FDA commissioner 'cautiously optimistic' about coronavirus vaccine after trial showed 'robust' immune response

FDA commissioner says he’s ‘cautiously optimistic’ about coronavirus vaccine studies

Promising vaccine study from Oxford University; FDA commissioner Dr. Stephen Hahn weighs.

Food and Drug Administration Commissioner Stephen Hahn is “cautiously optimistic” about a safe and effective coronavirus vaccine after promising results on a potential vaccine were published, he told “America’s Newsroom” on Monday.

The early results of Oxford University and AstraZeneca’s coronavirus vaccine trial showed “robust” immune system responses, according to the pharmaceutical firm.

In the research, scientists said that they found their experimental COVID-19 vaccine, AZD1222, produced a dual immune response in people aged 18 to 55. Dr. Adrian Hill, director of the Jenner Institute at Oxford University, said neutralizing antibodies were produced by the vaccine candidate.

In addition, the vaccine also causes a reaction in the body's T-cells, which help to fight off the coronavirus.

“We are seeing good immune response in almost everybody,” said Hill. “What this vaccine does particularly well is trigger both arms of the immune system.”

Hahn pointed out on Monday that the results were from an “early stage clinical trial of the Oxford vaccine, which showed that it was tolerable, seemed to be safe in this early stage trial, but also that it stimulated a strong immune response,” which he said is “important.”

However he added that “at the end of the day, we have to wait for the data to come in … from the larger clinical trials in larger groups of patients to help us determine whether the vaccine is ultimately safe or effective.”

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About 1,077 people took part in the study of AZD1222, which is also known as ChAdOx1 nCoV-19, and about half of the participants received the experimental vaccine.

A number of efforts to develop a coronavirus vaccine are underway around the world. Scientists at Israel’s Tel Aviv University and biopharmaceutical company Neovii, for example, recently announced a project to develop a COVID-19 vaccine.

Host Bret Baier asked Hahn, “how fast could something turn around” in terms of the larger groups of patients.

“That really depends upon when that large clinical trial is complete,” Hahn said, adding, “we’re all looking for a vaccine to get here as soon as possible and I am cautiously optimistic.”

He then pointed to the vaccine guidance the FDA has “put out, which really gets to the issue of what does the FDA want to see to make that judgment, to call the balls and strikes around safety and efficacy and that large clinical trial will be it.”

“We want to make sure the right populations are included, including vulnerable populations,” he continued, adding that the FDA would analyze the data to make a decision as to whether a vaccine is safe and effective.

“I can assure the American people we won’t cut corners on that, that we will use our standard approach that’s been tested for years to determine safety and efficacy,” Hahn said.

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Reported side effects from the trial include feeling tired, headaches, muscle aches, chills and fever. No serious side effects were noted.

Fox News’ James Rogers and The Associated Press contributed to this report.

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