Food and Drug Administration Commissioner Stephen Hahn is “cautiously optimistic” about a safe and effective coronavirus vaccine after promising results were released about a possible vaccine, he told “America’s Newsroom” on Monday.
Early results from the University of Oxford and AstraZeneca coronavirus vaccine trial showed “robust” responses from the immune system, according to the pharmaceutical firm.
In the research, scientists said they found that their experimental COVID-19 vaccine, AZD1222, produced a dual immune response in people ages 18 to 55. Dr. Adrian Hill, director of the Jenner Institute at Oxford University, said that the neutralizing antibodies were produced by the vaccine candidate.
In addition, the vaccine also causes a reaction in the body’s T cells, which help fight the coronavirus.
“We are seeing a good immune response in almost everyone,” Hill said. “What this vaccine does particularly well is to trigger both arms of the immune system.”
Hahn noted Monday that the results were from an “early-stage clinical trial of the Oxford vaccine, which showed that it was tolerable, appeared to be safe in this early-stage trial, but also that it stimulated a strong immune response,” which said that It is important”.
However, he added, “At the end of the day, we have to wait for the data to come … from the largest clinical trials in larger patient groups to help us determine if the vaccine is ultimately safe or effective.”
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About 1,077 people participated in the AZD1222 study, which is also known as ChAdOx1 nCoV-19, and about half of the participants received the experimental vaccine.
Various efforts are underway to develop a coronavirus vaccine worldwide. Scientists at Israel’s Tel Aviv University and the biopharmaceutical company Neovii, for example, recently announced a project to develop a COVID-19 vaccine.
Host Bret Baier asked Hahn, “How fast could something change” in terms of the largest patient groups.
“That really depends on when that big clinical trial is completed,” Hahn said, adding, “We are all looking for a vaccine to get here as soon as possible and I am cautiously optimistic.”
Then he pointed to the vaccine guide that the FDA has “introduced,” which really addresses the issue of what the FDA wants to see to make that judgment, to get attention and safety and efficacy, and that big clinical trial will be that. “
“We want to make sure that the right populations are included, including vulnerable populations,” he continued, adding that the FDA would analyze the data to make a decision on whether a vaccine is safe and effective.
“I can assure the American people that we will not attack on that, that we will use our standard approach that has been proven for years to determine safety and effectiveness,” said Hahn.
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Reported side effects from the trial include tiredness, headaches, muscle aches, chills, and fever. No serious side effects were observed.
James Rogers of Fox News and The Associated Press contributed to this report.
