Vaccine with two expiry dates: maker says it followed protocol
The manufacturer of Easyfive-TT - a vaccine following the administration of which an infant died at the Post Graduate Institute of Medical Education and Research (PGIMER) on April 22 - has said the company had permission to extend the expiry date of the vaccine.chandigarh Updated: May 28, 2013 23:15 IST
The manufacturer of Easyfive-TT - a vaccine following the administration of which an infant died at the Post Graduate Institute of Medical Education and Research (PGIMER) on April 22 - has said the company had permission to extend the expiry date of the vaccine.
Hindustan Times had on April 26 reported that the vial of the vaccine carried two expiry dates. However, its manufacturer Panacea Biotec has said the company had the requisite permission to extend the expiry date of that batch.
In a press release, Panacea Biotec general manager (corporate communications) PD Karan said Easyfive-TT vaccine batch no P1062/SBP-A was manufactured by the company in compliance with all the requisite parameters of quality, safety and efficacy.
The company said the shelf life of the vaccine was extended in line with guidelines of the national drug regulatory authority. He said the company had submitted suitable representation in this regard to the authority concerned and no batch of the vaccine was released without clearance by Central Research Institute (CRI), Kasauli.
The company said that though it had recalled the entire batch of the vaccine, the “quality, safety and efficacy of the said batch was uncompromised.” An infant died following vaccination at PGIMER last month. Doctors suspected death due to adverse affects of the vaccine. However CRI Kasauli had given a clean chit to the vaccine. Easyfive-TT is a combination of five different vaccines. It protects children from diseases such as Hepatitis-B, Diphtheria (an upper respiratory tract illness), Tetanus, Pertussis (whooping cough), Hib (for protection from pneumonia). Earlier, the same vaccine had courted controversy in Tamil Nadu as well.