Vaccine Development and Manufacturing

Pfizer and BioNTech have entered into a new agreement with the European Commission to supply 900 million doses of Comirnaty to the European Union with an option to request up to 900 million additional doses.

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Originally established in the 1970s as a fetal bovine serum supplier, Fujifilm Irvine Scientific continuously proved its strength in the cell culture solutions space.

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

BioNTech plans to expand its global footprint by establishing its regional headquarters for southeast Asia and a new mRNA manufacturing facility in Singapore.

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

Moderna will double the space at its Moderna Technology Center in Norwood, MA, to transform it from a production and lab space into an industrial technology center.

Moderna has entered into an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine to the 92 Gavi COVAX Advance Market Commitment low- and middle-income countries.

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space, executing advanced inventory management systems, and adding support areas to supplement capacity.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

As face masks start to come off, bio/pharma’s COVID-19 battle goes on.

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites.

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.

With a $5 million grant from DARPA, DNA Script and Moderna will develop a prototype for rapid mobile manufacturing of vaccines and therapeutics as part of the DARPA’s Nucleic Acids On-Demand World-Wide program.

Sanofi will perform the fill/finish of up to 200 million doses of Moderna’s COVID-19 vaccine at its Ridgefield, NJ, facility starting in September 2021.

The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.

Lipid production at Evonik’s Hanau, Germany, site was set up in eight weeks and met high-quality requirements, accelerating delivery time, which was originally set for mid-2021.

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility.

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.