News and Commentary

Two Companies Restart Late-Stage Coronavirus Vaccine Trials; Volunteer Illness Not Believed To Be Related To Vaccine
This picture taken on May 23, 2020 shows a laboratory technician holding a dose of a COVID-19 novel coronavirus vaccine candidate ready for trial on monkeys at the National Primate Research Center of Thailand at Chulalongkorn University in Saraburi. - After conclusive results on mice, Thai scientists from the centre have begun testing a COVID-19 novel coronavirus vaccine candidate on monkeys, the phase before human trials.

AstraZeneca and Johnson & Johnson restarted their late-stage coronavirus vaccine trials after a few volunteers became seriously ill, which was later ruled to not be related to the vaccine.

“Federal health regulators gave AstraZeneca the green light after a six-week pause, concluding there was no evidence that the experimental vaccine had directly caused the neurological side effects reported in two participants,” The New York Times reported. “Johnson & Johnson said that its trial, which had been on pause for 11 days, would restart after learning that a ‘serious medical event’ in one study volunteer had ‘no clear cause.'”

Paul Stoffels, chief scientific officer of Johnson & Johnson, told The Washington Post, “With the information which we gathered to date and the information from external experts, the company found no evidence the vaccine candidate caused it.”

The Wall Street Journal noted that in regards to AstraZeneca’s decision, the company did not find any evidence that the vaccine was responsible for the illnesses experienced by two volunteers, although it could not rule out a link either.

“AstraZeneca’s study involves 30,000 people in the U.S., with some getting the vaccine and others a dummy shot,” the Associated Press reported. “Testing was stopped after one British participant developed severe neurological symptoms consistent with a rare inflammation of the spinal cord called transverse myelitis. AstraZeneca testing had also been paused earlier in the summer.”

The New York Times reported last week that experts have “genuine confidence” that the pandemic, which originated in China, will end “far sooner” than originally expected and that President Donald Trump’s Operation Warp Speed — the administration’s efforts to facilitate and accelerate the development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics — has been “working with remarkable efficiency.”

The report noted that the U.S. was “faring much better than it did during the Spanish influenza,” which killed nearly 700,000 people in the U.S., adding, “the country’s population at the time was 103 million, so that toll is equivalent to 2 million dead today.”

It is “not unusual for someone to fall ill during large clinical trials; a pause is necessary to determine whether the illness is a result of the vaccine. The resumption indicates they are following FDA safety protocols, finding no evidence the vaccine caused the illnesses,” Nicole Saphier, MD, said in a statement. “The pause/ resumption of these two studies are steps forward in our fight against COVID-19. While most clinical trials and manufacturing can take years to accomplish, Operation Warp Speed has cut redundancy to make readily available any vaccine proving safe & efficacious.”

Dr. Anthony Fauci told MSNBC yesterday that he thinks it’s “quite realistic” that there will be a vaccine ready next month.

“Right now we have at least two of the six vaccines that the federal government has made a major investment in,” Fauci said. “I’m cautiously optimistic that it will be.”

This report has been updated to include additional information.

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