Sanofi’s H1N1 2009 swine flu vaccine batches recalled in US following drop in potency

Sanofi Pasteur, the vaccine division of the French drug maker sanofi-aventis, has recalled 800,000 pre-filled syringes of Influenza A (H1N1) 2009 Monovalent Vaccine after finding that vaccine doses meant for kids lost their potency.

Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine have been distributing across the country since November and most have already been used, according to the federal government’s Centers for Disease Control and Prevention.

CDC has already notified of the voluntary recall Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine.

Health officials are not clear how many doses have already been given. However, they don’t think children need to be re-vaccinated.

Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine passed all required tests before it was shipped, but one lot was found to have dropped in potency during follow-up quality-control testing the company routinely performs. That prompted additional testing, which discovered a similar drop in potency in three other lots, reports said.

Children in that age group are supposed to get two doses, a month apart.

Sanofi Pasteur reported the potency findings to the government officials and did a voluntary recall.

Sanofi Pasteur is the No. 1 manufacturer of flu vaccines in the world. It makes flu vaccine at sites in France and in Pennsylvania.

In November, GlaxoSmithKline recalled a lot of its H1N1 swine flu vaccine in Canada following complaints of adverse reactions from the vaccine, reports said.

GlaxoSmithKline has asked that the October batch of H1N1 swine flu vaccine be taken out of circulation because it produced serious and immediate anaphylactic reactions in one out of 20,000 vaccinations, compared with one out of 100,000 in other shipments.

Following this, Canada’s H1N1 flu vaccine manufacturer has asked the provinces to temporarily discontinue vaccinating Canadians from a lot of vaccine shipped in October due to a higher risk of adverse reactions.

GlaxoSmithKline has asked several provinces to set aside the 170,000 doses from the questionable batch.

More than 100,000 doses of the H1N1 vaccine are being withdrawn across the country.

GSK said the batch recall is a precaution an they will investigate to see whether there is something wrong with the batch.

Most of the vaccine Manitoba received from the suspect lot had already been used by the time the province received the alert. Of the 63,000 doses shipped, only 630 remained unused by the four regional health authorities in Manitoba that received them.

About 1,500 doses of the vaccine were sent to Ontario, but officials said none were administered. Officials are now shelving them until the investigation is complete.

The Alberta government has stopped giving out doses from the same batch, although it has  it had not seen any allergic reactions.