Dosage Forms

Articles

In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.

Moderna’s COVID-19 Vaccine Study in Adolescents Has Met its Primary Endpoints

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021. 

Moderna and Samsung Biologics Partner on Fill/Finish Manufacturing of Moderna’s COVID-19 Vaccine

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.

FDA Authorizes Increased Storage Time of Thawed Pfizer/BioNTech COVID-19 Vaccine

Pfizer and BioNTech have entered into a new agreement with the European Commission to supply 900 million doses of Comirnaty to the European Union with an option to request up to 900 million additional doses.

Pfizer and BioNTech to Supply EU with Up to 1.8 Billion Additional COVID-19 Vaccine Doses 

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

EMA Recommends Change in Storage Conditions for Pfizer/BioNTech Vaccine

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Sanofi and GSK Report Strong Immune Response with COVID-19 Vaccine Candidate

Jennifer Markarian is a contributing editor for 

Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future.

Tracking Technologies Guard Vaccine Cold Chain

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

FDA OKs Pfizer-BioNTech Vaccine for Adolescents

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for Their COVID-19 Vaccine

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

Vaccines