To combat the coronavirus, US vaccine makers consider an unprecedented strategy: work together – Boston News, weather, sports

(CNN) — As the United States embarks on an unprecedented effort to develop vaccines in record time — dubbedOperation warp speedAccording to the Trump administration—Scientists are choosing between two ways to test vaccines this summer with thousands of people.

One approach is more common and each company is working independently on its own exam, according to two members of COVID-19 therapeutic interventions and vaccine groups, or accelerated ACTIVs, Organized by the National Institutes of Health last month. The second includes several vaccine developers working in one large trial, an unprecedented way to develop vaccines in the US, they said.

“There is currently no final decision on which approach ACTIV will take,” NIH spokeswoman Renate Myles told CNN by email.

Members of the ACTIV Clinical Trials Working Group are expected to discuss options over the telephone on Wednesday. These members include representatives of vaccine companies.

“Things are moving so quickly that we hope to share more information in the coming weeks,” Miles writes.

Bioethicist Art Caplan said it was unprecedented that competing US vaccine companies were considering plans to collaborate in one large trial.

“This is all very recent,” he said.

According to the World Health Organization, three US companies have already tested the vaccine in humans. They are still in Phase I or Phase II trials and usually require dozens or hundreds of study subjects to be vaccinated.

Moderna, Massachusetts, is working on a vaccine with the National Institute of Allergy and Infectious Diseases, which is part of NIH. Pfizer is collaborating with the German company BioNTech and Pennsylvania-based Inovio is also in clinical trials.

Fourth company in the United States, Johnson & Johnson, Announced last week Clinical trials are scheduled to start in September.

Phase 3 of a vaccine trial usually involves thousands of subjects, some of whom are randomly assigned to vaccinate, others are randomly assigned to do nothing I will be injected with a placebo. The researchers then wait to see if there are differences in Covid-19 infection rates between the vaccine and control groups.

If vaccine developers unite in one large Phase 3 trial of all vaccines, they can all use the same placebo group and not have to hire their own.

“Yes, this is the most efficient way to do it,” said Dr. Paul Ofit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the ACTIV group.

But another member said it would be advantageous for each company to conduct its own case, as each company is currently in a different stage.

“One trial will definitely start in July, another will end late summer, another will start in September and October.” ACTIV Group.

Kaplan said each test method has advantages and disadvantages.

“It’s different from’sacred cow, you can’t do it this way, or you have to do it that way ‘,” he said.

Corey said the overall effort — some vaccine companies working so quickly are unprecedented.

“I don’t think there has ever been an infectious disease that could reach more people in such a short period of time in all history,” he said.

Whatever approach was taken for the trial, Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases dismissed Monday the hope that the vaccine would be completed by autumn.

“The idea of ​​having available treatments and vaccines to facilitate student re-enrollment into the fall semester will be too irreplaceable,” he told Senators. “Even at the fastest speed we’re progressing, we don’t see the vaccine working in individuals’ ability to go to school this term.”

He said, “We want to know that in late fall or early winter,” if the vaccine turns out to be successful in trials.

Fauci has revealed that the vaccine may not even work.

“There is no guarantee that the vaccine will actually work,” he said.

He added that he felt “it was cautiously optimistic that there was a candidate who would give it some strength.”

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