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J&J could launch its single-dose COVID-19 vaccine in March

Chief scientific officer Paul Stoffels said J&J is aiming for one billion doses in 2021

US pharma Johnson & Johnson (J&J) is planning to launch its single-dose COVID-19 vaccine in March, according to the company’s chief scientific officer Paul Stoffels. 

In an interview with Reuters, Stoffels added that the company is expecting to have ‘clear data’ on the efficacy of its COVID-19 vaccine by either the end of January or early February.

J&J initiated a large-scale phase 3 trial of its COVID-19 vaccine in September 2020, following positive interim results from a phase 1/2a clinical study.

The phase 3 ENSEMBLE trial was launched in collaboration with the US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) and the US National Institute of Allergy and Infectious Diseases (NIAID).

In an interim analysis of results from the ENSEMBLE phase 1/2a trial, J&J’s vaccine demonstrated a promising safety profile and immunogenicity after a single dose.

J&J’s COVID-19 candidate uses the company’s AdVac technology platform, which was also used to develop and manufacture the J&J’s existing Ebola vaccine, and to construct its other investigational candidates for Zika, RSV and HIV.

Addressing the company’s supply and manufacturing plans for the vaccine, Stoffels said that J&J is aiming to meet a target of delivering one billion doses of its vaccine in 2021.

“If it is a single dose, that means one billion people. But it will be in a ramp-up throughout the year,” he added.

According to Reuters, the vaccine could become available in the EU as soon as 1 April – the vaccine is currently being assessed by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) under a rolling review.

J&J previously signed an advance purchase agreement with the European Commission (EC) for 200 million doses of its COVID-19 vaccine following regulatory approval.

The contract was agreed following the conclusion of exploratory discussions with the EC and enables EU member states to exercise an option to secure up to 200 million additional doses after the initial supply.

In an agreement with the UK, J&J has committed to delivering 30 million vaccine doses, which are set to be supplied on a not-for-profit basis during the emergency pandemic.

J&J has also reached an agreement with the US government for 100 million doses of its vaccine candidate, with the US government committing $1bn for the initial supply.

Article by
Lucy Parsons

14th January 2021

From: Regulatory

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