Both Johnson & Johnson and the US Food and Drug Administration (FDA) refuse to offer details a week after pausing the pharmaceutical firm's Covid-19 vaccine trial.
Drug maker Johnson & Johnson and the FDA declined to discuss crucial details on the decision to pause the pharmaceutical giant's Covid-19 vaccine trial following an unexplained illness in one of its patients.
Unexplained illness
Last week, Johnson & Johnson chief financial officer (CFO) Joseph Wolk said the company had to stop the trial after an adverse event happened to one of its patients and that an investigation on the incident by the data and safety monitoring board will follow.
The firm voluntarily stopped enrolling study participants while board conducts its review.
"We’re letting safety protocol follow proper procedure here," Wolk said, stressing that pauses in clinical trials are “not uncommon.”
"What it should also do is reassure the public that every scientific, medical and ethical standard is being applied here," he noted.
The pharma giant confirmed in a statement that "pausing rule" in the 60,000-patient clinical trial had been met. However, the company did not reveal more details about the patient.
"We must respect this participant’s privacy," the company said. "We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information."
Lack of transparency despite promise
Public health experts have emphasized on the need for transparency in the Covid-19 vaccine clinical trials, pointing out that hundreds of millions of Americans will eventually be receiving a vaccine.
Both Johnson & Johnson and the FDA refused to answer questions on whether the study volunteer who got sick received the vaccine or the placebo, and if this is the first pause for the trial.
These questions are considered crucial to understanding the patient's illness and the vaccine's safety.
On the importance of transparency in the development of Covid-19 vaccines, FDA Commissioner Dr. Stephen Hahn tweeted: "We believe transparency in this process will help build public confidence & provide greater understanding of FDA's work."
However, FDA spokespersons have decline to answer the questions, arguing that federal regulations prohibit the agency from disclosing information as it has with other trials, and pointed to Johnson & Johnson.
Meanwhile, Johnson & Johnson also expressed its commitment to transparency and in a statement on its website, the company said: "At Johnson & Johnson, we believe the transparency of clinical trial data advances science and medicine and is in the best interest of the patients and consumers who use our pharmaceutical products and the healthcare professionals who prescribe them. We support the overall principles of clinical trial data transparency with the goal of advancing medical sciences."
However, when asked about the details of the pause, Johnson & Johnson spokesman Jake Sargent referred to the firm's October 12 statement and highlighted this sentence from the statement: "We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information."
Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research from 2003 to 2009, and the agency's chief scientist from 2009 to 2014, said it shouldn't take long to determine whether a study participant received the vaccine or a placebo.
"They could find that out very quickly, certainly within 24 hours," Dr. Goodman said.
