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J&J’s one-dose COVID-19 vaccine granted emergency use approval by FDA

Company has already started shipping doses of the vaccine to the US

Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine has received an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).

The authorisation quickly followed a positive meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which unanimously backed an EUA for the jab.

Last week, briefing documents published ahead of the VRBPAC meeting endorsed the safety and efficacy of J&J’s vaccine and reiterated its efficacy of 66.1% in a phase 3 trial.

The EUA was supported by data from the phase 3 ENSEMBLE trial, within which J&J’s vaccine demonstrated 85% efficacy against severe COVID-19 across all regions studied.

The study was conducted in eight countries across three continents, with 44% of participants enrolled in the US, 41% in Central and South America and 15% in South Africa.

Across all participants from the different geographies, the vaccine was 66.1% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination.

In the US, the efficacy rate increased slightly to 72%, while in Latin America and South Africa the vaccine was 66% and 57% effective, respectively.

In South Africa, J&J said that 95% of the COVID-19 cases observed in the study were caused by the newly discovered B.1.351 virus variant.

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,” said Paul Stoffels, chief scientific officer of J&J.

“A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalisation and death, will help ease the burden on people and the strain on health systems worldwide,” he added.

In a statement, J&J said that it is expecting to deliver 100 million one-dose vaccines to the US during the first half of 2021.

The company added that it has already started shipping its COVID-19 vaccine, with plans to deliver enough doses to vaccinate more than 20 million people in the US by the end of March.

J&J has also submitted its COVID-19 vaccine to the European Medicines Agency (EMA), seeking a conditional marketing authorisation for the jab.

The company has also filed an emergency use listing application for the one-dose vaccine with the World Health Organization (WHO).

In December 2020, J&J entered into an agreement in principle with Gavi to provide up to 500 million doses of its COVID-19 vaccine to the COVAX Facility that is co-led by the WHO.

The company expects to enter into an advanced purchase agreement with Gavi that would see these doses provided to COVAX until 2022.

Article by
Lucy Parsons

1st March 2021

From: Regulatory



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