STAT+: Pharmalittle: We\u2019re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to catch up on our reading, promenade with the official mascots, and hang around a festival. We also hope to hold still another listening party, where the rotation will include this<\/a>, this<\/a>, this<\/a>, this<\/a>, and this<\/a>. And what about you? This is a lovely time of year to enjoy the great outdoors, a perennial aspiration of ours. And there are many choices \u2014 boardwalks, hiking trails, and country roads are beckoning. You could also take a moment to curl up with a good book or perhaps enjoy some scrumptious food. Perhaps someone special could use a hug. Or you might want to simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and if Dad is around somewhere, take a moment to say hello. See you soon. \u2026<\/p>\n U.S. Food and Drug Administration Commissioner\u00a0Marty Makary\u00a0said the agency may fast-track new drugs from pharmaceutical companies that \u201cequalize\u201d the cost of their medicines between the U.S. and other countries<\/strong>, an unusual proposition from a regulator that has long avoided contentious pricing debates, Bloomberg News<\/a> reports. The comments offer insight into an idea floated to help the administration achieve one of President\u00a0Trump\u2019s main health-care goals: ensuring foreign countries are not getting a better deal on drugs. Trump demanded that Americans get similar or lower prices as consumers in other countries in an executive order\u00a0signed in May. Price adjustments may give companies another way to obtain \u201cnational priority vouchers,\u201d the reward that comes as part of a new program the FDA announced last month that would slash review times for companies it says are backing national interests. Makary did not offer details about how drugmakers would have to adjust their prices to qualify for a voucher.<\/p>\n Moderna\u2019s Covid-19 vaccine for children has been given full FDA approval<\/a>, making it the first Covid vaccine for children ages 6 months to 11 years in the United States that will no longer be administered under an emergency use authorization<\/strong>, STAT<\/a> writes. But the approval comes with a proviso: It is for use in children who have at least one medical condition that puts them at increased risk of severe illness from Covid. The vaccine, known as Spikevax, was issued a license by the FDA for use in people 12 years of age and older in early 2022. Children ages 6 months to 23 months who have never been vaccinated against Covid need two shots, spaced one month apart. Children who have been previously vaccinated, or who are older than 2 years of age, should get a single shot. The limitation follows an unprecedented announcement in May from U.S. health secretary Robert F. Kennedy Jr. that he unilaterally revised recommendations\u00a0on who should be vaccinated against Covid, specifically that Covid vaccines would no longer be recommended for healthy children and healthy pregnant people.<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n