Materials availability is a factor in vaccine production.

Supply Chain Hurdles for Vaccine Production

Can lessons learned during the pandemic pay off in shorter development timelines?

Boosting Drug Development

Genetic vaccine platforms demonstrate their potential.

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

Emergent BioSolutions Pauses Vaccine Manufacturing 

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.

Pfizer and BioNTech to Supply EU with 100 Million Additional COVID-19 Vaccine Doses

The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.

FDA Revokes Emergency Use Authorization for COVID-19 Treatment

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

FDA Weighs in on Remote Inspections

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. 

FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots 

FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.

FDA Accepts IND for Airway Therapeutics’ Treatment for Severe COVID-19 Patients

Eli Lilly has modified its purchase agreements with the US government for its emergency use authorized COVID-19 neutralizing antibody therapies, bamlanivimab and etesevimab, to be supplied and used together rather than individually.

Eli Lilly Modifies COVID-19 Purchase Agreement with the US Government

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

Plasma-Based COVID-19 Treatment Alliance Ends its Project as Trial Fails to Meet Endpoints

Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.

Catalent Expands COVID-19 Vaccine Fill/Finish Collaboration with Moderna

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

COVID-19 Update

Supply Chain Hurdles for Vaccine Production

Boosting Drug Development

Innovating to Fight the Pandemic