Panacea Biotec is upbeat with WHO nod to its EasyfiveTT mono (1 dose) and multi-dose (10 dose) presentations.
The World Health Organization (WHO) has recently completed the evaluation process of pre-qualification (PQ) of Delhi based Panacea Biotec's pentavalent vaccine EasyfiveTT (DTP-HepB-Hib) sucessfully and has, vide its communication dated September 17, 2013, conveyed that they are initiating the arrangements for PQ. This was announced by the company at a select press briefing held in New Delhi on September 19, 2013.
WHO has also informed the UNICEF (procurement agency for global markets) of the positive outcome of the evaluation process and will be issuing the letter to UNICEF informing the PQ of EasyfiveTT mono (1 dose) and multi-dose (10 dose) presentations and the details of PQ will be published on WHO webpage soon. The company has successfully completed the audit of its Lalru and Baddi facilities, conducted by WHO team from February, 28 till March 01, 2013.
Company is now preparing itself to supply EasyfiveTT vaccine (pentavalent vaccine that protects against five diseases-Dipheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influnzae type b (Hib) of early childhood.) to UNICEF and other international agencies involved in procurement of vaccines at global as well as national levels in various countries.
Speaking to media, Dr Rajesh Jain, joint management director explained, "It was a great experience to have worked with every individual involved in vaccines operations at both Lalru and Baddi sites in rebuilding our new Quality Management System (QMS). The whole effort was focused right from getting the organisation ready for change to designing systems to prevent problems. We had focused on getting our thinking process right and move from paper to robust QA system ensuring patient safety as our key goal."
Adding further, Dr Jain said, "Today, the company internally has subject matter experts and the champions on every aspect of QMS. The system brought in sufficient attention to science and decision making process while taking quality decisions keeping patient safety in mind. In the end it was a collective and collaborative effort for change and has to continue with even greater enthusiasm to the next level in the coming years. I would like to take this opportunity to thank all our customers, partners, suppliers, bankers, investors and employees for thier faith and continued support during this challenging period."
Panacea Biotec developed and introduced the world's first fully liquid pentavalent vaccine in the year 2005 and achieved WHO pre-qualification in July 2008. Since then untill June 2011, the company had supplied over 45 million doses for usage in around 31 GAVI/non GAVI countries worldwide.
Fully Liquid Pentavalent Vaccine continues to be a high priority vaccine for WHO, UNICEF and GAVI. UNICEF continues to increase procurement of pentavalent year on year and has purchased pentavalent vaccine 168.5 million doses worth US$ 418 million spending 40.5% of funds spent on all vaccines purchased in 2011 as compared to 97.5 million doses worth US$ 292 million purchased in the year 2010. As per the GAVI forecasts, the overall demand for pentavalent vaccine is expected to increase to over 234 million doses by 2016 and thereafter to 256 million doses by 2019 for all the 73 GAVI eligible countries.
