Johnson & Johnson has resumed recruitment, enrolment and vaccination in all clinical trials
of its investigational Janssen COVID-19 vaccine across Europe, after a temporary pause.
Trials in the U.S, South Africa and some Latin American countries are already ongoing.
Following consultation with the concerned EU regulatory authorities, clinical trials of the
Janssen COVID-19 vaccine candidate in Europe will resume this week. Clinical trials to be
resumed are the Phase 2a studies in Germany, the Netherlands and Spain, as well as the
Phase 1/2a study in Belgium.
Preparations are also ongoing for the initiation of a second Phase 3 clinical trial of
Janssen’s investigational COVID-19 vaccine candidate. The trial, which will study the
safety and efficacy of a two-dose regimen, is anticipated to start later this month across
several European countries. This follows positive interim results from the Company’s
Phase 1/2a clinical study, which showed that the safety profile and immunogenicity of
the Janssen COVID-19 vaccine candidate were supportive of further development.
At Johnson & Johnson, there is no greater priority than the health and safety of the
people we serve every day around the world. Our primary goal is to ensure the safety,
well-being and privacy of the participants and all those involved in our trials.
Johnson & Johnson is developing and testing its Janssen COVID-19 vaccine candidate in
accordance with high ethical standards and sound scientific principles, and we are also
committed to accurate medical information and protecting participant privacy. We plan
to disclose clinical trial data in our COVID-19 trials once those data are presented or
published at pre-specified milestones and will proactively disclose regulatory trial holds
requested by health authorities.
Johnson & Johnson is committed to bringing an affordable COVID-19 vaccine to the
public on a not-for-profit basis for emergency pandemic use.
Notice to Investors Concerning Forward-Looking Statements
This contains “forward-looking statements” as defined in the Private Securities Litigation
Reform Act of 1995 regarding development of potential preventive regimens for COVID19. 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 Janssen
Pharmaceuticals Inc., 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 December 29, 2019, 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.