Spot Shortages and New Approvals for US Influenza Vaccine

January 17, 2013
Jennifer Markarian

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October.

Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October. I received one of the last doses the clinic had on hand, and two other places I called were already out. Apparently, others in the US have been experiencing similar situations. FDA Commissioner Margaret Hamburg posted Jan. 14 on the FDA blog that vaccines are available but FDA is monitoring spot shortages.

Hamburg’s blog noted that healthcare providers can use a tracking system to find vaccine. US consumers can use a “Vaccine Finder” to identify vaccination facilities and see a user-contributed shortage report.

In the US, approximately 128 million doses had been distributed as of early January, and approximately 145 million doses are expected to be produced this season for the US, reports the CDC on its webpage. The spot shortages seem to be due to high demand. The nurse who administered my flu shot said that, in their office by January most years, most patients are no longer requesting flu shots, but that this year the requests keep coming.

Demand is good news for vaccine manufacturers. Other good news is the approval of two new cell-based, rather than chicken-egg based, influenza vaccines. Novartis’ Flucelvax vaccine, produced in mammalian cell culture, was approved in Nov. 2012, and, just as I was writing this blog, FDA announced approval of Protein Sciences Corp’s Flublok, produced using an insect-cell expression system. Cell-culture technology enables rapid response to urgent vaccine production within weeks, compared to the months required for traditional chicken-egg production, noted Novartis in a Nov. 20, 2012 press release. Flucelvax will initially be manufactured at Novartis’ facility in Marburg, Germany, and the company expects to begin supplying seasonal influenza vaccine from its Holly Springs, North Carolina facility to the US market once the facility is ready for full-scale commercial production. Because approval occurred late in the season, Flucelvax launch is planned for the 2013/2014 flu season in the US. Novartis is supporting the current vaccination campaign with the supply of 36 million doses of Fluvirin, more than its earlier stated commitment of more than 30 million doses, and is evaluating options to bring additional doses to the market to meet increased demand, as needed, said Novartis in a recent interview.

So, if you haven’t had your flu vaccine yet this year, you should check on availability before you go, but perhaps next year it will be a little easier to match supply and demand.