FLU VACCINE: MISSING THE MARK

Why last year's shot did not help you

Public health officials knew in Spring of 2003 that it was unlikely that last season's flu vaccine was going to protect against a mutated flu strain that was already spreading, yet they persisted in hyping the vaccine, and did not inform the public even after the vaccine's ineffectiveness was confirmed.

Numbered references appear at the end of this article.

from National Vaccine Information Center

On February 20, 2003, a committee of the Food and Drug Administration (FDA) met to try to figure out which three strains of influenza to include in the flu vaccine produced for the 2003-2004 flu season in the US.(1)

As they do every year, the members of this Vaccines and Related Biological Products Advisory Committee (VRBPAC), came together to consider reports by the World Health Organization (WHO) of the types of flu being identified in persons being treated for respiratory infections around the world.

A review of the FDA meeting transcript shows that there was little disagreement about selection of the first two strains of flu. The majority of the Committee concluded that the 2003-2004 flu vaccine should include A/Caledonia and B/Hong Kong strains, which were both in the previous year's vaccine. However, selection of the third strain was more difficult because there was strong evidence that a genetically mutated type A flu, known as A/Fujian, was emerging out of Asia and causing significant complications, including death.

The focus of the Committee's deliberations centered on the fact that epidemiological intelligence indicated that a mutated A/Fujian strain was rapidly moving from Asia through Europe and into Hawaii and the west coast of the US. Preliminary reports suggested that the close relative--A/Panama flu strain, present in the 2002-2003 flu vaccine formulation--had little or no effect on A/Fujian. In fact, flu experts from the FDA and the Centers for Disease Control (CDC) repeatedly told the Committee that A/Fujian had two genetic mutations, and therefore was enough different from A/Panama that A/Panama may only offer minimal cross protection, if any.

As a result, the FDA Committee voted to defer the selection of the third flu strain until the WHO made their recommendation three weeks later. When the Committee reconvened by phone on March 18, they learned that the WHO had decided to stay with A/Panama even though there was evidence that A/Fujian's two genetic mutations was preventing A/Panama from having much effect. When pressed, federal officials admitted that labs around the world were having trouble isolating and growing A/Fujian in a way that would allow mass vaccine production. Knowing that it takes about six months to ramp up flu vaccine production every year and concerned that further delay in strain selection would prevent a flu vaccine from being made available to the public by the fall, the majority of the Committee voted to go ahead and include A/Panama in the 2003/2004 flu vaccine.(2)

The March 18, 2003, VRBPAC meeting was the last for National Vaccine Information Center (NVIC) President Barbara Loe Fisher, who had served on the Committee as the consumer voting member since 1999. She chose to abstain from the strain selection vote, saying, "I feel uncomfortable voting for inclusion of an A/Panama-like virus, when what may really be needed is an A/Fujian-like virus. So I am going to abstain and urge that the public be informed that next year's flu vaccine may not be protective against an emerging strain."

At the earlier February 20 meeting, Fisher questioned whether there was follow-up of cases of flu every year to determine if the vaccine was effective. Dr. Cox of the CDC answered, "There is no systematic follow-up to see, to document whether the general population who receives flu vaccine is infected by flu virus because it's an impossible task. I mean we have 80 million doses or 70 million doses given and it would be impossible to follow-up." Dr. Cox also pointed out that only about 20 percent of all flu-like illnesses are actually due to an influenza virus. "There are many other pathogens that cause respiratory illness," she said.(1)

Despite doubts expressed by flu experts on the effectiveness of A/Panama, on September 23, the CDC held a press conference to promote mass vaccination with flu vaccine. "People have failed to appreciate how important and serious a disease influenza really is," CDC head Julie Gerberding said. Another doctor added, "It is the single leading cause of death from any vaccine-preventable disease."(3)

The head of the CDC's National Immunization Program, Walter Orenstein, MD, reported that the flu season which had just ended in Australia, New Zealand and other parts of the western hemisphere was "moderately severe" and was dominated by influenza A which was "covered" in the vaccine being used this year. Emphasis was placed on encouraging healthy children to get vaccinated, as well as traditionally high risk groups such as the elderly and those with chronic illness such as diabetes.

Fujian Flu Hits The US

In November, 2003 the media began reporting that a particularly nasty kind of flu was being seen in Texas and Colorado.(4) The CDC responded by issuing statements urging everyone to get their flu shots. CDC director Julie Gerberding, MD said, "This is very serious," pointing out that 36,000 flu-related deaths occur every year, though the year before the CDC stated an average of approximately 20,000 deaths.(5,6)

By early December, the media was reporting the flu-related deaths of several children. One 20-month old Colorado boy, whose death was widely reported, had been vaccinated.(7)

What followed was an explosion of publicity around the country about a possible severe flu epidemic and a higher-than-usual number of deaths, especially in children. There was a run on the flu vaccine and spot shortages began to be reported.(8) Part of the reason for the shortage was that the two manufacturers of the injectable flu vaccine had cut their combined production of doses to about 83 million down from some 95 million. This was in response to the fact that at the end of 2002 about 12 million unused doses of flu vaccine had to be discarded even though during the 2002 flu season the CDC had heavily promoted the idea that every American over 50 should get a flu shot and had encouraged healthy children to get vaccinated.(9)

But this year, with intense media coverage and a stream of statements from the CDC reporting flu deaths and pneumonia complications, the CDC had more success in convincing Americans that it was a good idea to get a flu shot. Predicting that the number of flu deaths could double to 70,000 this year, public health officials admitted the current flu vaccine was not an exact match with the circulating strain but asserted that the vaccine "was a very close match" and would offer "cross protection."(10,8)

Soon it became clear that a record number of adults and children were literally running to doctors and clinics to get vaccinated. Pharmaceutical manufacturers MedImmune and Wyeth, seeing an opportunity to capitalize on the publicity, sent out a press release on December 5, 2003, claiming that their new live virus nasal vaccine was more effective at preventing the current strain of flu that was circulating than the inactivated flu vaccine.(11) In fact, both the injectable vaccine and the newer "live-virus" nasal vaccines contain the exact same flu strains.

NVIC Calls For Full Public Disclosure

Watching not only the CDC's repeated calls for mass vaccination that prompted fearful Americans to line up in the rain and snow to get flu shots, but also MedImmune's misleading press release, NVIC decided to set the record straight. On December 10, 2003, NVIC issued a press release calling on federal health officials and flu vaccine makers to be honest with the American people. NVIC also posted the press release with links to the February and March VRBPAC meeting transcripts on the NVIC website so members of the public could have access to them.(12)

In NVIC's press release, Fisher said, "Public health officials knew last spring that it was highly likely that the A/Panama strain in the current vaccine was not going to protect against the mutated, more dangerous A/Fujian strain of flu. If there is solid new evidence that the vaccine is protective against A/Fujian, then it should be released. If there is no such evidence, then it is not right to lead people to believe that if they get vaccinated now, they will be protected against it."

That evening, Fisher appeared in an ABC Evening News report about the flu vaccine's likely ineffectiveness against the most serious kind of flu that was generating the long lines at vaccine clinics. In the following week, national newspapers from The Miami Sun-Herald to the Pittsburgh Post-Gazette and Sacramento Bee reported the story.(13,14,15)

CDC Admits Flu Vaccine Failed

By mid-January, 2004 CDC officials, who were aggressively following up on reported flu deaths in children for the first time, reported a total of 93 flu-associated deaths among children nationwide. The CDC also reported that out of nearly 60,000 suspected cases of influenza worldwide that were tested for flu virus, only 28 percent were positive (i.e., actually caused by the flu virus). Of these, about 99 percent were influenza A virus. Of the 518 influenza viruses collected by US labs, about 19 percent were similar to A/Panama and more than 80 percent were similar to the genetically mutated A/Fujian.(16)

A preliminary assessment of flu vaccine effectiveness conducted in Colorado found that the flu vaccine this year was virtually ineffective against the A/Fujian strain that had panicked Americans standing in long lines for their flu shots. There was little, if any, cross protection with A/Panama. Only 3 to 14 percent of those who got vaccinated were protected against the flu this year.(17) [The average yearly flu vaccine effectiveness is about 20-30 percent according to multiple studies. See Dr. Randall Neustaedter's The Vaccine Guide. --ed]

Congress To Consider Bail-Out Of Flu Vaccine Makers

Although last season's injected flu vaccine was a sellout, on January 28, 2004, a bill was introduced by US Senators Bayh (D-IN), Landrieu (D-LA), and Emanuel (D-IL) to reimburse flu vaccine manufacturers when they produce more vaccine than is used by the public. Entitled the "Flu Protection Act of 2004," the legislation requires the CDC to purchase back from the manufacturers unused doses of flu vaccine at the end of each season. It also requires the CDC to "conduct a public awareness campaign and education outreach efforts each year" and stress "the importance of receiving the influenza vaccine" and "the safety, efficacy and benefit of recommended vaccines for the public good."(18)

Once the CDC makes a final recommendation for "universal use" of flu vaccines in children, vaccine manufacturers will be protected against lawsuits for flu-vaccine-induced injuries and deaths under the federal vaccine injury compensation program. The CDC's "universal use" recommendation for flu vaccine is expected to be issued by the federal health agency's Advisory Committee on Immunization Practices (ACIP) in 2004.(19) Soon after that announcement, state health officials and vaccine manufacturers are expected to lobby state legislatures to add flu vaccine to state mandatory vaccination laws for children. Every vaccine that the CDC has recommended for universal use in children in the past 20 years has been mandated by some or all states for school entry, including a second dose of measles vaccine, four doses of haemophilus influenzae b (HIB) vaccine, three doses of hepatitis B vaccine, one dose of chicken pox vaccine, and four doses of pneumoccocal vaccine.(20,21)

Who Will Pay?

According to a 2003 Institute of Medicine (IOM) report, "Financing Vaccines in the 21st Century," the US government currently spends more than $1 billion annually to purchase childhood vaccines from vaccine manufacturers at discounted government prices to give to poor and uninsured children under the federal Vaccines for Children (VFC) program. This represents about 55 percent of the total childhood vaccine market. After the CDC recommended all children should use chicken pox and pneumococcal vaccines and these vaccines were added to the VFC program, the VFC budget doubled from $500 million to over $1 billion between 2000 and 2002. The cost of giving children all CDC-recommended vaccines in private pediatrician's offices jumped from $200 per child in 1997 to about $600 in 2001.(22)

The IOM report being circulated in Washington DC recommends a combined mandate, subsidy and voucher plan that would mandate insurance benefit coverage for all CDC recommended vaccines in private and public health insurance plans; a universal government subsidy for reimbursement of private and public insurers and physician providers of CDC recommended vaccines; and a government voucher for uninsured children and adults. Americans enrolled in private health care insurance plans would end up paying vaccine manufacturers and doctors twice for annual flu vaccinations they may or may not want--both through their increasing health insurance premiums and federal taxes.

References

1. Transcripts of the Vaccines and Related Biological Products Advisory Committee. February 20, 2003. US Food and Drug Administration, Center for Biologics Evaluation and Research. www.nvic.org/Diseases/Influenza.htm

2. Transcripts of the Vaccines and Related Biological Products Advisory Committee. March 18, 2003. US Food and Drug Administration, Center for Biologics Evaluation and Research. www.nvic.org/Diseases/Influenza.htm

3. Brown D. September 24, 2003. Officials urge wide use of flu vaccine. The Washington Post.

4. Associated Press. November 26, 2003. Four Colorado children die from flu. USA Today.

5. Wyatt K. November 18, 2003. CDC chief: Vaccine fails to match flu strain. Chicago Sun-times.

6. MMWR Recommendations and Reports. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). April 12, 2002. Centers for Disease Control.

7. Crecente BD. December 6, 2003. Flu virus attacks child despite vaccination. Rocky Mountain News.

8. December 8, 2003. Fears escalate over flu outbreaks. CBS News. www.cbsnews.com/stories/2003/11/26/health/printable585700.shtml

9. CDC Media Relations - Telebriefing Transcript. December 9, 2003. CDC News Conference: Influenza Update. Centers for Disease Control.

10. Graham J (Chicago Tribune). December 5, 2003. 70,000 deaths expected from especially widespread flu. The Sun Herald.

11. MedImmune, Inc. * Investors * News Releases. December 5, 2003. New Data Suggest That a Live Attenuated Influenza Vaccine May Induce Immunity Against Currently Circulating Drifted A/Fujian-Like Influenza Strain.

12. NVIC Press Release. December 10, 2003. Informed Consent Advocate Says Government and Industry Should Release Flu Vaccine Effectiveness Data. The National Vaccine Information Center. www.nvic.org/Diseases/Influenza.htm

13. Tasker F, Borenstein S (Knight Ridder Newspapers). December 16, 2003. Inherently difficult vaccine process, plus bad luck, create flu woes. The Miami Herald.

14. Srikameswaran A. December 19, 2003. Vaccine shortage a question of timing. The Pittsburgh Post-Gazette.

15. Griffith D. December 14, 2003. Flu vaccine injects a dose of confusion. The Sacramento Bee.

16. MMWR Weekly. Update: Influenza Activity. January 16, 2004. Centers for Disease Control.

17. MMWR Weekly. January 16, 2004. Preliminary Assessment of the Effectiveness of the 2003-04 Inactivated Influenza Vaccine - Colorado, December 2003. Centers for Disease Control.

18. Flu Protection Act of 2004. (S.2038; H.R.3758) 108th Congress.

19. National Immunization Program. October 15, 2003. The ACIP Vote to Recommend Influenza Vaccination for Children Aged 6 to 23 months for influenza season 2004-05. Centers for Disease Control.

20. National Immunization Program. 2004 Childhood Immunization Schedule. Centers for Disease Control.

21. State Mandates on Immunization. www.immunize.org/laws/index.htm

22. Report Brief. Financing Vaccines in the 21st Century: Assuring Access and Availability. Institute of Medicine. www.iom.edu/includes/dbfile.asp?id=14454