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The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.
More technologies and treatments are emerging for COVID-19—along with new variants.
Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.
May 26, 2021
MilliporeSigma has launched SAFC, a high-purity synthetic cholesterol product, nine months ahead of schedule to meet the lipid demands for COVID-19 messenger RNA therapeutics.
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.
May 24, 2021
The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.
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.
May 21, 2021
The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.
May 20, 2021
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.
May 19, 2021
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.
May 18, 2021
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.
May 11, 2021
Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.
May 10, 2021
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.