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Holding the Government Accountable

Commentary: Flu Vaccine Shortage: Why Did It Happen? How Can It Be Overcome?

As the influenza pandemic spreads, manufacturers and federal agencies are racing to produce vaccine for novel H1N1 swine flu. Within a week or so, small amounts of vaccine will become available for vaccinating certain groups, according to the director of the CDC in testimony on September 29.1 Up to now there has been little outcry over the shortage of vaccine. But soon that is likely to change.

In the coming winter of 2009, as the pandemic spreads and as vaccine becomes available, but in insufficient amounts, some of those who want vaccine for themselves or their families will be unable to get it. The clamor for vaccine may grow louder as many illnesses and a few deaths – some of them preventable – occur among those denied vaccine because of the shortage.

If complaints about the shortage intensify, the White House and the Department of Health and Human Services may be pressed for an explanation.

The unexplained six-month delay

There has been a long delay – six months – from the start of the pandemic last spring until adequate supplies of vaccine will finally become available in the late fall or winter of 2009. Why did it take so long? Was the long delay intrinsic to the production process and unavoidable? Or were there misjudgments and mistakes in planning within DHHS during the last few years that delayed the production of vaccine when a pandemic began?

We at the Project On Government Oversight believe that it was the latter – that vaccine could and should have been available far sooner. However, we also believe that the effects of the faulty planning can be mitigated and that similar deficiencies can be avoided in the future.

An unusual, thoroughly tested, safe and effective type of vaccine – "recombinant vaccine" – can be produced much more quickly than the customary vaccines. If there had been an appropriate sense of urgency and adequate government funding, many doses of recombinant vaccine – perhaps tens of millions of doses – would be available at present. Large-scale nationwide vaccinations would be taking place now.

In a separate article, we explain how the manufacture of recombinant vaccine for H1N1 swine flu should have begun much earlier and how this mistake and others can be avoided in the future.2

U.S. dependence on foreign sources of vaccine

This country may also be dangerously dependent on foreign sources of H1N1 swine flu vaccine.

Two non-government public health experts have indicated in public statements that perhaps as much as 70 or 80 percent of the total supply of H1N1 vaccine for this country is being manufactured abroad under U.S. government contracts.3 Both expressed concern about the possibility that, if the pandemic grows much worse in some of the vaccine‑producing countries, then the governments of those countries may put the needs of their own citizens first and block export of vaccine to the U.S., despite the contracts.

The possible shutoff of vaccine shipments to the U.S. is not discussed on the government website, or other readily accessible site. It should be. Some may argue: why alarm the public by discussing the possible shutoff and its consequences, a possibility that is unlikely to occur? We believe that in matters like this, the public is better served by full disclosure, whether the news is good, bad, uncertain, or worrisome. Secrecy only fuels mistrust.

In March 2008 the previous Secretary of HHS described very clearly the agency's policy on domestic versus foreign production of vaccine:

A condition of HHS' funding for the participating companies is that their manufacturing facilities be located within the United States.4

The importance of domestic vaccine production was not a novel idea for senior officials of DHHS. Undoubtedly they – like other public health experts – knew long before 2008 about the risks of relying on vaccine production abroad. And so it is surprising that during the period of several years before the Secretary's statement, they had negotiated and signed contracts for vaccine production, most of which were with companies with manufacturing facilities outside the U.S. The commitments they made were less expensive at the time, but riskier later on, in a pandemic.

POGO asks Secretary Sebelius to lay out the facts. She should describe the current level of U.S. dependence on foreign sources of H1N1 swine flu vaccine, the status of partially completed and fully active U.S. manufacturing facilities, and the timetable for U.S. self‑sufficiency. Visitors to the government's pandemic flu website, or other readily accessible site – laymen and experts alike – should have ready access to the documents and decision processes in the government's program for production of H1N1 swine flu.

As part of a broad range of disclosures, the U.S. should take the lead in disclosing the details of vaccine sales and delivery. There is too little public information about the worldwide private commercial arrangements between the H1N1 vaccine manufacturers and the countries purchasing the vaccine. Similarly, information about deliveries of vaccine are difficult to obtain. Both parties – the country and the manufacturer – have generally been reluctant to disclose the details. The U.S. should set an example by making the information about its own contracts and deliveries readily available. The U.S. government should also press all flu vaccine manufacturers and all purchasing nations to do likewise. This information, gathered by the World Health Organization in a single database, would be invaluable to the global public health community and would be recognized as a contribution of the U.S. to global health.

Other information that should be disclosed

There have been major successes and some failures in the government's program for producing vaccine for a flu pandemic. Just how serious were the failures, and how much harm will they have caused? It's not known, in large part because the program has suffered from a lack of transparency. The disclosures urged in this article are essential not only for understanding the past, but for future planning.5

During the past 18 months, POGO has repeatedly called for greater transparency in all facets of the government's program for producing pandemic flu vaccine. In the present article we have mentioned only two of the areas in need of full disclosure: recombinant vaccine as a superior alternative to the customary vaccines, and U.S. dependence on foreign sources of vaccine. There are other documents, information, and ideas that should be disclosed to the public, as spelled out in the POGO report of March 6, 2008, and other documents and letters since then.6

The disclosures of past decisions on vaccine policy, as recommended here, would have a wholesome effect on the future decisions of government officials. The disclosures of their past decisions would remind them that their decisions might continue to come under the same sort of disclosure and scrutiny in the future. "Sunlight is the best disinfectant," and its benefits are long-lasting.

Subsequent documents are as follows:

April 6, 2008. Message on the need for full transparency to Secretary Leavitt through his online blog.

June 2, 2008 "Commentary: Pandemic flu vaccine program needs help," by Ned Feder. Article in Federal Times.

April 28, 2009. Online commentary, "Pandemic Flu Threat Raises Question: Is U.S. Ready to Protect the Public?"

July 20, 2009. Online commentary, "Flu Vaccine Shortage? The Whole Truth, Please."

July 20, 2009. Letter to Secretary Sebelius.

August 26, 2009. Online article, "Lives at Risk in Swine Flu Pandemic: POGO Asks DHHS Secretary Sebelius to Disclose Deficiencies in Government Plans for Vaccine Production."

August 26, 2009. Letter to Secretary Sebelius.