New ACIP Provisional Recs Cover Multiple Immunization Topics

Panel Expresses 'General Preference' for Combination vs. Component Vaccines

By David Mitchell
7/8/2009

The CDC's Advisory Committee on Immunization Practices, or ACIP, produced several provisional recommendations during its June 24-26 meeting in Atlanta, including one expressing an overall preference for combination versus component vaccines. Other recommendations ACIP members voted on range from changes in the postexposure rabies vaccination protocol to expanding meningococcal immunization recommendations for at-risk individuals.

The CDC now will consider whether to adopt the provisional recommendations. If adopted, the final recommendations will be published in future issues of the agency's Morbidity and Mortality Weekly Report.

Combination vs. Component Vaccines

Although committee members approved a recommendation stating a general preference for the use of combination vaccines rather than separate injections of equivalent component vaccines, they said clinicians should consider various factors when making such decisions, including patient preference, the potential for adverse events, comparative vaccine storage costs and availability, and the likelihood of patient compliance.

The committee made an exception in its recommendation for the combined measles, mumps, rubella and varicella, or MMR-V, vaccine. Compared with separate injections of MMR and varicella vaccines, administration of MMR-V vaccine has been associated with one more febrile seizure per 2,000 children immunized.

ACIP members said that for children ages 1 year through 3 years, either the combination MMR-V or MMR plus varicella separately were acceptable, but they noted that physicians should discuss the risks and benefits of both options with parents. For children ages 4 and older, the committee deferred to its aforementioned preference for combination products.

Other Business

In other votes, the ACIP made several additional recommendations.

The committee recommended reducing the number of doses of postexposure rabies vaccinations from five to four based on vaccine shortage and evidence that the fifth dose is not necessary.
ACIP members also voted to remove "physician-diagnosed disease" as evidence of MMR immunity for health care workers and replace it with a requirement for laboratory-confirmed diagnosis of disease. Institutions with unvaccinated health care workers who lack laboratory evidence of immunity should consider vaccinating those workers with two doses of MMR (or one dose for rubella coverage). During an outbreak, the CDC wording would say "recommend" rather than "consider," with two doses for outbreaks of mumps and measles and one dose for rubella outbreaks.
The ACIP is recommending that individuals ages 7 through 55 who remain at increased risk for meningococcal disease five years after vaccination with meningococcal polysaccharide diphtheria toxoid conjugate vaccine, or MPSV, should be revaccinated with quadrivalent meningococcal conjugate vaccine, or MCV4. Those at risk include people with complement deficiencies or asplenia, microbiologists who have routine exposure to Neisseria meningitidis isolates, and people who live in or frequently travel to areas with a high prevalence of meningitis. Children at high risk who received their first dose at ages 2 through 6 years should be revaccinated after three years.
The committee updated its recommendations for immunization against Japanese encephalitis to include Ixiaro, a vaccine that was approved by the FDA in March, for travelers to Asian countries where the disease is endemic. The currently available vaccine, JE-Vax, is no longer being manufactured. ACIP members also said travelers should be advised of the risks of Japanese encephalitis and how to avoid mosquito bites.
The current recommendations for polio vaccine were amended to stress that the last dose should be given after 4 years of age and six months after administration of the previous dose.

Investigational Pneumococcal Vaccine

During the June meeting, ACIP members also were briefed on the development of a new pneumococcal polysaccharide conjugate vaccine.

Wyeth Pharmaceuticals, which manufactures the currently recommended seven-valent pneumococcal vaccine marketed in the United States as Prevnar, said in a recent news release that it expects its 13-valent pneumococcal vaccine for children to be licensed soon by the FDA. The new vaccine, known in Europe and elsewhere in the world as Prevenar 13, is expected to replace the seven-valent vaccine.

According to Wyeth, the FDA has granted priority review for the manufacturer's biologic license application for Prevenar 13 because if the vaccine is approved, it "would be a significant therapeutic or public health advance."

According to Doug Campos-Outcalt, M.D., M.P.A., the AAFP's liaison to the ACIP and associate head of the department of family and community medicine at the University of Arizona College of Medicine, Phoenix, the vaccine could be an important tool in the fall because pneumococcal disease is a common complication of influenza.

H1N1 Update

The World Health Organization, or WHO, said July 6 that there were more than 94,000 laboratory-confirmed cases of the novel virus worldwide, with 429 deaths reported in more than 120 countries and territories. A July 2 CDC update said that there were nearly 34,000 confirmed or probable cases in the United States, with 170 deaths.

In addition, the first cases of H1N1 resistance to oseltamivir during the outbreak have been reported in Denmark, Japan and Hong Kong. According to a July 8 WHO news brief, however, "these instances of drug resistance appear to represent sporadic cases of resistance. At this time, there is no evidence to indicate the development of widespread antiviral resistance among pandemic H1N1 viruses."

The CDC's Advisory Committee on Immunization Practices, or ACIP, was briefed on several topics related to the novel virus during its June 24-26 meeting in Atlanta. The agency said July 7 that ACIP will convene a special meeting on July 29 in Atlanta to again address the H1N1 situation.

Although a meeting agenda was not available as of July 8, the agency said topics likely would include H1N1 epidemiology in the United States and around the world; vaccine development and formulations; communications; a report from the FDA's Vaccines and Related Biological Products Advisory Committee meeting, which is scheduled for July 23; and ACIP working group recommendations for vaccination.

According to the CDC, an average of 36,000 Americans die from flu-related causes each year. Public health officials are concerned that the coming flu season will see even more influenza activity because of the novel influenza A (H1N1) virus.

Compared with the current seven-valent vaccine approved for use in the United States, the new vaccine would protect children from six additional Streptococcus pneumoniae serotypes, including three that Wyeth said are increasing in prevalence in many countries. One of those serotypes is often resistant to antibiotics, the manufacturer said.

Pneumococcal disease is the leading cause of vaccine-preventable death in children younger than age 5 years worldwide.

Existing recommendations (1-page PDF; About PDFs) for pneumococcal polysaccharide conjugate vaccine call for doses at ages 2, 4 and 6 months, with another administered at age 12-15 months.

However, because the new vaccine would protect children against nearly twice as many types of pneumococcal disease, Campos-Outcalt said the ACIP likely will consider whether a catch-up dose should be recommended for children who already have been vaccinated with the seven-valent product.

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