NEW BRUNSWICK, N.J.,
Nov. 10, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) has entered
into an agreement with the U.S. Government and Gavi, the Vaccine
Alliance (Gavi), to enable access to its single-shot COVID-19
vaccine through a novel mechanism – the COVAX Humanitarian Buffer –
that will serve to protect the world's most vulnerable people. The
first deliveries to the COVAX Humanitarian Buffer are
anticipated to begin in the coming days.
The COVAX Humanitarian Buffer is part of the COVAX Facility and
is designed to ensure that people in conflict zones or humanitarian
settings can access COVID-19 vaccines, even if they live beyond the
reach of traditional, government vaccination campaigns. Governments
and national and international humanitarian agencies are eligible
to apply to receive doses from the COVAX Humanitarian Buffer. If
applications are granted and the doses allocated, the governments
or humanitarian agencies that filed the application then carry out
the vaccination campaigns to ensure people are protected from
COVID-19.
"We believe our single-shot COVID-19 vaccine has a critical role
to play in conflict zones and other humanitarian settings that
can't be reached by government vaccination campaigns, and we are
proud to be part of this effort to protect the world's most
vulnerable people," said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and
Chief Scientific Officer. "From the beginning of the
pandemic, Johnson & Johnson has recognized that no one is safe
until everyone is safe and has worked to develop and deliver a
vaccine that can protect the health of people everywhere."
The establishment of the COVAX Humanitarian Buffer is of
critical importance to global health and ending the COVID-19
pandemic for everyone, everywhere. The Inter-Agency Standing
Committee, the longest-standing and highest-level humanitarian
coordination forum of the United Nations system, estimates that
approximately 167 million people, including an estimated 60-80
million people in areas beyond the reach of national health
authorities, are at risk of exclusion from COVID-19 vaccination.
Vaccinating these people, who represent some of the world's most
vulnerable populations, is crucial given that many of them may lack
access to other healthcare resources should they be sickened by
COVID-19.
Equitable Global Access to the Johnson & Johnson COVID-19
Vaccine
Johnson & Johnson is committed to facilitating
equitable global access to its COVID-19 vaccine, and believes it is
critical to protect as many people as possible against
hospitalization and death. The Company has committed to providing
its vaccine on a not-for-profit basis globally for emergency
pandemic use, and is making available up to 900 million doses of
its vaccine to the COVAX Facility and the African Union through
2022.
The Company firmly believes that inequitable access to COVID-19
vaccines will only prolong the pandemic, and is strongly advocating
that governments with available doses follow the example of the
U.S., the U.K. and other countries, and immediately ramp up dose
sharing, particularly through the COVAX Facility.
About the Johnson & Johnson COVID-19 Vaccine
The
Johnson & Johnson COVID-19 vaccine was developed and is being
manufactured using Janssen's
proprietary AdVac® viral vector technology.
The AdVac® vaccine platform is also used for the Company's
Ebola vaccine regimen, and its candidates for preventing
respiratory syncytial virus (RSV) and HIV.
The profile of the COVID-19 vaccine enables delivery to remote
areas. The vaccine is estimated to remain stable for two years at
-20 °C (-4 °F). It can be kept at temperatures of 2-8 °C (36-46 °F)
for a maximum of six months of that two-year period, based on local
labelling requirements. This enables the vaccine to be shipped
using the same cold chain technologies used to transport other
medicines and vaccines in routine use.
The Johnson & Johnson single-shot COVID-19 vaccine received
an Emergency Use Authorization (EUA) in the United States on February 27, 2021, and on October 20, 2021,
the FDA authorized for emergency use a booster shot of the Johnson
& Johnson COVID-19 vaccine for adults aged 18 and older at
least two months following primary vaccination with the Company's
single-shot vaccine.
In addition, the European Commission
granted Conditional Marketing Authorization (CMA) on
March 11, 2021, the WHO
issued Emergency Use Listing on March 12, and the Company received
an interim recommendation from the Strategic Advisory
Group of Experts (SAGE) on Immunization for the WHO on March 17. Many more authorizations have been
granted in countries worldwide, and regulatory submissions are
ongoing.
For more information on the Company's multi-pronged approach to
helping combat the pandemic, visit: www.jnj.com/covid-19.
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 www.janssen.com. Follow us at @JanssenUS and
@JanssenGlobal. Janssen Research & Development, LLC is part of
the Janssen Pharmaceutical Companies of Johnson & Johnson.
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 www.jnj.com.
Follow us at @JNJNews.
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.
1 Inter-Agency Standing Committee. Frequently Asked
Questions: The COVAX Humanitarian Buffer. 8
November 2021. Available at:
https://interagencystandingcommittee.org/system/files/2021-11/Frequently
Asked Questions- The COVAX Humanitarian Buffer%2C 8 November
2021.pdf. Accessed 9 November
2021.
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SOURCE Johnson & Johnson