Vaccine Development and Manufacturing

The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.

Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Facility and equipment design are important, but the team and its experience matter most.

Amid high expectations for a COVID-19 vaccine, biopharma readies production capacity, weighs external pressures.

Novavax and the Government of Canada will finalize an advanced purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning in the second quarter of 2021.

Oxford Biomedica will reserve capacity for AstraZeneca in three of its manufacturing suites in its new commercial manufacturing center, Oxbox, for 18 months.

Negotiations for a final advance purchase agreement where the Government of Canada purchases the vaccine candidate on a not-for-profit basis for emergency pandemic use are underway.

The vaccine will be supplied by Moderna and distributed in Japan by Takeda Pharmaceutical starting in the first half of 2021 if the vaccine candidate receives regulatory approval.

The European Commission (EC) and Moderna have concluded exploratory talks on the potential purchase of Moderna’s COVID-19 vaccine candidate for Europeans.

The contract is valued at $106.3 million and is supported by Operation Warp Speed.

CDMO Avid Bioservices will provide development and drug substance manufacturing for Oragenics’ novel COVID-19 vaccine candidate, Terra CoV-2.

EC finalizes agreement to purchase millions of doses of AstraZeneca's COVID-19 vaccine.

Novavax has signed an agreement with the UK government for 60 million doses of a COVID-19 vaccine and a Phase III clinical trial.

In combination with BARDA’s previous award, the commitment for early access to Moderna’s vaccine candidate has now reached to up to $2.48 billion.

SK bioscience will manufacture the vaccine antigen component for use in the final drug product at its vaccine facility in Andong L-house, South Korea.

Questions about safety and efficacy surround Putin’s announced approval of a COVID-19 vaccine with no supporting clinical trial results.

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.