Janssen COVID-19 Vaccine Candidate 72% Effective in US Trials

On Jan 29, 2021

Johnson & Johnson (J&J) announced that the COVID-19 vaccine candidate being developed by the company’s Janssen Pharmaceutical Companies is 72% effective in US Phase 3 clinical trials. On a global basis, the vaccine is 66% effective.

At today’s state COVID-19 press conference, Gov. Phil Murphy said the major takeaway of this news is that the J&J one-dose shot, which does not require cold chain storage like the Pfizer/BioNTech vaccine, “could be a game changer in our ability to ramp up the administration and distribution of vaccines in the state.”

The Janssen vaccine still must be approved by the Food & Drug Administration and receive Emergency Use Authorization from the agency, which J&J intends to apply for early next month. It must then be reviewed by the CDC Advisory Committee on Immunization Practices for its recommendations. “This is not a tomorrow event,” Governor Murphy said.

On a positive note, he did say that J&J is committed to putting 100 million doses “on the street by the end of June.”

According to J&J, its Phase 3 ENSEMBLE clinical trial study is designed to evaluate the efficacy and safety of the Janssen vaccine candidate in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination.

Among all participants from different geographies, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. As mentioned previously, the level of protection against moderate to severe COVID-19 infection was 72% in the US, 66% in Latin America, and 57% in South Africa, 28 days post-vaccination.

“Johnson & Johnson embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” said Alex Gorsky, chairman, board of directors and chief executive officer, Johnson & Johnson. “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”

The vaccine candidate was 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.

The Janssen COVID-19 vaccine candidate demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO)), with no reported cases among participants who had received the Janssen COVID-19 vaccine, 28 days post-vaccination.

“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” said Paul Stoffels, M.D., vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.

“A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. 85% efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities,” Stoffels said.

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