Many scientists are working on developing a vaccine against Covid-19. In the United States, the pharmaceutical group Johnson & Johnson had to interrupt its phase 3 because one of the people who volunteered to test the vaccine fell ill.
Known information
The Johnson & Johnson vaccine is one of the most advanced. He entered phase 3 of the clinical trial. The latter aims to inject the product into a few thousand volunteers. Then, the scientists take a time to observe the protection of the vaccine over time (a few weeks, a few months, etc.). They also look for possible side effects and assess the effectiveness of the vaccine according to the person’s profile (age, sex, etc.). They also want to know the risk benefit of the vaccine. The laboratory had started recruiting volunteers at the end of September, hoping to hire 60,000 participants. A total of 200 sites are available in the United States and elsewhere. It turns out that one of the participants fell ill, in circumstances still unknown. This is what the group explains, in a press release: “We have temporarily interrupted the additional dosage in all our clinical trials of an experimental vaccine against Covid-19, including the entire phase 3 trial. , due to an unexplained illness in a participant ”.
A committee seized
This results in the suspension of phase 3 of the vaccine as well as the cessation of online registrations to become a voluntary candidate. The Johnson & Johnson group informs us that serious adverse events are “an expected component of any clinical study, especially large studies”. An investigation is underway to determine if the event in question is vaccine-related and if the study can be resumed. An independent committee for patient safety was thus called upon. Indeed, the stakes are high, in this context of a pandemic and nothing should be neglected. The clinical trial must be flawless and the vaccine must prove its efficacy and safety.
The AstraZeneca vaccine
Phase 3 of the British vaccine, AstraZeneca, had also been interrupted, due to “an unexplained illness” in one participant. However, clinical trials resumed, after “the Medicines Regulatory Authority (MHRA) confirmed that it was safe.” Tens of thousands of volunteers are testing the vaccine in the UK, Brazil and South Africa.
