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Johnson & Johnson Expands Phase 2a Clinical Trial of COVID-19 Vaccine Candidate to Include Adolescents

Apr 02, 2021
United States

Expansion of ongoing trial to include adolescents 12-17 years of age reflects commitment to people of all ages affected by pandemic

 

New Brunswick, NJ (April 2, 2021)  Johnson & Johnson (the Company) has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.

“The COVID-19 pandemic has had a profound impact on adolescents, not just with the complications of the disease, but with their education, mental health, and wellbeing,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “It is vital that we develop vaccines for everyone, everywhere, to help combat the spread of the virus with the goal to return to everyday life.”

The randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) has been ongoing since September 2020, and was initially designed to evaluate the safety, reactogenicity (expected reactions to vaccination, such as swelling or soreness) and immunogenicity (ability to induce an immune response) of single-dose and two-dose regimens of the Johnson & Johnson COVID-19 vaccine candidate in healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study is now including adolescents 12 to 17 years of age.

Among the study’s goals are to evaluate reactogenicity and immunogenicity of two dose levels of the vaccine candidate, and to evaluate potential vaccination schedules at one, two and three-month intervals in two-dose vaccine regimens.

“Our COVID-19 vaccine candidate development program is designed to deliver on our commitment to protect people of all ages from this pandemic,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “In addition to expanding this ongoing study to include adolescents, we are in discussions with health authorities and are hard at work to initiate studies in pregnant women and children in the near future.”

The Johnson & Johnson COVID-19 vaccine candidate will initially be tested in a small number of adolescents aged 16-17 years. Following the review of initial data in this Phase 2a trial, the study will be expanded to a larger group of younger adolescents in a stepwise approach.

This trial is currently enrolling participants in Spain and the United Kingdom; enrollment will commence shortly in the United States, the Netherlands and Canada, with Brazil and Argentina to follow.

Janssen’s COVID-19 Vaccine Candidate
The Company’s Janssen COVID-19 Vaccine leverages the AdVac® vaccine platform, a proprietary technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

Research and development activities for the Company’s COVID-19 vaccine, including the delivery of doses to the U.S., have been funded in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).

Johnson & Johnson has worked with BARDA since 2015 on innovative solutions for influenza; chemical, biological, radiation and nuclear threats; and emerging infectious diseases such as Ebola.

Regulatory Filings
The Johnson & Johnson single-shot COVID-19 vaccine was granted Emergency Use Listing from the World Health Organization (WHO) on March 12, Conditional Marketing Authorization from the European Commission on March 11 and Emergency Use Authorization by the U.S. Food and Drug Administration on February 27, 2021. The single-shot COVID-19 vaccine has also been granted Interim Order authorization in Canada, and additional rolling submissions have been initiated in several countries worldwide.

For more information on the Company’s multi-pronged approach to helping combat the COVID-19 pandemic, visit: www.jnj.com/coronavirus.

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Authorized 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) in individuals 18 years of age and older.

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 immune system

are pregnant or plan to become pregnant

are breastfeeding

have received another COVID-19 vaccine

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 to any ingredient of this vaccine.

HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?
Side effects that have been reported with the Janssen COVID-19 Vaccine include:

Injection site reactions: pain, redness of the skin, and swelling.

General side effects: headache, feeling very tired, muscle aches, nausea, fever.

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

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 trials.

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.

The FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information are available at: www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf.

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Cautions Concerning Forward-Looking Statements
This statement 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.