The FDA is expected to decide as early as Wednesday whether the 15 million Americans who got the single-dose J&J shot by Janssen Pharmaceutical Companies should get a second dose.
With an FDA decision on boosters expected as early as Wednesday, people waiting on a final recommendation respond with relief, eager anticipation.
Catch up on the developing stories making headlines.Bob Daemmrich/ZUMA PressFor Mitchell Kronenberg, answers on the Johnson & Johnson vaccine can't come soon enough.A 42-year-old dad living outside Charlotte, North Carolina, Kronenberg enrolled in a clinical trial for the single-dose vaccine and got his shot last January. Since then, he's been patiently waiting for U.S. federal regulators to tell him what to do next to stay safe: Should he get another Johnson & Johnson shot? Switch to Moderna or Pfizer? Is his single-shot vaccination enough to protect him from spreading the virus to his unvaccinated 4-year-old son?
"Why is it taking so long? You have people out on a ledge out here," he said of the process.The U.S. Food and Drug Administration is expected to decide as early as Wednesday whether the 15 million Americans who got the single-dose J&J shot by Janssen Pharmaceutical Companies should get a second dose. The decision comes after studies suggested effectiveness against moderate and severe symptoms climbed from 70% with one dose to 94% with two doses.
MORE: J&J recipients should 'feel good' about booster recommendation: FauciAlso anticipated is a decision on possible third booster shots for Moderna recipients and whether Americans can mix vaccine brands when getting a booster.With a decision expected soon, an advisory panel to the Centers for Disease Control and Prevention planned to meet Thursday to offer the public a final recommendation. headtopics.com
Emily Elconin/ReutersA patient receives their COVID-19 vaccine booster during a Pfizer-BioNTech vaccination clinic in Southfield, Mich., Sept. 29, 2021.Typically a wonky endeavor ignored by most Americans, the FDA and CDC regulatory process is now being closely followed by millions of Americans. People describe joining private Facebook groups to swap the latest research and repeatedly getting their antibody levels checked, even if experts warn it's an incomplete measure of a person's immunity.
Some have even opted to mix booster shots on their own even without the federal government's blessing."Every day, I was researching, Googling, reading everything I could get my hands on," said Lynne Conway, a 59-year-old development officer for an animal shelter in Ithica, New York.
Conway said she experienced mild heart inflammation following her first dose of Moderna last March. After ruling out other causes, her doctor recommended she get the J&J so she can be fully protected against COVID-19. She got that shot in August, despite there being no official green light from regulators to mix shots in such a way.
"The relief of finally deciding to get the (J&J) vaccine, and have it over with, was monumental," she said.J&J recipients are among those who expressed being most on edge emotionally, with the 70% effectiveness after one shot -- lower than the two doses of Pfizer or Moderna. headtopics.com
MORE: Independent FDA panel votes to authorize booster shots for Johnson & Johnson vaccineJadzia Pierce, who lives outside of Washington, D.C., said she was relieved regulators were inching toward a decision. In her early 30s, Pierce isn't at serious risk of major complications from COVID-19.
But she also would like to visit higher-risk relatives this holiday season and to know she's not at risk of infecting them."Even if the answer is (that it puts) other people around at risk, then I guess I just won't go home," she said."I just feel like safety is the most important thing at this point and that's really all that matters to me."
Bob Daemmrich/ZUMA PressThe booster shot for the Pfizer vaccine against COVID-19 is administered to a Texas resident over 65 at a pharmacy clinic in Austin, Texas, Oct. 4, 2021.J&J declined to comment for this article, citing pending action by regulators. But last Friday, after a meeting of FDA advisors, a top company official told ABC News the J&J vaccine likely protects people by triggering the protection of a person's T-cells, which is harder to measure than antibodies.
J&J's"biggest, most impressive components are T-cells, which contribute to both efficacy and durability of our vaccine," said Mathai Mammen, global head of R&D at the Janssen Pharmaceutical Companies of Johnson & Johnson.For its part, the FDA says its staff is working around the clock to comb through technical data. The CDC too has to hear from its own advisory panel before making a decision. headtopics.com
Kronenberg, who has to travel for work as a director for a medical device company, said he still worries about spreading the virus to his son. He says he understands wanting to get it right but wishes the various agencies could get in a room together and hash it out immediately, rather convene separate meetings and reviews that can drag on for weeks.
Pierce, also in limbo having received the J&J, said she's torn on whether to be frustrated with the regulatory bureaucracy."I'm trying to be patient. I do realize that this stuff takes time, and I don't want to be following advice that is too rushed and not complete," she said.
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Poke me like its Facebook in 2007 I know people who don't agree with getting the COVID-19 vaccine, but the politics they like & listen to are saying we need to get a COVID-19 vaccine. And do those people are now saying we need to get a COVID-19 vaccine just because the politics they like & listen to are saying it
BrianLaundrie parents know what happened to GabbyPetito Roberta, Christopher and Brian Laundrie have blood on their hands. Get it and you will die They told us that it was 95% effective with one dose! 🙄 Lies, lies, lies. Be prepared to be told to have two, three or four doses per year… 😡😡😡 Seriously how can we believe anything the FDA, CDC abc cnn says under the Biden Administration? Wake me up after the next election.
Vaccine efficacy is limited, and my grandfather said during his lifetime that vaccination was better than a single dose. My grandfather was a doctor. Amen CrystalCOdomsCurrently40YearsOldAndFullyPfizerVaccinated
FDA Will Reportedly Let Americans Mix And Match Covid BoostersU.S. health officials hope to ramp up Covid-19 vaccine booster shots in the coming weeks. good luck Uncle Rico would be proud choose your flavor
FDA proposes over-the-counter hearing aids for AmericansThe proposed rule aims to facilitate innovation and increase competition by lowering the barriers to entry for new hearing aid manufacturers, the agency said. The proposed rule follows an instruction in President Joe Biden's broad competition executive order, which had told the Department of Health and Human Services to 'promote the wide availability of low-cost hearing aids,' among many other instructions aimed at a wide variety of industries. The White House had estimated that allowing over-the-counter sales of hearing aids could save people with hearing loss thousands of dollars.
FDA Nearing Approval for Mixing and Matching Covid-19 Booster ShotsThe FDA is nearing a move to allow people to get a Covid-19 booster that's different from their initial vaccine, people familiar with the matter say What could go wrong ? Please provide data of long term effects - Thanks COVID-19 vaccines profits in 2021 Pfizer, Johnson & Johnson, Moderna, AstraZeneca ... mix but shaken, not stirred
COVID-19 updates: FDA may allow mixed boosters: SourceLATEST: A national state of emergency for children's mental health has been declared by the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry and the Children’s Hospital Association. Let's keep the kids in masks. That should help. FCSSuptLooney pay attention, your policies on masks are part of this problem! End mask mandate now!!
FDA May Soon Allow Mix-And-Match COVID-19 Boosters: ReportMillions of Americans could be eligible for a booster shot of a coronavirus vaccine by the end of the week, The New York Times reported. My mom has already had her booster. She said it made her fall asleep in her favorite chair that afternoon. She's 83, she falls asleep in her chair every afternoon.
FDA to allow ‘mix-and-match’ approach on coronavirus booster vaccinesThe Food and Drug Administration is expected to say that people should generally stick to the same vaccine if possible, but to allow other brands of boosters.