The race for an approved COVID-19 vaccine is dealing with a setback. Johnson & Johnson has paused their late stage clinical trial after a participant got sick.
"It is not too uncommon to have these temporary halts on the trial while they kind of wait for the dust to settle, to see what happens and whether or not this was a potential side effect,” Dr. Frank Esper, a pediatric infectious disease specialist with the Cleveland Clinic told Newsy.
Esper says during these pauses, investigators are likely reaching out to other participants to compare if anything similar has happened. The drugmaker isn’t saying much, just that a vaccine tester got an “unexplained illness”.
It's unclear if this person got an active vaccine or a placebo. The individual is being evaluated by an independent data safety monitoring board and J&J's internal clinical and safety physicians.
This unexplained illness isn’t likely a cold or flu. Those types of side effects aren’t enough to stop a trial. sudden illness — or something called a “serious adverse event” — is what can.
"Serious adverse event doesn't necessarily mean that it was actually life-threatening. It could be a very profound rash or a swelling, substantial swelling at the injection site. Or it could be that the patient had chest pain, but it didn't have anything to do with, you know, a heart or the vaccine," Esper said.
AstraZeneca’s 30,000 participant us trial has been on hold since September 8th after a participant came down with a serious neurological condition. The FDA is still investigating.
This all as a second wave of coronavirus cases is expected in the U.S. As the weather cools and more people are inside, where this virus spreads easily. In the UK, hospitals are already seeing a surge.
"We very much are back to where we were earlier in the year and trying to understand what the demand, the capacity requirements are with each day and which with each week that goes by," Dr. Alex Crowe, Warrington and Halton NHS Trust Medical Director said.
While we don’t know when the paused U.S. trials will resume at least two other U.S. vaccine candidates remain in the late stage clinical trials.