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.

60 Million Doses of the COVID-19 Vaccine is Added to Moderna’s Supply Agreement with the UK

December 03, 2021

Moderna’s agreement with the UK government includes 29 million COVID-19 vaccine doses for delivery in 2022 and 31 million doses for delivery in 2023.

The Key Elements for Assay Transfer Success

December 01, 2021

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp to Build mRNA Vaccine Manufacturing Capacity

November 29, 2021

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

Vaccine Makers Seek to Address Omicron SARS-CoV-2 Variant

November 29, 2021

The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions.

EMA Recommends Pfizer and BioNTech’s COVID-19 Vaccine for Children

November 29, 2021

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.

GreenLight Biosciences, Samsung Biologics Collaborate to Advance COVID-19 Vaccine Candidate

November 29, 2021

Samsung Biologics will manufacture GreenLight BioSciences' COVID-19 vaccine candidate for clinical trials and commercial sales.

FDA Authorizes COVID-19 Boosters for All Adults

November 19, 2021

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

Celltrion Gains Nod from EC for Regdanvimab

November 19, 2021

EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.

EMA Begins Evaluation of Novavax COVID-19 Vaccine Marketing Authorization Application

November 19, 2021

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

EMA Recommends Two COVID-19 Treatments

November 11, 2021

The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.