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J&J brings forward COVID-19 vaccine trial to July

Programme had been accelerated based on strength of preclinical data

J and J

Johnson & Johnson says it will start human testing of its COVID-19 vaccine candidate in July, two months earlier than expected, in more than 1,000 healthy volunteers.

The placebo-controlled phase 1/2a trial of the adenovirus-based candidate – called Ad26.COV2-S – will be carried out in the US and Belgium and involves two groups of adults, one aged 18 to 55 and another aged 65 and older.

J&J’s candidate was one of the five vaccines against SARS-CoV-2, the virus that causes COVID-19, selected by the Trump Administration for inclusion in Operation Warp Speed, which aims to have a vaccine available by the end of the year.

J&J’s chief scientific officer Paul Stoffels said that the programme had been accelerated “based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities”.

The company also says it is investing in the manufacturing capacity needed to make the vaccine at scale, and intends to forge alliances with other organisations to “ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic”.

It has previously committed to providing a billion doses of Ad26.COV2-S available worldwide on a non-profit basis in 2021.

J&J is already working with the US government’s Biomedical Advanced Research and Development Authority (BARDA) on the vaccine and have collectively committed $1bn to the project, to be spent on R&D and clinical testing of the vaccine, with additional funding also earmarked for coronavirus antiviral drug development.

It is also in discussions with the National Institutes of Allergy and Infectious Diseases (NIAID) with the objective of starting a phase 3 trial ahead of its original schedule, depending on the outcome of phase 1 studies.

J&J’s candidate is one of ten in clinical trials, according to the World Health Organization, and is one of three adenovirus-based vaccines being tested, along with the University of Oxford and AstraZeneca’s ChAdOx1-S – already in a phase 2/3 trial - and another vaccine developed by China’s CanSino Biological that is in mid-stage testing.

Moderna’s mRNA-based vaccine mRNA-1273 is considered to be slightly in front at the moment, with its phase 2 trial of 600 patients due to generate results shortly which could lead to a phase 3 programme as early as next month.

Article by
Phil Taylor

11th June 2020

From: Research



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