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FDA Authorizes First Covid-19 Vaccines for Young Children

Some 1½ years after first authorizing the shots for people of older ages, the Food and Drug Administration on Friday expanded use of the vaccines to the nearly 20 million children in the U.S. from 6 months to under 5 years. A national campaign to vaccinate the young children is expected to kick off as soon as Monday, after the Centers for Disease Control and Prevention signs off in the coming days. To be ready, the Biden administration has been gearing up to get sufficient supplies of the shots to hospitals,…

FDA Advisers Review Pfizer, Moderna Covid-19 Vaccines in Young Children

A positive recommendation would likely lead soon to expanding the U.S. Covid-19 vaccination campaign to the 19.6 million children 6 months old to under 5 years of age, the last group of people in the U.S. waiting for shots. Moderna’s two-dose vaccine is up for the Food and Drug Administration’s authorization in children 6 months to 5 years, while Pfizer’s three-dose shot is under review for children 6 months to 4 years. FDA staff have reviewed data from the companies’ clinical trials, finding the vaccines were…

FDA Advisers to Consider Moderna’s Covid-19 Vaccine for Ages 6 to 17

A panel of advisers to the Food and Drug Administration is set to meet Tuesday to consider whether use of Moderna Inc.’s Covid-19 vaccine should be expanded to include children ages 6 through 17.The advisory committee is expected to vote Tuesday afternoon on whether the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older. An FDA authorization could…

Three-Dose Pfizer Covid Vaccine Works Safely in Young Children, Review Says

The FDA staff also said, in a review of study data posted online Sunday, that there were no new safety concerns using the vaccine in young children compared with older age groups. The assessment is the latest sign that authorities are moving closer to clearing inoculations for children under 5 years old, the last group ineligible for Covid-19 vaccination. On Friday, the FDA released a staff review finding that two doses of Moderna Inc.’s Covid-19 vaccine were generally safe and effective in children ages 6…

Moderna’s Covid-19 Vaccine Works Safely in Kids, Including Those Under Age 5, FDA Says

Moderna Inc.’s Covid-19 vaccine was effective at preventing symptomatic disease in children ages 6 months through 5 years, Food and Drug Administration staff said in a review of the evidence.The FDA staff also said Friday that Moderna’s vaccine was generally safe in children in studies, including those under 5 years who haven’t had access to any shots. The assessment of the vaccine, part of the FDA’s standard process for deciding whether to permit use of a medicine, might bode well for the…

AstraZeneca Breast-Cancer Drug Shown to Slow Tumor Progression

A new study of an AstraZeneca PLC breast-cancer drug showed it cut the risk of tumor progression by half for people with the most advanced form of the disease, offering the prospect of a new treatment for one of the most widely diagnosed cancers.AstraZeneca and Japan’s Daiichi Sankyo Co. said Enhertu, which the drugmakers developed jointly, stopped disease progression in patients who took it in the study for an average of 9.9 months, compared with 5.1 months for…

Pfizer Asks FDA to Authorize Its Covid-19 Vaccine for Children Under 5

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Baby-Formula Shortage Worsened by Drop in Breast-Feeding Rates

One of the contributing factors in the U.S. baby-formula shortage is a significant shift in the way parents feed their babies: Breast-feeding declined during the pandemic, reversing a decadeslong trend, health practitioners say.Since 2020, the share of breast-fed one-year-olds has plummeted from an estimated 34% to an estimated 14% this year, according to surveys conducted by Demographic Intelligence, a forecasting firm that specializes in births and works with formula manufacturers including Abbott…

Baby Formula Makers and FDA to Discuss Shortage With Lawmakers

Officials from the Food and Drug Administration and from the major formula manufacturers are expected to testify before the House Energy and Commerce Committee’s oversight and investigations subcommittee about their attempts to address the short supply. The Energy and Commerce panel oversees the FDA, which regulates baby formula. Rep. Frank Pallone (D., N.J.), chairman of the full committee, said, “The focus of this hearing will be on better understanding the causes of the shortage, what has…

Abbott to Release 300,000 Specialty Baby Formula Cans

Abbott Laboratories will release about 300,000 cans of a specialty infant formula for children in urgent medical need, while U.S. health regulators cleared the import of about 2 million cans of formula from the U.K. to try to mitigate a shortage. Abbott, of Abbott Park, Ill., said Tuesday it is releasing limited quantities of EleCare, an amino acid-based powder for infants with severe food allergies or gastrointestinal disorders. The company…