Flu outrunning vaccine, experts say - washingtonpost.com

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Shots may not be widely available until December or January

By David Brown
Washington Post Staff Writer
Thursday, November 5, 2009

Two state and city public health officials briefing Congress on Wednesday said they don't expect to have enough pandemic-flu vaccine to meet the needs of their high-priority population groups until well into December, and possibly not until January.

The officials said that their predictions are a result of maddening vaccine shortages throughout the fall but that they amount to little more than guesses.

Federal health officials at the same briefing refused to endorse the gloomy timetable -- or any other one -- although they acknowledged that the current wave of H1N1 influenza may be mostly over by the time the vaccine is abundant.

"Current projections show that 62 percent of Alabama's vaccine will not be available until after December 1," Donald E. Williamson, the state's health officer, told a House Appropriations subcommittee. Offering flu shots to people outside the five priority recipient groups "may not be possible until late December or January."

The director of the public health department in St. Paul, Minn., said he thinks it will be "sometime between Christmas and mid-January" before there is enough vaccine to fully immunize the high-risk groups -- pregnant women, health workers, parents caring for newborns, people 6 months through 24 years old and chronically ill people ages 25 through 64.

"I don't think we'll have enough before then," said Rob Fulton, adding that what's true for St. Paul is probably true for all of Minnesota.

The federal government has ordered 250 million doses of pandemic H1N1 influenza vaccine. It has said that will be more than enough to satisfy demand among the country's 308 million residents. The high-priority groups include 159 million people.

As of this week, 32.3 million doses of pandemic vaccine had been made available to states and cities by the federal government, which is controlling the entire U.S. supply.

Members of the House Appropriations subcommittee on Labor, Health and Human Services, Education and Related Agencies repeatedly queried the federal officials about timelines for future supplies. While five weeks ago they were still predicting that there would be more than 100 million doses by now, none of the officials would hazard a guess.

"We have been working extremely hard with each manufacturer to make sure all of the stumbling blocks are out of the way," Nicole Lurie, assistant secretary for preparedness and response at the Department of Health and Human Services, told Rep. David R. Obey (D-Wis.), chairman of the subcommittee. "Flu is really unpredictable. We're pretty hesitant about projecting ahead more than week to week."

Thomas R. Frieden, director of the Centers for Disease Control and Prevention, also declined to look ahead, saying, "We have been burned, quite frankly, by predictions that have not come to pass." Under later questioning, he did say that "it is quite likely that the current wave of influenza will peak, crest and begin to decline before there are ample supplies" of vaccine.

Pandemic influenza -- defined as a highly contagious strain to which virtually everyone in the world is susceptible -- tends to move through populations in waves, sometimes over several years. For example, the Asian flu of 1957, which bears many similarities to the current pandemic, was responsible for about 60,000 "excess deaths" in the United States. About 40,000 occurred in the summer and fall of 1957, and 20,000 in the late winter and early spring of 1958.

The chief reason there is so little flu vaccine is that the novel H1N1 grows slowly in fertilized chicken eggs, the medium where it is made in industrial quantities.

Normally, vaccine-makers expect to get two to three doses of vaccine out of each egg injected. At the start of production in the summer, the yield was 0.2 to 0.5 doses per egg, said Robin Robinson, director of the Biomedical Advanced Research and Development Authority, which is part of HHS. After tinkering with growth conditions and other variables, it is now 1.3 to 2 doses per egg.

"If we had been getting 2.5 doses per egg [throughout the summer and fall], we wouldn't be having this hearing now," he said.

The vaccine shortage is the consequence of the virus's biology, not human laziness or incompetence, the officials told the lawmakers many times.

"I don't want people to get the impression that it is the drug companies' fault in not getting this delivered," said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

Government officials have asked the four makers of injectable vaccine to put most of their current production into multi-dose vials, which can be filled about five times more quickly than single-dose vials or pre-filled syringes and may save a little time.