Kansas City, Missouri 2021-09-17 17:44:57 –
Washington (AP) —Giving the White House a devastating setback, a government advisory board overwhelmingly rejected plans to give Pfizer COVID-19 booster shots entirely on Friday, instead over 65 or severe illness Risk is high.
The twin vote has hit Biden’s radical effort to strengthen the protection of almost all Americans a month ago in the epidemic of the highly contagious delta variant. rice field.
The ruling came from an influential committee of outside experts advising the Food and Drug Administration.
Surprisingly, the panel rejected almost everyone’s booster with a 16-2 vote. Members cited the lack of safety data on additional doses and questioned the value of mass boosters rather than targeting specific groups.
Then, in an 18-0 vote, we approved additional shots for a portion of the US population, the part at highest risk for the virus.
It helps save some of the White House campaign, but it’s still a big step from the widespread proposal to provide Americans with booster shots of both Pfizer and Moderna vaccines eight months after the second vaccination. is.
Friday’s ruling was only the first step in the process. The FDA itself is expected to make booster decisions within a few days, but usually follows the Commission’s recommendations.
Booster offerings are also subject to review by the Centers for Disease Control and Prevention. The CDC Advisory Board will address the question on Wednesday. The CDC says it is considering boosters for the elderly, nursing home residents, and front-line healthcare professionals, rather than all adults.
The FDA and CDC are most likely to decide at a later point whether the person receiving the Moderna or J & J shot needs to get a booster.
During a few hours of lively debate on Friday, panel members questioned the value of providing boosters to almost anyone over the age of 16.
Dr. Cody Meissner of Tufts University said: “And the main message we send is that everyone needs to be given twice.”
Dr. Amanda Korn of the CDC said: “At this point, it is clear that unvaccinated people are promoting the infection in the United States.”
Scientists inside and outside the government have recently been divided on the need for boosters and who should get them, and the World Health Organization is rich when poor countries do not have enough of the first vaccine. The country strongly opposes the third vaccination.
Studies show that the immune level of vaccinated people declines over time, and boosters can reverse it, but Pfizer vaccines remain among the delta variants for serious illness and death. Very protective.
The sudden change in the event could reinforce recent criticism that the Biden administration was ahead of science in promoting boosters. President Joe Biden promised early on that his administration would “follow science” following the disclosure of political interference in the Trump administration’s coronavirus reaction.
The overwhelming first refusal of the FDA panel began providing boosters to citizens in July, despite full debate about the need for boosters from both Pfizer and Israeli health authorities.
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.”
And Pfizer’s representative argued that it was important to begin to strengthen immunity before protection began to erode. According to a company survey of 44,000 people, the efficacy against symptomatic COVID-19 was 96% 2 months after the second dose, but decreased to 84% in about 6 months.
Both Pfizer and Israeli representatives faced backlash from panelists. Some were skeptical of the link between Israel’s experience and the United States. Another concern was whether the third dose exacerbated the rare side effects such as heart inflammation seen in young men.
Pfizer pointed out Israeli data from nearly 3 million boosters, suggesting that side effect rates are similar to those already reported.
Dr. Paul Offit, a vaccination expert at the Philadelphia Children’s Hospital, supported a third dose for adults over the age of 60 or 65, but it’s “really embarrassing” for anyone up to the age of 16. I have. “
Extra shots will probably reduce mild or asymptomatic cases, at least temporarily, but “the question is how it affects the pandemic arc, but that may not be so many. No, “Ofit said.
Biden’s top health advisors, including the FDA and CDC heads, first announced plans for a wide range of booster shots in mid-August, setting the week of September 20 as an almost certain start date. But that was before FDA staff scientists completed their own assessment of the data.
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 said the study showed that the shot was working well.
On Friday, U.S. Surgeon President Vivek Murthy said the Biden administration’s announcement was not aimed at encouraging regulators to act, but instead provided transparency to the public and in case boosters were approved. He said it was an attempt.
“We have always said that this initial plan relies on independent assessments by the FDA and CDC,” Mercy said.
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.
The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.
US panel backs COVID-19 boosters only for elderly, high-risk | News Source link US panel backs COVID-19 boosters only for elderly, high-risk | News