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J&J submits one-dose COVID-19 vaccine to WHO for emergency use listing

In phase 3, J&J's vaccine was 66% effective overall at preventing moderate-to-severe COVID-19

Johnson & Johnson (J&J) has submitted an application to the World Health Organization (WHO) seeking an emergency use listing (EUL) for its one-dose COVID-19 vaccine.

The WHO submission follows J&J's recently published safety and efficacy data from a phase 3 trial evaluating the vaccine.

In the ENSEMBLE trial, J&J’s vaccine was 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination.

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.

In the US, the efficacy rate was 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, J&J said that the jab was 85% effective in preventing severe disease across all regions studied.

A WHO EUL is designed to enable potential vaccines to become available globally at a faster rate, by expediting access to products in many countries across the globe.

It is also a prerequisite to supply vaccines to the international vaccines-sharing facility COVAX.

COVAX is the vaccine pillar of the WHO’s ACT Accelerator – a collaborative initiative co-led by Gavi, the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI) that is aiming to accelerate the development, production and equitable access to COVID-19 tests, treatments and vaccines.

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.

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

“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering commitment to equitable access,” said Paul Stoffels, vice chairman of the executive committee and chief scientific officer of J&J.

"If we are to end the global pandemic, lifesaving innovations like vaccines must be within reach for all countries,” he added.

Last week, J&J announced that it had applied for EU authorisation of its COVID-19 vaccine, with this submission also based on the top-line data from the ENSEMBLE trial.

The company has also filed an application for emergency use of the vaccine with the US Food and Drug Administration (FDA), with further rolling reviews having been initiated in several additional countries across the globe.

Article by
Lucy Parsons

24th February 2021

From: Regulatory

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