EMA Confirms Overall Benefit-Risk Profile Remains
Positive
Company to update the COVID-19 Vaccine Janssen Summary of
Product Characteristics and Package Leaflet to include important
information on very rare adverse event
Johnson & Johnson remains committed to supplying 200
million doses of its COVID-19 vaccine to the European Union,
Norway and Iceland
NEW BRUNSWICK, N.J.,
April 20, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced that the European Medicines Agency's (EMA)
Pharmacovigilance Risk Assessment Committee (PRAC) has provided
updated guidance for use of the Company's COVID-19 vaccine and
confirmed the overall benefit-risk profile remains positive. The
guidance follows PRAC review of a small number of cases of a very
rare adverse event involving blood clots in combination with low
platelet counts that can occur within approximately one to three
weeks following injection with the Company's COVID-19 vaccine.
As a result, Johnson & Johnson will update its COVID-19
vaccine Summary of Product Characteristics and Package Leaflet to
include important information on the diagnosis and management of
this very rare adverse event. Healthcare professionals will be
alerted to the signs and symptoms of thromboembolism with
thrombocytopenia, as well as the appropriate course of
treatment.
Following the PRAC recommendation, the Company will resume
shipment of the Janssen COVID-19 vaccine in the European Union
(EU), Norway and Iceland. The updated EMA and Healthcare
Professionals guidance will be available to national healthcare
authorities.
"The safety and well-being of the people who use our products is
our number one priority. We appreciate the rigorous review of the
PRAC and share the goal of raising awareness of the signs and
symptoms of this very rare event to ensure the correct diagnosis
and appropriate treatment," said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and
Chief Scientific Officer at Johnson & Johnson. "We strongly
believe in the positive benefits of our single-shot, easily
transportable COVID-19 vaccine to help protect the health of people
everywhere and reach communities in need globally. We are committed
to equitable access and to bringing an affordable COVID-19 vaccine
to the public on a not-for-profit basis for emergency pandemic
use."
Data from the global ENSEMBLE Phase 3 trial demonstrated the
Company's single-dose vaccine provided protection against COVID-19
related hospitalization and death across demographics and
geographies, including areas with emerging
variants.1
The U.S. Centers for Disease Control and Prevention (CDC) and
the U.S. Food and Drug Administration (FDA) currently are reviewing
these same cases.2 On April
14, 2021, the CDC convened a meeting of the Advisory
Committee on Immunization Practices (ACIP) to review these cases
and assess their potential significance.2 The ACIP plans
to reconvene on April 23, 2021, for
further discussion.
Johnson & Johnson's COVID-19 Vaccine
The Johnson & Johnson COVID-19 vaccine, developed by the
Janssen Pharmaceutical Companies of Johnson & Johnson, received
Conditional Marketing Authorization from the European Commission on
March 11, 2021, to prevent COVID-19
in individuals 18 years of age and older.2
This decision was based on the totality of scientific evidence,
including data from the Phase 3 ENSEMBLE study that demonstrated
the vaccine was 85 percent effective in preventing severe disease
across all regions studied, and showed protection against COVID-19
related hospitalization and death, beginning 28 days after
vaccination.3,4
For more information on the Company's multi-pronged approach to
helping combat the pandemic,
visit: https://www.janssen.com/emea/our-focus/infectious-diseases-vaccines/respiratory-infections/covid-19.
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 https://www.janssen.com/emea/. Follow
us at @JanssenEMEA.
About the Janssen Pharmaceutical Companies of Johnson &
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 https://www.janssen.com/emea/. Follow
us at @JanssenEMEA.
Cautions Concerning Forward-Looking Statements
This
press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995 regarding
development of a potential preventive vaccine for COVID-19. 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 developments.
REFERENCES:
1 Janssen. Johnson & Johnson Announces
Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary
Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial.
Available at:
https://www.janssen.com/emea/sites/www_janssen_com_emea/files/johnson_johnson_announces_single-shot_janssen_covid-19_vaccine_candidate_met_primary_endpoints_in_interim_analysis_of_its_phase_3_ensemble_trial.pdf.
Last accessed April 2021.
2 Johnson & Johnson Single-Shot COVID-19 Vaccine
Granted Conditional Marketing Authorization by European Commission.
Available at:
https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission.
Last accessed: April 2021.
3 Johnson & Johnson. Johnson & Johnson
COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First
Single-Shot Vaccine in Fight Against Global Pandemic. Available at:
https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic.
Last accessed April 2021.
4 European Medicines Agency. EMA recommends
COVID-19 Vaccine Janssen for authorisation in the EU. Available at:
https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-janssen-authorisation-eu.
Last accessed April 2021.
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