FDA advisory panel endorses Pfizer's vaccine for widespread use
A U.S. government advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine Thursday, putting the country just one step away from launching an epic vaccination campaign against the outbreak that has killed close to 300,000 Americans.
Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation.
In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and older.
A day-long virtual hearing about whether the Pfizer COVID-19 vaccine is both safe and effective. The FDA is expected to take the advice of this outside group and could then start shipping millions of doses of the vaccine.
“We must demonstrate the vaccine is highly effective in the majority of people," said Sarah Christopherson from National Women’s Health Network.
Ongoing studies have proven the vaccine to be more than 90% effective. It’s the same vaccine being used in the UK as of this week. Canada has also approved emergency use.
During a lengthy public comment period…
“Nothing felt rushed and I never felt like a Guinea pig," Phase 1 NYU trial participant Evan Fein said in the provided testimony about long-term side effects of the vaccine:
“It’s been more than 5 months now since my first shot," Fein said. "I can happily report there are none.”
Later, the debate grew about whether trial participants who received the placebo should be notified and receive the vaccine early:
“There are many prioritization criteria out there and I haven’t seen one that includes trial participating as a basis for jumping the queue," he said.
If approved, Wisconsin will play an important role. Pfizer plans to ship the vaccine from two hubs – one of them is in Pleasant Prairie. Healthcare workers and residents of long-term care facilities will be the first to roll up their sleeves, followed by essential workers, adults with high-risk medical conditions and seniors. The general public may not be eligible until late spring or early summer.
Wisconsin is expected to get about 50,000 doses right away. By comparison, there are more than 400,000 health care workers in the state.
Associated Press contributed to this article.