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Moderna clinical trial numbers show there is no way Trump can have a vaccine by election day



“There is no way. There is 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 vaccine would be ready around Election Day on November 3rd.

“I believe we will have the vaccine before the end of the year, of course, but around that date, yes. I think so,” Trump said Thursday.

CNN received part of a Moderna email sent Friday to top vaccine test investigators. He says 4536 study subjects have been registered in trials.

The trial began on the morning of July 27 and aims to register 30,000 case studies. The company has said it is “on track to complete registration in September”

;.

Moderna will not make that 30,000 in September if they continue at the pace of the first two weeks, but it is likely that enrollment speeds will increase, as as of Friday only 54 of the 89 study sites were operational, according to the email company for his scholars.

Moderna numbers increased significantly from the first week of the trial to the second week.

Even if Moderna does not achieve its goal of full registration by September, the company will still not have a vaccine on the market until Election Day, say infectious disease experts.

“I do not see how it would be possible,” said Dr. Paul Offit, a vaccinologist at Philadelphia Children’s Hospital.

Fauci 'satisfied' with registration for the first week of the Covid-19 vaccine trial

Once Moderna records her subjects and gives them their first shot, they then have to wait 28 days before giving them a second shot.

This means that participants registered at the end of September will not receive their second injections until the end of October. Offit said they then have to wait two weeks for the vaccine to become fully effective.

“This passes you on election day,” Offit said.

After that, researchers have to wait and see who gets Covid-19 and who does not. Half of the study participants are getting the real vaccine, and half are getting a placebo, or a stroke that does nothing. Neither the participants nor the doctors giving the vaccines know who got which injections.

Both Offit and Hotez predict that there will be results from the Moderna study in the first quarter of 2021 earlier.

“Maybe by Inauguration Day we can have a glow if the vaccine is working and be able to 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 registration will be done by the end of September is realistic or not, but I think the daily registrations should increase in the next two weeks, compared to where they were for the first two weeks,” he 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 begin enrolling patients in his country in mid-August. He said his goal is to enroll 500 patients, and already 2,500 patients have approached him asking about the trial.

“We are getting good numbers,” he told the trial. “I think this accrual will hit its target fairly quickly.”

Pfizer began the Phase 2/3 study in the United States on the evening of July 27th. Company President and CEO Albert Bourla told The Washington Post last week that “we expect to receive 30,000 participants by early September,” but did not specify whether by that time all 30,000 would have received a dose. or two.

Bourla said they had vaccinated more than 2,000 by the first week of August.

Bourla added that he thought “by the end of September beginning of October” Pfizer would know if the vaccine worked or not, and would approach the US Food and Drug Administration for regulatory review in October. He told the Post he was hoping for a speedy approval and there would be vaccines produced and ready for distribution.

Hotez and Offit both said Bourla’s schedule seemed very unlikely, given that, like Moderna, Pfizer had to give two doses, wait for the vaccine to become fully effective, and then follow the study subjects to see if ill with Covid-19.


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