COVID-19 vaccine development and rollout were crucial to gaining control of the pandemic. When the success of these efforts became dependent on the ability to maintain lower than typical temperatures during distribution, the importance of reliable and continuous cold chain solutions for mRNA-based formulations was thrust into the spotlight. Beyond pandemic mitigation measures and outside…

French drugmaker Sanofi (Nasdaq:SNY) said it would spend €935 million (about $1.1 billion) between 2022 and 2026 to produce mRNA-based vaccines. That funding is part of a larger €2 billion (about $2.4 billion) initiative to accelerate its mRNA development capability, Sanofi explained on its French-language website. The company intends to use the funds to ramp…

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca. The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch. Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and…

For any vaccine, some degree of waste is expected. The problem is inspiring supply-chain companies to explore new technologies that can address a longstanding struggle. “Before COVID-19, we often saw waste of about 8–10%,” said Ranjeet Banerjee, CEO of Cold Chain Technologies, which provides insulated packaging for drugs and biologics. A 2019 World Health Organization report citing…

A former FDA inspector accused the agency of downplaying safety problems at a Merck plant tapped to manufacture Johnson & Johnson’s COVID-19 vaccine.  The whistleblower alleged that a 2018 inspection uncovered evidence that employees in the facility in Durham, N.C. engaged in a host of unsanitary practices. A letter to President Biden from the U.S.…

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts. Also in the plan are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential. The “full-scale, wartime” plans have considerable relevance…

President Joe Biden has unveiled a series of anti-COVID-19 measures in his first full day in office, including signing an executive order instructing federal agencies to use the Defense Production Act (DPA) and other tools to speed the manufacture of COVID-19 vaccines and materials. In total, the president has signed 10 executive orders intended to…

Last week, President-elect Joe Biden vowed to release COVID-19 vaccine doses from a government stockpile.  On Jan. 13, the U.S. Department of Health and Human Services (HHS) echoed that sentiment, stating it would “no longer stockpile millions of COVID-19 vaccine doses held to ensure Americans receive their second shot,” according to a brief notice.  But federal…

President-elect Joe Biden has announced a proposal for a $1.9 trillion economic rescue package that includes $415 billion to fight the pandemic, including boosting COVID-19 vaccine deployment. Of that latter total, some $20 billion would be invested in a national vaccination program to establish community vaccination centers across the country, including mobile vaccination units in…

The White House Coronavirus Task Force promised a swift rollout of COVID-19 vaccines — but one of a number of takeaways from its first briefing since July. The briefing yesterday gave the task force a chance to once again urge Americans to heed COVID-19 guidance while also providing an update on vaccines and therapeutics.   The…