#USA, March 1, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) on February 27 (2021) announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
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.
The terms of the EUA allow use of
the vaccine while more data are gathered. The Company plans to file for a
Biologics License Application (BLA) with the FDA later in 2021.
“This milestone follows a year of
incredible work by our dedicated teams and unprecedented collaboration with
health leaders around the world – all of whom shared a goal of bringing a
single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief
Executive Officer at Johnson & Johnson. “We will do everything we can to
help bring this pandemic to an end, in the United States and throughout the
world.”
“We believe the Johnson &
Johnson single-shot COVID-19 vaccine is a critical tool for fighting this
global pandemic, particularly as it shows protection across countries with
different variants. A vaccine that protects against COVID-19, especially
against the most dire outcomes of hospitalization and death, will help ease the
burden on people and the strain on health systems worldwide,” said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific
Officer, Johnson & Johnson. “We look forward to our continued efforts
around the world as we collectively aim to change the trajectory of this global
pandemic.”
Johnson & Johnson is
committed to making its COVID-19 vaccine available on a not-for-profit basis
for emergency pandemic use. The Company has begun shipping its COVID-19 vaccine
and expects to deliver enough single-shot vaccines by the end of March to
enable the full vaccination of more than 20 million people in the U.S. The
Company plans to deliver 100 million single-shot vaccines to the U.S. during
the first half of 2021. The U.S. government will manage allocation and
distribution of the vaccine in the U.S. This will be prioritized according to
the populations identified by the CDC’s Advisory Committee on Immunization
Practices (ACIP) guidelines.
Johnson & Johnson also
recently announced its submission of
a European Conditional Marketing Authorisation Application to the European
Medicines Agency as well as its filing for an Emergency Use Listing
(EUL) with the World Health Organization for
its COVID-19 vaccine candidate. In addition, rolling submissions for the
single-dose COVID-19 vaccine candidate have been initiated in several countries
worldwide.
The EUA follows a unanimous vote by
the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee
(VRBPAC) on February 26, 2021.
“We are thankful for the efforts
of all those who have volunteered to participate in our clinical trials, our
scientists, collaborators, clinical trial sites and investigators. Through the
combined commitment of everyone involved, we have been able to discover,
develop and manufacture a single-shot COVID-19 vaccine to protect people around
the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research
& Development, Johnson & Johnson.