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NEW COMBINATION VACCINE FOR HIB AND HEPATITIS B MAY REDUCE NUMBER OF CHILDHOOD SHOTS NEEDED
WEST POINT, Pa., January 17, 1997--Newly-revised government recommendations for immunizing infants against serious childhood diseases create new options and decisions for many parents and physicians. Now, a newly-available combination vaccine from Merck & Co., Inc., COMVAX [Haemophilus b conjugate (meningococcal protein conjugate) and Hepatitis B (recombinant) vaccine], offers a unique choice that may reduce the number of total injections required in the first 18 months of life from as many as 15 to as few as 11.
Licensed by the U.S. Food and Drug Administration (FDA) in October, 1996, Comvax is indicated for vaccination against hepatitis B, an important cause of viral hepatitis,and against haemophilus influenza type b, or Hib. Hib causes serious childhood illness, including bacterial meningitis.
The Advisory Committee on Immunization Practices (ACIP)--the U.S. Department of Health and Human Services' official reference committee on vaccination--and the American Academy of Pediatrics (AAP)--endorse universal infant immunization against both Hib and Hepatitis B.
Prior to the introduction of effective vaccines in 1990, Hib had been the most frequent cause of bacterial meningitis and other serious, systemic infections in young children worldwide. About five percent of those who developed Hib meningitis died, and -more- among those who survived, up to 35 percent develop neurologic problems, including seizures, deafness, and mental retardation.
Hepatitis B virus produces major health problems in the U.S. Young children who become infected are more likely to develop serious chronic liver disease as adults. There are approximately 750,000 to one million chronic carriers, who are infectious to others, in the U.S. Worldwide, there are estimated to be more than 285 million hepatitis B carriers.
Combination vaccines, in general, help simplify the complexities of national childhood immunization recommendations and assure that children get the shots they need, according to Harry Keyserling, M.D., Associate Professor of Pediatrics, Emory University, Atlanta, Georgia. "Comvax protects against two of the most serious of the diseases now targeted for prevention and eradication," he said. "Since the introduction of Hib vaccines in 1990, there has been a sharp decline in the number of cases of Hib-related illness. Hepatitis B, however, still is common and leads to about 5,000 adult deaths from cirrhosis or liver cancer caused by infection during infancy. Vaccinating infants against hepatitis B will help to halt the spread of this disease and to reduce the disease burden its victims incur as adults."
Comvax is the first combination product indicated for vaccination of infants as young as six weeks against Hib and hepatitis B. "Combination vaccines like this one are an attractive option for physicians and for their young patients," Dr. Keyserling said, "because they may help reduce the number of shots that must be administered. In the case of Comvax, physicians now have flexibility in the use of the new, safer acellular pertussis vaccine without having to increase the number of total shots."
The hepatitis B component of the vaccine was the first genetically-engineered human vaccine to be licensed and has been widely used since its introduction in 1986. The Hib component, first available in 1990, uses "conjugate" technology to chemically bond part of the Hib bacteria with that of another bacteria to stimulate antibody response.
Comvax is not, however, a straightforward blending of its two component vaccines. The scientific challenges associated with its development were significant, according to Gordon Douglas, M.D., president of the Merck Vaccine Division. "This is a fine achievement in vaccine research and development. In clinical trials, the safety profile and immune response in individuals to whom Comvax was administered were similar to that of the two components of the vaccine administered separately."
Usage of Comvax
Comvax is administered as an intramuscular injection. Infants should be vaccinated with a three-dose series at approximately 2, 4, and 12 to 15 months of age, with a two month interval between the first two initial doses.
Comvax can be administered at the same time as other standard pediatric vaccines including DTP (diphtheria, tetanus and pertussis), oral polio vaccine, VARIVAXÆ (Varicella virus vaccine), M-M-RÆ II (measles, mumps, rubella), enhanced inactivated polio vaccine (eIPV), and a booster dose of DTaP (diphtheria, tetanus and acellular pertussis) at approximately 15 months of age, using separate sites and syringes. Comvax has also been administered along with the primary series of DTaP to a limited number of infants. Immune response data are satisfactory for Comvax but are currently not available for DTaP.
Comvax has been shown to be generally well tolerated and to produce high levels of immunity in infants 6 weeks to 15 months of age. Adverse experiences were generally similar in type and frequency to those observed in infants who received the individual antigens. These included soreness, redness, and swelling at the site of injection, and some irritability, sleepiness and crying. As with any vaccine, however, there is the possibility that broad use of Comvax could reveal adverse experiences not observed in clinical trials. This product is contraindicated in individuals with known hypersensitivity to any component of the vaccine.
Merck & Co., Inc. is a worldwide leader in vaccine research. In the last 25 years, more than 300 million people have received Merck vaccines. The company introduced the first U.S. vaccines against measles, mumps, and German measles, pneumococcal pneumonia, chickenpox and hepatitis B. It is a leader in research and development in hepatitis A and is currently engaged in research and development of additional combination vaccines.
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