US reduces order for CSL's H1N1 vaccine

Jan 11, 2010 (CIDRAP News) – The US government recently cut back its contract for H1N1 influenza vaccine from Australian-based CSL Biotherapies by about 60%, mainly as a result of delays related to the company's commitment to make vaccine for Australia first.

The Department of Health and Human Services (HHS) has reduced its order from the original 36 million doses to 14 million doses, said Gretchen Michael, a spokeswoman for the HHS Office of the Assistant Secretary for Preparedness and Response. She said the step was taken at the end of 2009 and that production of the 14 million doses is still under way.

HHS had ordered a total of 251 million doses from five manufacturers. Michael said there were no immediate plans to cut back on orders from the other four companies—Sanofi Pasteur, Novartis, MedImmune (a unit of AstraZeneca), and GlaxoSmithKline. In the face of sagging vaccine demand, several European countries have taken recent steps to reduce their vaccine orders.

"At the end of 2009, HHS agreed to adjust the contract of CSL when we were informed that there would be significant delays in the manufacturer's delivery schedule," Michael said. "This delay was caused in large part to CSL shifting some of their production to the government of Australia earlier in 2009."

Last fall, CSL's obligation to supply vaccine first to Australia was cited as one of the causes of slow deliveries of vaccine to the US government. The main reason was that most of the manufacturers had lower-than-expected yields of the vaccine virus, which is grown in eggs.

The first word of the CSL contract reduction came in a Reuters report from Australia today. The story said the order had been reduced by half.

Michael said she was aware of no other plans to reduce HHS's vaccine orders. "Everything can change from day to day; we're looking at demand, supply, who's got what coming out," she commented.

She said the vaccine contracts were designed to be flexible.

"Our initial contracts were signed last spring before we knew many critical pieces of information, such as whether people would need one or two doses for an adequate immune response," she stated. "Given these uncertainties, the contracts were designed to give us flexibility to adjust as needed as we learned more information, and we have done just that as the program has progressed over the fall and winter. We will continue to do that to ensure that we meet the needs for vaccine demand."

CSL's original contract to deliver 36 million doses of H1N1 vaccine was worth $180 million, according to earlier reports. Michael said she couldn't put a number on the cost of the reduced order. CSL Biotherapies officials today did not return a phone call seeking more information.

At least two other vaccine makers, Sanofi Pasteur and Medimmune, have finished making all the bulk vaccine needed for their HHS orders, though not all lots have been released, according to company officials.

"I think you could say it's essentially finished. It's all been formulated and filled, though there may be some batches awaiting final release," said Sanofi spokeswoman Donna Cary in a Jan 8 interview.

Sanofi has made 75 million doses in bulk form, which will amount to 78 million finished doses, because some of the doses are for children, Cary reported. "We've fulfilled that commitment, and it should be all shipped in the next week or so."

"We have no indication that the US government isn't going to take [all] the doses they ordered from us, and we have orders from other countries that have said, 'If anyone doesn't want it, we'll take it,'" Cary commented.

MedImmune, which makes the live attenuated intranasal vaccine, has made extra vaccine beyond the 42 million doses ordered by the government, company spokeswoman Karen Lancaster said in a Jan 8 interview.

"We did finish making all the bulk [vaccine], and we made some beyond that in case of more demand," she said. "It can be used for more monovalent vaccine or it could be used next season if needed."

Most of the 42 million doses have passed the final production steps, and about 27 million have been shipped to distributors, Lancaster said.

Details were not available today on the progress of H1N1 vaccine production by Novartis and GSK. Earlier reports said Novartis was under contract to make about 35% of the US supply of H1N1 vaccine, whereas GSK's share was reported to be less than 5%.

News of the reduced CSL contract comes as National Influenza Vaccination Week gets under way, with public health and medical groups urging people to get vaccinated if they haven't done so yet.

Last week the Centers for Disease Control and Prevention (CDC) said the vaccine should be available nearly everywhere and warned of the risk of a third wave of infections later in the winter. The cumulative number of doses made available was put at 136 million on Jan 7.

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