot in persons aged 18 years and above.
For more information on the Company's multi-pronged approach to
helping combat the pandemic, visit: www.jnj.com/covid-19.
AUTHORIZATION OF USE
The Janssen COVID-19 Vaccine is authorized for use under an
Emergency Use Authorization (EUA) for active immunization to
prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Primary vaccination regimen for the Janssen COVID-19 Vaccine is
a single-dose (0.5 mL) administered to individuals 18 years of age
- A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be
administered at least 2 months after the primary vaccination to
individuals 18 years of age and older.
- A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL)
may be administered to individuals 18 years of age and older as a
heterologous booster dose following completion of primary
vaccination with another authorized or approved COVID-19 vaccine.
The dosing interval for the heterologous booster dose is the same
as that authorized for a booster dose of the vaccine used for
IMPORTANT SAFETY INFORMATION
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE
YOU GET THE JANSSEN COVID-19 VACCINE?
Tell the vaccination provider about all of your medical
conditions, including if you:
- have any allergies
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects your
- are pregnant or plan to become pregnant
- are breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?
You should not get the Janssen COVID-19 Vaccine if you:
- had a severe allergic reaction after a previous dose of this
- had a severe allergic reaction to any ingredient of this
- had a blood clot along with a low level of platelets (blood
cells that help your body stop bleeding) following Janssen COVID-19
Vaccine or following AstraZeneca's COVID-19 vaccine (not authorized
or approved in the United
HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen COVID-19 Vaccine will be given to you as an
injection into the muscle.
Primary Vaccination: The Janssen COVID-19 Vaccine is
administered as a single dose.
- A single booster dose of the Janssen COVID-19 Vaccine may be
administered at least two months after primary vaccination with the
Janssen COVID-19 Vaccine.
- A single booster dose of the Janssen COVID-19 Vaccine may be
administered to individuals 18 years of age and older who have
completed primary vaccination with a different authorized or
approved COVID-19 vaccine. Please check with your health care
provider regarding timing of the booster dose.
WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?
Side effects that have been reported with the Janssen COVID-19
- Injection site reactions: pain, redness of the skin, and
- General side effects: headache, feeling very tired, muscle
aches, nausea, fever.
- Swollen lymph nodes.
- Blood clots.
- Unusual feeling in the skin (such as tingling or a crawling
feeling) (paresthesia), decreased feeling or sensitivity,
especially in the skin (hypoesthesia).
- Persistent ringing in the ears (tinnitus).
- Diarrhea, vomiting.
Severe Allergic Reactions
There is a remote chance that the Janssen COVID-19 Vaccine could
cause a severe allergic reaction. A severe allergic reaction would
usually occur within a few minutes to one hour after getting a dose
of the Janssen COVID-19 Vaccine. For this reason, your vaccination
provider may ask you to stay at the place where you received your
vaccine for monitoring after vaccination. Signs of a severe
allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
Blood Clots with Low Levels of Platelets
Blood clots involving blood vessels in the brain, lungs,
abdomen, and legs along with low levels of platelets (blood cells
that help your body stop bleeding), have occurred in some people
who have received the Janssen COVID-19 Vaccine. In people who
developed these blood clots and low levels of platelets, symptoms
began approximately one to two-weeks after vaccination. Blood clots
with low levels of platelets following the Janssen COVID-19 Vaccine
have been reported in males and females, across a wide age range of
individuals 18 years and older; reporting has been highest in
females ages 30 through 49 years (about 1 case for every 100,000
vaccine doses administered), and about 1 out of every 7 cases has
been fatal. You should seek medical attention right away if you
have any of the following symptoms after receiving the Janssen
- Shortness of breath,
- Chest pain,
- Leg swelling,
- Persistent abdominal pain,
- Severe or persistent headaches or blurred vision,
- Easy bruising or tiny blood spots under the skin beyond the
site of the injection.
These may not be all the possible side effects of the Janssen
COVID-19 Vaccine. Serious and unexpected effects may occur. The
Janssen COVID-19 Vaccine is still being studied in clinical
Guillain Barré Syndrome
Guillain Barré syndrome (a neurological disorder in which the
body's immune system damages nerve cells, causing muscle weakness
and sometimes paralysis) has occurred in some people who have
received the Janssen COVID-19 Vaccine. In most of these people,
symptoms began within 42 days following receipt of the Janssen
COVID-19 Vaccine. The chance of having this occur is very low. You
should seek medical attention right away if you develop any of the
following symptoms after receiving the Janssen COVID-19
- Weakness or tingling sensations, especially in the legs or
arms, that's worsening and spreading to other parts of the
- Difficulty walking.
- Difficulty with facial movements, including speaking, chewing,
- Double vision or inability to move eyes.
- Difficulty with bladder control or bowel function.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go
to the nearest hospital.
Call the vaccination provider or your healthcare provider if you
have any side effects that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event
Reporting System (VAERS). The VAERS toll-free number is
1-800-822-7967 or report online to
https://vaers.hhs.gov/reportevent.html. Please include "Janssen
COVID-19 Vaccine EUA" in the first line of box #18 of the report
form. In addition, you can report side effects to Janssen
Biotech Inc. at 1-800-565-4008.
CAN I RECEIVE THE JANSSEN COVID-19 VACCINE AT THE SAME TIME
AS OTHER VACCINES?
Data have not yet been submitted to FDA on administration of the
Janssen COVID-19 Vaccine at the same time as other vaccines. If you
are considering receiving the Janssen COVID-19 Vaccine with other
vaccines, discuss your options with your healthcare provider.
Please read Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers)
including full EUA Prescribing Information available
About Johnson & Johnson
At Johnson & Johnson,
we believe good health is the foundation of vibrant lives, thriving
communities and forward progress. That's why for more than 130
years, we have aimed to keep people well at every age and every
stage of life. Today, as the world's largest and most broadly-based
healthcare company, we are committed to using our reach and size
for good. We strive to improve access and affordability, create
healthier communities, and put a healthy mind, body and environment
within reach of everyone, everywhere. We are blending our heart,
science and ingenuity to profoundly change the trajectory of health
for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies of Johnson &
At Janssen, we're creating a future where disease is
a thing of the past. We're the Pharmaceutical Companies of Johnson
& Johnson, working tirelessly to make that future a reality for
patients everywhere by fighting sickness with science, improving
access with ingenuity, and healing hopelessness with heart. We
focus on areas of medicine where we can make the biggest
difference: Cardiovascular & Metabolism, Immunology, Infectious
Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary
Hypertension. Learn more at www.janssen.com. Follow us at
Cautions Concerning Forward-Looking
This press release contains "forward-looking
statements" as defined in the Private Securities Litigation Reform
Act of 1995 regarding development, manufacture and distribution of
the Johnson & Johnson COVID-19 vaccine. The reader is cautioned
not to rely on these forward-looking statements. These statements
are based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of the Janssen Pharmaceutical
Companies, and/or Johnson & Johnson. Risks and uncertainties
include, but are not limited to: challenges and uncertainties
inherent in product research and development, including the
uncertainty of clinical success and of obtaining regulatory
approvals; uncertainty of commercial success; manufacturing
difficulties and delays; competition, including technological
advances, new products and patents attained by competitors;
challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; changes in
behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
January 3, 2021, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in the company's most
recently filed Quarterly Report on Form 10-Q, and the company's
subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online
at www.sec.gov, www.jnj.com or on request from
Johnson & Johnson. None of the Janssen Pharmaceutical Companies
nor Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or