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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As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

EMA Approves New Manufacturing Site for Moderna COVID-19 Vaccine

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

AGC Biologics to Supply More Plasmid DNA for Pfizer-BioNTech COVID-19 Vaccine

Agnes Shanley is senior editor of Pharmaceutical Technology.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk. 

Prioritizing  Cleaning Validation

The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site. 

Lonza and Moderna to Expand Their COVID-19 Vaccine Drug Substance Manufacturing Collaboration

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Moderna Initiates Rolling Submission of Biologics License Application for its COVID-19 Vaccine

FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19. 

FDA Issues EUA for mAb Therapy for the Treatment of COVID-19

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

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally. 

Vaccine Makers Ramp Up Production, Donations to Protect IP

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

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