Biological E. Limited (BE), a leading Hyderabad-based vaccine and pharmaceutical company, announced that the World Health Organisation (WHO) has granted pre-qualification (PQ) to its 14-valent Pneumococcal Conjugate Vaccine, PNEUBEVAX 14® (BE-PCV-14).
This approval makes PNEUBEVAX 14® BE’s 11th WHO pre-qualified vaccine. The vaccine helps prevent invasive pneumococcal diseases and protects against 14 Streptococcus pneumoniae serotypes. These include 22F and 33F, which are not covered by some other PCVs currently available in India. The vaccine is given to infants from six weeks of age and protects against pneumonia, meningitis, and sepsis as part of routine immunisation.
Strong Safety and Immune Response
Clinical studies show that PNEUBEVAX 14® has a good safety profile. It produces strong and functional immune responses for all 14 serotypes.
In addition:
- It shows cross-protection against serotype 6A through the inclusion of serotype 6B.
- 69% of subjects seroconverted for serotype 6A, broadening overall protection.
- Its safety profile is similar to PCV-13, with most reactions being mild.
- It met non-inferiority criteria for all common serotypes and for additional serotypes 22F and 33F.
- All 14 serotypes achieved the main immunogenicity goals.
- Strong OPA responses were recorded across serotypes that overlap with PCV-13.
These results meet WHO TRS-977 standards.
Leadership Statement
Ms. Mahima Datla, Managing Director, Biological E. Limited, said:
“We are delighted that PNEUBEVAX 14® has received WHO pre-qualification. This is an important step for global access to high-quality pneumococcal vaccines. WHO PQ helps expand vaccine availability through global immunisation programmes. We remain committed to supporting public health partners with affordable and reliable vaccines in India and worldwide.”
Global Impact
With WHO pre-qualification, PNEUBEVAX 14® will support a stable, accessible, and affordable supply of Pneumococcal Conjugate Vaccines. The vaccine strengthens global efforts to increase immunisation coverage and reduce the burden of pneumococcal disease in children.
About Biological E. Limited
Biological E. Limited (BE), founded in 1953, is India’s first private-sector biological products company and the first pharmaceutical company in Southern India. BE develops, manufactures, and supplies vaccines and therapeutics.
- Supplies vaccines to 140+ countries
- Therapeutic products are sold in India, the USA, and Europe
- Portfolio includes 11 WHO-approved vaccines and 10 USFDA-approved injectables
BE is also working on new initiatives, including:
- Developing specialty injectables for global markets
- Creating novel vaccines
- Building sustainable API manufacturing
