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FDA briefing document backs J&J’s one-dose COVID-19 vaccine

Company is seeking an emergency use authorisation in the US

A briefing document published ahead of a US Food and Drug Administration (FDA) expert meeting to review Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine has endorsed the safety and efficacy of the jab.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet tomorrow to discuss potential emergency authorisation of the J&J vaccine in the US.

In its briefing document, the FDA highlighted the vaccine efficacy of 66.1% demonstrated in a phase 3 trial of J&J’s jab.

The agency also reiterated key secondary endpoints that demonstrated vaccine efficacy against severe and critical COVID-19 of 76.7% at least 14 days after vaccination and 85.4% at least 28 days after vaccination.

The FDA also noted that analysis of safety data supported a ‘favourable safety profile with no specific safety concerns identified that would preclude issuance of an emergency use authorisation (EUA)’.

J&J is seeking an EUA from the FDA based on phase 3 clinical trial data from the global ENSEMBLE study.

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.

Although the vaccine is less effective against the B.1.351 variant that was first discovered in South Africa, the jab was 85% effective in preventing severe disease across all regions studied – as highlighted in the FDA briefing document.

In a statement issued earlier this month, J&J said that it expects to be able to ship doses of its COVID-19 vaccine ‘immediately’ following authorisation in the US.

J&J reached an agreement with the US government in August 2020 to supply 100 million doses of its COVID-19 vaccine.

Under the terms of the deal, the US Biomedical Advanced Research and Development Authority (BARDA) and the US Department of Defense are committing $1bn for the first 100 million doses.

The US government also has the option to purchase an additional 200 million doses under a subsequent agreement.

In addition, the European Commission has an advanced purchase agreement with J&J for 200 million doses of the vaccine, which includes an option to secure up to 200 million additional doses after the initial supply.

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

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

25th February 2021

From: Regulatory



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