Manufacturing

Articles

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents 

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa

Pall has secured a manufacturing contract with Exothera for the suspension-based manufacture of gene therapies and viral vector-based vaccines.

Pall Enters Multi-Million Dollar Contract with Exothera for Viral Vector Manufacturing

MTBVAC has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults.

Zendal and IAVI to Advance Tuberculosis Vaccine Candidate into Efficacy Trials

ImmunityBio will proceed with a Phase I/II/III trial in South Africa of their dual-antigen T-cell vaccine as a boost in participants who were previously vaccinated against COVID-19.

SAHPRA Authorizes ImmunityBio to Proceed with Trial of T-Cell Vaccine as Booster Against COVID-19

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing. 

NIIMBL Receives Federal Funding for Biopharmaceutical Manufacturing Projects

Univercells Technologies and VectorBuilder to produce custom viral vectors for cell and gene therapies as well as vaccine applications.

Custom Viral Vector Manufacturing Protocols to be Produced by Univercells Technologies and VectorBuilder

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

EMA Approves Scale-Up Process for Janssen COVID-19 Vaccine

The first participants, both previously vaccinated and unvaccinated, receive AstraZeneca’s new COVID-19 variant vaccine AZD2816. 

Vaccine Development and Manufacturing