GSK, Sanofi see setbacks in flu vaccine production for US market

Issues at GlaxoSmithKline’s production plant in Ste-Foy, Canada, reduced the total amount of flu vaccines doses available this year for the US market and delayed other shipments. 

“We originally expected to sell between 28 to 33 million doses of flu vaccine in the US market this year. We now are on track to provide between 26 and 27 million doses by the end of November; we already have shipped about 20 million doses since August. We have a limited amount of flu-vaccines supply still available for healthcare providers to order​,” a GSK spokesman told In-PharmaTechnologist.com. 

The setback comes as the Canadian flu plant was hit with a US FDA warning letter due to endotoxin contamination issues, though the vaccine maker previously told us it was confident it would meet Flulaval production targets​.   

In August, Health Canada also signed off on an action plan​ to remediate the issues at the facility. The company had to discard 20 lots of vaccine because of the contamination. 

Sanofi​ 

In addition to GSK, a Sanofi Pasteur spokesman confirmed to us that the company “has informed customers that shipments of certain presentations of Fluzone influenza vaccine have been delayed.  These presentations are Fluzone Quadrivalent vaccine, 0.5ml syringe, Fluzone Quadrivalent vaccine (Pediatric Dose), 0.25 mL syringe, and Fluzone trivalent vaccine, 0.5 mL syringe​.”  

The spokesman did not elaborate on the production issues, though he noted: “Given the nature of manufacturing any vaccine, potential delays in production are not always known ahead of time.” 

Sanofi shipped the majority of doses for the US market in October but some doses will continue to ship into November. Despite the setback, Sanofi said it “plans to deliver every dose of the more than 65 million we committed to produce and distribute this influenza season​.” 

“Although the timing of our shipments are later than originally planned, we are doing everything we can to expedite the release and delivery of our Fluzone vaccine shipments​,” the spokesman said. “We are working closely with our customers with the common goal of getting patients immunized prior to peak disease season​.”  

Other Options​ 

Luckily for the US market, GSK and Sanfi aren’t the only suppliers of flu vaccines. According to the US CDC, as of mid-October, seven influenza vaccine manufacturers are projecting that as many as 151 million to 156 million doses of influenza vaccine will be available for use in the US this flu season. Novartis and Protein Sciences are two other major manufacturers. 

The US FDA also approved in August a new needle-free flu vaccine injection system​ that works with bioCSL’s vaccine Afluria. 

In addition, MedImmune offers a vaccine known as FluMist that can be administered as a nasal spray.