Beware of HIB vaccine

by Dr Robert Mendelsohn MD

Just as with the older vaccines, the best advice I can give parents is to carefully read the prescribing information before permitting the doctor to use this new Hemophilus influenza b vaccine.

You then will learn that, in addition to the active agent or germ, the vaccine injection also contains lactose, thimerosal (a derivative of mercury) and sodium chloride. You might ask your doctor whether any studies have shown that the injection of these materials——sugar, mercury and salt——is safe. I know of none.

Be sure that your doctor has a second syringe available if he gives your child the shot. The prescribing information states that an epinephrine (adrenaline) injection should be available for immediate use if an anaphylactoid (shock—like) reaction should occur. Also, be sure he takes a careful history and performs a physical examination on your child, since any febrile illness (one that is accompanied by a fever) or active infection is reason to delay the vaccine.

If you decide to have the doctor inject the vaccine, watch that he injects it in the right place. The vaccine should be given under the skin (subcutaneously) and not intradermally (between the layers of the skin), intravenously or intramuscularly. The safety and efficacy of these other routes of administration have not been evaluated.

Where has the vaccine come from? Has it been sitting on a table or in a drawer? The prescribing information says the Hib vaccine should be refrigerated upon receipt and should be stored when not in use at 35 to 46 degrees Fahrenheit. Be sure the vaccine is taken out of the refrigerator and not out of the freezer, since the prescribing information carries the warning——DO NOT FREEZE.

If you can, determine when the doctor mixed the vial of vaccine with the vial of diluting fluid, since, after mixing, the vaccine is stable for only 30 days when stored as directed. The date of mixing (reconstitution) should be recorded on the label of the vial containing the vaccine. Look at the label before the shot is given to make sure the expiration date has not passed.

 Since the Hib vaccine first was introduced a few years ago, I have been warning people about the tendency of doctors to use a new medicine as fast as they can before all the adverse effects are known. Now, the darker side of this new vaccine, designed to prevent children from getting meningitis, is beginning to surface.

In an article entitled, "Meningitis Risk Seen from Use of Vaccine" (St. Paul Pioneer Press Dispatch, April 21, 1987), Minnesota state epidemiologist Michael Osterholm reported that, instead of protecting children from meningitis, the Rib vaccine increases the risk of illness. Speaking to physicians and health experts from around the United States who were gathered at the National Institutes of Health, Osterholm reported that a study of children who had received the Rib vaccine since its introduction in 1985 showed they faced a fivefold increase in the risk that they Will be infected by the Hemophilus influenza type b bacteria (against which the vaccine is supposed to protect them). This Minnesota study found the vaccine has an effective rate of minus 86 percent, meaning the number of infected children grew. In Minnesota, many doctors have stopped administering the vaccine until they get a definitive response from the FDA.

In contrast, the original study of children in Connecticut, Pittsburgh, and Dallas which was done by Dr. Eugene Shapiro of the Yale University School of Medicine, found the vaccine to be effective 89 percent of the time. The most startling revelation is that Shapiro excluded Minnesota from his study (even though that study used the same methodology) because the state’s results were so far out—of—line from the other areas examined. I hope every reader of this Newsletter, whether in the United States or in Canada, is aware of the almost uncontrollable tendency of researchers to throw out findings that don’t agree with their preconceived conclusions!

In view of this important news, every parent whose doctor recommends the Hib vaccine must ask the doctor if he knows what’s happening in Minnesota.

The authoritative Centers for Disease Control publication, Morbidity and Mortality Weekly Report, reported in its August 21, 1987 edition that invasive Hib disease was occurring in children who previously had been vaccinated with that immunizing agent.

When the vaccine was introduced in 1985, the FDA asked its manufacturers to conduct post—marketing studies. As a result, the FDA, CDC, vaccine manufacturers and individual vaccine investigators have received spontaneous reports of these vaccine failures.

The word "spontaneous" is important. It indicates that government agencies and vaccine manufacturers have depended on passive surveillance in their search for adverse effects. "Passive surveillance" is the epidemiological term used when there is only voluntary, spontaneous and therefore spotty reporting of adverse effects by patients and doctors to the government or drug companies. In contrast, "active surveillance" refers to a situation in which the company making the drug" or vaccine and the government’s health and watchdog agencies make an effort to check up on the patients to determine the extent of adverse effects.

For example, in active surveillance, a vaccine manufacturer or the FDA might keep a file card on each person who was given the vaccine during field trials. Then at some point——days, weeks, months or even years later—each vaccinee and his family would be contacted, examined and closely questioned to determine both the efficacy and safety of the vaccine.

As you can see, from the scientific standpoint, active surveillance is vastly superior to passive surveillance. However, not too unsurprisingly, vaccine manufacturers are quite resistant to the idea of active surveillance. They claim it is too expensive, too time—consuming, etc.

I often have felt that a more basic reason for opposition to active surveillance is vaccine manufacturers’ fears of what such a scientific study might turn up. But even with inadequate, slapdash and sloppy passive surveillance, bad news about the Hib vaccine has surfaced. Investigators at the Northern California Kaiser Permanente Health Plan and the Minnesota Department of Health have reported some cases of invasive Hib disease during the one—week period following vaccination.

Last year, one investigator suggested in the New England Journal of Medicine that these vaccine failures might be due "to an inability to induce an appropriate antibody response." Translating this into English, the vaccine might not work.

The CDC says further investigation is necessary to evaluate the meaning of Hib cases found soon after vaccination. They warn that physicians should be aware that "cases may occur in the week after vaccination, prior to onset of the protective effects of the vaccine."

I will not argue with the CDC that physicians should be aware of the vaccine failure. But just in case your physician does not have time to read this weekly government publication, I think it important that patients get the message directly.