The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.

Combatting Future Viral Threats with Vaccine Advances

More technologies and treatments are emerging for COVID-19—along with new variants.

What’s Next for COVID-19 Vaccines and Variants?

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

Key Elements for Assay Transfer Success

Topic

Articles

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

EMA's Pharmacovigilance Risk Assessment Committee is reviewing very rare cases of unusual blood clots in the US, following administration of Janssen’s COVID-19 vaccine.

Safety Review of Janssen COVID-19 Vaccine Continues in Europe

EMA is continuing to monitor the incidences of very rare blood clots with low blood platelets occurring after vaccination with the AstraZeneca COVID-19 vaccine (Vaxzevria).



Further Context on AstraZeneca COVID-19 Vaccine Risks to be Provided by EMA

EMA has started its review of monoclonal antibody VIR-7831 (also known as GSK4182136) as a treatment for patients with COVID-19.

EMA Review of VIR-7831 for COVID-19 Underway

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.

COVID-19 Update

Combatting Future Viral Threats with Vaccine Advances

What’s Next for COVID-19 Vaccines and Variants?

Key Elements for Assay Transfer Success