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☆ FDA approves $3.5 million treatment for hemophilia, now the most expensive drug in the world
▼ + stars: | 2022-11-23 | by ( Deidre Mcphillips | ) edition.cnn.com time to read: +2 min

CNN —The US Food and Drug Administration on Tuesday approved Hemgenix, a new drug to treat hemophilia. Manufacturer CSL Behring set the price at $3.5 million per treatment, making it the most expensive drug in the world. In a recent cost-effectiveness analysis of the drug, weighing health benefits against offset costs, ICER suggested that a fair price for the drug to be between $2.93 million and $2.96 million. According to an analysis by GoodRx, the most expensive drug in the US previously was Zolgensma, which was approved by the FDA in 2019 to treat spinal muscular atrophy and priced at $2.1 million for a course of treatment. FDA approved Hemgenix based on safety and effectiveness evaluated in two studies of about 60 adult men.

☆ FDA says two studies showing omicron boosters weren't much better than old Covid shots were too small to come to any conclusions
▼ + stars: | 2022-10-28 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

The recently authorized booster vaccine protects against the original SARS-CoV-2 virus and the more recent omicron variants, BA.4 and BA.5. The Food and Drug Administration said two studies this week showing that the new omicron boosters weren't that much better than the old shots were too small to come to any real conclusions. The antibody responses were slightly higher with the omicron boosters, though the studies concluded the difference wasn't significant. The studies are of public interest because there's very limited human data on how the omicron BA.5 boosters perform right now. The FDA also looked at data directly on the BA.5 shots that came from animal studies.

☆ Updated Covid-19 boosters offer protection, but new studies suggest they don't offer an edge against Omicron
▼ + stars: | 2022-10-26 | by ( Brenda Goodman | ) edition.cnn.com time to read: +13 min

Similar immune responsesThe studies have important limitations, and they aren’t the final word on the updated boosters. In Barouch’s study, antibody concentrations were 15 times higher after the original boosters, rising from 184 to 2,829. They were 17 times higher after the updated shots, jumping from 211 to 3,693. After waiting the recommended three months since his last Covid-19 infection, President Joe Biden got an updated booster Tuesday and urged eligible Americans to do the same. Worobey says that when the strains are combined as they are in the updated boosters, they actually end up competing.

☆ Pfizer-BioNTech releases first human results on updated booster, citing an increase in antibodies
▼ + stars: | 2022-10-13 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

The results are based on blood samples taken from adults one week after they received the updated booster. The FDA also authorized Moderna's updated booster based on similarly limited data. The FDA authorized the updated shots based on studies in mice — plus human trial results from a similar booster that targets the original omicron strain, called BA.1. At the time, Dr. Peter Marks, the FDA's top vaccine regulator, said the agency hoped the updated vaccines will provide stronger protection against symptomatic disease than the older vaccines. Moderna didn't immediately respond to a request for comment about when it will release new data on its updated booster.

☆ Pfizer says omicron shots substantially boosted antibodies against BA.5 subvariant in early human data
▼ + stars: | 2022-10-13 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Pfizer and its German partner BioNTech on Thursday said their new omicron boosters substantially increased protective antibodies against the dominant omicron BA.5 subvariant for adults in the first direct human data released to the public on the new shots. The participants who received the first generation vaccine saw a limited increase in antibodies against BA.5, according to the companies. The early data indicate that the safety profile of the new boosters is the same as the original vaccine, the companies said. The first generation shots were developed only against the first strain of the virus. The FDA authorized the omicron shots without direct human data on how they perform against omicron BA.5, which is causing most infections in the U.S. right now.

☆ FDA authorizes Covid omicron booster shots for kids as young as 5 years old
▼ + stars: | 2022-10-12 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration on Wednesday authorized Covid booster shots that target the omicron variant for preschoolers through elementary school students. Pfizer's new omicron boosters are now authorized for children ages 5 to 11 and Moderna's shots for kids ages 6 through 17. The new boosters target omicron BA.5 as well as the original strain of Covid that first emerged in Wuhan, China, in 2019. The first generation of Covid shots were developed in 2020 to target the original strain of Covid. More than 11 million Americans ages 12 and older have received the new booster shots so far, according to CDC data.

☆ U.S. authorizes updated COVID booster shots for children as young as 5
▼ + stars: | 2022-10-12 | by ( ) www.reuters.com time to read: +2 min

Oct 12 (Reuters) - U.S. health regulators authorized the use of Omicron-tailored COVID-19 booster shots from Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N) in children as young as 5, a move that will expand the government's fall vaccination campaign. The U.S. Food and Drug Administration on Wednesday green-lighted Moderna's bivalent vaccine for those aged six and above, while Pfizer's updated shot was authorized in children aged five and above. The U.S. Centers for Disease Control and Prevention also backed the FDA's authorization, clearing the way for the shots to be administered in children. Overall, COVID-19 vaccination rates in the United States have stayed low among kids, with nearly 40% of children aged 5-11 vaccinated with one dose of a vaccine so far. Around 11.5 million people received the updated shots over the first five weeks of the rollout last month, which represents just 5.4% of the people aged 12 or older who are eligible to receive them.

☆ Pfizer wants approval for its Covid booster for children over 5 years old
▼ + stars: | 2022-09-26 | by ( The Associated Press | ) www.nbcnews.com time to read: +1 min

Pfizer asked U.S. regulators Monday to expand the use of its updated Covid-19 booster shot to children ages 5 to 11. Elementary school-aged children already received kid-sized doses of Pfizer’s original vaccine, a third of the dose given to everyone 12 and older — two primary shots plus a booster. Pfizer and its partner BioNTech also announced a new study of the omicron-focused booster in even younger children, those ages 6 months through 4 years, to test different doses. Updated boosters made by both Pfizer and rival Moderna rolled out earlier this month for everyone 12 and older. As of last week, the Centers for Disease Control and Prevention said 4.4 million Americans had gotten an updated booster so far.

☆ Pfizer asks FDA to authorize omicron Covid booster shots for kids ages 5 to 11
▼ + stars: | 2022-09-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Pfizer on Monday asked the Food and Drug Administration to authorize its new Covid booster shots that target the omicron BA.5 subvariant for children ages 5 to 11. The company, in a statement, said its request is based on human data from a similar vaccine that targets the omicron BA.1 subvariant and data from animal studies on the BA.5 shots. Pfizer's main competitor on Covid shots, Moderna, asked the FDA to authorize its omicron shots for kids ages 6 through 17 on Friday. Officials at the FDA and CDC expect the omicron BA.5 shots will provide significantly better protection against infection and disease this fall and winter. The new boosters target the dominant omicron BA.5 subvariant as well as the original strain of Covid that first emerged in Wuhan, China in 2019.

☆ Less than 2% of U.S. adults have gotten updated Covid booster shots
▼ + stars: | 2022-09-23 | by ( Aria Bendix | Aria Bendix Is The Breaking Health Reporter For Nbc News Digital. | ) www.nbcnews.com time to read: +5 min

At least 4.4 million people have received an updated Covid booster since the start of the month, according to data released Thursday by the Centers for Disease Control and Prevention. The CDC signed off on updated versions of Pfizer’s and Moderna’s booster shots on Sept. 1, and pharmacies and other vaccination sites began administering the new shots around Labor Day weekend. As of Tuesday, the U.S. had shipped more than 25 million bivalent booster doses to tens of thousands of sites. Some pharmacies reported shortages of Moderna's updated booster earlier this week. Biden administration officials have pointed to the updated boosters, however, as a critical step to pushing the U.S. out of the pandemic.

☆ Omicron-specific Covid boosters for children ages 5 to 11 are 'only a matter of weeks away,' says FDA vaccine chief
▼ + stars: | 2022-09-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

New omicron-specific Covid boosters for children ages 5 to 11 are "only a matter of weeks away," according to the U.S. Food and Drug Administration's vaccine chief. Marks added that an authorization for the youngest age group — kids under 5 — is still "a few months away." The CDC expects Pfizer's redesigned booster to be for children ages 5 to 11, and Moderna's to be for children ages 6 to 17. Currently, children ages 5 to 11 are only eligible to receive Covid vaccines for their primary series, and a single monovalent booster dose from Pfizer. If the new bivalent boosters receive approval from the FDA and CDC, the monovalent boosters may no longer be authorized for the age group, according to the CDC's planning guide.

☆ Time to get your Omicron booster shot. Here's everything you need to know about the 2 vaccines offered, and when to get it.
▼ + stars: | 2022-09-09 | by ( Hilary Brueck | ) www.businessinsider.com time to read: +5 min

New, reformulated COVID-19 booster shots are out from Pfizer and Moderna. These may be the last free COVID-19 vaccines you'll getThis fall booster campaign is likely the last chance you'll get to have free COVID-19 shots from the US government. Epidemiologist Katelyn Jetelina recommends waiting at least two months after a COVID-19 infection, the same as you would after any previous COVID-19 shot. "One COVID-19 shot, once a year, each fall," he said on Tuesday in a statement. Many are hoping that new kinds of COVID-19 vaccines being developed could be better long-term solutions than the shots we have now.

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