Coronavirus vaccine, J&J stops testing. “Unexplained illness in a volunteer”

Rome, October 13, 2020 – New stop in the race to Vaccine for coronavirus. This time it is the Johnson & Johnson pharmaceutical group to stop clinical trials after one of the volunteers you have contracted what is called an “unexplained disease.” To make the announcement, the company itself explains in a note: “We have temporarily suspended additional dosing in all of our clinical studies of an experimental vaccine against Covid-19, including the full study of step 3, due to an unexplained disease in a participant. “The online registration platform to recruit participants in phase 3 of the study is also temporarily closed. As was the case in September for the candidate Astrazeneca vaccine, the independent safety commission of patients to investigate the incident.

Coronavirus, the newsletter for October 13. Data and table

What happens now

Johnson & Johnson will follow the protocols and ensure that serious adverse events are “an expected component of any clinical trial, particularly large trials.” Statements in line with those reported last month by Astrazeneca. The study is suspended to see if the “unexplained illness” is related to the administration of the drug. If the two events are not related, experimentation can be resumed. In the case of the vaccine that Astrazeneca works on according to the University of Oxford, considered one of the most promising, tests have resumed in Japan in early October but not yet in the United States, where the pharmaceutical giant claims to collaborate with industry authority.

Phase 3

Johnson & Johnson vaccine development progressed rapidly into phase 3. Volunteer recruitment began in late September, with the goal of involving 60,000 participants at more than 200 locations in the United States and other countries. Trials were also underway in Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa. J&J had become the 10th group in the world to conduct a Phase 3 evaluation, the fourth in the US, from where it had received approximately $ 1.45 billion in funding.

J & J’s candidate vaccine is based on a single dose of an adenovirus, which causes the common cold, modified so that it cannot replicate, and combined with a part of the Sars-CoV-2 coronavirus called protein peak, used to infect human cells. It is the same technique that the Johnson & Johnson laboratory uses for its vaccine against Ebola hemorrhagic fever, a serum that received a green light from the European Commission for marketing in July.