About Covid-19
Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants: Yesterday, the “U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.”
One major update is guidance for vaccine modifications to combat variants. Akin to influenza vaccine policy, such Covid-19 vaccine modifications will not have to conduct the same extensive testing as new products.
At least 44.5 million people have received one or both doses of the vaccine in the U.S.: “This includes more than 19.9 million people who have been fully vaccinated. 82.1 million doses have been distributed.”
‘Held to ransom’: Pfizer demands governments gamble with state assets to secure vaccine deal: “Pfizer has been accused of ‘bullying’ Latin American governments in Covid vaccine negotiations and has asked some countries to put up sovereign assets, such as embassy buildings and military bases, as a guarantee against the cost of any future legal cases…
In the case of one country, demands made by the pharmaceutical giant led to a three-month delay in a vaccine deal being agreed. For Argentina and Brazil, no national deals were agreed at all.”
While the alleged demands are excessive, it does raise the issue of liability for an essential global product.
This concern is addressed in this related article: No-fault compensation programme for COVID-19 vaccines is a world first: “The World Health Organization (WHO) and Chubb Limited (NYSE: CB), through ESIS Inc., a Chubb company, signed an agreement on behalf of the COVAX Facility on 17 February 2021 for the administration of a no-fault compensation programme for the 92 low- and middle-income countries and economies eligible for support via the Gavi COVAX Advance Market Commitment (AMC) of the COVAX Facility.”
Pharmacists say 'pooling' Covid vaccines could save thousands of doses: “Inova pharmacists did an experiment, taking 100 vials that had residual vaccine. Eighty of them had significant amounts left over. The pharmacists found that with the vaccine left in the 80 vials, they could make 40 additional full doses. That meant that on a typical vaccination day, when the hospital will typically give more than 4,000 shots, it could give an additional 400 vaccination shots with the same supply.
Even though pooling is common [with other injectables], the FDA says pharmacists and other clinicians cannot pool leftover Covid-19 vaccine because neither Moderna's nor Pfizer's products contain preservatives, which help stop microbial growth in case the vaccine is contaminated with bacteria or other germs.”
J&J Seeks WHO Emergency Use Listing for COVID-19 Vaccine: “Johnson & Johnson (J&J) has filed with the World Health Organization (WHO) for an Emergency Use Listing (EUL) for its COVID-19 vaccine — a listing that would clear the way for the vaccine to be distributed through the WHO’s COVAX vaccine-sharing program.
J&J reached an agreement in December with Gavi, the Vaccine Alliance, a co-leader of COVAX, to provide up to 500 million vaccine doses through 2022.”
UK real-world data show COVID-19 vaccine linked to lower infection, hospitalisation rates: “Data from new analyses were released Monday shedding light on the short-term impacts of COVID-19 vaccinations in the UK. One analysis from Public Health England's (PHE) SIREN study appears to corroborate early evidence that Pfizer and BioNTech's vaccine BNT162b2 offers high levels of protection against infection and symptomatic disease from the first dose, while another conducted by Public Health Scotland (PHS) indicates that COVID-19 vaccinations have lowered the risk of serious disease by cutting hospital admittance rates. Neither is peer-reviewed and both were released as preprints by The Lancet…
Results, which focused on Pfizer's vaccine, demonstrated that BNT162b2 was 72% effective at reducing the risk of symptomatic and asymptomatic infection 21 days after the first dose, rising to 86% seven days after the second in the antibody-negative cohort. Overall, hospitalisation and death from COVID-19 declined by over 75% in those who received a dose of the vaccine.”
OCR lifts HIPAA fines for use of COVID-19 vaccine scheduling tools: “Healthcare organizations won't be penalized for potential Health Insurance Portability and Accountability Act (HIPAA) violations related to the good faith use of online or web-based scheduling applications for COVID-19 vaccine appointments.
The Office for Civil Rights (OCR) at the U.S Department of Health and Human Services announced (PDF) this week that it won't enforce fines against providers when using apps and other digital tools that don't fully comply with HIPAA.”
Pfizer eyes higher prices for COVID-19 vaccine after the pandemic wanes: exec, analyst: “A top Pfizer exec said the drugmaker aims to charge more after the ‘pandemic pricing environment,’ and an influential analyst says the company could be eying prices 3 to 4 times higher.”
About health insurance
Biden administration asks U.S. Supreme Court to dump Medicaid work case: “President Joe Biden’s administration on Monday asked the U.S. Supreme Court to cancel an upcoming oral argument on a policy introduced under his predecessor Donald Trump backing work requirements for people who receive healthcare under the Medicaid program for the poor.
Acting Solicitor General Elizabeth Prelogar said the Biden administration has started the process of reversing the previous policy and asked the justices to dump the scheduled March 29 arguments concerning pilot programs adopted by the states of Arkansas and New Hampshire.”
Affordable Coverage Coalition Principles for Extending Coverage and Protecting Patients: This statement by a number of major healthcare organizations calls for principles to implement universal healthcare coverage. The initiative is based on ACA expansion. For example: “Ensure everyone with an income up to 138 percent of the federal poverty level has comprehensive coverage. To provide incentives for states that have not yet expanded Medicaid to act, Congress should again fund a three-year, 100 percent federal match for Medicaid expansion.”
Health Care Reform: One (Percent) Step At A Time: This article from Health Affairs (open access) reviews 16 strategies for saving health costs- each having an impact of <1%. They add up to 8.87% savings. For a country with about 3.7 trillion in healthcare spending, that’s about $337 billion less cost. The authors are part of the 1% Steps for Health Care Reform Project.
Oscar Health, Inc. Announces Launch of Initial Public Offering: “Oscar Health, Inc. (“Oscar”)… announced the launch of its initial public offering of 31,000,000 shares of its Class A common stock. The offering consists of 30,350,920 shares of Class A common stock offered by Oscar and 649,080 shares of Class A common stock to be sold by certain of Oscar’s existing stockholders.”
The offering could raise more than $1 Billion.
About pharma
High Court Knocks Out PBM Group's 8th Circ. Preemption Win: “The U. S. Supreme Court struck down a win Monday for a trade group that brought an ERISA case challenging North Dakota's oversight of the pharmacy benefit manager industry, sending the suit back to the Eighth Circuit for another look in light of the justices' recent Rutledge ruling. The justices granted the Pharmaceutical Care Management Association's petition for them to take up the case, then vacated the group's Eighth Circuit victory in a deregulation fight invoking the Employee Retirement Income Security Act.”
For background on the case, see: Eighth Circuit: State’s PBM Law Preempted by ERISA, Unenforceable.
Charles River Buys Cognate BioServices for $875 Million: “Charles River Laboratories is acquiring Cognate BioServices, a Baltimore, Md.-based cell and gene therapy contract development and manufacturing firm for $875 million.
The Cognate BioServices acquisition will provide biopharmaceutical clients ‘an integrated solution to help accelerate their cell and gene therapy programs from discovery and nonclinical development through commercialization,’ said Charles River CEO James Foster.”
Johnson & Johnson tots up a potential $4B talc bill as tens of thousands of lawsuits pile up: “Johnson & Johnson has been battling for years against lawsuits claiming its talc powders cause cancer, but now investors are getting a sense of what the litigation could cost the drug giant. And it's about twice as much as J&J had figured on last year.
In an annual filing with the SEC, J&J said its multibillion-dollar 2020 litigation expense is “primarily associated with talc related reserves and certain settlements” worth $3.9 billion. The company faces 25,000 lawsuits alleging the household products cause cancer, and it's still in the process of appealing a massive verdict out of Missouri.”