Health Horizons : MEDICINE : A Dose of Reality : Today’s vaccines are only a portion of what could be available by 2000. But all the technology in the world won’t help if families can’t afford to immunize children.
My 4-year-old cowered in a corner and let out a shrill scream.
The nurse and I exchanged worried glances. My 1-year-old, unknowing what lay ahead, nevertheless stiffened in my arms.
Immunizations.
Measles, mumps, rubella, diphtheria, tetanus, pertussis, hepatitis B, influenza, Haemophilus influenza type b. You name it. We’ve had it.
I am thankful that my children have protection from many dreadful diseases. But while restraining my daughter for the shot, I couldn’t help lamenting at how complex and costly the childhood immunization schedule has become.
And yet today’s vaccines represent only a portion of what could be available by the turn of the century, health experts say.
The science and technology of vaccination is advancing so rapidly that the number of diseases covered by childhood vaccines may leap from 10 now to 15 or more by the end of the decade.
But that may not mean more than the current total of six shots.
Advances will include combining many vaccines into one dose called a cocktail or super shot. Experts are also researching delivering the vaccines orally or by skin patch. And efforts to develop one time-released vaccine might prevent the need for booster shots.
Finally, these new vaccines are considered safer than ever.
“We’re in the midst of an explosion right now,” says Dr. Regina Rabinovich, a vaccine expert at the National Institute of Allergy and Infectious Diseases. “We have new products coming on-line. And manufacturers are thinking of new ways to present these products.”
Much of the effort is being powered by the Children’s Vaccine Initiative, an international effort to create more and better vaccines.
Founded in 1990, the CVI’s goals are two-pronged: to increase the number of children receiving vaccines and to add to the vaccine arsenal. The intent is to eradicate diseases that cause many deaths worldwide as well as diseases that cause great expense and inconvenience.
“We need new vaccines and we have the technology to develop them,” Rabinovich says.
But the discussions on the future of immunization don’t center just on science. Health officials admit that technological advances won’t matter unless people have access to vaccines and can afford them.
Even now in the United States, half of all preschool-age children don’t get all the recommended vaccines. This failure is blamed on the need for multiple trips to the doctor’s office and high costs, which are rarely covered by insurance, says Dr. Philip K. Russell of the Johns Hopkins University School of Hygiene and Public Health.
“The vaccines currently available, while effective, are a major hindrance to efficient vaccination programs,” he says.
Vaccine manufacturers agree.
“There are going to have to be changes in the way we deliver immunizations,” says Ronald J. Saldarini, president of Lederle-Praxis Biologicals. “We should be immunizing every kid and not missing any.”
Thirty years ago when the measles vaccine was introduced, cases plummeted from 400,000 to 700,000 a year to about 3,000 a year by 1988.
After the poliomyelitis vaccine was introduced in 1955, cases fell from 21,000 annually to seven in 1974--considered the benchmark year because cases fell to less than 10. No cases of wild polio were reported in the United States last year. (“Wild polio” is caused by the virus itself, as opposed to polio caused by the vaccination--which occurs in rare instances.)
The Haemophilus influenza type b (Hib) vaccine that became available in 1987 for children ages 2 to 5 has led to a sixfold drop in cases in three years, according to the Centers for Disease Control and Prevention. A Hib vaccine for infants, approved in 1990, has led to a 94% reduction in bacterial meningitis, which can lead to mental retardation.
“You never heard about it, but Hib caused 18,000 cases of bacterial meningitis each year and about 1,000 infants died each year,” Saldarini says.
Within reach are similar declines in other serious diseases, experts say.
The 1992 recommendation for universal immunization of all infants with the hepatitis B vaccine should dramatically curtail the 300,000 new cases seen each year in the United States. The disease can cause liver failure in adults.
The distribution of hepatitis B vaccines to infants and children is a new tactic in combatting disease in adults by immunizing children. Hepatitis B is primarily a sexually transmitted disease contracted in adolescence or early adulthood. But public health officials are not certain if the tactic will be supported by physicians. Early surveys indicate that many pediatricians are not recommending the vaccine for infants.
“The rationale of immunizing children to prevent disease as adults has been set,” Rabinovich says. “It’s going to be a matter of how palatable this is.”
Moreover, the government is expected to approve this year a vaccine to prevent chicken pox (the varicella zoster virus). The disease afflicts three million U.S. children each year at a cost of about $400 million, mostly in lost work time by parents, according to a government report. In children and adults with weakened immune systems, chicken pox occasionally can cause serious complications.
Also on the horizon are vaccines for:
* hepatitis A, which can cause liver disease;
* pneumococcal pneumonia, which causes about half of all inner-ear infections in children, and an otitis media vaccine for other organisms that cause middle-ear infections;
* herpes simplex virus types 1 and 2, which cause fever blisters (type 1) and genital sores (type 2). If transmitted by an infected mother to her newborn, type 2 herpes can cause severe neurological damage or death in the infant;
* a wide range of influenza immunizations, with long-lasting immunity against many different organisms;
* respiratory syncytial virus, an acute respiratory infection that can be fatal in infants;
* rotavirus, a major cause of diarrhea and dehydration;
* shigella, which causes diarrhea;
* meningococci meningitis, several strains of which cause serious bacterial infections;
* streptococcus pneumonia, a cause of severe bacterial infections.
Dozens of other vaccines are in basic research or early phases of human testing, according to the Jordan Report, a 1992 summary of vaccine research. These include vaccines for Epstein-Barr virus, leprosy, cholera, group A and group B streptococcus, cytomegalovirus, gonorrhea and chlamydia.
The trouble with all this good news, says Douglas, is that “as more vaccines are developed for pediatric use, the opportunity increases for confusion in the marketplace.”
The childhood immunization schedule will simply break down if anything more is added to the costs and complexity, many experts argue.
“Look at how complicated (the immunization schedule) has gotten in the United States,” says Rabinovich. “It doesn’t matter if you make a better product if no one will use it. But there is no question that the schedule can be made more cost-effective. And there are other things you can do to vaccines to make them easier to give.”
Immunizing a child from birth to 1 year (three doses of DTP, three doses of Hib, three doses of hepatitis B, two doses of polio, one dose of MMR) in a Southern California private pediatrician’s office requires an out-of-pocket cost of $430. Most indemnity insurance plans do not cover vaccinations.
Because of the high cost, many parents don’t get their children immunized. Another problem is that some doctors do not offer vaccines because of low government reimbursement rates, the Children’s Defense Fund contended in a 1992 report.
According to the report, total cost of immunization climbed from $10.96 in 1977 to $230.39 in 1991. Given the added charges to administer the vaccine, those costs can more than double.
As a result, the CDF is promoting a government-funded, free, universal immunization program that has gained the support of the Clinton Administration. The plan involves the purchase of vaccines by federal and state health agencies at a negotiated discount price. The agencies would then distribute the vaccines free.
Although many pharmaceutical company officials say the plan would be so unprofitable that it would stop research into new vaccines, some industry leaders acknowledge the need for a cheaper delivery system.
“We think immunization should be . . . covered 100% by insurance,” Saldarini of Lederle-Praxis Biologicals says.
Other pharmaceutical companies are exploring ways to increase vaccination for poor children without submitting to a free universal program that would slash profits.
Merck & Co. has created a program under way in Virginia, and which may soon begin in California and several other states, to encourage physicians reluctant to accept Medicaid patients by providing the vaccine free. Rather than the physician paying for the supply and then waiting for Medicaid reimbursement, Merck would receive reimbursement directly from the state.
Health officials and manufacturers are also exploring ways to set fair price controls.
Technological advances, such as combining several vaccines into a “cocktail,” might also help to control costs and promote compliance with the vaccine schedule.
A combination vaccine for DTP and Hib, manufactured by Lederle-Praxis Biologicals, is under final FDA review and could become available this year. SmithKline Beecham is working on a five-in-one vaccine for DTP, plus an influenza vaccine and hepatitis B. At Stanford, researchers are assessing whether the measles, mumps, rubella shot can be combined with the chicken pox vaccine.
At a meeting with the National Institute of Allergy and Infectious Diseases last fall, officials suggested that a cocktail of DTP, Hib, hepatitis B, polio and perhaps hepatitis A, pediatric pneumococcal and an influenza vaccine might be available by the end of the decade.
“We think there are so many more things that we can put into one immunization,” says Saldarini. “But I don’t know how many (vaccines) that will be before we see a problem--if we see a problem. Vaccines could interfere with each other.”
Another way to ease delivery is through oral vaccines or skin patches, says Rabinovich. With the additions of Hib and hepatitis B vaccines, pediatricians have voiced concerns over making “pin cushions” of their patients.
“The child usually does pretty well with injections, but no one likes it,” she says.
As always, safety is the primary concern with all vaccine development, experts says. Possible adverse effects to some vaccines--such as the DTP vaccine, which can cause brain damage in rare cases--continue to generate controversy.
Even President Clinton’s proposal for free universal vaccination has been met with resistance by Dissatisfied Parents Together, a vaccine watchdog group concerned with side effects. In a letter to Clinton in February, the group warned against the high cost of compensating victims of adverse reactions if all children were immunized. According to the group, 17,221 adverse reactions, including 360 deaths, were reported to the government in a 20-month period ending in July, 1992.
“We know that these reported figures are only the tip of the iceberg,” said Jan Erickson of the National Vaccine Information Center, an arm of Dissatisfied Parents Together. “For some vaccines, we may be approaching the point at which the risks outweigh the benefits--that is, far more persons are becoming ill from the vaccine than from the disease.”
But medical experts dispute many of the claims and say the true number of adverse reactions is less than critics suggest. And safer vaccines, including a new pertussis vaccine in development, should curb those, they say.
The newer vaccines made using biotechnology, such as the Hib vaccines, are considered much safer.
“The products that are biotechnologically derived have considerable differences as far as adverse reactions,” Saldarini says.
Another barrier to the new age of vaccination is whether the public will want to have their children immunized for 15, 25 maybe 40 diseases--many of which they have never heard of.
“Many of these organisms will not be recognized as being terribly important,” Saldarini says, citing hepatitis C and cytomegalovirus.
The ultimate dilemma of vaccination programs, however, is that as more people are immunized, diseases become rare and people are no longer convinced of the necessity of vaccination.
Rabinovich proposes a possible solution: As diseases become less common, she says, public health officials may have to use new enticements, such as free vaccines or convenient distribution at schools or day-care centers, to encourage people to get the immunizations.
“If you’re doing a good job of it, it looks transparent,” Rabinovich says. “For this to work, there has to be a sense that everybody is at risk.”
When to Get Those Shots
Shaded squares denote childhood immunization schedule for current vaccines. At bottom is a list of some of the vaccines to come.
Months Years Birth 2 4 6 6-18 12-15 15-18 4-6 11-12 14-16 DPT * * * * * Polio * * * * MMR * * Hepatitis B** * * * Hib * * * * Tetanus-diptheria *
** Hepatitis B can also be given at 2, 4, 6-18 months.
Probable Addition This Year: Varicella (chicken pox).
Possible Combination Vaccines in Near Future: DTP plus Hib; DTP plus influenza plus hepatitis B; MMR plus varicella
Possible New Vaccines This Decade: Hepatitis A; Rotavirus; Streptococcus pneumonia; Pneumococcal pneumonia; Respiratory syncytial virus; Influenza
Source of current schedule: U.S. Department of Health and Human Services.
Source of future vaccines: Times interviews
