Vaccines

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates.

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally.

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021.

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.

Pfizer and BioNTech have entered into a new agreement with the European Commission to supply 900 million doses of Comirnaty to the European Union with an option to request up to 900 million additional doses.

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future.

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

Moderna has entered into an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine to the 92 Gavi COVAX Advance Market Commitment low- and middle-income countries.

Complex formulations, personalized medicines, COVID-19 therapies, and sustainability goals are driving innovations in drug packaging.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

The European Medicines Agency and the European Centre for Disease Prevention have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites.