Oct. 16 (Bloomberg) -- Swine flu vaccine production is taking longer than expected, delaying the biggest U.S. influenza prevention program just as disease rates reached their highest level, U.S. health officials reported.

The delays will have “a substantial impact” on state schedules for inoculation as deaths including 11 children in the past week rise above epidemic levels, Anne Schuchat, head of the National Center for Immunization and Respiratory Diseases at the U.S. Centers for Disease Control and Prevention, said today on a conference call.

There were 11.4 million doses available as of Oct. 14, while previous estimates from the CDC and the Department of Health and Human Service called for as many as 50 million vaccines available for shipping by the end of this week. Swine flu is now widespread in 41 states compared with 37 reported last week, and for the first time mortality rates have surpassed the threshold for an epidemic, Schuchat said.

“It is very difficult to predict how many doses we will have in the weeks ahead,” Schuchat said. “More vaccine is becoming available regularly.”

So far 86 children have died from swine flu, more than the pediatric toll for a typical year of influenza, Schuchat said. Forty-three Americans have died since Aug. 30 from the flu, also known as H1N1.

“These are very sobering statistics,” Schuchat said.

Seasonal flu kills 46 to 88 children a year, mostly in the winter months, she said. Flu rates typically peak in the U.S. in February.

8 Million Doses

States had ordered 8 million doses as of Oct. 14, the CDC said. The first doses reached U.S. doctors beginning Oct. 6. The country’s biggest influenza prevention program is aimed at curbing the earliest flu season in at least four decades. The U.S. has ordered more than 250 million doses from vaccine makers including Novartis AG in Basel, Switzerland, Sanofi-Aventis SA in Paris and AstraZeneca Plc in London. Schuchat said production is going slower than expected and an estimated 30 million doses will have been shipped by the end of October.

“We started shipping on Sept. 29, which was a little bit earlier than we had anticipated, and we’re tracking pretty much on schedule with our shipment,” said Donna Cary, a Sanofi spokeswoman. “We’ve been asked by HHS not to disclose shipping figures.”

AstraZeneca’s MedImmune Inc., producer of a nasal spray version of the vaccine, is about 300,000 doses behind in its production, said Karen Lancaster, a company spokeswoman. MedImmune, based in Gaithersburg, Maryland, has shipped at least 6.5 million doses to the U.S. government and plans to send a total of 11 million by the end of October, she said.

Produced Enough

“We have already produced enough bulk vaccine to meet the government contract,” she said. “We have people working 24-7 to get the vaccine into sprayers.”

Melbourne-based CSL Ltd. said the company was “on schedule” with its delivery of the 36 million doses purchased by the U.S. Department of Health and Human Services, according to Sheila Burke, a company spokeswoman.

“We are shipping as fast as we can,” she said.

Novartis has the biggest contract to provide the vaccine to the U.S. government. Kathy Bloomgarden, a spokeswoman for Novartis, didn’t respond to requests for comment.

Distribution Report

San Francisco-based McKesson Corp., which is distributing the vaccine, has been filling all H1N1 vaccine orders on “the same day they are received, and shipping them via overnight delivery,” said James Larkin, a company spokesman. “You’ll need to speak with Novartis regarding supply questions.”

Individual states will decide how vaccine doses are distributed, Schuchat said. Many regions will focus on inoculating health-care workers in the initial days when supply is most limited, she said.

The first vaccines also will be aimed at children, pregnant women and people with chronic conditions that put them at risk for complications. Most adults, including the elderly, should wait until additional supplies arrive, the CDC has said.

To contact the reporters on this story: Pat Wechsler in New York at pwechsler@bloomberg.net; Tom Randall in New York at trandall6@bloomberg.net

Last Updated: October 16, 2009 16:40 EDT