JUST IN: FDA advisory panel votes to recommend Moderna booster shots for emergency use authorization for certain at-risk groups.
Jacqueline Miller, therapeutic area head for infectious diseases at Moderna, said in her presentation to the committee that the company chose the half dose because it wanted to use the lowest dose possible needed to induce an immune response.
compared to people who received their vaccinations several months later, Miller said. Nearly all of these breakthrough infections were caused by the delta variant."We are concerned about the breakthrough disease that we’ve been observing in the participants in the [original clinical trial], and particularly the breakthrough cases that we’re starting to see in severe disease in the older adults," Miller said.
However, the booster trial didn’t include enough participants to evaluate whether the extra dose raised the risk forMyocarditis, or inflammation of the heart muscle, has been linked to both Moderna and Pfizer’s Covid-19 vaccines. The condition is rare and mostly commonly seen in men under 30. In data from Israel, where 3.7 million people have received a Pfizer booster shot, 17 cases of myocarditis were reported, said Dr. Sharon Alroy-Preis, director of public health services for Israel’s Ministry of Health, who presented Thursday.
France Dernières Nouvelles, France Actualités
Similar News:Vous pouvez également lire des articles d'actualité similaires à celui-ci que nous avons collectés auprès d'autres sources d'information.
FDA Staff Don’t Take Position on Moderna Covid-19 BoosterIn an unusual move, FDA staff didn't take a position on Moderna's application for a booster shot, indicating there may be insufficient data to support one
Lire la suite »
FDA Neutral on Moderna Bid for Booster Ahead of Decisive MeetingThe FDA is keeping its cards close to the vest when it comes to the potential approval of a booster dose of Moderna’s COVID-19 vaccine.
Lire la suite »
FDA to take up Moderna, J&J Covid-19 booster questions this weekVaccine advisers to the FDA meet Thursday and Friday of this week to tackle the next round of questions about booster vaccines for Covid-19 — and they might be seeing the first trickle of data on mix-and-match boosters.
Lire la suite »
COVID-19 Live Updates: FDA to hold crunch talks over J&J and Moderna vaccine boostersThe Food and Drug Administration is set to hold crucial meetings over the next two days to decide whether to issue booster shots of Johnson & Johnson and Moderna COVID vaccines. Follow Newsweek's liveblog for all the latest.
Lire la suite »
FDA panel debates lower-dose Moderna COVID shots for boosterU.S. health advisers are debating if millions of Americans who received Moderna vaccinations should get a booster shot -- this time, using half the original dose. Already millions who got their initial Pfizer shots at least six months ago are getting a booster of that brand.
Lire la suite »
White House vetting former FDA Commissioner Dr. Rob Califf to once again lead agencyCNN News, delivered. Select from our newsletters below and enter your email to subscribe.
Lire la suite »