Register Now: From Clinical to Commercial: Accelerating ADC Late-Stage Development with Technology Innovation and Integrated Platform
|Articles|January 29, 2021

J&J’s COVID-19 Vaccine Candidate Effective in Preventing Moderate to Severe COVID-19

The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.

Johnson & Johnson (J&J) announced on Jan. 29, 2021 that data from a Phase III trial for its COVID-19 vaccine candidate showed that the vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.

The randomized double-blind, placebo-controlled clinical trial was designed to determine the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older, J&J said in a company press release. Participants were enrolled in the United States, Central and South America, and South Africa and the vaccine showed an effectiveness of 72% in the United States, 66% in Latin America, and 57% in South Africa, 28 days post-vaccination.

The vaccine also showed to be 85% effective in preventing severe disease across all regions studied, with efficacy against severe disease increasing over time. No cases of COVID-19 were reported in vaccinated participants after day 49, according to the press release.

“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, MD, vice-chairman of the executive committee and J&J’s chief scientific officer, in the press release. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution, and compliance. Eighty-five percent 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.”

“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 J&J’s CEO,in the press release. “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”

Source: Johnson & Johnson


Related to this article

The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.