In this March 2, 2021 file photo, pharmacy engineer Hollie Maloney loads a syringe with Pfizer’s COVID-19 vaccine at the Portland Expo in Portland, Maine. (AP Photo / Robert F. Bukaty, File)
Washington (AP) —Influential Federal Advisory Board has categorically rejected plans to provide most Americans with Pfizer booster shots against COVID-19.
Friday’s 61-3 vote hit the Biden administration’s efforts to increase people’s protection against the virus among the highly contagious delta mutants.
During a few hours of discussion, members of the Food and Drug Administration panel of outside experts complained that Pfizer provided little data on the safety of additional doses.
And they complained that the data provided by Israeli researchers about their booster campaign might not be suitable for predicting the US experience.
This is the latest news update. The previous story of AP is as follows.
Washington (AP) — When the government’s advisory board met to decide whether to approve additional doses of the Pfizer vaccine, the Biden administration’s embarrassing plan to distribute COVID-19 booster shots to most Americans We faced the first big hurdle on Friday.
Scientists inside and outside the government have recently disagreed on the need for boosters and who should get them, and the World Health Organization says that when poor countries don’t have enough vaccines, rich countries Their first strongly opposes giving a third inoculation.
A panel of outside experts advising the Food and Drug Administration was less important than the clear case: studies show that the immune level of vaccinated people declines over time, and boosters reverse it. Although suggesting that it can be done, the Pfizer vaccine is still very protective against serious illness and death, even with the prevalence of highly contagious delta variants.
FDA experts were planning to vote on one basic question. Does the evidence show that Pfizer boosters are safe and effective for people over the age of 16? If voted in favor, the FDA is expected to promptly approve Pfizer’s shot boosters.
But that’s just one step in the process. The more annoying question of who should be shot when will be discussed by an advisor to the Centers for Disease Control and Prevention on Wednesday. The CDC typically adopts group recommendations for setting policies for US vaccination campaigns.
The CDC says it is considering boosters for the elderly, nursing home residents, and front-line healthcare professionals, rather than all adults.
People who receive Moderna or J & J shots will need separate decisions from the FDA and CDC to get boosters.
The meeting on Friday was held as Delta Variant continues to bring US cases and deaths back to levels not seen since last winter. The Biden administration said vaccination of people was a priority in the first place, but the growing crisis urged efforts to strengthen Americans’ protection against the virus by giving them booster shots. Gave.
Dr. Peter Marks, FDA’s top vaccine regulator, acknowledged a fierce disagreement in the opening remarks to the Advisory Board.
“We know that there may be different opinions on the interpretation of the data,” he said. “We strongly encourage you to express and discuss all the different perspectives on complex and evolving data.”
Israel has already provided boosters to its citizens, and the UK announced this week that it plans to begin providing boosters to people over the age of 50 and other vulnerable groups six months after the second dose. bottom.
In the first presentation of the day, British researcher Jonathan Stern presented many questions about ongoing research to accurately show how effective the vaccine is at different times in different countries. ..
“We need to be very careful about the obvious short-term benefits of vaccination,” he said.
Israeli health officials have released data from the experience of providing additional doses to approximately 3 million adults since late July. The government began its efforts among the first vaccinated people after signs of Pfizer vaccine prevention dropping from 97% to 85% by July this year.
Sharon Alroy-Israel Health Department Preis said booster doses improve protection against infections in people over the age of 60 by a factor of 10.
“It’s like a fresh vaccine,” she said, returning protection to its original level and helping Israel “mitigate the serious cases of the fourth wave.”
A Pfizer study of 44,000 people showed that efficacy against symptomatic COVID-19 was 96% 2 months after the second dose, but decreased to 84% in about 6 months. rice field. The company argued Friday that it was important to strengthen immunity before defenses against severe illness began to erode, but many scientists point out that it is not clear if that will happen.
“It’s time to restore protection with a safe and effective booster dose …” Pfizer’s Dr. William Gruber told the panel.
According to a study by one company, boosting about 300 people six months after the second dose resulted in higher levels of antibodies fighting the major virus than in previous shots. More importantly, they were strong enough to handle delta mutants and other nasty strains. ..
President Joe Biden’s top health advisors, including the FDA and CDC heads, first announced plans for a wide range of booster shots a month ago, with the week of September 20 as an almost certain start date. The booster will be dispensed eight months after the second dose of the Pfizer and Moderna vaccines.
But that was before FDA staff scientists completed their own assessment of the data. Some experts questioned whether Biden had broken his own pledge to “follow science” at COVID-19 by being ahead of government scientists.
Earlier this week, two top FDA vaccine reviewers joined a group of international scientists and published an editorial denying the need for boosters for healthy people. Scientists say ongoing research shows that shots work well despite the delta variant.
On Friday, U.S. Surgeon President Vivek Murthy added that the Biden administration was not trying to pressure regulators to act when announcing its booster program, but instead was transparent to the public. He said he was preparing for the shot if it was approved.
“We have always said that this initial plan relies on independent assessments by the FDA and CDC,” Mercy said. “We follow that assessment and its recommendations and make sure that the final plan reflects that.”
The Biden program also raised major ethical concerns about the poorest parts of the world seeking vaccines. However, the government argued that the plan was not ours or their choice and pointed out that the United States is supplying large quantities of vaccine to other parts of the world.
The United States has already approved Pfizer and Modana boosters for certain people with weakened immunity, such as cancer patients and transplant recipients.
Some Americans, healthy or unhealthy, could get boosters simply by appearing and asking for shots. And some healthcare systems are already providing additional doses to high-risk people.
FDA Advisory Board Rejects Extensive Pfizer Booster Shots | Chicago News
Source link FDA Advisory Board Rejects Extensive Pfizer Booster Shots | Chicago News
The post FDA Advisory Board Rejects Extensive Pfizer Booster Shots | Chicago News appeared first on Illinois News Today.
No comments:
Post a Comment