[ad_1]
Public health experts have encouraged transparency in clinical trials of the Covid-19 vaccine, considering that eventually hundreds of millions of Americans will 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 placebo, and two, whether this is the first pause in the trial.
The answers to both questions are critical to understanding what this participant’s illness might mean for the safety of a vaccine.
Dr. Paul Offit, a member of an FDA advisory committee that will review vaccines, said Johnson & Johnson should answer these basic questions.
“By hiding this in secret and filtering things into pieces, it somehow conveys the message that something strange is happening,” Hotez said.
Responses from the FDA and Johnson & Johnson
FDA Commissioner Dr. Stephen Hahn has written about the importance of transparency in the Covid-19 vaccine development process.
Spokesmen for his agency declined to respond to CNN’s questions about the Johnson & Johnson lawsuit, saying, as with other lawsuits, that federal regulations prohibit the agency from releasing information. The agency referred CNN to Johnson & Johnson.
The pharmaceutical company has also said that it is committed to transparency, including transparency about its Covid-19 vaccine trial.
When asked about the COVID-19 trial pause, a Johnson & Johnson spokesperson referred CNN to the Oct. 12 statement when it announced the pause.
In an email to CNN, the spokesperson, Jake Sargent, highlighted this phrase from the statement: “We are also learning more about the disease from this participant, and it is important to have all the facts before sharing additional information.”
Did the sick recipient receive a vaccine or a placebo?
It shouldn’t take a week to determine whether a study participant received the vaccine or a placebo, according to vaccine specialists.
In the study, half of the participants receive the vaccine and the other half receive the placebo, which is an injection of saline that does nothing. The study is blinded, which means that the company does not know who receives which, nor do the participants or the doctors conducting the trial.
If the participant who got sick got the placebo, that doesn’t mean anything to the trial. However, if the participant received the vaccine, that could raise safety concerns.
“They could find out very quickly, certainly in 24 hours,” said Dr. Jesse Goodman, director of the FDA’s Center for Biological Evaluation and Research from 2003 to 2009, and the agency’s chief scientist from 2009 to 2014.
When CNN asked whether the volunteer received the vaccine or the treatment, the Johnson & Johnson spokesperson pointed to the company’s Oct. 12 statement, which notes that “as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study “. treatment or a placebo. ”
On Oct. 13, on the earnings call, Mathai, the Johnson & Johnson executive, said the company had shared data with the monitoring board.
“We have provided our set of information that we know to the DSMB, and they have asked a number of specific questions. We do not know if, they have not informed us of their, they are entitled to blind. We are still blind. So we do not know the treatment arm, the vaccine arm, “he said.
It is not clear whether Johnson & Johnson learned as of Wednesday whether the participant received the vaccine or the placebo.
“It’s certainly possible that DSMB is investigating and the company doesn’t yet know which group it’s in, and it would be helpful if they clarified that,” said Goodman, a former FDA official.
Offit said that it is clear to him that the participant received the vaccine; otherwise, the trial would not have been suspended or held on hold for one week.
“Why would you pause a trial if the person got the placebo? It just doesn’t make sense,” said Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia.
“I find it hard to believe that they have hundreds of researchers in this trial that will have 60,000 participants, this huge steamboat is moving forward, and you stop because a participant who received the placebo got sick? That just defies logic.”
Is this the first pause of the trial?
Johnson & Johnson and the FDA also declined to answer whether this was the first hiatus for their 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 openness is important.
“Transparency is always better, especially with simple, basic questions,” he said.
Participants who took a similar vaccine made by another company also fell ill.
The Johnson & Johnson vaccine and the AstraZeneca vaccine use an adenovirus as part of their Covid-19 vaccine. Adenoviruses cause the common cold and other illnesses, but the viruses are genetically modified so they don’t reproduce or cause illness, according to the companies.
The AstraZeneca trial was stopped once in July and again in September due to illness. The September break is still in effect in the United States.
Offit said drug companies should inform the public about the breaks and, if the trial is allowed to continue, explain why the illnesses were a coincidence and not due to the vaccine.
“You can inform them so that people don’t assume that something bad happened, so they don’t assume the worst and think ‘this makes me very hesitant to take this vaccine,'” he said.
Casey Hicks contributed to this story.
[ad_2]
