Friday, October 2, 2009

CIDRAP: First H1N1 vaccine doses headed to states, cities

Oct 1, 2009 (CIDRAP News) – The first 600,000 doses of pandemic H1N1 vaccine—all of them the nasal-spray formulation—are on their way to 25 states and major cities and should arrive by Tuesday, Oct 6, matching earlier predictions, federal health officials said today.

"We are transitioning from the planning to the implementation phase" of the H1N1 vaccination effort, Dr. Anne Schuchat of the Centers for Disease Control and Prevention (CDC) said at a news briefing.

States and large cities began placing orders for vaccine yesterday, said Schuchat, who is director of the CDC's National Center for Immunization and Respiratory Diseases. She didn't name the states or cities, but urban areas that work directly with the CDC program are Washington, New York, Chicago, and Los Angeles County.

"Vaccine ordered yesterday should be arriving out to the sites by Tuesday," she said. "We're really pleased that this is starting, and it's earlier than we were planning."

In response to a question about when the doses will become available, Schuchat said, "There's a good chance they'll be available later next week in a lot of the sites."

CDC officials have been predicting that the earliest doses would reach providers in early October. CDC Director Thomas Frieden said last week that the first doses could reach providers as early as Oct 6.

Schuchat said that—as predicted previously—all of the earliest doses will be the live-virus nasal-spray vaccine, which is made by MedImmune. Like the company's seasonal vaccine, FluMist, it is approved for healthy people aged 2 through 49 years, but not for pregnant women or people with chronic conditions that raise their risk for flu complications.

"We believe a lot of the states will be directing those early doses to healthcare workers," Schuchat said. "There's a bit of a myth out there that the workers shouldn't get the live vaccine, but that's a myth. Most healthcare workers who are under 50 and don't have those chronic conditions can receive the nasal spray."

She said the CDC plans to release information each Friday on how much vaccine was available for ordering and how much was shipped to each of the states and large cities, as of the preceding Wednesday.

The CDC has contracted with McKesson Corp. to distribute the vaccine doses to vaccination sites designated by state health departments. McKesson also distributes vaccines in the CDC's Vaccines for Children program.

Schuchat cautioned that the vaccination drive will face some bumps in the road. "At the beginning we'll have a bit of a slow start. But we've ordered enough [vaccine] so everyone who wants to be vaccinated can be."

HHS releases children's Tamiflu to states
In other comments, Schuchat said Health and Human Services Secretary Kathleen Sebelius has released 300,000 pediatric doses of the antiviral drug Tamiflu (oseltamivir) from the national stockpile for distribution to states that may need it.

"Basically each state that needs their proportion of that supply will receive this Tamiflu over the next week," she said.

The CDC said earlier this week that Tamiflu for children could run short as the flu spreads and advised that pharmacists may need to formulate the medication, sold as a liquid, on site by mixing the adult formulation with other ingredients.

"Some of the liquid formulation will have an expiration date that may have passed, but the FDA [Food and Drug Administration] has extended the expiration date of those courses after careful testing," Schuchat said today.

She reported that Texas and Colorado have already requested and received allocations of the liquid antiviral, getting 22,000 and 4,600 doses, respectively.

Death toll in pregnant women rises
On another topic, Schuchat updated the CDC's numbers on H1N1 complications in pregnant women. As of late August, 100 pregnant women in the United States had required intensive hospital care for H1N1 and 28 had died, she said.

On a conference call with clinicians earlier this week, CDC officials said that about 5% of H1N1 deaths have been in pregnant women, though they make up only about 1% of the population. As of Aug 20, 24 of the 484 deaths in the country involved pregnant women, officials said.

"The H1N1 influenza in pregnant women has really been striking," Schuchat said today. CDC obstetricians have been talking to "doctors around the country who have never seen this kind of thing before."

She added that the CDC has not previously tracked seasonal flu complications in pregnant women, so it's not entirely clear if complications are actually much more common with the new virus or if it just seems that way because of increased surveillance.

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