Pfizer ($PFE) announced in December it had extended its advance market commitment (AMC) to the Global Alliance for Vaccine and Immunisation (GAVI) for the pneumococcal vaccine Prevnar 13. The drug giant promised an additional 180 million doses through 2023, as did GlaxoSmithKline ($GSK), for its pneumococcal vaccine on top of an existing promise for 300 million doses. Total commitment: 480 million steeply discounted doses.
We asked Mike McDermott, VP for the specialty/biotech operating unit of Pfizer Global Supply, about the GAVI undertaking. He oversees Pfizer plants worldwide from his base in New York City. McDermott proudly stated he has 5 daughters, all of whom have been vaccinated with Prevnar.
FiercePharmaManufacturing: Do the volumes and duration of your Prevnar 13 commitment strain capacity for other Pfizer products?
McDermott: To meet the demand, we're increasing manufacturing capabilities through capital investment, process improvements and efficiency measures throughout the supply network. [One example is its planned investment of $200 million to upgrade the Grange Castle, Ireland, plant, "a key and strategic node in our network."]
We have regular discussions with UNICEF about projected demand under the AMC. We schedule production and supply accordingly, across several years.
FPM: Does the recent FDA approval of Prevnar 13 for adults 50 and older complicate scheduling for AMC production?
McDermott: No. We're thrilled for the new indication, which increases our volume. The approval reinforces our decision to invest to increase capacity.
FPM: Huge volumes aside, how difficult is it to make Prevnar 13?
McDermott: It's among the most complex biologics. It combines a carrier protein with polysaccharides found on the cell coats of 13 different bacterial strains, making it 13 vaccines in one.
Prevnar 13 is made using a multifaceted aseptic manufacturing process. Grange Castle is a large supplier to this effort, but it's just one in a network of Pfizer sites in the U.S. and Europe that contribute. The network includes plants in North Carolina, New York, and the U.K., as well as some contractors, although we maintain all polysaccharide production in house. From to start to finish, production takes 9 to 12 months.
FPM: How about distribution?
McDermott: Our commitment is to deliver product to UNICEF, which then works with the receiving countries to make sure they have the infrastructure. Prevnar 13 requires handling at 2 to 8 degrees Celsius. The markets must be able to manage that, even though in some cases the destinations are remote villages. We've helped UNICEF.
FPM: Did the AMC call for any changes to the commercial vaccine?
McDermott: GAVI wanted it in single-dose vials, rather than syringes.
Now, part of our work is developing a preserved, four-dose vial, which will allow for multiple syringe piercings. When approved, it will be used in countries with difficult infrastructure and save on transportation costs. - George Miller