Supply Chain

FDA has agreed to extend the shelf life of the Johnson & Johnson COVID-19 to six months. The previous shelf life was four and a half months. The regulatory agency based its decision on data from ongoing studies involving vaccine doses stored at the previously indicated storage temperature of 2–8°C (35.6–46.4°F). There is currently a…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine. Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) today announced an agreement with Biovac to manufacture the companies’ COVID-19 vaccine for distribution in Africa. Cape Town, South Africa-based Biovac will perform manufacturing and distribution activities within Pfizer and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network to aid in distribution within the African Union, according to a…

The executive board of the International Monetary Fund (IMF) today approved a $650 billion allocation for COVID-19 vaccines. IMF managing director Kristalina Georgieva issued a statement today confirming that the executive board concurred in her proposal for a new general Special Drawing Rights (SDR) allocation of $650 billion — the largest allocation in the IMF’s…

The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply. Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan…

In the early days of the pandemic, the subarctic storage requirements for mRNA COVID-19 vaccines sparked renewed interest in the cold chain. One potentially overlooked element of the cold chain is silica, according to the specialty chemicals company Evonik. The company states that its Aerosil fumed silica supports passively cold transport units using cool packs…

The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing. According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large…

FDA has issued guidance documents to help pharmaceutical stakeholders identify illegitimate products and remove them from the supply chain. Two of the documents are final, while another two are draft guidance.  “Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of…

Pharma industry contract manufacturer Exelead recently announced that it has delivered its first precursor batch of Prizer-BioNTech’s COVID-19 vaccine, produced at its recently expanded facility in Indianapolis. Exelead plans to add 50 jobs to help it meet COVID-19 vaccine demand. “We are extremely proud to be part of the manufacture of the Pfizer-BioNTech COVID-19 vaccine,…

U.S. Trade Representative Katherine Tai announced this afternoon that the Biden administration supports waiving IP protections for COVID-19 vaccines. “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement. Tai said the U.S. will actively participate in World Trade Organization text-based negotiations…