Vaccines

J&J Initiates COVID-19 Vaccine Approvals in Canada and Europe

December 03, 2020

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

Modular Processes and Facilities Enable Flexible Vaccine Manufacturing

December 03, 2020

The COVID-19 pandemic has accelerated the need for modular designs to rapidly expand vaccine production capacity.

BD to Invest $1.2 Billion Over Four Years in Pre-Fillable Syringe Manufacturing Capacity

December 02, 2020

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

The COVID-19 Vaccine Blind Spot

December 02, 2020

Transparency and open-dialogue are vital to sway the vaccine-hesitant community.

Moderna Files for FDA EUA for mRNA-1273

December 01, 2020

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

CureVac and Wacker Sign Manufacturing Contract for COVID-19 Vaccine Candidate

November 24, 2020

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

EC Approves Sanofi’s Meningococcal Meningitis Vaccine

November 24, 2020

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

HMA and EMA Release Joint Statement on the Approval of Vaccines

November 24, 2020

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

AstraZeneca Vaccine Candidate ‘Highly-Effective’ in Preventing COVID-19

November 23, 2020

An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.

FDA Schedules COVID-19 Vaccine Review for Dec. 10. 2020

November 23, 2020

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.