Janssen Pharmaceutica, the Belgian pharmaceuticals company founded by Paul Janssen in 1953 and now owned by Johnson & Johnson, has announced it hopes to start clinical tests on humans of a new vaccine against Covid-19 in the second half of July.
The company originally issued a statement at the end of March announcing that trials could begin as early as September, with the possibility the vaccine could be authorised for emergency use by early 2021.
However the company now says work has advanced so far that the date for clinical trials can be brought forward by some four to six weeks.
The development of the vaccine is part of a joint project between parent company Johnson & Johnson and the US government’s department of health and human services. Together, the two partners have devoted more than $1 billion for research and development and testing.
They are also collaborating on research into a possible anti-viral medication for Covid-19 patients.
The joint venture between the American parent of Janssen and the US administration raises questions about access to the vaccine by other countries, and how much they may have to pay.
In March, Johnson & Johnson said it planned to begin production at its own risk – that is, before certification – “and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.”
CEO Alex Gorsky said, “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. As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day.”
The human trials will take the form known as a Phase 1/2a study of the recombinant vaccine Ad26.COV2-6, and will involve 1.045 healthy adults aged between 18 and 55, as well as a number of people over the age of 65. The tests will take place both in Belgium and the US.
The purpose of the test is to examine the levels of reactogenicity – the usual inflammatory reaction to the vaccine, such as slight fever or pain at the injection site, which is less desirable – as well as immunogenicity, or the ability of the vaccine to provoke a response from the immune system, which is very desirable and indeed essential.
Meanwhile talks are also under way for the organisation of a Phase 3 test, carried out on a larger number of people.