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U.S. health regulators cleared use of retooled Covid-19 vaccines that target the latest versions of Omicron, in preparation for a fall booster campaign that could start within days.The action by the Food and Drug Administration on Wednesday permits people 12 years and older to receive an additional shot of the vaccine from Pfizer Inc. and BioNTech SE, and people 18 and older to receive a Moderna Inc. booster at least two months after…

The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans. Instead, the agency plans to assess the shots using data from other sources such as research in mice, the profiles of the original vaccines and the performance of earlier iterations of boosters targeting older forms of Omicron. “Real world evidence from the current mRNA Covid-19…

Moderna Inc. sued rival Covid-19 vaccine makers Pfizer Inc. and BioNTech SE, alleging that the companies’ shot infringes on key intellectual property owned by Moderna.Pfizer and BioNTech’s vaccine relies on messenger RNA technology that Moderna had developed and patented years ago, including a chemical modification that avoids prompting an undesirable immune response, Moderna said in lawsuits filed Friday. Moderna filed a lawsuit in…

Pfizer Inc. and BioNTech SE have asked U.S. health regulators to clear use of a Covid-19 shot modified to target the newest versions of the Omicron variant. The U.S. Food and Drug Administration is expected to clear the shots for use in the coming weeks, in time for a planned fall booster campaign. The Pfizer-BioNTech booster shot targets the original coronavirus plus the BA.4 and BA.5 subvariants of Omicron,…

The Biden administration is planning for an end to its practice of paying for Covid-19 shots and treatments, shifting more control of pricing and coverage to the healthcare industry in ways that could generate sales for companies—and costs for consumers—for years to come.The Department of Health and Human Services intends to hold a planning session on Aug. 30 that would bring together representatives from drugmakers, pharmacies and state health departments with a stake in a Covid-19 treatment industry. Both the Trump and…

The Biden administration said it would spend $1.74 billion to buy 66 million doses of Moderna Inc.’s updated Covid-19 vaccine, as well as the option to purchase up to 234 million additional doses, as part of a fall booster campaign. The deal Friday, which follows an agreement to buy 105 million doses of updated vaccines from Pfizer Inc. and partner BioNTech SE, is expected to give the federal…

Governments, drugmakers and vaccination sites are discarding tens of millions of unused Covid-19 vaccine doses amid sagging demand, a sharp reversal from the early days of the mass-vaccination campaign, when doses were scarce.Vaccine manufacturer Moderna Inc. recently discarded about 30 million doses of its Covid-19 shot after failing to find takers, while pharmacies and clinics have had to throw out unused doses from multi-dose vials from Moderna and Pfizer Inc.…

Advisers to U.S. health regulators are set to meet Tuesday to consider whether and how Covid-19 vaccines should be updated to better target circulating variants of the coronavirus, in preparation for a fall booster-shot campaign.The advisory panel to the Food and Drug Administration, which includes doctors and public-health specialists, is expected to vote later in the day on whether to recommend updating Covid-19 vaccines to target the Omicron variant. Advisers to U.S. health regulators are set to meet Tuesday to…

A Food and Drug Administration committee will meet Tuesday to discuss how to move forward with the next generation of vaccines ahead of a booster campaign this fall. Paying for them is another matter.Congress has so far failed to approve additional funding for the shots—bad news for the U.S. population at large, but not bad at all for vaccine makers. They will just charge higher prices in the private market. The White House already is preparing to ration its vaccine supply to the most vulnerable Americans, according to…

Pfizer Inc. and BioNTech SE vaccines modified to target the Omicron variant produced a significantly larger immune response than the companies’ currently available vaccine in a study, they said.A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot in study volunteers a month after administration, depending on the dose, the companies said Saturday. Pfizer Inc. and BioNTechSE vaccines modified to target the Omicron variant produced a…