Vaccines and Expectation

It is hard not to be cynical these days about pharmaceutical companies especially as a solo pediatrician who spends upwards of $80,000 per year on immunization purchases for my office. The exigencies of a capitalist market system are clearly more important motivating factors to vaccine companies than the health care needs of children.

For example, several months ago Sanofli Pasteur introduced Menactra, a meningococcal vaccine to the health care community. Information about the new vaccine was covered both in the mass media and on the Internet within a few days of its release and CDC listed specific criteria for its use. It was suggested that children aged 11-12 and students entering high school or college receive the vaccine. We received calls about the vaccine from families of patients as soon as an article appeared in the local newspapers and on local television channels.

The current situation is disturbing. I can order a limited amount of Menactra (the quota is twenty doses every thirty days per account) and then have it shipped according to Sanofli Pasteur’s schedule rather than my medical need.

When I called to ask about the short supply I was told “that the demand is too high because doctors are ordering it for everyone from age 11 on.” So, in a paraphrase of Pogo, the enemy is seemingly us.

I gave a sigh of resignation and things were copasetic until the push to pre-order influenza vaccine for 2006 flu season came on January 31st . Sanofli Pasteur had set up that date as a national call in for vaccine. At 10 AM I tried to get through to them on the Internet www.vaccineshoppe.com but was unable to sign on; their phone lines were incessantly busy. Throughout the day, in brief moments of calm to continued my effort to reach Sanofli Pasteur to no avail.

The very next day I got the following email from Sanofli Pasteur:

Sanofi Pasteur Experiences Unprecedented U.S. Demand for Influenza Vaccine for 2006-2007 Influenza Season

Swiftwater, PA – February 1, 2006 – Recognizing Sanofi Pasteur Inc. as a reliable supplier of influenza vaccine, immunization providers contacted the company in record numbers yesterday requesting Fluzone®, Influenza Virus Vaccine for the 2006-2007 season. During the first 30 minutes of accepting prebooking requests, the company received over 40,000 phone calls and more than 200,000 calls came in during the first eight hours.

As a result of the unprecedented demand, the company has committed all influenza vaccine doses planned for production for the next season except its no preservative Fluzone vaccine in pediatric doses.

Sanofi Pasteur anticipated a surge in demand for its influenza vaccine and doubled the capacity of its phone lines and on-line ordering systems. Under normal conditions, the company receives an average of 1,500 customer calls per day. During the eight-hour period from noon to 8 PM yesterday, the company received as many calls as it normally receives in a six-month period.

The company plans to produce approximately 50 million doses of all Fluzone vaccine formulations for U.S. distribution by the end of October. Additional doses could be produced for delivery in November or December based on customer needs and production yields. To determine customer need, Sanofi Pasteur established a waiting list of customers who were unable to prebook and will contact those providers to offer the alternative of accepting later delivery. Customers willing to accept later delivery will have the option to cancel their request later in the year if they are able to obtain earlier delivery from another supplier. At this time, the company is no longer accepting additional customers on the waiting list.

The company is currently unable to supply the entire U.S. influenza vaccine market. However, based on public statements made by other influenza vaccine manufacturers, the company anticipates that there will be an adequate supply of vaccine to meet the nation’s needs for the 2006-2007 season. Sanofi Pasteur is sending apologies to its customers for the frustration they experienced in attempting to place their requests. Immunization providers who were unable to prebook their vaccine with Sanofi Pasteur will likely be able to look to other manufacturers to meet their vaccine needs.

Then on February 10th I received an apologetic form letter in which the company reiterated its dilemma in providing adequate, non-Thimerisol containing vaccine for this year. The last paragraph read as follows:

To help the longer-term needs of the country, Sanofli Pasteur has committed $150 million to construct a new manufacturing facility what will double our capacity to produce influenza vaccine for both routine immunization and in case of an influenza pandemic. We broke ground on this new facility in July 2005 and expect it to come online for the 2008-2009 influenza season.

Sanofli Pasteur’s influenza dilemma is understandable on one level: since they claim their markup on influenza vaccine is not large they must calculate months in advance what the demand for vaccine will be and then prepare to make it. Since the strain specific vaccine does not have a long shelf life (in fact it is protective only for the specific year for which it is made) it is not a vaccine that can be easily used from year to year. Thus Sanofli is confronted with the conundrum of producing supply for an uncertain demand each year. The bottom line becomes and economic one.

The other problem is one relating to the media and consequent public understanding of the issues involved. The media creates a demand, in this case about influenza vaccine, which, this year may have been compounded by ongoing discussion of possibility of incipient bird flu epidemic. Those of us in the front lines, primary care physicians, end up explaining about prophylaxis by vaccine, the propriety of immunizing certain populations first, and the various options for vaccination. Most parents these days want Thimerisol free vaccines.

The fact that Sanofli Pasteur’s inability to either create a reasonable system through which we can order vaccine or, more significantly, anticipate the medical need and meet it leaves me questioning the company’s motives and sad about the medical consequences of its short sightedness.

by Louis Borgenicht