The pause on Johnson & Johnson’s coronavirus vaccine research study due to an adverse reaction by one of the participants is “quite common” in vaccine clinical trials, Health and Human Services Secretary Alex Azar told “Varney & Co.” on Tuesday.
“I think those who have concerns about vaccines generally should be reassured, actually, by this,” Azar said. “This shows that the system is working.
“A single case of a possible adverse event and they stop the trial, they check to see was that patient on the vaccine or a placebo? Is there a reason to believe there’s a connection between whatever that individual suffered and the vaccine?” he went on to explain.
He added that these situations “usually get resolved rather quickly” and stressed that Johnson & Johnson is “being scrupulously careful” and is “looking out for patient safety.”
The 60,000-patient clinical trial was shut down in line with the “pausing rule,” and the online patient enrolling system was closed as well, the company disclosed.
“We must respect this participant’s privacy," J&J said in a statement. "We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information."
|JNJ||JOHNSON & JOHNSON||164.96||-2.12||-1.27%|
Azar told host Stuart Varney on Tuesday that the Trump administration is “proceeding ahead” and that Johnson & Johnson’s pause “shouldn’t impact” the administration’s timeline for a vaccine “at all at this point.” He stressed that “we’re not going to cut any corners” to adhere to “Operation Warp Speed,” the U.S. government's plan to quickly ramp up the development and production of vaccines to prevent the spread of COVID-19.
“We’ve got six vaccines that we’ve invested in or contracted with,” he went on to explain. “We’ve got two that are almost completely enrolled in terms of their phase three trials and we’ll hope to get data relatively soon.”
“At this point, it’s really just a matter of waiting to see if they get enough events, so they need people in those trials to actually get COVID and those need to be people who didn’t get the vaccine,” he explained. “And when enough of those people get COVID who didn’t get the vaccine, there’s a kick out from the data and safety monitoring board of the data to the company and the FDA.”
Azar said that could happen in the next several weeks to months, but it “really just depends on the course of the disease in those trials.”
He also told Varney that simultaneously “millions of doses" of the vaccines are being manufactured by “all six of the manufacturers.”
“We expect by the end of this year to have close to 100 million doses of FDA-approved vaccine, enough to make sure we vaccinate those most vulnerable by the end of January,” Azar said, explaining that that would include seniors, health care providers and frontline emergency workers.
He added that there will be enough doses “for every American by the end of March to early April.”
Azar said that the “American people should feel very reassured” as the vaccines would have “made it through FDA’s processes, their independent, career scientists’ judgment that they meet the statutory and regulatory criteria for use by the American public.”
Fox News’ Nick Givas contributed to this report.