Johnson & Johnson is the second company to pause a Phase 3 study of COVID-19 vaccines.
This study aims to recruit 60,000 participants, one of whom developed “an unexplained disease”. The company’s study break is the standard protocol in these cases.
According to a Johnson & Johnson press release, the patient’s disease will be reviewed by the study’s independent Data Safety Monitoring Board and the company’s clinical and safety physicians.
“Adverse events – illnesses, accidents, etc. – even those that are serious – are an expected part of any clinical trial, especially large trials,” the press release said.
The company does not disclose any information about the patient and the illness that caused the temporary hold. Because the study is a randomized, double-blind, placebo-controlled study, neither the participant nor the investigators who administered the vaccine know whether the participant received the actual vaccine or a placebo. This will be part of the investigation.
In early September, AstraZeneca also suspended a lawsuit when the company was investigating a participant’s illness. The J&J vaccine and the AstraZeneca vaccine have two things in common. Both vaccines are based on what is known as adenovirus, which instructs cells to make the necessary vaccine proteins. They are also part of the US government’s Operation Warp Speed, the public-private partnership to approve and distribute a vaccine. Warp Speed was recently heavily criticized after an NPR investigation found that various pharmaceutical companies, including J&J, received at least $ 6 billion in funding through a third-party defense contract management company. This secondary step of the established acquisition process, in which it is described in detail how federal contracts are to be awarded, makes it possible to keep the award process under lock and key.
Related article: AstraZeneca Pauses COVID-19 Vaccine Study Due to Volunteer Illness
The AZ process has now been resumed in all participating countries with the exception of the USA. According to the STAT, this has caused concern among some American study participants. They received their first dose of the 2-dose vaccine candidate but will not be able to receive the post-injection until the study has restarted. Johnson and Johnson’s vaccine candidate is a single-dose vaccine.