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

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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.

Industry Backs Clear FDA Standards for COVID Vaccine Authorization

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

Rentschler to Partner with BioNTech for COVID-19 Vaccine Manufacturing 

Independent research performed at the University of St. Andrews in the UK has reportedly demonstrated the effectiveness of Alfacyte in-vitro against SARS-CoV-2.

Independent Research Demonstrates Effectiveness of Alfacyte Against SARS-CoV-2

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

First Participant Dosed in CureVac’s COVID-19 Vaccine Clinical Trial

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

EMA Confirms Standards for COVID-19 Treatment Evaluations

Sean Milmo is a freelance writer based in Essex, UK.

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

Regulating with Flexibility: The Pandemic Effect

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Misleading messages contribute to eroding trust in public health agencies.

Fighting the (Dis)Information Pandemic

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Regulatory Review of COVID-19 Vaccine Begins in Europe

The Serum Institute of India will receive upfront capital to expand manufacturing capacity, pending vaccine approval, to ensure distribution.  

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