GlaxoSmithKline ($GSK) has been battling manufacturing issues at its influenza vaccine plant in Canada that have become very public since the facility this year was tagged with an FDA warning letter. But it turns out that Sanofi Pasteur, the largest supplier of flu vaccine to the U.S., has had some issues of its own. The bottom line for the U.S. is that deliveries have fallen behind just as vaccination programs are underway, leaving some providers with insufficient supplies.
A Sanofi ($SNY) spokesperson told The Wall Street Journal that it has delayed some forms of its Fluzone because the flu strains used to produce the shot did not grow as fast as expected. Sanofi said that it will continue to ship three versions of the vaccine into November. It still thinks it will eventually produce the 65 million doses it originally expected to have for the U.S. this season.
In an email Tuesday, a Sanofi spokeswoman said, "We have resolved the situation and are on-track to delivering our initial planned supply; however, recovery from this delay, from a shipping timeline perspective, has taken some time."
A GSK spokesman said in an email Monday that it has cut its production targets to 26 million to 27 million doses for the U.S. from the 28 million to 33 million doses originally anticipated. Robert Perry said, "The manufacturing challenges have reduced the total amount of flu vaccines doses available this year from Ste-Foy for the U.S. market and delayed some other shipments of our flu vaccines."
He said GSK has shipped 20 million doses since August and is on track to ship the remaining 6 million to 7 million doses by the end of November. The company alerted providers as early as July "to give them the option to source flu vaccines from other suppliers," Perry said.
In GSK's case, the reasons have been discussed since June when the FDA sent the Ste-Foy, Quebec, facility a warning letter in which FDA inspectors questioned the quality of the new FluLaval vaccine and its intermediates. In August, GSK said new issues have developed at the plant affecting production but that it still expected to have at least 28 million doses for the U.S. Some of its flu vaccines for the U.S. come from a plant in Germany.
GSK also cut the amount of product it would be able to deliver in Canada by about 2 million doses, which accounts for about 15% of the total doses Canada was expecting from all suppliers. Sanofi earlier this month said it expected to be able to fill some of the shortfall for a four-strain flu vaccine in Canada that had developed as a result of GSK's plant problem.
Several healthcare providers told the WSJ that they were postponing vaccination programs because they hadn't received enough supplies to vaccinate everyone. One university said it was referring students to pharmacies for their shots.
- here's the WSJ story (sub. req.)