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Alert for the lack of volunteers for other COVID-19 vaccines that may be essential

2020-11-22T02:40:37.718Z

The encouraging results from Pfizer and Moderna lead to an unexpected complication: a decrease in volunteers in other studies. We explain why this can be terrible.



By Erika Edwards - NBC News

Dr. William Hartman directs one of the laboratories where AstraZeneca's phase 3 clinical trial of the COVID-19 vaccine is being conducted at UW Health Hospital in Madison, Wisconsin.

Last week, he says, a large number of volunteers canceled or simply did not show up for their scheduled appointments to be inoculated. 

"People ask if they can retire," Hartman explains.

Although he has so far been able to replace the retired volunteers with people on the waiting list, he believes the reason for this setback may be the apparent success of two other vaccines made by Pfizer and Moderna.

Both companies have announced promising results in the preliminary analyzes of their phase 3 clinical trials, and Pfizer requested this Friday the approval of the US authorities. 

Moderna has also announced that it intends to do the same in the coming weeks.

That would prepare them to deliver the first doses in December.

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Hartman suspects that if such authorizations are, in fact, imminent, his volunteers may choose to "wait for the vaccine that's just around the corner." 

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But public health officials say it is a mistake. 

Stephen Hahn, commissioner of the Food and Drug Administration (FDA, in English), was "concerned" about a possible decrease in participation in the remaining trials.

"Until we analyze the data, until we have a clear sense of efficacy and safety, these trials should continue," Hahn said.

"I would encourage people to sign up," he added.

Pfizer Vaccine.Getty Images

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It's clear that one or two shots will ultimately not be enough to fight Hartman's team aims to enroll up to 1,000 participants.

Right now, it has around 150 registered volunteers.

"If we have multiple labs that make various safe and effective vaccines, then we can vaccinate more people quickly," said Buddy Creech, an infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennesse.

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Vanderbilt has been involved in Moderna's clinical trials, and last week launched a separate trial for Johnson & Johnson's candidate vaccine.

Creech stressed that he has been able to avoid notable losses of study volunteers by reminding people that it will be months before sufficient doses are available for those who wish to be vaccinated.

"The number of doses available to people in our area will be really limited in the next four to six months," Creech emphasized.

"Go ahead and enroll in clinical trials. It is a good opportunity to be able to contribute more in this pandemic," he urged. 

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Even if the FDA approves a vaccine for emergency use in the coming weeks, experts reminded those eagerly awaiting vaccines that such authorization is not the same as full approval.

Such approval will require more intense scrutiny by regulators and more data from clinical trials.

"We will not have a complete idea of ​​safety and efficacy" in the event of an emergency vaccine authorization for use, said Norman Baylor, president of the consulting firm Biologics Consulting and former director of the FDA's Office of Vaccine Research and Review. .

"We have to continue and complete the studies so that the FDA can make a determination on whether the vaccines should be approved," he said.

"We cannot rest," he clarified and considered that it is "good" that several candidate vaccines are being prepared. 

Four pharmaceutical companies are in the middle of phase 3 clinical trials in the United States and more than 100 are in development or other stages of study.

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Paul Kilgore, a vaccine researcher at Henry Ford Health System in Detroit, said that having multiple vaccine manufacturers "provides the assurance that if one manufacturer or another has to stop production, even temporarily, we would have a plan A, a plan B. and a plan C. "

Kilgore's team has been involved in clinical trials of the Moderna and Johnson & Johnson candidate vaccines and noted that it is crucial to run the trials "to the end, to make sure we collect as much safety and response data as possible. immune as well as efficacy data ".

Realistically, for the general public, I don't think a vaccine will be available before April or May, he predicted.

Baylor warned of other factors that could delay the launch of any vaccine.

Moderna and Pfizer have predicted that they could provide hundreds of millions of doses of vaccines in the coming months.

While there is no reason not to believe such projections, manufacturing issues may arise. 


"What happens if you fall short?" Baylor wondered. 

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Carlos del Rio, of the Emory University School of Medicine in Atlanta, urged Americans to remember that despite the encouraging data and on vaccines, "there is not one available at this time." 

As of Friday, the spread of COVID-19 had reached unprecedented levels in the United States with increases in infections in all states.

"This is not a time to give up face masks" and other measures to prevent the spread, such as hand washing and physical distancing.

"The world is there and, realistically and for the general public, I do not believe that a vaccine will be available before April or May," estimated del Río.

Source: telemundo

All news articles on 2020-11-22

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