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GlaxoSmithKline, makers of the Arepanrix vaccine, have ordered doctors to hold off giving any more doses from one particular batch while the company investigates a higher than normal number of allergic reactions.
The number of doses on hold are about 170,000 – a fraction of the 7.5 million doses already delivered to Canada. Six cases of anaphylaxis from this batch were reported in Manitoba, and while all victims have recovered, it has spurred further investigation.
Two reports, first this one from Bloomberg News (hat tip Florida1 at FluTrackers), and then one from Manufacturing Net, which talks of Japan’s concerns regarding this development.
Glaxo Puts Hold on Some Swine Flu Shots in Canada (Update1)
By Michelle Fay Cortez
Nov. 23 (Bloomberg) -- Canadian doctors should hold off on using a batch of GlaxoSmithKline Plc’s swine flu vaccine temporarily while the company probes reports of higher-than- expected occurrences of a side effect known as anaphylaxis, a spokeswoman for the U.K. drugmaker said today.
The batch of 172,000 doses of Arepanrix was linked to more cases of acute allergic reactions, including swollen tongues and throats, than is normally expected, spokeswoman Gwenan White said in a telephone interview. Typically, about 1 person in 100,000 will suffer such a reaction, she said.
GlaxoSmithKline Halts H1N1 Vaccinations In Canada
Manufacturing.Net - November 23, 2009WASHINGTON (Kyodo) -- British drug maker GlaxoSmithKline Plc. is suspending the use of 170,000 doses of its new H1N1 influenza vaccine in Canada given a higher-than-usual rate of reported side effects, Canadian media reported Monday.
Japan's Health, Labor and Welfare Ministry, which has a contract with the pharmaceutical firm to buy two-shot doses for 37 million people, will send a fact-finding mission to Canada by early December, health minister Akira Nagatsuma said in Tokyo.
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The Japanese health ministry was informed of the development by the company's Japanese unit, GlaxoSmithKline K.K., and is gathering information to determine if the problem is related to specific batches or the vaccine as a whole, ministry officials said.
