U.S. FDA advisers reject broad COVID-19 boosters for all but recommend for older adults
Record ID:
1637282
U.S. FDA advisers reject broad COVID-19 boosters for all but recommend for older adults
- Title: U.S. FDA advisers reject broad COVID-19 boosters for all but recommend for older adults
- Date: 17th September 2021
- Summary: GAINESVILLE, FLORIDA, UNITED STATES (SEPTEMBER 17, 2021) (REUTERS) (SOUNDBITE) (English) PROFESSOR OF BIOSTATISTICS AT THE UNIVERSITY OF FLORIDA DR. IRA LONGINI SAYING: "The assessment from Israel on the effectiveness and safety of boosters is based on very limited follow-up: just a matter of weeks or maybe a month at the most. So we really don't know from those data really how effective boosters are or how safe they are. I would like to point out that the epidemic in Israel is very concerning. It is not going down. In fact, it is increasing even after the boosters were rolled out." WASHINGTON, D.C., UNITED STATES (SEPTEMBER 17, 2021) (REUTERS) PAN OF OVER 650,000 WHITE FLAGS ON GROUND OF NATIONAL MALL REPRESENTING U.S. PERSONS WHO HAVE DIED OF COVID-19 GAINESVILLE, FLORIDA, UNITED STATES (SEPTEMBER 17, 2021) (REUTERS) (SOUNDBITE) (English) PROFESSOR OF BIOSTATISTICS AT THE UNIVERSITY OF FLORIDA DR. IRA LONGINI SAYING: "If we rolled out a third dose, a booster dose, in the U.S. right now, we're talking about 200 million people getting vaccinated again. We just have to be very, very careful that the benefits outweigh the risks. I think the global shortage of vaccines, if we could actively vaccinate throughout the planet in countries where transmission is occurring, we could slow transmission of the virus and slow the rate at which these very deadly variants are arising. And that probably should be a higher priority to use vaccines that are available to get the global pandemic under control rather than using those doses to boost when we're not even sure the boosters are necessary." INTERNET (SEPTEMBER 17, 2021) (REUTERS) (SOUNDBITE) (English) DR. JAY PORTNOY, PEDIATRIC ALLERGIST AND IMMUNOLOGIST AT CHILDREN'S MERCY HOSPITAL IN KANSAS CITY, MISSOURI, PROFESSOR AT UNIVERSITY OF MISSOURI KANSAS CITY SCHOOL OF MEDICINE AND MEMBER OF THE FDA ADVISORY COMMITTEE, SAYING: "It would be great to wait until we have all the data about safety but I work at a children's hospital. My hospital is filling up with kids that have COVID. We didn't want to rush into approving the vaccine for them and now look where we are. It's very frustrating because we're just inundated with kids who supposedly weren't going to get COVID. The concern that we have that people are going to get myocarditis from COVID vaccine is real. The question we really need to be asking though is whether it or any other severe adverse reaction from the vaccine is greater than the risk of getting it from breakthrough infection. Myocarditis is generally a short-term condition. Most people who get it recover from it. I worry more about long-term systemic complications of COVID which are real and can be prevented with the vaccine."
- Embargoed: 1st October 2021 23:11
- Keywords: COVID-19 vaccine boosters FDA panel Longini Lonnie Bunch
- Location: INTERNET / WASHINGTON, D.C.; GAINESVILLE AND PEMBROKE PINES, FLORIDA; COLUMBUS, OHIO, UNITED STATES
- City: INTERNET / WASHINGTON, D.C.; GAINESVILLE AND PEMBROKE PINES, FLORIDA; COLUMBUS, OHIO, UNITED STATES
- Country: USA
- Topics: Health/Medicine,United States
- Reuters ID: LVA009EV3ZH3B
- Aspect Ratio: 16:9
- Story Text: A panel of expert outside advisers to the U.S. Food and Drug Administration voted on Friday (September 17) to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.
The panel also recommended that the FDA include healthcare workers and others at high risk of occupational exposure to the virus that causes COVID-19, such as teachers.
Dr. Ira Longini, a biostatistics professor at the University of Florida who was one of the authors of a recent article in the Lancet medical journal advocating against mass boosters, said there just isn't enough medical evidence that the boosters are necessary or even how they would be most effective.
"I think we need the scientific evidence before we go forward with such a large and important campaign such as boosting. And we may very well need boosters and it may become an important part of our vaccination strategies but we need to do this based on scientific evidence and not on innuendo or opinion. And I really think within six months we'll have very clear answers about this issue," he said.
"If we rolled out a third dose, a booster dose, in the U.S. right now, we're talking about 200 million people getting vaccinated again. We just have to be very, very careful that the benefits outweigh the risks. I think the global shortage of vaccines, if we could actively vaccinate throughout the planet in countries where transmission is occurring, we could slow transmission of the virus and slow the rate at which these very deadly variants are arising. And that probably should be a higher priority to use vaccines that are available to get the global pandemic under control rather than using those doses to boost when we're not even sure the boosters are necessary," he added.
Not all doctors agreed. Dr. Jay Pourtnoy, a medical professor and pediatric allergist and immunologist at Children's Mercy Hospital in Kansas City, Missouri, said while he welcomed more data, time was critical in protecting patients from COVID-19.
"It would be great to wait until we have all the data about safety but I work at a children's hospital. My hospital is filling up with kids that have COVID. We didn't want to rush into approving the vaccine for them and now look where we are. It's very frustrating because we're just inundated with kids who supposedly weren't going to get COVID. The concern that we have that people are going to get myocarditis from COVID vaccine is real. The question we really need to be asking though is whether it or any other severe adverse reaction from the vaccine is greater than the risk of getting it from breakthrough infection. Myocarditis is generally a short-term condition. Most people who get it recover from it. I worry more about long-term systemic complications of COVID which are real and can be prevented with the vaccine," said Portnoy.
The White House earlier on Friday said it was ready to roll out boosters of the Pfizer /BioNTech vaccine next week if health officials approve them. But Friday's vote if followed by the FDA would represent a more modest rollout of booster shots than outlined by the Biden administration, which called for their widespread use six months after people received their first round of shots.
Panel members rejected Pfizer's request for full approval for booster shots for those aged 16 and older. Instead, the advisory panel's recommendation was for an emergency use authorization for the narrower group.
Panel members unanimously approved the recommendation for a third dose for older Americans, and were convinced by evidence showing these individuals were at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots.
The FDA will take the panel's recommendation into consideration in making its final decision on the boosters.
The vote came as a group of officials gathered at the National Mall to view artist Suzanne Brennan Firstenberg installation in Washington comprised of more than 650,000 white flags - one for every person in the United States who had died from COVID-19.
The exhibition, entitled "In America: Remember," will remain on display through Oct. 3, 2021.
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