The company continue to develop this program for the WHO markets, thereby providing coverage and protection for more infants globally in time to come
Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial
The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.
First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
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