Public health experts have encouraged transparency in clinical trials of the Covid-19 vaccine, considering that hundreds of millions of Americans will eventually be asked to roll up their sleeves and get vaccinated.
The company and the FDA declined to answer two questions from CNN: one, whether the study volunteer who became ill received the vaccine or the placebo, and two, whether this is the first break in treatment. the test.
Answers to both questions are essential to understanding what this participant’s illness could mean for vaccine safety.
Dr Peter Hotez, director of the Center for Vaccine Development at Texas Children’s Hospital, agreed, noting that polls show many Americans don’t want to get a Covid-19 vaccine once it hits the market.
“By wrapping it up in secrecy and leaking things in pieces, it kind of sends the message that something untoward is going on,” Hotez said.
FDA and Johnson & Johnson responses
FDA Commissioner Dr Stephen Hahn wrote about the importance of transparency in the Covid-19 vaccine development process.
Spokesmen for his agency declined to answer CNN’s questions about the Johnson & Johnson lawsuit, saying, as has been the case with other lawsuits, federal regulations prohibit the agency from releasing information . The agency referred CNN to Johnson & Johnson.
The pharmaceutical company also said it is committed to transparency, including transparency of its Covid-19 vaccine trial.
“At Johnson & Johnson, we believe that transparency of clinical trial data advances science and medicine and is in the best interests of the patients and consumers who use our pharmaceuticals and the healthcare professionals who prescribe them. We support the general principles of clinical trials. data transparency to advance medical science, ”according to a statement posted on the company’s website.
When asked about the Covid-19 trial break, a Johnson & Johnson spokesperson referred CNN to the October 12 statement when it announced the break.
In an email to CNN, spokesperson Jake Sargent highlighted this line of the statement, “We’re also learning more about this participant’s illness, and it’s important to have all the facts before sharing. additional information. “
Did the sick recipient receive a vaccine or a placebo?
According to vaccine specialists, it shouldn’t take a week to determine whether a study participant received the vaccine or a placebo.
The Johnson & Johnson trial began on September 23, with plans to recruit 60,000 patients in eight countries, including the United States.
The company learned of the “unexplained illness” from the study volunteer on Sunday, Oct. 11, Dr Mathai Mammen, global head of research and development at Janssen Pharmaceuticals, a division of Johnson & Johnson, said on Tuesday at the call for the company’s third quarter results.
In the study, half of the participants are given the vaccine and the other half are given the placebo, which is an injection of saline that does nothing. The study is blinded, which means the company doesn’t know who gets what, the participants or the doctors running the trial.
If the participant who became ill was given the placebo, that does not mean anything for the trial. If the participant were to receive the vaccine, however, this could raise safety concerns.
Only the Data Safety and Monitoring Board of the trial, a group of independent scientists, can disclose the status of the sick participant and whether they received a vaccine or a placebo.
“They could find out very quickly, certainly within 24 hours,” said 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.
When CNN asked if the volunteer received the vaccine or the treatment, the Johnson & Johnson spokesperson pointed to the company’s Oct. 12 statement, which notes that “because many trials are placebo-controlled, it doesn’t is not always immediately obvious whether a participant received a study. treatment or a placebo. ”
On October 13, during the earnings call, Mathai, chief executive of Johson & Johnson, said the company had shared data with the supervisory board.
“We gave our body of information that we know to the DSMB, and they asked a number of specific questions. We don’t know if – they haven’t informed us of their – they have the right to We are still blind. So we don’t know the treatment arm, the vaccination arm, ”he said.
Johnson & Johnson’s CFO on Wednesday reiterated that the company did not know what the volunteer received.
“We don’t even know at this point if this individual is on the placebo arm or the vaccinated arm,” Joseph Wolk told CNN’s Richard Quest.
It is not known whether Johnson & Johnson has learned since Wednesday whether the participant received the vaccine or a placebo.
“It’s certainly possible that the DSMB is investigating and the company still doesn’t know which group they belong to, and it would help if they clarify that,” said Goodman, the former FDA official.
Offit said it was clear to him that the participant had received the vaccine – otherwise the trial would not have been suspended and would have waited for a week.
“Why would you stop a trial if the person was given the placebo?” It just doesn’t make sense, ”said Offit, director of the vaccine education center at Philadephia Children’s Hospital.
“I find it hard to believe that there are hundreds of investigators in this trial which will have 60,000 participants, this huge steamer moving forward, and you stop because a participant who received the placebo is get sick?
Is this the first break in the trial?
Johnson & Johnson and the FDA have also declined to respond if this is the first break for its Covid-19 vaccine trial.
The answer is important, because if two or more participants develop similar illnesses after receiving the vaccine, it is an important red flag that the vaccine could pose safety risks.
Speaking generally about vaccine trials, former FDA Commissioner Dr Peggy Hamburg said the opening was important.
“Transparency is always better, especially with simple and straightforward questions,” she said.
Participants who took a similar vaccine made by another company also became ill.
The Johnson & Johnson vaccine and the AstraZeneca vaccine both use an adenovirus as part of its Covid-19 vaccine. Adenoviruses cause colds and other illnesses, but viruses are genetically engineered so that they don’t replicate and cause disease, the companies say.
Johnson & Johnson uses human adenovirus, and AstraZeneca & Oxford vaccine uses chimpanzee adenovirus.
Volunteers in the trial conducted by AstraZeneca and the University of Oxford developed “unexplained neurological symptoms, including change in sensation and weakness in limbs,” according to a fact sheet from a participant of the university.
The AstraZeneca trial was suspended once in July and again in September due to illnesses. The September break is still in effect in the United States.
Offit said drug companies should inform the public of the breaks and, if the trial is allowed, explain why the illnesses were accidental and not due to the vaccine.
“You can educate them in a way that people don’t assume that something bad has happened, so they don’t assume the worst and think ‘it really makes me hesitate to take this vaccine’”, a- he declared.
Casey Hicks contributed to this story.