Pfizer Wants Govt to Take a Shot at its Vaccine
Co in talks with govt to include its multi-dose vial pack of pneumococcal vaccine Prevnar 13 in the country’s immunisation programme Pfizer Packs a Vaccine Punch
Mumbai: Pharmaceutical giant Pfizer is in talks with the Indian government for inclusion of its multidose vials of pneumococcal vaccine, Prevnar 13, in the country’s immunisation programme. The New York-headquartered company won European approval for the multi-dose vial pack of the infant and children’s vaccine, which works against 13 strains of streptococcus pneumonia bacteria. The drug is Pfizer’s top-selling brand locally (ahead of Corex cough syrup). It raked in .₹ 251 crore in sales last year. Susan Silbermann, president for Pfizer’s global vaccines operations, told ET that if the new vials of Prevnar 13 are to be included in India’s national immunisation programme (NIP), the company will be keen to work with the government to ensure that the product is introduced by the end of the year. She said the company has discussed with health officials for an accelerated review process for the vaccine in the new pack. Prevnar 13 competes with GSK’s brand Synflorix, which is also available in the private market. Each multi-dose vial can be used for four doses as against the one-time use of the pre-filled syringes of Prevnar 13 that are currently marketed.
Data shows that over 100,000 child- ren below the age of five die of pneumococcal pneumonia in India every year. In the new form, a box that once carried vaccines for 50 infants and children can now potentially vaccinate 200, and is expected to lead to significant savings in health budgets of scores of countries that have included the product in their national vaccination programmes.
Pfizer expects the multi-dose vials play an instrumental role as the country closely examines the modalities to include the vaccine in its Universal Immunisation Programme, which offici- als have hinted may be announced by the end of the year. The company announced that the vials laced with a preservative can be used for four doses and will be priced at $3.1 for each shot under the GAVI (Global Alliance for Vaccine and Immunisation) Advance Market Commitment programme. In India, the vaccine has a maximum retail price of .₹ 3,801 per dose in the private market.
An April 6 statement from Pfizer said its product received an approval from the Committee for Medicinal Pro- ducts for Human Use (CHMP) of the European Medicines Agency (EMA). “This new multi-dose vial presentation was developed to help maximise efficiency for healthcare workers by helping to significantly reduce storage requirements and shipping costs in communities with health systems that are still developing,” the company noted in the statement.
Pfizer said it plans to make new submission to the World Health Organisation (WHO) for prequalification, which, if approved, will allow for the global use of the new presentation of Prevenar 13 by United Nations agencies and countries that require WHO prequalification. “If and when prequalified, the MDV presentation is expected to be introduced under the Advance Market Commitment program in early 2017, for shipment to countries covered by GAVI,” it said.
Earlier this year, GAVI committed $500 million to be spent over a five year period (2016-2021) to bolster India’s existing immunisation programme and add newer vaccines to its list. Last month, MSF, the humanitarian aid agency, filed a patent opposition against Prevnar 13, calling the government to block granting patent for the vaccine so as to facilitate wide availability of lower-cost versions of the product. Pfizer’s Silbermann told ET that the company has reviewed the opposition and is in the process of responding.