FDA advisory panel meets to discuss Johnson & Johnson COVID boosters
Information about FDA advisory panel meets to discuss Johnson & Johnson COVID boosters
Members of a Food and Drug Administration advisory panel are expected to meet again Friday to discuss a host of issues surrounding COVID-19 vaccines, including whether “mix-and-match” doses should be approved.
The panel, which on Thursday endorsed a low-dose Moderna booster for certain populations, will consider a booster shot of the one-dose Johnson & Johnson.
It’s unclear whether the committee will have sufficient data to approve the J&J extra dose. About 8,000 people were studied after receiving a second dose two months after their first, and only 17 were tracked after getting a second shot at six months.
The panel will also consider whether people who initially got a J&J one-dose shot should receive an extra dose of either the Pfizer or Moderna shots. A National Institutes of Health study published this week suggested that the best booster for J&J recipients may be from one of the other two manufacturers. The study found a J&J shot followed by a booster from another manufacturer provided more protection than two doses of J&J.
An extra dose of Pfizer for older adults, adults with underlying conditions and those who work in high-risk environments has already been approved. According to the CDC, 5.3% of American adults have received a booster dose of their COVID vaccine.
Also in the news:
►The United States will allow vaccinated foreign nationals to enter the country starting Nov. 8 under a new international travel system. Foreign national air travelers will need to be vaccinated and provide proof of vaccination to fly to the U.S. and ahead of boarding will need to show a pre-departure negative test within three days of travel.
►British health officials said Friday an estimated 43,000 people in England may have received false-negative COVID-19 test results due to problems at a private laboratory.
►Italy’s strict vaccine requirements for all workers went into effect Friday. The rule requires all workers to show a health pass to get into their place of employment. Police were out in force as protests against the rule were expected and could turn violent.
►More than 100 workers at Los Alamos National Laboratory, the nuclear lab where the atomic bomb was created, are suing over a vaccine mandate that gives them until Friday to be vaccinated or fired.
►Finnish President Sauli Niinsto’s office says he is self-isolating as a precaution after he may have been exposed to coronavirus following a meeting with a Latvian colleague in Sweden.
►Anyone age 12 and older will have to provide either proof of COVID-19 vaccination or a recent negative test to attend large events in Washington state starting Nov. 15.
📈 Today’s numbers: The U.S. has recorded more than 44.7 million confirmed COVID-19 cases and more than 721,500 deaths, according to Johns Hopkins University data. Global totals: More than 239.7 million cases and 4.8 million deaths. More than 188.2 million Americans — 56.7% of the population — are fully vaccinated, according to the CDC.
📘 What we’re reading: Amid the pandemic, some college football coaches cashed in despite COVID-related cutbacks. Doing so, created a “bewildering” dissonance between “spending as usual” and “poormouthing and penny-pinching” since the start of the pandemic, said Brian Goff, economics professor at Western Kentucky.
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Newly released Centers for Disease Control and Prevention data shows how vaccinated people across age groups and with all three vaccine brands used in the United States fared much better with COVID-19 infections and deaths than the unvaccinated.
In August, unvaccinated people were 11.3 times more likely to die of COVID-19 and 6.1 times more likely to test positive, the real-world data show.
On the worst reported week of deaths around Aug. 8, for example, unvaccinated people died at a rate of 13.23 per 100,000, compared to Johnson & Johnson recipients at 3.14, Pfizer at 1.43 and Moderna at 0.73.
The vaccines also dramatically change COVID-19 outcomes for the elderly compared to the unvaccinated. Fully vaccinated people aged 80 or older were somewhat less likely to die of the disease than unvaccinated people in their 50s or early 60s. Vaccinated people of every age group were far less likely to test positive than any age group of unvaccinated people.
The CDC says the data come from 16 governments representing about 30 percent of the population, from Florida to Wisconsin to Utah, as well as New York City.
– Mike Stucka
When India was facing a massive COVID-19 surge earlier this year, Jayaram Tadimeti was happy to get vaccinated as soon as possible. Now, it’s a decision he partially regrets.
The 32-year-old got two doses of Covaxin, a COVID-19 vaccine popular in India, in May and June. He worries his vaccine choice will prevent him from visiting friends and family in the U.S. when the country starts allowing international visitors to enter next month. Only foreign nationals who have been fully vaccinated with a drug approved by the U.S. Food and Drug Administration or World Health Organization can enter the country. As of Thursday, that list does not include Covaxin.
U.S. officials’ decision to revamp the country’s entry requirements was welcome news for many travelers, but those who received vaccines that haven’t gotten the WHO’s stamp of approval are left wondering when they’ll get a chance to reconnect with loved ones in the states.
Tadimeti recently moved to Toronto and purchased plane tickets to attend a friend’s wedding in Texas over Thanksgiving weekend, but he’s not sure he’ll be able to attend. Read more here.
– Bailey Schulz
The Food and Drug Administration said Thursday it would convene a panel of outside experts next month to review the safety and efficacy data of Merck’s pill to treat COVID-19.
While those panels have been standard for review of vaccine data, the FDA has not yet convened a similar panel for COVID-19 treatments.
“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating,” said Dr. Patrizia Cavazzoni, director of FDA’s drug center.
The group will meet Nov. 30, meaning Merck’s pill likely won’t receive authorization until December at the earliest.
Earlier this month, Merck said its trial data shows the experimental drug prevented half of severe coronavirus infections that would otherwise have sent people to the hospital.
As an FDA panel considers Johnson & Johnson booster shots Friday, a day after supporting lower-dose Moderna boosters, some recipients of the first J&J shot say they don’t necessarily want another dose of the company’s vaccine.
“I’m going to break up with J&J,” said Jill Oliver, 56, a resident of Boulder, Colorado. She was hesitant to get the company’s shot in March. Although she wanted to wait for a Moderna or Pfizer vaccine, she listened to public health leaders and got the first vaccine available to her.
“I thought I was doing the right thing,” Oliver said. “Now, I’m walking around with my mask on and not feeling protected when I’m the one who stepped up to the plate and did what I was told.”
Studies have shown that while it remains highly effective at preventing severe illness and death, the J&J vaccine is less effective at preventing symptomatic COVID infection compared to Moderna and Pfizer. And the data on J&J’s boosters remains limited.
– Adrianna Rodriguez
Florida will challenge the Biden administration’s vaccine mandate in federal court, Gov. Ron DeSantis said Thursday, vowing that the pending requirement on businesses and hospitals “will go down.”
President Joe Biden’s mandate has yet to be released but is expected this month. It would apply to hospitals that treat Medicare and Medicaid patients and employers with 100 or more employees.
Some Florida hospitals already have COVID-19 vaccine requirements in anticipation of the coming federal rule.
“We are going to contest that immediately,” DeSantis said Thursday at a Florida Department of Health office, where he was linking his promotion of monoclonal antibody treatments to the recent drop of COVID hospitalizations statewide. “And I think that the mandate is going to lose in court. I also think that we have a responsibility at the state level to do whatever we need to do to protect Floridians from mandates that could result in them losing their jobs.”
DeSantis, who has been steadfast in his opposition to vaccine requirements, also cited unverified figures from the monoclonal treatment centers suggesting that large percentages of people seeking those treatments have already been vaccinated. The USA TODAY Network — Florida filed a public records request more than a week ago seeking those figures. The Florida Department of Health has not produced them.
– Frank Gluck, Fort Myers News-Press
A federal advisory committee unanimously supported booster shots of the Moderna COVID-19 vaccine for people 65 and older, as well as younger adults with certain medical conditions or jobs that put them at increased risk for infection. The booster would be half the regular dose, given at least six months after the second shot.
If the panel’s decision is verified by a second advisory group and by top officials at the Food and Drug Administration, Moderna’s booster will be the second one to receive emergency use authorization. The Pfizer-BioNTech extra shot was authorized late last month.
– Karen Weintraub and Elizabeth Weise, USA TODAY
Contributing: The Associated Press