CBC

Wed Jan 3, 12:42 pm

Flu Vaccine Probe Continues

The B.C. Centre for Disease Control and Health Canada are still trying to determine why so many Canadians reported bad reactions to the flu vaccine. One thousand cases have been reported nation-wide. The Division of Immunization at Health Canada is leading the investigation. So far it appears something in the processing of the Bio-Chem Pharma vaccine may be to causing an allergic type reaction. Patients report swollen eyes, tightness in the chest, and wheezing. The reaction typically occurs three to four hours after vaccination, and goes away on its own. No one has died from the vaccine. As for the flu itself, there have been a few isolated cases of influenza but no major outbreaks. However, flu season is just arriving. Typically, influenza kills up to 1,500 Canadians every year.

-- Rachel Gibson (rgibson@hotmail.com), January 03, 2001

Answers

Everyone has read that both manufacturers of the flu vaccine had manufacturing problems that resulted in delays in vaccine production and release. But I never read anything about what the problems were. Does anyone know why the vaccines were delayed? Was it computer related versus biological virus strain problems? Mainly curious that both (2) manufacturers had problems this year.

-- slza (slzattas@erols.com), January 03, 2001.

I have asked that question but have yet
to receive an answer from Aventis in
France.

-- spider (spider0@usa.net), January 03, 2001.

Thanks for this heads-up about Canada; I have not heard of any warnings about side effects here in the United States so far this season.

The major reason given for the delays in 2 of the 3 U.S. manufacturer's delivery of influenza vaccine was relatively slow growth of one of the three viral strains used to make the vaccine (note, the viruses are killed as part of the vaccine-making process-- you don't get influenza infection from the vaccine!). Sometimes the virus just doesn't grow as fast in the lab as expected, although unfortunately slow lab growth doesn't seem to correlate with less virulence in causing disease. The slow-growing strain was one of the “A” viruses that was expected to be the major problem this season, so the manufacturers especially didn’t want to deliver vaccine lacking that particular component. I can't tell you why this slow growth happens, I'm afraid it’s not my subspeciality, but this isn’t the first time I have heard of the generic problem.

Nonetheless, clearly this year's backlog in production is extreme. The July MMWR article giving a brief statement on why the delay was occurring can be found at:

http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4927a4.htm

Note the statement that “For the 2000--01 influenza season in the United States, lower than anticipated production yields for this year's influenza A(H3N2) vaccine component and other manufacturing problems are expected to lead to a substantial delay in the distribution of influenza vaccine…” I don’t know what those “other manufacturing problems” were.

Also see:

http://www.cdc.gov/od/oc/media/pressrel/r2k1228.htm

for the latest CDC press release on vaccine availability, 28 December 2000.

The FDA website at:

http://www.fda.gov/cber/flu/flulot122700.htm

gives the following names and corporate addresses for U.S. licensed vaccines (the ‘flu vaccine trade name is in parentheses):

Aventis-Pasteur Inc. [former Connaught Laboratories, Inc.] Discovery Drive Swiftwater, PA 18370-0187 (800) 720-8972 fax: 888-889-7129 (Fluzone)

Medeva Pharma Ltd. Gaskill Road Speke, Liverpool United Kingdom L24 95D (888) 963-3382 fax: (716) 272-3935 in the U.K. 011-44-49-46-6111 (Fluvirin)

Wyeth Laboratories, Inc. Wasp and Biddle Streets P.O. Box 354 Marietta, PA 17547-0354 (800) Flushield (800) 358-7443 (Flushield)

Note that the company mentioned in the Canadian article (Bio-Chem Pharma) doesn’t seem to be the same as the three U.S. licensed companies, but I don’t know the details of the corporate connections and manufacturing plant locations.

--Andre Weltman, M.D., M.Sc., public health physician

-- Andre Weltman (aweltman@state.pa.us), January 04, 2001.