J&J says COVID-19 vaccine could be ready in early 2021

Also receives US federal backing to increase manufacturing for the shot

Johnson and Johnson has joined the ranks of groups developing vaccines for the new coronavirus, saying it will start clinical trials of its lead candidate in September.

Batches of the vaccine could be approved for emergency use as early as the start of 2021, if efficacy data is available by the end of the year, says the drugmaker.

Coronavirus vaccine

It has also received US federal backing to ramp up manufacturing for the shot, including new capacity in the US and expanded production overseas, with the aim of making a billion doses available worldwide on a non-profit basis.

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

“The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible,” said J&J’s chief executive Alex Gorsky.

The vaccine – which has two back-ups – is based on constructs developed after scientists in China released the genetic sequence of the COVID-19 virus in January. Shares in J&J leaped 8% yesterday after the announcement.

The candidate has been created using J&J’s well-established AdVac adenovirus gene carrier technology and PER.C6 manufacturing platform, which have already been deployed to make vaccines for Ebola, Zika, HIV and respiratory syncytial virus (RSV) candidates.

During the Ebola virus epidemic in West Africa, J&J’s Janssen unit used the platforms to produce more than two million vaccine courses in less than one year.

J&J joins companies including Sanofi, GlaxoSmithKline, Pfizer and others in preparing for trials of COVID-19 vaccines, but at the moment US biotech Moderna is out in front, having dosed its first patients with its mRNA-based shot earlier this month.

Meanwhile, academic groups are also advancing candidates, including research teams in China and Oxford University.

New point-of-care diagnostic approved

There has also been encouraging news from another US corporation – Abbott – which is launching a rapid test for COVID-19 next week that uses a portable instrument the size of a toaster and can be deployed quickly in the field.

The company says the ID NOW test gives a positive result in five minutes and a negative result in 13, and now has emergency use authorisation in the US. It is ramping up production and expects to be able to make 50,000 tests a day.

The kit sits alongside Abbott’s lab-based COVID-19 diagnostic, and across the two platforms the company thinks it could supply about 5 million tests a month.

Source PMLive http://www.pmlive.com/pharma_news/j_and_j_says_covid-19_vaccine_could_be_ready_in_early_2021_1332633