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WHO backs emergency use of J&J’s one-dose COVID-19 vaccine

Vaccine is already approved for emergency use by the European Commission and the FDA

The World Health Organization (WHO) has granted an emergency use listing (EUL) for Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine for use in adults aged 18 years of age and older.

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 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.

"From the beginning of the pandemic, we have worked to develop and deliver a vaccine that could protect the health of people everywhere, and today's milestone represents significant progress toward ensuring global access to our single-shot vaccine," said Alex Gorsky, chairman and chief executive officer of J&J.

"We are moving forward with urgency and purpose to meet our commitments to the global community as we do all we can to help end the pandemic,” he added.

In the phase 3 ENSEMBLE trial, J&J’s 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.

In addition to the WHO’s EUL, J&J’s vaccine has also been granted an emergency use authorisation by the US Food and Drug Administration (FDA) and a conditional marketing authorisation from the European Commission (EC).

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

The company plans to begin delivery of the vaccine to the EU in the second half of April, and to supply 200 million doses to the EU in 2021.

Article by
Lucy Parsons

15th March 2021

From: Regulatory

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