COVID-19 Update

FDA Prioritizes Vaccine Approvals and Process Improvements; image: W.Scott McGill - stock.adobe.com

FDA Prioritizes Process Improvements

Better coordination in development and review of vaccines is needed.

Subunit Vaccines and the Fight Against COVID-19

Advances in technology are accelerating the development and manufacture of subunit vaccines.

Meeting the Demand for Lipid Excipients

Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.

Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children

May 18, 2022

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

Pfizer and BioNTech Update COVID-19 Vaccine Supply Agreement with EC

May 18, 2022

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

FDA Limits Use of Janssen COVID-19 Vaccine

May 06, 2022

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

FDA’s Office of Compliance Releases 2021 Annual Report

May 03, 2022

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

Moderna Submits EUA of COVID-19 Vaccine for Use in Young Children

May 02, 2022

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

FDA Approves Veklury for Treatment of COVID-19 in Pediatric Patients

April 25, 2022

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

ReiThera and Exothera Collaborate on Manufacturing Vaccines for Low and Middle-income Countries

April 14, 2022

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine

April 13, 2022

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

University Hospital Hamburg-Eppendorf Leads Trial to Explore Personalized Medicine in COVID-19

April 12, 2022

Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine for treatment of COVID-19.

FDA Grants Priority Review to Intravenous Treatment of COVID-19 in Hospitalized Adults

April 08, 2022

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.