Johnson & Johnson announces advance purchase agreement with the African Vaccine Acquisition Trust

Johnson & JohnsonJanssen 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°C, a maximum of three months of which can be at routine refrigeration at temperatures of 2°-8°C. This enables the vaccine to be shipped using the same cold chain technologies used to transport other medicines and vaccines in routine use.

About Johnson & Johnson's COVID-19 Vaccine

The Johnson & Johnson COVID-19 vaccine uses the AdVac® 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.

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.

Most Popular Now

Pfizer's elranatamab granted FDA Breakthrough Ther…

Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administrati...

Vividion Therapeutics names Jenna Goldberg as Chie…

Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision the...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron ...

Bayer with continued strong performance

The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we...

Sanofi and GSK's next-generation COVID-19 booster …

After the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn® Beta, the vaccine was approved by t...

Sugar molecules as a target in cancer therapy

Cancer cells use sugar molecules on their surface to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism ...

COVID vaccination improves effectiveness of cancer…

Patients with nasopharyngeal cancer are often treated with drugs that activate their immune system against the tumor. Until now, it was feared that vaccination against Co...

GSK announces positive Phase IIa study results for…

GSK plc (LSE/NYSE: GSK) announced positive results from a Phase IIa study demonstrating that GSK3036656, a first-in-class investigational antitubercular agent, was well t...

Making melanoma immortal: Pitt scientists discover…

Scientists at the University of Pittsburgh School of Medicine have discovered the missing puzzle piece in the mystery of how melanoma tumors control their mortality. I...

New drug shows promise for fighting both COVID-19 …

While vaccination can provide life-saving protection against COVID-19, scientists are still searching for ways to treat severe infections, including in people who cannot ...

Machine learning can help predict patient response…

Predicting which patients will respond well to treatment is a quandary that has plagued the field of cancer immunotherapy for more than four decades. Now, researchers at ...

Study reveals vaccine confidence declined consider…

A new study suggests that, despite the success of the COVID-19 vaccination campaigns, vaccine confidence has declined significantly since the start of the pandemic. Re...