COVID-19 Update

Combatting Future Viral Threats with Vaccine Advances

The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.

What’s Next for COVID-19 Vaccines and Variants?

More technologies and treatments are emerging for COVID-19—along with new variants.

Key Elements for Assay Transfer Success

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

Pfizer Pill Reduces Severe COVID-19 Risks by 89% in Phase II/III Study

November 09, 2021

Pfizer’s investigational oral antiviral COVID-19 candidate reduced COVID-19-related hospitalization or death by 89% in patients who received it within three days of symptom onset.

MHRA Approves COVID-19 Antiviral Drug

November 05, 2021

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

Eli Lilly Withdraws COVID-19 Treatments from EMA Review

November 04, 2021

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.

Novavax COVID-19 Vaccine Receives EUA in Indonesia

November 03, 2021

Novavax and Serum Institute of India’s COVID-19 vaccine, Covavax, received an Emergency Use Authorization from the Indonesian government.

GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 Pandemic

November 02, 2021

An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.

FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children

November 01, 2021

The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.

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.

FDA Advisory Committee Votes in Favor of EUA for Pfizer-BioNTech COVID-19 Vaccine in Children

October 29, 2021

The panel voted 17 to 0 to recommend that FDA grant Emergency Use Authorization for Pfizer-BioNTech’s COVID-19 vaccine in children aged 5 to 11 years old.

Merck and MPP Enter Into License Agreement for Investigational Oral Antiviral COVID-19 Medicine

October 29, 2021

Merck’s agreement with the Medicines Patent Pool (MPP) aims to facilitate affordable global access for molnupiravir.

Moderna Announces Positive Results in Study On COVID-19 Vaccine in Children

October 26, 2021

Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.