Johnson & Johnson Announces Advance Purchase Agreement with the African Vaccine Acquisition Trust for the Company's COVID-19 Vaccine Candidate
PR88733
NEW BRUNSWICK, N.J., March 29, 2021 /PRNewswire=KYODO JBN/ --
- Up to 400 million doses of the Company's single-shot vaccine candidate will
be made available to African Union member states
- Availability of the vaccine is subject to national regulatory approvals
- Data have demonstrated vaccine candidate protects against COVID-19 related
hospitalization and death in broad geographic regions, including those with
variants of significant concern
Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union's 55 member states with delivery beginning in the third quarter of 2021. AVAT also has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful approval or authorization by the national regulatory authorities of AU member states.
"From the beginning of this pandemic, Johnson & Johnson has recognized that no
one is safe until everyone is safe, and we have been committed to equitable,
global access to new COVID-19 vaccines," said Alex Gorsky, Chairman and Chief
Executive Officer of Johnson & Johnson. "Our support for the COVAX Facility,
combined with supplementary agreements with countries and regions, will help
accelerate global progress toward ending the COVID-19 pandemic."
Johnson & Johnson is committed to ensuring equitable global access to its
single-shot COVID-19 vaccine candidate on a not-for-profit basis for emergency
pandemic use. In December 2020, the Company entered into an agreement in
principle (
) with Gavi, the Vaccine Alliance (Gavi) in support of the COVAX Facility,
which is supporting the initial vaccination needs of 190 participating
economies, including many countries in Africa. The Company and Gavi expect to
enter into an Advance Purchase Agreement (APA) that would provide up to 500
million doses of the Company's vaccine to COVAX through 2022.
Additionally, Johnson & Johnson recognizes the increasingly severe impact of
COVID-19 in Africa, as well as the emergence and continued spread of a
SARS-CoV-2 variant in the Republic of South Africa that demonstrates increased
transmissibility.
Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19
vaccine was well tolerated and demonstrated a 67 percent reduction in
symptomatic COVID-19 disease in participants who received the vaccine in
comparison to participants given the placebo. The onset of protection was
observed from day 14 and was maintained 28 days post-vaccination.
The data also 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 across countries with different
variants, beginning 28 days after vaccination. Variants observed in an ongoing
analysis in the ENSEMBLE study included the B.1.351 variant which was
identified in 95 percent of the COVID-19 cases in South Africa.
Manufacturing and Supply Chain Information
Johnson & Johnson has established a global manufacturing and supply network for
its COVID-19 vaccine, collaborating with nine partners across four continents,
including Aspen Pharmacare in South Africa. Aspen will support vaccine shipments to the AU member states and will also contribute to global availability of the vaccine.
The Johnson & Johnson COVID-19 single-shot vaccine is compatible with standard
vaccine storage and distribution channels enabling delivery to remote areas.
The vaccine is estimated to remain stable for two years at -25 to -15 degrees
C, a maximum of three months of which can be at routine refrigeration at
temperatures of 2 degrees-8 degrees C. This enables the vaccine to be shipped
using the same cold chain technologies used to transport other medicines and
vaccines in routine use.
Johnson & Johnson's COVID-19 Vaccine
The Johnson & Johnson COVID-19 vaccine uses the AdVac(R) 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.
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 pandemic, visit: www.jnj.com/coronavirus.
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 (
).
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 @JanssenGlobal (
).
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 Company, any of the
other 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.
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SOURCE Johnson & Johnson
CONTACT: Media Contacts: Jake Sargent, +1 732-524-1090, JSargen3@its.jnj.com,
or Seema Kumar, +1 908-405-1144, SKumar10@its.jnj.com, or Ronan Collins, +47
488-425-00, RCollin5@its.jnj.com, or Investor Relations: Chris DelOrefice, +1
732-524-2955, or Jennifer McIntyre, +1 732-524-3922
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