Online Magazine Download now Europe Diplomatic Magazine

The study will take place in the U.S. and Belgium.

Johnson & Johnson announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic.”

Paul-Stoffels-M.D.-Vice-Chairman-of-the-Executive-Committee-and-Chief-Scientific-Officer-Johnson-Johnson

The randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium.

The Company is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule, pending outcome of Phase 1 studies and approval of regulators.

As the Company progresses the clinical development of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, it continues to increase manufacturing capacity and is in active discussions with global partners to ensure worldwide access. The Company committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.

Johnson & Johnson’s efforts to expedite development and production of a SARS-CoV-2 vaccine are enhanced by a collaboration between Janssen and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.

COVID-19 is caused by SARS-CoV-2, which belongs to a group of viruses called coronaviruses that attack the respiratory system. There is currently no approved vaccine for COVID-19.

Click here to read the 2020 June edition of Europe Diplomatic Magazine

Download EuropeDiplomatic Magazine
By

Related articles

TURN ON, TUNE IN, DROP OUT (OF SIGHT) – The darknet gains drug seekers in lockdown

EUROPEAN REGION LOSES GROUND IN EFFORT TO ELIMINATE MEASLES

EUROPEAN COMMISSION SECURES EU ACCESS TO REMDESIVIR FOR TREATMENT OF COVID-19

to

Latest news

THE UBIQUITOUS EUROPEAN – The very public life and views of Josep Borrell

  • 10 mn

TOXIC LEGACIES – The USSR and Russia : A timeline of political poisonings

  • 10 mn

TREASURE ISLAND – How Cyprus has become a haven for a crooked elite

  • 10 mn

A BELGIAN-GUINEAN POLITICIAN’S AMBITION: Taking over the Guinean presidency in 2020

POSEIDON’S TRIDENT – Turkey and Greece rattle sabres over undersea gas

  • 12 mn

HAWKS AND HANDSAWS – Mike Pompeo says Europe is “siding with the ayatollahs”

  • 10 mn