Vaccine Development and Manufacturing

The UK government has secured early access to 90 million COVID-19 vaccine doses from the BioNTech/Pfizer alliance and Valneva.

Preliminary data from a German Phase I/II trial shows Pfizer/BioNTech COVID-19 vaccine candidate produces immune response.

Study reports immune and T-cell response from CanSino COVID-19 vaccine candidate.

GSK and CureVac will collaborate on mRNA-based vaccines and mAbs. Separately, the EIB and others provided CureVac with financing for development of its CVnCoV vaccine candidate and expansion of manufacturing.

Strong immune response by patients receiving two doses of vaccine suggests a possible treatment strategy.

A strong immune response by patients receiving two doses of AZD1222 vaccine suggests a possible dosing strategy for COVID-19 vaccine.

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

The agreement will accelerate production of SiO2’s plastic vials for vaccines and therapeutics for Operation Warp Speed.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

GlaxoSmithKline (GSK) and Medicago have announced a collaboration for the development and evaluation of a COVID-19 vaccine candidate.

The agreement will fund the late-stage clinical development, a Phase III clinical trial, large-scale manufacturing, and the delivery of 100 million doses of Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373.

Emergent is entering into a five-year agreement with Janssen Pharmaceuticals for the large-scale drug substance manufacturing of Johnson & Johnson’s investigational COVID-19 vaccine, Ad26.COV2-S.

Intravacc will license CimCure’s iBoost technology, and the companies will jointly develop a COVID-19 vaccine candidate.

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

The refurbishment provides enhanced glass melting power, improved glass distribution, and the production of transparent and amber type I glass bottles to meet the increase in demand for glass vials for vaccines and life-saving medicines.

The company’s oral COVID-19 vaccine has been chosen to participate in a non-human primate challenge study organized and funded by Operation Warp Speed.

The test results could potentially be used in the development of COVID-19 vaccines and the screening of convalescent plasma for prophylactic and therapeutic use.

Catalent will offer vial filling, packaging capacity, and additional staffing at the site to support the production of the initial 100 million doses of the vaccine candidate to supply the US market beginning in the third quarter of 2020.

The company has expanded its laboratory test portfolio with five new molecular, serology, and functional assays for COVID-19 vaccine and therapy development programs.

Symbiosis Pharmaceutical Services has signed a supply agreement with AstraZeneca for the sterile manufacture of AZD1222, a COVID-19 recombinant adenovirus vaccine, to be used in clinical trials.

Inovio received a $71-million contract from the US Department of Defense to scale up manufacture of its Cellectra smart device to deliver its DNA vaccine.

The companies are expanding their existing collaboration and license agreement to develop mRNA vaccines for infectious diseases.

The company will invest EUR 610 million (USD$682 million) into a new vaccine production site and research center in France.