Tubes of vaccine in the Leiden lab of Janssen Vaccines. (Photo: JnJ)
These are exciting days for the corona vaccine from the Leiden company Janssen Vaccines. Due to a ‘possible side effect’, the administration to poof persons was halted worldwide on October 12. That break has not ended after nine days. Parent company Johnson & Johnson also doesn’t provide any information about what’s going on. In the US, criticism of this is growing.
The Leiden vaccine is one of the promising vaccine candidates to which the Netherlands and other European countries have subscribed. Our country hopes to have at least 7.8 million doses next year. But first it has to be seen whether the vaccine is really effective and safe. That is why an international ‘phase 3’ study is now running 60,000 subjects. That study was interrupted last week because one of the test subjects turned out to be seriously ill.
Such a break is not special in itself. Even if a case of illness does not seem to have anything to do with the vaccination, this must be checked first. This is a standard procedure that all pharmaceutical companies in the Western world use. The break with the Leiden vaccine was also not imposed from above; Johnson & Johnson volunteered him for week. So far, nothing special.
Irritation
Nevertheless, the enthusiastic mood about the Leiden vaccine is now starting to turn. That’s because Johnson & Johnson hasn’t released a single detail since October 12. The American news channel CNN showed up there on Monday very critical of it.
According to experts cited by CNN, it should at least be known after a week what serious illness the test subject has. And whether it concerns someone who actually received the vaccine, or someone from the control group who only gets a shot with a saline solution.
Today it also appeared that the Leiden branch of the company, Janssen Vaccines, could not provide any further explanation. The spokesperson ‘is also not known what the detected disease is or how long it will take before the studies can start again’.
There still doesn’t have to be anything special going on, but the radio silence of Johnson & Johnson does cause irritation. All a J&J spokesperson answered to questions from CNN was, “We are learning more about this participant’s disease and it is important that we have all the facts before disclosing more.”
In fact, there has been radio silence for nine days about any side effects of the Leiden vaccine. This is diametrically opposed to the view that openness and transparency on such matters are desperately needed to ensure that the public maintains confidence in the vaccines that are expected in the future.
Delay
After months of purely positive news about the Leiden vaccine – it proved to be effective in small groups of test subjects after just one dose – the now inserted pause is the first setback for the drug. This pause also applies to the small-scale ‘phase 2’ study at the Leiden institute CHDR, in which 35 test subjects are participating. The CHDR is also not aware of what exactly is wrong with the test subject in the international study.
In September, a similar pause was inserted in the studies with the Oxford vaccine from AstraZeneca, to which the Netherlands has also subscribed. But in that case, details were soon revealed. One test subject developed nervous problems. After the necessary checks, most countries gave permission for the continuation of the investigation, because there was no connection between the complaints and the vaccination.
The break with the Oxford vaccine did cause a delay. In England, studies resumed after four days, India and South Africa followed soon after. But Japan didn’t give the green light until more than three weeks later, and in the US, health authorities are still chewing the file. Because among all test subjects was a second case with nervous problems. People first want to know more in order to rule out that this is not a side effect of the vaccine.
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