CDC will release stockpile to expand flu immunization

Jan 27, 2005 (CIDRAP News) – Federal health officials today announced two unusual steps to encourage more Americans to get influenza shots: releasing a federal emergency stockpile of 3.1 million doses and, where local conditions permit, freeing doses normally reserved for certain groups of children.

The actions are one-time steps the Centers for Disease Control and Prevention (CDC) has chosen to reduce what CDC Director Julie Gerberding, MD, termed "supply and demand mismatches."

In addition, healthcare providers in areas with ample vaccine may choose to expand vaccination beyond the groups routinely recommended to receive the vaccine, the CDC said.

"These steps are designed to help us make the very best use of the vaccine we have," Gerberding said in a news teleconference this afternoon. She emphasized that the actions are "extraordinary measures" and not intended to set precedents.

"Too many people who are at high risk for the serious complications of influenza are not vaccinated and quite frankly that is just tragic," Gerberding stated in a news release.

The CDC will relinquish its stockpiled doses to vaccine producer Sanofi Pasteur (formerly Aventis Pasteur) for redistribution, Gerberding explained. Physicians can buy vaccine from Sanofi Pasteur and give it to any patient. Providers will be refunded for unused doses of vaccine and will only pay return shipping costs, the CDC release said.

Sanofi Pasteur will use its existing distribution system to efficiently move the vaccine to places where it is needed, Gerberding said. "What is sold and used will be credited to the stockpile for next year," she explained.

In addition, CDC is freeing about 1.3 million doses of flu vaccine intended for the Vaccines for Children (VFC) program, which normally serves uninsured and Medicaid-eligible children (age 18 and younger) and children of American Indians and Alaskan Natives. Those doses will be available to state health departments for non-VFC use where the demand among eligible children has already been met.

The emphasis will remain on getting shots to the priority groups, Gerberding said, but "we certainly don't want vaccine to go unused," she added. "These steps are designed to help us make the very best use of the vaccine we have."

The CDC action today is one of several steps the agency has taken in response to the loss last October of about 48 million doses of Chiron Corp. flu vaccine because of contamination in a British plant. That amounted to nearly half of the projected US supply.

At that time, CDC sought to head off a vaccine shortage by recommending that available doses be limited to groups at risk for serious flu complications: 6- to 23-month-old children and their caregivers, people over 65, pregnant women, people with chronic medical conditions, healthcare workers, and children on chronic aspirin therapy. On Dec 22, CDC expanded those priority groups to include adults aged 50 to 64 and caregivers and household contacts of people in priority groups.

Today CDC said that in states that have ample vaccine supplies, it supports health agencies that want to expand vaccination beyond groups for which it is routinely recommended.

Gerberding continued to walk a narrow line between advocating dropping all restrictions on who can get a shot and advocating that only those at risk for flu complications obtain shots.

"We're not encouraging everyone who wants a flu shot to go out and get it," she said, but added that the CDC does encourage everyone, especially those at high risk, to ask their providers for shots. Providers in turn can get guidance from their local health agencies and may choose to buy more doses from Sanofi Pasteur.

The 4.4 million doses freed today appear small next to the estimated 57 or 58 million doses that have already been purchased this year, Gerberding said. But she added, "Our high-priority groups are under-vaccinated compared to what we achieved last year."

Although the flu season has not been extreme this year, she also warned it isn't over and may not have peaked. As of mid-January, 24 states were reporting widespread flu activity, the CDC said.

The prognosis for next year's US vaccine supply remains murky. It's not yet clear whether Chiron will be able to supply vaccine, and even if it does, it will lack its earlier production capability, Gerberding said. She declined to speculate on whether a vaccine from GlaxoSmithKline would be licensed in time for next flu season. Meanwhile, ordering of next year's vaccine is temporarily delayed.

"We simply have to come up with a more robust manufacturing process," she said. In addition, health officials are considering more comprehensive means to vaccinate adults and find "what really would be the best way to optimize flu vaccine delivery every year to stabilize demand and get the kind of coverage we would like to see."

Those efforts are for the long term. In the short term, the nation may need to brace for the possibility that things won't change quickly.

For next year, "We have to be prepared for a supply that does not meet our need," Gerberding said.

See also:

Jan 27 CDC news release
http://www.cdc.gov/media/pressrel/r050127.htm

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