Hundreds of thousands of newly designed COVID boosters bound for Michigan could significantly tamp down a fall infection surge, according to data modeling. But even with new booster shots revamped to stop the latest variants, there is still plenty of uncertainty: Will people take the boosters? And even if lots of Michiganders roll up their sleeves, could the coronavirus evolve enough to duck even the newly redesigned boosters? “We really don’t know what the properties of a new variant will be. There's a lot of wiggle room in what could happen,” said Marisa Eisenberg, an epidemiologist at the University of Michigan who works on the COVID-19 modeling that the state uses. “A lot hinges on whether or not the booster matches” [...]

The Food and Drug Administration on Wednesday authorized updated versions of Pfizer-BioNTech’s and Moderna’s Covid booster shots that target the highly contagious BA.5 omicron subvariant. The FDA authorized Pfizer’s modified booster for people ages 12 and older; Moderna's shot was authorized for those 18 and up. People who’ve received the two-dose primary series of either vaccine and those who’ve received the initial two doses plus one or two boosters are eligible for the updated shots as long as two months have passed since their last shot, the agency said in a statement. The FDA’s signoff isn’t the last step: The decision will now go to the Centers for Disease Control and Prevention and its advisory committee to issue their own recommendation on [...]

Moderna has requested regulatory clearance of its reformulated COVID-19 vaccine, which the company is prepared to start delivering next month with FDA's authorization. The updated product is configured to fight the strain of coronavirus that emerged in 2019 as well as the Omicron BA.4 and BA.5 subvariants now in heavy circulation. Based on favorable results from previous evaluation of a version that targeted the original strain plus Omicron BA.1, Moderna CEO Stéphane Bancel says the new bivalent vaccine "may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster." A clinical trial is underway to assess the updated booster. Manufacturing team Pfizer-BioNTech, meanwhile, is preparing to launch a study this month of its own updated [...]

Pfizer and BioNTech have applied for FDA authorization of their reformulated COVID-19 booster dose, which targets Omicron subtypes BA.4 and BA.5 as well as the original strain of SARS-CoV-2. Omicron cases are now dominant in the United States, but research has suggested that currently approved vaccines are less effective against the mutation and its subtypes. Human trials of the modified vaccine are only now about to kick off, according to the companies; however, animal studies yielded favorable results. The manufacturing partners are already making doses of the bivalent boosters and stand prepared to distribute them to the U.S. government ahead of a fall vaccination campaign. The goal is to blunt the effect of a potential surge in cases during the [...]

Time Magazine - Aug 23, 2022 The Federal Trade Commission recently launched an inquiry into the practices of pharmacy benefit managers, known in the industry as PBMs. PBMs are the hidden middlemen who were supposed to make drug distribution more efficient. Yet over time, they have grown in size and power, and research suggests they have contributed to the rapidly rising costs of prescription drugs, while taking home a growing chunk of those ballooning prices. The way that their growth and growing profits puts critical drugs out of reach for many, contributing to avoidable deaths and disease, may be extreme but it’s not an aberration. It is instead reflective of the way the growing size and power of middlemen is undermining the [...]