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.

Europe Lifts COVID-19 Business Continuity Status

May 10, 2023

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

FDA and Industry Prepare for End to COVID-19 Emergency

May 01, 2023

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

Crossing the Same River Multiple Times

January 02, 2023

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

December 20, 2022

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

EMA Recommends Adapted Spikevax Vaccine

October 21, 2022

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

EMA Extends Use of COVID-19 Vaccines to Children

October 21, 2022

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five and Older

October 13, 2022

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

Pfizer to Supply up to 6 Million PAXLOVID Treatment Courses for Low-and-Middle-Income Countries

September 27, 2022

Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.

FDA Authorizes Bivalent COVID-19 Boosters

September 02, 2022

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.