U.S. Moves to Expand Flu Vaccine Supply
Officials also endorse local efforts to offer shots to all if surplus exists
THURSDAY, Jan. 27, 2005 (HealthDayNews) -- Warning that the flu season probably hasn't peaked yet, federal health officials said Thursday they would not lift all restrictions on flu vaccines, but they endorsed moves by state and local officials to expand the pool of people eligible for a shot.
The officials also said they were making moves to increase the vaccine supply. They will do this by first selling back 3.1 million doses of flu vaccine currently in the U.S. Centers for Disease Control and Prevention stockpile to Sanofi Pasteur (formerly Aventis Pasteur) so the company can, in turn, sell the vaccine to public and private providers. In addition, about 1.3 million doses that had been reserved for the Vaccine in Children program will be made available for other users.
"We are dealing with a national shortage of flu vaccine but a supply-and-demand mismatch at the local level," Dr. Julie Gerberding, CDC director, said at a news conference. "We know that the flu is unpredictable, that supply is unpredictable, and we are discovering now that demand is also very unpredictable. The new steps we're taking today include measures to help make good use of supply, as well as measures to encourage immunization of those who need or want to be vaccinated."
Flu activity has been relatively low throughout the United States, but has been increasing since mid-December. According to the CDC, as of mid-January, 24 states were reporting widespread or regional flu activity.
Despite the widely publicized shortage of vaccine, many areas have been reporting a glut of vaccine. As of mid-January, 20 states had flu vaccine to spare, and many had lifted some or all of the restrictions on who could get a shot.
Gerberding emphasized the CDC is not changing its own recommendations as to who gets flu shot priority. "We are emphasizing our support for local and state jurisdictions who are broadening availability of flu vaccine to people who are not in previously recognized priority groups," Gerberding said. "If a local area has the vaccine and can't redistribute it, it makes sense that they would open it up to anyone who would like it."
"We are not encouraging everyone to go out" and get a shot, she added. "We are encouraging people, particularly in priority groups, to continue to check with their providers and local health officials to see whether they may be able to get a vaccine in the community."
Original CDC guidelines said that priority be given to children aged 6 months to 23 months, adults aged 65 and over, people with underlying chronic medical conditions, pregnant women, and residents of nursing homes and long-term care facilities, among others. In December, the CDC added out-of-home caregivers, people in contact with those in high-risk groups, and adults aged 50 to 64 to the high-priority list.
There are no restrictions on who can get the vaccine doses being bought back by Sanofi Pasteur. Also, there is no financial risk to providers because any unused vaccine can be returned for a refund. Similarly, Sanofi will only pay for what it sells, Gerberding said.
The 1.3 million doses from the Vaccines for Children program are also available to anyone who wants them. Typically, the vaccine in this category can only go to children 18 years and under who are eligible for Medicaid, uninsured, or are American Indian or Alaskan Native. That demand will need to be met before the vaccine is distributed more widely.
Gerberding could not say how many high-priority people had been vaccinated, only that these groups are "under-vaccinated compared to what we achieved at the same time last year." About 56 million to 58 million doses have been purchased so far this season and "hopefully, the majority have been used," she added.
The vaccine shortage was triggered in October when British regulators, citing bacterial contamination, suspended the license of the Chiron Corp. to manufacture vaccines at its plant outside Liverpool, England. The move slashed by nearly half the estimated 105 million doses that U.S. health officials had been counting on for this flu season.
Meanwhile, Chiron, along with U.S. agencies, is busy trying to get its production back on line. There is no guarantee, however, that this will happen in time for next year's flu season.
"The company has acknowledged some uncertainty in its ability to do that, and we are cautiously hopeful that they will be able to be successful, but we can't count on it," Gerberding said. "We have to be prepared for the possibility that they can't come back on line and, if they do come back on line, that they will not have the production capacities they were expected to have this year."
The U.S. government is talking to overseas manufacturers to beef up next year's supply. That vaccine would be secured under an investigational new drug (IND) application, she said.
"We look at IND as an insurance policy. If we get into trouble, we would have it available," Gerberding said. "It's also helping us interact with international vaccine producers in constructive ways that might allow us to more easily access vaccine in the future. Everyone agrees we need a broader market for flu vaccine. We're setting the stage for speeding up our ability to purchase vaccine."
The U.S. Centers for Disease Control and Prevention has more on the flu and on the flu vaccine shortage.