Why such a shortage of swine flu vaccine?
Administration points to drugmakers, and both point to science

By Michael D. Shear and Rob Stein
Washington Post Staff Writer
Tuesday, October 27, 2009

Administration officials sought Monday to explain why so much less H1N1 flu vaccine is available than had been promised, blaming the manufacturers and the vagaries of science for nationwide shortages.

Public anxiety has surged as the swine flu sweeps across the country and doctors and clinics are forced to turn away many people. Confusion and frustration at immunization sites have increased the pressure on government officials and executives of the vaccine manufacturers to explain why optimistic pronouncements this summer about the vaccine's availability ended up so far off the mark.

In July, Obama administration officials said companies could make 80 million to 120 million doses by mid-October. They outlined an aggressive response to the pandemic, spending more than $2 billion to buy 250 million doses of vaccine and promising enough to inoculate every American.

But only about 16.5 million doses have become available so far, putting the administration in an uncomfortable political position regarding what President Obama declared last week to be a national emergency.

Health and Human Services Secretary Kathleen Sebelius said in television interviews Monday that officials had been "relying on the manufacturers to give us their numbers, and as soon as we got numbers we put them out to the public. It does appear now that those numbers were overly rosy."

Her deputy, Nicole Lurie, said in a separate interview with The Washington Post that when the companies "hit some stumbling blocks, they sometimes thought the fix was around the corner and didn't always feel the need to tell us, and then sometimes it turned out the fix wasn't around the corner."

Representatives of the companies said they kept the government informed along the way about challenges, including a slower-than-expected growth of the vaccine inside chicken eggs.

"We have a formal call with them once a week and are in touch with them probably on a daily basis," said Donna Cary, the top spokesperson for Sanofi Pasteur of Lyon, France. "We're pretty much right on track."

The administration's response has generally received high marks from public health experts and medical observers. Harvey V. Fineberg, president of the National Academy of Science's Institute of Medicine, said: "I think they've been fairly candid. They've always qualified their statements and made no excessive promises."

But remaining unsatisfied are some other medical experts and politicians whose constituents have been unable to get the vaccine. Local governments have been forced to shift vaccination campaigns and, in many cases, limit who is allowed to get the vaccine, at least for now.

In Fairfax County, for example, school officials announced a mass weekend immunization at its schools, only to cancel it and replace it with a more targeted clinic last weekend for pregnant women and kids younger than 3, citing limited quantities of the vaccine. On Monday, Fairfax immunized more than 1,000 people, but health workers said they were forced to turn others away.

Caught in the middle are parents who have heard contradictory messages and remain unable to get their children immunized.

"I don't know if all departments are communicating within the government," Silver Spring mother Robyn Dixon said Monday. She left a long line in Rockville last week when it was clear that her 18-month-old son would not receive the vaccine. "I think it's them trying to get information out too quickly without really doing their research into how involved it is to make the vaccine.

"I want them to get it right," she added. Still, "I'm at their mercy."

In a letter to Sebelius, Sen. Susan Collins (R-Maine) wrote Monday that she is "troubled that HHS has assured the public since August that the government would have enough vaccine to meet demand. It seems that HHS gave its assurance of sufficient supply in August without adequate information to make such a commitment."

Collins, the ranking Republican on the Senate Homeland Security and Governmental Affairs Committee, was criticized earlier this year for opposing the inclusion of funding for pandemics in Obama's economic stimulus bill, though she supported the funding in an appropriations measure later.

Sen. Joseph Lieberman (I-Conn.), the chairman of the committee, said he shares her concerns. And he said he intends to question Sebelius about whether her department was too slow to alter its distribution plan for the vaccine.

"My concern now is that the spread of the disease has gone beyond the government's ability to take actions to prevent and respond to them," Lieberman said.

David P. Fidler, a professor of health law at Indiana University, said the government's inability to accurately predict the vaccine doses threatens to undermine its credibility.

"Are we going to see this sort of nationwide impact that's also going to be seared in the nation's mind in the way Katrina was?" he said. "One of the possibilities is that the administration and state governments will lose their credibility, because the response strategies and the promises made about the vaccine, at least in the public's eye, the promises will look again like empty promises."

Administration officials counter that they have successfully pushed to get a vaccine developed in record time and will earn the public's belief in their credibility as much more of the vaccine is produced and distributed beginning next month.

So far, public confidence in the government's ability to handle the swine flu remains high, but is tepid and has slipped somewhat since August. In the latest Washington Post-ABC News poll, 69 percent of respondents said they were confident in a federal response to the outbreak, but only 19 percent expressed a great deal of faith.

But others have questioned whether officials raised unrealistic expectations by predicting more vaccine would be available than was practical. The vaccine is being produced by five companies: Sanofi Pasteur, Novartis, MedImmune, GlaxoSmithKline and CSL.

Administration officials said they have reported the production slowdowns along the way, and said they were at the mercy of a science that is highly unpredictable and unreliable. They said it did not become clear how short the production was going to fall until around Columbus Day.

"We wish this could have been smoother, that we had a larger supply. We knew it would come in waves," Sebelius said.

While officials were predicting last week that 50 million doses of vaccine would be available by November and 150 million would be available by December, Lurie was clearly chastened by criticism that earlier estimates had been overly optimistic. On Monday, she would say only that about 10 million more doses will be available this week, with more coming every week after that.

"I don't want to be in a position of making projections," Lurie said. "It's probably best not to go out on a limb."

Staff writer Michael Laris contributed to this report.

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