The U.S. Food and Drug Administration’s vaccine advisory panel on Friday voted 16–3 to recommend against providing booster shots of the Pfizer COVID-19 vaccine for individuals aged 16 and older. The panel later voted to endorse the Pfizer booster for individuals who are aged 65 and older and for those who are at high risk.
Throughout the meeting, independent scientists who advise the Food and Drug Administration (FDA) struck a skeptical tone on the need for boosters, or third doses, for Pfizer’s COVID-19 vaccine for the general public. The advisory panel’s discussion is the first major test for the Biden administration’s vaccination agenda as top health officials last month announced they would try to roll out boosters for everyone by Sept. 20.
But for people aged 65 and older and those at high risk of occupational exposure, booster doses were recommended in an 18–0 vote.
It’s not clear when a final FDA decision could come on booster doses, while the Centers for Disease Control and Prevention (CDC) has scheduled a meeting next week to distribute boosters around the United States. The Epoch Times has contacted the FDA for comment.
“We are not bound at FDA by your vote, just so you understand that. We can tweak this as need be,” Dr. Peter Marks, the agency’s top vaccine official, said after the votes were cast.
In a statement following the vote, a White House spokesman said: “Today was an important step forward in providing better protection to Americans from COVID-19. We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week.”
While U.S. health officials, some other countries, and vaccine makers have argued that boosters are needed for everyone, many scientists, including some inside the FDA and the CDC, have disagreed. Booster doses have been previously recommended by the CDC for immunocompromised individuals.
But an FDA slide said the risk of COVID-19 for a healthy 30-year-old is just 0.0004 percent, or 1 in 250,000, bolstering arguments against boosters being recommended for the general population. Some recommended a booster for older individuals but several experts said they want more data about whether the booster shots can contribute to myocarditis, a type of heart inflammation.
Dr. James Hildreth, a voting member on the FDA expert panel, said that he “[has] a serious concern of myocarditis in young people.” The FDA previously issued warnings that, while rare, Pfizer and Moderna vaccines, both of which are built on messenger RNA technology, could cause myocarditis or pericarditis among younger individuals.
“I honestly don’t think there is enough good quality data at this point to make an informed decision,” Brittany Kmush, an epidemiologist at Syracuse University, said of the Israeli study, noting the 12-day follow-up period and the variability of the authors’ estimates.
Another FDA advisor, Dr. Melinda Wharton, meanwhile, echoed Hildreth’s concerns and said she would “not feel comfortable” with recommending boosters to younger people due to the risk of myocarditis. Younger people are not at risk of developing severe illness from COVID-19 or becoming severe breakthrough cases, she noted during the panel.
Earlier this week, the FDA uploaded Pfizer’s arguments that cited studies in Israel and the United States suggesting that the COVID-19 vaccine’s efficacy drops over time and said that booster doses are necessary to deal with new variants of the CCP (Chinese Communist Party) virus, which causes COVID-19.
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FDA Panel Votes 16–3 Against Approving Pfizer COVID-19 Booster Shots
The U.S. Food and Drug Administration (FDA) advisory panel on Friday voted 16-3 to recommended against providing booster shots of the Pfizer COVID-19 vaccine for individuals aged 16 and older.
Throughout the meeting, independent scientists to the FDA struck a skeptical tone on the need for boosters, or third doses, for Pfizer’s mRNA COVID-19 vaccine for the general public. The advisory panel’s discussion is the first major test for the Biden administration’s vaccination agenda as top health officials last month announced they would try to roll out boosters for everyone by Sept. 20.
While U.S. health officials, some other countries and vaccine makers have argued that boosters are needed, many scientists, including some inside the FDA and the U.S. Centers for Disease Control and Prevention (CDC), have disagreed. Booster doses have been previously recommended by the CDC for immunocompromised individuals.
But to boost arguments against boosters being recommended for the general population, an FDA slide said the risk of COVID-19 for a or healthy 30-year-old is just 0.0004 percent, or 1 in 250,000. Some recommended a booster for older individuals but several experts said they want more data about whether the booster shots can contributed to myocarditis.
Dr. James Hildreth, a voting member on the FDA expert panel, said that he “[has] a serious concern of myocarditis in young people,” referring to a type of heart inflammation. The FDA previously issued warnings that while rare, Pfizer and Moderna vaccines could cause myocarditis among younger individuals.
“I honestly don’t think there is enough good quality data at this point to make an informed decision,” Brittany Kmush, an epidemiologist at Syracuse University, said of the Israeli study, noting the 12-day follow-up period and the variability of the authors’ estimates.
And another FDA advisor, Dr. Melinda Wharton, meanwhile, echoed Hildreth’s concerns and said she would “not feel comfortable” with recommending boosters to younger people due to the risk of myocarditis. Younger people are not at risk of developing severe illness from COVID-19 or becoming severe breakthrough cases, she noted during the panel.
Earlier this week, the FDA uploaded Pfizer’s arguments that cited studies in Israel and the United States suggesting that the COVID-19 vaccine’s efficacy drops over time and said that booster doses are necessary to deal with new virus variants.
Read Full Article on TheEpochTimes.com
