A hiccup in manufacturing production has caused delays in distributing the vaccine for the pandemic influenza A(H1N1) virus, Health and Human Services Secretary Kathleen Sebelius testified during a hearing of the Senate Committee on Homeland Security and Governmental Affairs.
Reasons for the delays are twofold, she said. First, antigen production was yielding lower results than had initially been anticipated. “We have been assured by the producers that this has been fixed, so their yields are more robust and those numbers are beginning to change,” she said.
Secondly, new production lines were established by the five vaccine manufacturers, Ms. Sebelius said. “That's the good news. The bad news is, there were glitches in some of those production lines. In discussions with all the manufacturers, those issues have been corrected, so we anticipate that number growing exponentially as we move through the season. By early November we are confident that the vaccine is going to be more widely available. We are pushing it out as quickly as we can.”
“The reality is, there's not enough [vaccine] now,” said committee chair Joe Lieberman (I-Conn.). “We've got to get ahead of the spread of the disease.”
Influenzalike illness net rates were higher in October than they have been at the peak of the last five influenza seasons, Dr. Lyn Finelli said at the fall meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
Epidemiologic data suggest that groups at increased risk have not changed since the spring wave of H1N1 illness. The epidemiology, with deaths increasing in young adults but tapering off in the 50- to 64-year-old age group, is also the same as was seen in the spring, Dr. Finelli said.
Overall, approximately 72% of the lab-confirmed H1N1 related deaths in the United States occurred in the 19- to 64-year-old age group, based on data from 292 lab-confirmed deaths from the H1N1 virus reported to the CDC between the week ending Aug. 30 and the week ending Oct. 16. Approximately 17% of deaths occurred in those aged 0-18 years, and approximately 12% occurred in those aged 65 years and older, she said.
In the data set of 292 deaths, a total of 67% of individuals younger than 18 years had underlying medical conditions, as did a majority of individuals in other age groups, Dr. Finelli said. And pregnant women remain at increased risk of poor outcomes. Most of the reported cases of H1N1-related deaths in pregnant women (90%) were in women in the second or third trimester of pregnancy, she noted.
Communication remains a challenge. Dr. Pascale Wortley of the CDC reviewed results of a Harvard University poll conducted Sept. 14-20 of 1,042 adults aged 18 and older. In the poll, 52% of the respondents said they were concerned about the H1N1 flu, compared with 38% in a similar poll at the end of June. But only 33% said they thought the vaccine was safe for most people, 18% of people thought it was safe for children aged 6 months to 2 years, and 13% thought it was safe for pregnant women.
The CDC's Dr. Anthony Fiore summarized data from clinical trials and emphasized the safety and effectiveness of the H1N1 vaccine, based on early results. The ACIP's target prioritizations remain “reasonable and evidence based,” he said, but he emphasized the importance of decision making at the local level, especially while the vaccine supply remains limited.
As of Oct. 12, states have ordered 11 million doses of the vaccine. “We are up to 150,000 sites where the vaccine is automatically delivered,” Ms. Sebelius said.
Ms. Sebelius warned that the United States is “too dependent on vaccination production in other countries, and we're still using old, egg-based technology. We are committed to developing cell-based and newer technology with a faster growth time.”
Heidi Splete contributed to this report.
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