By Carl O’Donnell and Manas Mishra
(Reuters) – Johnson & Johnson said on Tuesday it would take at least a few days for an independent safety panel to evaluate an unexplained illness of a study participant that led to a pause in the company’s COVID-19 vaccine trial.
J&J shares fell more than 2% following news of the pause and safety review. Rival AstraZeneca Plc’s U.S. trial for its coronavirus vaccine candidate – which uses a similar technology – has remained on hold for more than a month after a participant in the company’s UK trial fell ill.
J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as by its own clinical and safety team.
The data board, which is also reviewing AstraZeneca’s U.S. trial, is required to submit its findings to the U.S. Food and Drug Administration before the study can be restarted.
Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.
“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.
He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo. Mammen added that J&J remains on track to complete recruitment for its 60,000-person trial in the next two to three months.
EVIDENCE OF ‘INTEGRITY’
The company said such pauses are not unusual in large trials.
It noted that the voluntary “study pause” in giving doses of the vaccine candidate to trial participants was different from a “regulatory hold” imposed by health authorities.
J&J has said it expects to have enough data to apply for U.S. regulatory clearance by the end of the year. Pfizer Inc and Moderna Inc have said they expect to be able to apply for FDA clearance for their vaccine candidates even sooner.
Former FDA chief Scott Gottlieb said on Twitter that the oversight of safety boards for COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.
Health experts have voiced concerns that U.S. President Donald Trump could put pressure on the FDA and drugmakers to rush an unsafe vaccine to market to bolster his re-election prospect. He has repeatedly said a vaccine could be available prior to the Nov. 3 election.
AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious unexplained illness in a British study participant. While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial remains on hold.
The J&J and AstraZeneca vaccines both use modified, harmless – although different – versions of adenoviruses to deliver genetic instructions to human cells in order to spur an immune response to the target virus, in this case the novel coronavirus.
They are both also part of the U.S. government’s Operation Warp Speed program to support vaccine development. J&J on Sept. 22 became the fourth Warp Speed participant to enter the final stage of human vaccine testing.
“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.
The Pfizer and Moderna vaccines employ an entirely different technology.
AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon.
“Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.
“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an earlier stage clinical trial. Results from the paused pivotal trial had been expected by the end of this year or early 2021.
Stat News reported https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic the pause on Monday, citing a document sent to outside researchers. The document said a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.
(Reporting by Ayanti Bera and Manas Mishra in Bengaluru, Deena Beasley in Los Angeles, Peter Henderson in Oakland, Ludwig Burger in Frankfurt, Carl O’Donnell in New York; Editing by Louise Heavens, Mark Potter and Bill Berkrot)