EXCLUSIVE: Tayside vaccine trial halted over 'possible link' to blood clots
Janssen has paused all vaccinations
Last updated 21st Apr 2021
Tay News can exclusively reveal a major vaccine trial in Tayside, which was inundated with thousands of volunteers, has been halted.
Janssen has paused all vaccinations due to 'possible links' to blood clots.
Now Dundee University, which is working with the pharmaceutical firm along with NHS Tayside, has confirmed work here has also stopped.
A spokesperson said: "It was paused in coordination with all Janssen trials and we’ll await news from Janssen about restarting."
Yesterday the EU's drug regulator confirmed clots should be listed as a 'very rare' side effect and add the benefits outweigh the risks.
Professor Neil Mabbot from Edinburgh University, who's an expert in diseases, wasn't surprised to hear of the potential link.
"It's a very similar platform to the AstraZeneca vaccine, which has been used quite extensively in the UK at the moment," he said.
Trials in Tayside were launched last November, when 400 volunteers were asked to come forward to take part in the study.
It involved receiving two injections weeks apart. Some contained the Janssen vaccine, others were a placebo.
The drug, which is also known as Johnson & Johnson, has yet to be approved in the UK, but 30 million doses have been ordered.
"I've every confidence that the vaccine itself will be approved for use in the UK, and for other areas around the world as well," added Professor Mabbot.
"One thing we have to remember is, this vaccine has the potential to be extremely useful around the world.
"Unlike the Pfizer, Moderna and the AstraZeneca, which many of us have probably been injected with over the past few months, need two doses.
"The Johnson & Johnson or the Janssen vaccine is different in that we only need one dose."
The decision to halt all trials was taken by Janssen last week.
A spokesperson said: "Following the recommendation from the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) on 13 April, Janssen decided to voluntarily pause vaccinations in all COVID-19 vaccine clinical trials while we update guidance for investigators and participants.
"All of Janssen’s COVID-19 clinical trials will remain paused until there is alignment across international regulators’ recommendations, including the FDA.
"The safety and well-being of every individual who receives a Johnson & Johnson product is our first priority.
"We will continue to inform trial participants, collaborate with medical experts and global health authorities to elevate awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis, appropriate treatment and expedited reporting by health care professionals, while we work toward continuing vaccinations to end the global pandemic.
"As soon as able, Janssen will work with countries to resume vaccinations in COVID-19 vaccine clinical trials. Trial participants will be fully informed and to continue their participation, will provide consent"