- Vaccine passports are latest flash point in COVID politics (apnews.com)
Vaccine passports being developed to verify COVID-19 immunization status and allow inoculated people to more freely travel, shop and dine have become the latest flash point in America’s perpetual political wars, with Republicans portraying them as a heavy-handed intrusion into personal freedom and private health choices...They currently exist in only one state — a limited government partnership in New York with a private company — but that hasn’t stopped GOP lawmakers in a handful of states from rushing out legislative proposals to ban their use...READ MORE
- AHA, ASHP seek meeting with FDA to address insurer ‘white bagging’ policies (fiercehealthcare.com)
Hospitals and health system pharmacists are urging the Biden administration to review insurer "white bagging" policies...Payers use white bagging to dispense drugs to hospitals, requiring these medications come from select network specialty pharmacies. AHA and ASHP said in the letter that doing so circumvents hospital supply chain protocols aimed at patient safety..."White bagging has surged in frequency over the past decade, creating what amounts to a shadow inventory that hospitals and health systems do not legally own and which exists largely outside of the DSCSA’s track and trace requirements,"...READ MORE
- PBM Reform Legislation Progresses in Michigan (drugtopics.com)
A new legislation recently passed by the Michigan’s House of Representatives would require reforms to many pharmacy benefit manager reimbursement practices in the state...The provisions listed in HB 4348 would prohibit PBMs from reimbursing pharmacies affiliated with the PBM more than non-affiliate pharmacies; prohibit patient steering to PBM-owned pharmacies; prohibit retroactive clawbacks; require reimbursement be based on the National Average Drug Acquisition Cost; and establish fair audit procedures for community pharmacies...READ MORE
- New CDC study: mRNA vaccines 90% effective (msn.com)Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers — Eight U.S. Locations, December 2020–March 2021 (cdc.gov)
In their clinical trials, the Pfizer and Moderna vaccines did okay, well enough for the FDA to grant emergency use authorization. But in a real-world study, where participants were all on the front lines fighting Covid, the vaccines proved 90% effective against the virus – not just the symptomatic disease. In the clinical studies, Pfizer and Moderna were testing against disease...According to the CDC-sponsored study released today, it didn’t matter which vaccine the participants received. What mattered was that both vaccines were designed using messenger RNA to repel the coronavirus. The results showed that the vaccines were even effective against asymptomatic virus...READ MORE
- Gilead has sole rights to COVID-19 blockbuster Veklury, GAO concludes (fiercepharma.com)
Throughout the frantic response to the pandemic last year, drugmakers worldwide tested hundreds of potential treatments. Gilead’s antiviral remdesivir quickly rose to the top of treatment guidelines, and with the pandemic spiraling out of control, advocacy groups called on the U.S. government to step in and enforce patents against the company...But it turns out the government has no intellectual property covering remdesivir, the Government Accountability Office concluded in a new report...READ MORE
- Up to 15M Johnson & Johnson coronavirus vaccine doses ruined due to human error: NYT (fiercepharma.com)
Workers at an Emergent BioSolutions plant in Baltimore mixed up vaccine ingredients weeks ago and ruined a large batch of the vaccine containing up to 15 million doses...The FDA is investigating the mistake, but the episode has led to a temporary halt of future J&J shot deliveries from the site...In a statement, J&J said it's working with federal authorities to deliver 24 million doses of the vaccine in April...The mistake happened early in the production process, so none of the doses made it out to distribution...READ MORE
- Tracking the success of Johns Hopkins’ high-profile COVID-19 website (healthcareitnews.com)Johns Hopkins Coronavirus Resource Center (coronavirus.jhu.edu)
Here's a look at how it was created, what it offers – and how it grew to reach more than 38 million visits in seven months...Amid the COVID-19 pandemic, Johns Hopkins Medicine needed to provide accurate content very quickly in an information environment that was changing by the hour...In a pre-pandemic world, the organization's content team would look to search engine optimization strategies to see what questions people are asking and determine what information would be most useful. However, that data was just not yet available for COVID-19 when the pandemic hit...READ MORE
- FDA downplayed serious red flags at Merck vaccine plant slated for J&J COVID shot, whistleblower says (fiercepharma.com)
An FDA inspector-turned-whistleblower claims the agency soft-pedaled violations at a range of pharma manufacturing plants, including a Merck & Co. vaccine facility in Durham, North Carolina, where staff allegedly destroyed evidence of unsanitary practices. Those allegations have now been passed along to the White House… The whistleblower alleged that employees at Merck's plant were moving between cleanrooms and uncontrolled areas without properly ungowning, and that a biohazard bin contained employee uniforms soiled with blood, urine and feces. Employees were soiling their uniforms rather than taking restroom breaks, the whistleblower claimed, citing a confidential informant, because staffers would have otherwise needed to remove sterile gowning and leave manufacturing areas…READ MORE
- On the heels of CFO scandal, former Eli Lilly exec alleges sex discrimination, harassment in bombshell lawsuit (fiercepharma.com)
Eli Lilly faced a high-level personnel scandal last month when CFO Josh Smiley left under a cloud of "inappropriate" communications with employees. But a sex discrimination lawsuit from a former internal lobbyist uncovers an entirely new controversy—and offers an alleged look inside the culture of a key team...Sonya Elling, a longtime biopharma lobbyist who worked in Lilly's government affairs operation, sued the company alleging mistreatment by her supervisors on the basis that she is a female...During Elling's time at the company, her first- and second-level supervisors called her “mean,” “nasty,” “disruptive,” “rude,” “aggressive,” and a “bitch,” according to the suit. They did so because she is a "strong, assertive female," who didn't "conform to traditional gender stereotypes," the suit says...READ MORE
- WHO warns about fake COVID-19 vaccines on the dark web (healthcareitnews.com)
Forged vaccination certificates and fake negative tests are also reportedly available for purchase on the black market...The World Health Organization...issued a warning about counterfeit and stolen COVID-19 vaccines being sold on the dark web...Fake vaccination certificates are also being sold, as well as fake negative tests, aimed at those traveling abroad...The WHO is "aware of vaccines being diverted and reintroduced into the supply chain, with no guarantee that [the] cold chain has been maintained...READ MORE