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.”
The Trump campaign would be wise to cite this NYT story as part of its closing message — particularly the success of Operation Warp Speed. pic.twitter.com/cSN8vYlkxT
— Josh Kraushaar (@HotlineJosh) October 13, 2020
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.”
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. 3/3
— Nicole Saphier, MD (@NBSaphierMD) October 24, 2020
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.”
Fauci to Chuck Todd on a vaccine next month: “I think it’s quite realistic. Right now we have at least two of the six vaccines that the federal government has made a major investment in… I’m cautiously optimistic that it will be.”
— Joe Concha (@JoeConchaTV) October 23, 2020
This report has been updated to include additional information.
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