Atlanta, Georgia 2021-09-17 16:36:00 –
(CNN)-US Food and Drug Administration Vaccine Advisor unanimously voted on Friday, urgently six months after Pfizer’s vaccine boost to people over the age of 65 and those at high risk of severe Covid-19. We have recommended permission to use it.
Members of the FDA’s Vaccine and Related Biopharmaceutical Advisory Board reject an extensive application to approve a booster dose of Pfizer’s vaccine for all persons 16 years and older six months after being fully vaccinated. Did.
Members of the committee questioned the safety of booster immunization in young adults and teens and complained about the lack of data on the safety and long-term efficacy of booster immunization.
Biden administration officials have previously announced plans to begin boosting immunization to the general population in the week of September 20, awaiting approval from the FDA and the US Centers for Disease Control and Prevention.
Some advisors, including a group of vaccine specialists, immunologists, pediatricians, infectious disease specialists, and public health professionals, say the process is in a hurry for that target date.
On Friday, some said they wanted to see more data, or believed that boosters were likely needed, but for a more limited segment of the population.
“I don’t think the booster effect will contribute significantly to the suppression of pandemics,” Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, said at a conference.
“The main message we still convey is that everyone has to be given two doses. Everyone has a primary series. This booster dose is a big part of this pandemic behavior. It can’t make a difference .. “
During the meeting, Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said that people’s immunity can be weakened, and that it actually weakens and that booster doses restore immunity. Said that it shows. vaccination. He said people who took the booster had no more side effects than were seen after the first two doses.
And while the double-dose Pfizer vaccine continues to provide adequate protection from severe infections, hospitalizations and deaths, Gruber said there are hints that may change.
The company relied heavily on data from Israel, where vaccinated people began to develop breakthrough infections. Israeli researchers have previously told the conference that adding booster shots to Israel helped keep many people away from the hospital.
“Israel’s experience could foreshadow the future of Covid-19 in the United States,” Gruber said. “Real-world evidence in Israel and the United States suggests that the effectiveness of the vaccine against Covid-19 infection diminishes about 6-8 months after the second dose,” he added.
“In addition, recent US CDC data suggest a reduced efficacy of the Covid-19 vaccine for serious illness and hospitalization in the United States,” he said. “The efficacy of this reduced vaccine is followed for a longer period between two doses of the vaccine and exposure to SARS coronavirus.”
However, FDA staff and advisors have pushed back the data available so far.
Dr. Phil Krause, Deputy Director of the FDA’s Vaccine Research Review Office, said Pfizer is using data that has not been reviewed by experts.
“One of the problems with this is that much of the data presented and discussed today has not been peer-reviewed and reviewed by the FDA,” Krause told the Vaccines and Related Biological Products Advisory Board meeting. Told.
Krause, along with another FDA vaccine stakeholder, Marion Gruber, signed a Lancet treatise published earlier this week, arguing that it was too early to start providing boosters to people.
Dr. Michael Krilla, an infectious disease specialist at the National Center for Advancing Translational Sciences, said the study relies heavily on antibody measurements without looking at other important aspects of the immune response.
“It’s a little disappointing that there are few reports of cell-mediated immune responses and the full focus on neutralized antisera,” said Krilla. “Clearly essential for that high-risk population, but for a wide population from a protection standpoint, this seems to be well-held over the long term-(it) should be for a proper cell-mediated immune response. But we don’t have that sign.
“Therefore, it is unclear if we need to boost everyone, except for a subset of the population that are clearly at high risk of serious illness.”
Pfizer has received full FDA approval for the vaccine, and the request for additional booster doses complements that approval. Pfizer (and other researchers) say their study shows that people develop strong immunity after two doses of the vaccine, but antibody levels begin to decline after a few months.
The FDA said in its briefing document that Pfizer’s vaccine (and the vaccine produced by Moderna and Johnson & Johnson) provides strong protection against severe illness, hospitalization, and death, even if the antibody declines over time. Said.
After the FDA Advisory Board makes recommendations, the FDA decides whether to approve booster doses.
The CDC is planning a meeting of vaccine advisors on September 22nd and 23rd. The CDC must give a stamp of approval that the booster dose will be officially given. In a letter sent Thursday and obtained by CNN, the CDC urged local and state health authorities to wait for boosters to be administered until approved by both agencies.
The third dose has already been approved for certain immunocompromised people, but not for the general public.
This is the latest news and will be updated in the future.
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