Vaccines

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.

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 Starts Evaluation of Moderna’s COVID-19 Vaccine for Children

November 10, 2021

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

Taking an Alternative Approach to Drug Delivery

November 03, 2021

Alternative drug delivery approaches are promising, but due to their complexity, they need to be sufficiently justified.

Novavax Files for Authorization of its COVID-19 Vaccine in the UK and Australia

October 29, 2021

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

EMA Approves Two New Manufacturing Sites and a New Formulation for Comirnaty

October 22, 2021

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

EMA Starts Evaluation of Comirnaty in Children

October 22, 2021

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

In Vivo Falls Behind In Vitro for Adventitious Agent Testing

September 29, 2021

Alternatives to animal testing and in-vivo assays are occurring as a result of recent scientific advances.

Celsion and Poly Pharm to Manufacture Celsion’s DNA-Based Vaccine

September 23, 2021

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.