“There’s no way. There’s just no way,” said Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine and a CNN medical analyst.
Last week, President Trump said he was “optimistic” a fax would be ready for election day on November 3.
“I believe we’ll have the fax before the end of the year, sure, but around that date, yes. I think so,” Trump said Thursday.
CNN received part of an email that Moderna sent on Friday to the lead investigators of their fax tests. It says 4,536 research researchers have registered themselves in tears.
The trial began on the morning of July 27 and aims to enter 30,000 research topics. The company said it was “on track to complete enrollment in September.”
Moderna will not make that 30,000 in September if they continue with the rate of the first two weeks, but it is likely that the rate of enrollment will go up, as as of Friday, only 54 of the 89 pages of the study works, according to the company email to its researchers.
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The numbers of Moderna increased significantly from the first week of the trial to the second week.
Even if Moderna reaches the goal of full enrollment in the month of September, the company will still not have a vaccine on the market, experts from Infectious Disease say.
“I do not see how that could be possible,” said Dr. Paul Offit, a vaccinologist at Children’s Hospital of Philadelphia.
After Moderna enters their subjects and has given their first shot, they have to wait 28 days before giving a second shot.
This means that participants enrolled at the end of September will not receive their second injection until the end of October. Offit said they would then have to wait two weeks for the vaccine to become fully effective.
“That brings you past election day,” Offit said.
After this, the researchers have to wait and see who gets sick with Covid-19 and who does not. Half of the study participants get the real vaccine, and half get a placebo, like a shot that does nothing. Neither the participants nor the doctors who give the vaccines know who received the injections.
Both Offit and Hotez predict that there will be first results from the Moderna study in the first quarter of 2021.
“Maybe by Inauguration Day we can have a smile as the vaccine works and assess its safety,” Hotez said.
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The National Institutes of Health is collaborating with Moderna on the coronavirus vaccine.
“I can not comment on whether their enrollment done at the end of September is realistic or not, but I think the daily enrollments in the next few weeks should go up compared to where they were the first two weeks,” said Dr. Francis Collins, director of the NIH.
Dr. Carl Fichtenbaum, who is conducting the Moderna trial at the University of Cincinnati, said he expects to register patients on his site by mid-August. He said his goal is to enroll 500 patients, and already 2,500 patients have reached out to him and investigated the trial.
“We get good numbers,” he said of the trial. “I think these attacks will reach their goal pretty quickly.”
Pfizer began its Phase 2/3 study in the United States on the evening of July 27th. Business chairman and CEO Albert Bourla told The Washington Post last week that “we expect to get the 30,000” participants by early September, but did not specify if he meant at that time all 30,000 received one dose or two.
Bourla said she vaccinated more than 2,000 in the first week of August.
Bourla added that he thought “in late September to early October” Pfizer would know if the vaccine worked or not, and would approach the U.S. Food and Drug Administration for regulation in October. He told the Post he hopes for a speedy approval and will have produced faxes and is ready to distribute.
Hotez and Offit both said Bourla’s schedule looks highly unlikely, considering Pfizer, like Moderna, should give two doses, wait for the vaccine to be fully effective, and then follow up on study topics to see if they get sick with Covid. 19.
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