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COVID-19 vaccine trial at UW Health still on hold as Trump, FDA clash on approval rules

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Dr. Jeff Pothof, UW Health’s chief quality officer, on Sept. 2 became the first person at UW Hospital to get an injection in a phase 3 trial of AstraZeneca’s experimental COVID-19 vaccine, which was put on hold the next week. It's not clear when the study might resume.

A COVID-19 vaccine trial at UW Health and around the country, halted a week after it started last month, has not resumed and it’s not clear when it might.

UW Health planned to enroll 1,600 people in the late-stage study of AstraZeneca’s experimental vaccine, one of 100 sites around the country expected to include 30,000 people. But the company said Sept. 8 it was putting the trial on hold after a study participant in Britain became ill with what has been reported to be transverse myelitis, a rare spinal inflammatory disorder.

Regulators allowed the company to restart its trial in Britain a few days later, and similar studies have resumed in Brazil, South Africa, India and Japan.

The U.S. Food and Drug Administration continues to investigate the matter, according to AstraZeneca. “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the U.S. trial,” company spokeswoman Michele Meixell said Thursday.

At UW Hospital, where the study started Sept. 2, 37 people received injections before the trial was stopped, UW Health spokeswoman Emily Kumlien said. Two-thirds of participants were expected to get the experimental vaccine, known as AZD1222, and one-third a placebo, with everyone receiving two injections four weeks apart.

Kumlien said she couldn’t comment further on the trial, other than to say it’s still on pause.

The AstraZeneca vaccine is one of nearly 200 vaccines being developed for COVID-19, 42 of which are in human studies, the World Health Organization said last week. It is one of 11 in phase 3 trials required before approval can be sought, according to The New York Times. That list includes candidates by Moderna, Johnson & Johnson and Novavax, which along with AstraZeneca have received federal support for the effort.

The FDA this week released guidelines for approval of any COVID-19 vaccines under emergency-use authorization. President Donald Trump criticized the move, saying in a tweet the rules would “make it more difficult for them to speed up vaccines for approval before Election Day.”

Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization, called the guidelines “an important step forward in providing greater regulatory clarity for vaccine makers and in earning the American people’s trust in any future vaccines.”

Two Madison-based companies are developing nasal spray vaccines against the coronavirus:

FluGen, based on research by UW-Madison scientists Yoshihiro Kawaoka and Gabriele Neumann, is adapting its experimental flu vaccine to target COVID-19 and flu. The candidate, CoroFlu, is being developed with Bharat Biotech, in Hyderabad, India, a

  • nd could enter a human trial in India by late this year, FluGen CEO Paul Radspinner said in August.
  • Pan Genome Systems is developing a human COVID-19 vaccine adapted from an experimental immunization for another coronavirus that infects chickens. The human candidate is in mouse studies, Adel Talaat, a UW-Madison microbiology professor and founder of the company, said in July.

Radspinner and Talaat couldn’t be reached for comment Thursday.

A lab at UW-Madison’s Waisman Center is partnering with a North Carolina company to make an experimental COVID-19 vaccine for clinical trials, the university said.

Waisman Biomanufacturing plans to produce a COVID-19 vaccine for Heat Biologics for use in phase 1 and phase 2 clinical trials. Phase 1 trials could begin early next year, with UW-Madison a possible trial site.

Meanwhile, UW Health is involved in a study of a drug called ruxolitinib that is being tested to treat immune system overreactions in COVID-19 patients. Clinical trials are also underway there for an “antibody cocktail” developed by New York-based Regeneron Pharmaceuticals, which Trump received Friday and for which the company on Wednesday sought emergency approval.

UW Health is among centers also continuing to study and use convalescent plasma, from donors who recovered from COVID-19, to help those with serious complications of the disease to fight it.


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