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Exclusive: U.S. FDA Finds Control Lapses at Moderna Manufacturing Plant
U.S. drug regulators in September found quality control lapses at Moderna’s (MRNA.O) main factory including with equipment used to manufacture drug substances for its COVID-19 vaccine, according to the report obtained by Reuters via a Freedom of Information Act request.
The Sept. 11-21 inspection by the U.S. Food and Drug Administration took place at Moderna’s facility in Norwood, Massachusetts, which is used to manufacture the company’s COVID shot Spikevax and an experimental mRNA cancer vaccine being developed with Merck & Co (MRK.N).
The FDA report noted five separate observations, including that Moderna had released eight batches of “drug substance” — the active ingredient used to make mRNA vaccines — that was produced with equipment that had failed the company’s cleaning verification tests.
The FDA did not say in the report if those batches were released to the public but identified the drug substance involved as being for the COVID vaccine. The agency declined to comment on the report.
The FDA also found in its report that Moderna did not have the right measures at its facility to ensure expired materials were not used to make vaccines and that airborne contaminates did not make it into any products.
‘They See a Cash Cow’: Corporations Could Consume $50 Billion of Opioid Settlements
The marketing pitches are bold and arriving fast: Invest opioid settlement dollars in a lasso-like device to help police detain people without Tasers or pepper spray. Pour money into psychedelics, electrical stimulation devices, and other experimental treatments for addiction. Fund research into new, supposedly abuse-deterrent opioids and splurge on expensive, brand-name naloxone.
These pitches land daily in the inboxes of state and local officials in charge of distributing more than $50 billion from settlements in opioid lawsuits.
The money is coming from an array of companies that made, sold, or distributed prescription painkillers, including Johnson & Johnson, AmerisourceBergen, and Walgreens. Thousands of state and local governments sued the companies for aggressively promoting and distributing opioid medications, fueling an epidemic that progressed to heroin and fentanyl and has killed more than half a million Americans. The settlement money, arriving over nearly two decades, is meant to remediate the effects of that corporate behavior.
But as the dollars land in government coffers — more than $4.3 billion as of early November — a swarm of private, public, nonprofit, and for-profit entities are eyeing the gold rush. Some people fear that corporations, in particular — with their flashy products, robust marketing budgets, and hunger for profits — will now gobble up the windfall meant to rectify it.
The Weight Loss Drug Boom Isn’t Over yet — Here’s What to Expect in the Year Ahead
Weight loss drugs exploded into the public eye this year, and 2024 will bring more change to the evolving market.
The drugs skyrocketed in popularity in 2023 as they helped patients shed significant weight, despite hefty price tags, mixed insurance coverage and a handful of unpleasant side effects.
Demand for the drugs is unlikely to slow down in 2024, especially as treatments gradually become more accessible. Much of Wall Street believes the weight loss drug market will only expand, with some analysts projecting that it will be worth $100 billion by the end of the decade. Goldman Sachs analysts expect 15 million U.S. adults to be on obesity medications by 2030.
Novo Owner Commits $265 Million of Wegovy Windfall to Respiratory Diseases
The Novo Nordisk Foundation, which controls drug maker Novo Nordisk (NOVOb.CO), said on Monday it would commit up to 1.8 billion Danish crowns ($265 million) to setting up an initiative aimed at improving vaccines for respiratory diseases.
A huge windfall from the runaway success of Novo Nordisk’s weight-loss drug Wegovy has bulged coffers of the foundation, potentially making it a major philanthropist and environmental, social and governance (ESG) investor.
The initiative aims to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis, influenza and group A streptococcus, which collectively cause more than 2.5 million deaths per year, the foundation said.
The Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI) initiative follows Norway’s Coalition for Epidemic Preparedness Innovations (CEPI), which helps fund vaccine research with funding from governments including the U.S., Britain and Norway, and private contributors like the Gates Foundation.
BioNTech Aims to Start mRNA Vaccine Output in Rwanda in 2025
COVID-19 vaccine maker BioNTech (22UAy.DE) aims to start production at its mRNA vaccine factory site in Rwanda in 2025, company officials said on Monday, the first foreign company mRNA vaccine manufacturing site on the continent.
The German company’s first modular factory elements, based on shipping containers, were delivered to the Kigali construction site in March and were then assembled into so-called BioNTainers.
“Africa will have one of the most advanced manufacturing facilities in the world,” Ugur Sahin, BioNTech co-founder and chief executive officer, said. “These BioNTainers will be able to manufacture any kind of mRNA vaccines.” The company said in a statement it had fully funded the facility, committing a total of $150 million.
BioNTech on Monday reiterated that the BioNTainers could make other mRNA vaccines, depending on product development progress and public health priorities.
EU Countries Destroy €4 Billion Worth of COVID Vaccines
At least 215 million doses of COVID-19 vaccines purchased by EU countries at the height of the pandemic have since been thrown away at an estimated cost to the taxpayer of €4 billion, an analysis by POLITICO reveals. And that’s almost certainly an underestimate.
Since the first coronavirus vaccines were approved in late 2020, EU countries have collectively taken delivery of 1.5 billion doses (more than three for every person in Europe). Many of these now lie in landfills across the Continent.
Calculations based on available data show that EU countries have discarded an average of 0.7 jabs for every member of their population. Top of the scale is Estonia, which binned more than one dose per inhabitant, followed closely by Germany, which also threw away the largest raw volume of jabs.
If this average waste rate is projected across the rest of the EU, it would equal more than 312 million destroyed vaccines.
