Johnson & Johnson has a legacy of responding during crises. We have actively engaged in fighting global epidemics and outbreaks from TB to HIV and Ebola, and we leveraged this knowledge and experience in our actions to help fight COVID-19. We have been and continue to be intensively engaged in activities to help halt the COVID-19 pandemic through developing an easy-to-deploy vaccine, conducting trials, obtaining regulatory authorizations, building supply chain capabilities and engaging with partners around the world to support health systems and healthcare providers involved in combating COVID-19—all at an unprecedented speed. Consistent with this legacy, Johnson & Johnson was among the early responders to the global pandemic in January 2020, where we invested substantially in both antigen design and vaccine drug product development to enter into trials by mid-2020, and launch into large global studies of our COVID-19 vaccine by the third quarter of 2020.
A commitment to global equity has guided the Company’s response since the beginning of the pandemic, starting with the decision to pursue a vaccine that can provide protection with a single dose and be easily stored and distributed with standard refrigeration globally, including in resource-limited, rural or remote settings. Johnson & Johnson supported the development of its vaccine with a global and inclusive clinical research program that studied the vaccine in the U.S., Europe, Africa, Asia and Latin America as we sought to generate evidence across multiple geographies and diverse, at-risk populations, including in resource-limited settings.
In 2021, our progress in delivering our COVID-19 vaccine included:
Completing our Phase 3 COVID-19 vaccine trials: In January 2021, Johnson & Johnson shared top-line efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that a single dose of the Company’s COVID-19 vaccine met all primary and key secondary endpoints. The final analysis of this study was published in The New England Journal of Medicine in March 2022 and demonstrated that a single shot provided 75% efficacy in preventing severe/critical COVID-19 at least 28 days following vaccination.
We also conducted the Phase 3 "ENSEMBLE 2" study to evaluate the safety and efficacy of a homologous (same vaccine) booster shot administered 56 days after primary vaccination. A final analysis of the double-blind phase of this trial is currently undergoing blinded peer review and has been submitted to a scientific journal.
Securing regulatory authorizations: In 2021, based on the results of our clinical studies, we applied for and received:
- Emergency Use Authorization (EUA EUA Emergency Use Authorization ) by the FDA FDA U.S. Food and Drug Administration 33;
- Conditional Marketing Authorization by the European Commission;
- Emergency Use Listing (EUL EUL Emergency Use Listing ) issued by the WHO WHO World Health Organization ;
- Interim Order authorization in Canada and subsequent full approval by Health Canada; and
- Regulatory authorizations and waivers in 50 African countries and in other countries worldwide.
Additionally, the Johnson & Johnson COVID-19 vaccine has been authorized as a booster by multiple regulators and healthcare bodies around the world, including a recommendation by the Strategic Advisory Group of Experts on Immunization (SAGE) for the WHO, an EUA from the FDA, as well as a Positive Opinion for use of the Company’s COVID-19 vaccine as a booster from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Boosting with the vaccine is permitted in homologous (same vaccine) and/or heterologous (“mix-and-match”) vaccination regimens.
Acting swiftly on vaccine safety: The safety and well-being of the people who use our products is always our number one priority. For the Johnson & Johnson COVID-19 vaccine, we were notified of reports of a very rare adverse event (thrombosis with thrombocytopenia syndrome, TTS), which can occur following vaccination. In response, we acted swiftly and in full collaboration and transparency with the FDA, CDC CDC Centers for Disease Control and Prevention , EMA, WHO and others to investigate; take appropriate action; and update our COVID-19 Vaccine Fact Sheets for healthcare providers, vaccine recipients and caregivers. Johnson & Johnson continues to collaborate with health authorities around the world to ensure HCPs HCPs Healthcare professional and individuals are fully informed about TTS, enabling correct diagnosis, appropriate treatment and expedited reporting. In May 2022, Johnson & Johnson, in close coordination with the FDA, updated its U.S. COVID-19 Vaccine Fact Sheet to increase awareness about the risk of thrombosis with TTS, a rare but potentially life-threatening condition.
Generating real-world evidence: In January 2022, Johnson & Johnson announced results, which were subsequently peer reviewed and published in JAMA Network Open, from the largest study conducted in the U.S. to date on the durability of COVID-19 vaccines. The study found that a single shot of the Johnson & Johnson COVID-19 vaccine resulted in protection at least six months against COVID-19 breakthrough infections, hospitalizations and intensive care unit admissions. The study showed that the effectiveness of the vaccine against breakthrough infections and hospitalizations remained especially durable. In parallel, our research indicated that the vaccine induces a very strong cellular immune response, distinguishing it from other vaccines and likely contributing to its durability of protection and its breadth of protection from emerging variants.
In December 2021, we announced new preliminary results from the South African Phase 3b Sisonke (TOGETHER) study, which showed that a single shot of the Johnson & Johnson COVID-19 vaccine demonstrated 85% effectiveness against COVID-19-related hospitalization. Through the Sisonke study, the Government of South Africa was able to make 500,000 donated doses of the Johnson & Johnson COVID-19 vaccine immediately available to healthcare workers for use in South Africa. The study was sponsored and conducted by the South African Medical Research Council (SAMRC) and showed that the Johnson & Johnson booster reduced the risk of hospitalization from COVID-19 among healthcare workers in South Africa after Omicron became the dominant variant. In November 2021, the next phase of the study, called “Sisonke 2”, began offering booster shots of the Johnson & Johnson COVID-19 vaccine to Sisonke clinical trial participants.
Data from the Sisonke study confirm that the Johnson & Johnson COVID-19 booster shot provides robust effectiveness against hospitalization in areas where Omicron is dominant. This adds to our growing body of evidence, which shows that the effectiveness of the Johnson & Johnson COVID-19 vaccine remains strong and stable over time, including against circulating variants such as Omicron and Delta.
Equitable access to our COVID-19 vaccine: Johnson & Johnson remains committed to ensuring equitable global access to its COVID-19 vaccine candidate for people around the world. In 2021, Johnson & Johnson provided its vaccine globally at a not-for-profit price and through its advance purchase agreements (APAs) and country donations, shipped approximately 70% of its global vaccine supply to LMICs LMICs Low- and middle-income countries . As of March 2022, Johnson & Johnson has shipped more than 220 million vaccine doses to Africa through a combination of our APAs with the African Vaccine Acquisition Trust (AVAT); South Africa and Gavi, the Vaccine Alliance; and on behalf of the COVAX Facility, along with government donations. COVAX aims to support the world’s COVID-19 vaccination needs, particularly in lower-income countries globally, while AVAT procures COVID-19 vaccines on behalf of the African Union’s 55 member states. As part of our efforts for global vaccine equity, we have supported the donation of Johnson & Johnson COVID-19 vaccine doses by the U.S. government and EU member states to COVAX. Additionally, we support the COVAX Humanitarian Buffer through an agreement with the U.S. government and Gavi that enables access to our COVID-19 vaccine for the world’s most vulnerable people.
Supplying our COVID-19 vaccine: Johnson & Johnson launched unprecedented efforts to manufacture our COVID-19 vaccine. We forged partnerships across four continents, including manufacturers in South Africa and India, to establish the manufacturing capacity and capabilities that would enable us to deliver our vaccine on a global scale. We also worked efficiently with numerous suppliers to quickly source the more than 160 different materials required for vaccine production.
Our COVID-19 manufacturing collaborations each include a license to our technology and the sharing of manufacturing know-how to enable the safe and high-quality production of our vaccine. We worked with our partners, regulatory authorities and governments to expedite all steps of the vaccine production process and to activate our manufacturing sites as quickly as health authority approvals allowed. As with all vaccines, the manufacturing and supply chain for our COVID-19 vaccine is highly complex, and it takes time to scale up production. Although we have experienced challenges in fully activating our global supply network, we have overcome these challenges and continue to focus our efforts on ensuring our vaccine is available during the pandemic where people are most in need.
Catalyzing vaccine production in Africa for Africa: Early in the pandemic, we sought a strategic partner in Africa to whom we could transfer our ‘fill-and-finish’ manufacturing technology. In 2021, our strategic partner, Aspen Pharmacare in South Africa, successfully manufactured millions of doses of our vaccine for delivery globally, including across Africa, which is critically important given the comparatively low vaccination rates across the continent. Building on this, in March 2022, Johnson & Johnson announced a landmark agreement between Janssen Pharmaceuticals and Aspen SA Operations (Pty) Ltd, which enables the first COVID-19 vaccine to be manufactured and sold by an African company for people living in Africa, with the goal of increasing COVID-19 vaccination rates across the continent.
Contributing to vaccine confidence: Vaccines can only be effective in a pandemic if they are accepted as a positive health intervention by the majority of people. In this context, Johnson & Johnson funded a large-scale multicountry study, conducted by the London School of Hygiene and Tropical Medicine (LSHTM), aiming to explore the public’s intent to accept a COVID-19 vaccine. The study examined the sociodemographic and emotional determinants of COVID-19 vaccine uptake for more than 19,000 individuals in 17 countries and provided important insights into worldwide variations in COVID-19 vaccine uptake intent. We believe that continued work in vaccine confidence is critical to understanding public sentiment and informing the creation of the most effective channels and communications for vaccine deployment.
Johnson & Johnson is also contributing to the collective vaccine confidence effort in Africa by leveraging our market research expertise to produce insight-based tools in support of public vaccine education campaigns.
Supporting WHO COVID-19 vaccine research: In 2021, the WHO launched a new platform of clinical trials to evaluate the efficacy and safety of promising new COVID-19 vaccines. The Solidarity Trial Vaccines (STV) started recruitment in Colombia, Mali and the Philippines and are expected to expand to more countries. Critical to the success of STV is the Vaccination Monitoring Platform (VMP), a digital tool that helps improve participant identification and tracing, data management and two-way communication with participants to implement impactful clinical trials. Our contribution in helping make STV a success was recognized by the WHO in a public statement at the launch of the study.