Bad news all around on the fight against the coronavirus. First, Johnson and Johnson says they have suspended vaccine trials after an “unexplained illness” struck one of the participants in the study.
And a Nevada man is reported to have been reinfected with the coronavirus after contracting COVID-19 and then recovering.
The suspension of another vaccine trial and news that humans can contract the virus again diminishes hopes that a solution to the pandemic will come sooner rather than later.
AstraZeneca’s final-stage vaccine trial was hit with a “clinical hold” after two patients suffered from unknown neurological illnesses. A “hold” is more severe than a “pause” in that a clinical hold is a regulatory action while a “pause” is initiated by the manufacturer conducting the study in order to investigate an anomaly.
AstraZeneca’s trial is now back up and running, but it’s unknown how long the Johnson and Johnson pause will last.
The data and safety monitoring board, or DSMB, convened late Monday to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo.
Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19.
The massive study involves 60,000 participants who signed up online.
A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT.
Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details.
But the real test of a vaccine will be how much immunity the serum will supply. It’s generally believed that it will take more than one dose of vaccines currently under trial to make a vaccine effective. But if immunity is a useless goal, what can be done?
An otherwise healthy 25-year-old Nevada man is the first American confirmed to have caught COVID-19 twice, with the second infection worse than the first.
He has recovered, but his case raises questions about how long people are protected after being infected with the coronavirus that causes the disease, and potentially how protective a vaccine might be.
It was always known that getting COVID was not the same as getting the measles, which makes one immune for life. But it was hoped that the antibodies produced naturally in our bodies to fight the coronavirus would last longer than a few months. Can a vaccine do any better?
There have been at least 22 documented cases of reinfection worldwide since the start of the pandemic, but it’s unclear how many cases there have actually been, and how common it may be among people who don’t even know they’re infected.
“It could be a one in a million event, we don’t know,” said Akiko Iwasaki, an immunologist at Yale University and an investigator with the Howard Hughes Medical Institute, who wrote a commentary with the study.
Or it could be the tip of the iceberg. “It’s possible that the vast majority of people are completely protected from reinfection, but we’re not measuring them, because they’re not coming to the hospital,” said Dr. Iwasaki. Also, with so many asymptomatic people — many of them never showing any symptoms — it’s impossible at this point to say if someone had contracted the coronavirus and was never tested and then tested again and discovered to have it.
That doesn’t appear to be the case with a Nevada man who apparently got sick twice, the second time being more severe. But again, how can you “follow the science” when science doesn’t know?
Maybe Biden should change his slogan.