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GSK’s MMR vaccine safe, effective for US infants
GlaxoSmithKline’s measles, mumps and rubella vaccine was found to be safe and effective in healthy children in a phase 3 clinical trial.
The findings of the study were previously presented at IDWeek and have now been published in the Journal of the Pediatric Infectious Diseases Society.
Nicola P. Klein, MD, PhD, a senior research scientist at the Kaiser Permanente Northern California Division of Research and director of the Kaiser Permanente Vaccine Study Center, and colleagues wrote that only one vaccine that protects against measles, mumps and rubella — MMR II (Merck) — is available for use in the U.S.
“We believe that if MMR-RIT (Priorix, GlaxoSmithKline) is licensed, it could provide a valid option to prevent measles, mumps and rubella in U.S. children,” Klein told Infectious Diseases in Children. “Plus, it could also help to reduce the potential risks of a vaccine shortage.”
In the study, healthy children in Estonia, Finland, Mexico, Spain and the U.S. aged 12 to 15 months were randomly assigned to receive a dose of either MMR-RIT, pulled from one of three lots, or MMR II in addition to all other age-recommended routine immunizations. The infants’ antibody concentrations and seroresponse rates were examined 43 days following vaccination.
Klein and colleagues observed “robust and noninferior” immune responses in infants vaccinated with MMR-RIT compared with those who received MMR II, and the immunogenicity of the three lots of MMR-RIT were consistent, with the researchers noting that nearly all (more than 97%) infants had a seroresponse to the MMR components.
Immunoresponses related to other vaccines given at the same time were comparable among infants receiving MMR II and MMR-RIT, and infants in both groups had similar reactogenicity profiles.
Furthermore, Klein and colleagues did not observe any safety concerns related to vaccination with MMR-RIT.
Like MMR II, MMR-RIT is a live virus vaccine.
“These results suggest that MMR-RIT could be a valid option for preventing measles, mumps and rubella in children in the U.S. and help to ensure that the U.S. has a second MMR vaccine available in the event of a hypothetical MMR vaccine shortage,” Klein and colleagues wrote. – by Katherine Bortz
Disclosures: Klein reports that she has received grants from GlaxoSmithKline, Merck, Pfizer, Sanofi Pasteur, Novartis, Protein Science and MedImmune. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Although endemic measles has been eradicated in the U.S. through highly successful immunization programs, ongoing outbreaks continue to occur when introduced into communities with pockets of unimmunized individuals. Presently, MMR II is the only measles-containing vaccine licensed in this country.
A phase 3 trial comparing another MMR vaccine with a slightly different measles vaccine strain to the Merck vaccine demonstrated noninferior immune responses and equivalent safety profiles between these two vaccines. Additionally, the GSK vaccine has been used in more than 100 countries on a similar vaccine schedule since the 1990s. Having a second licensed vaccine available could potentially protect against a vaccine shortage.
Given these phase 3 trial results and the additional experience with this vaccine, it seems reasonable to expect that it will receive approval for the same indications as the currently licensed MMR vaccine from the FDA and the Advisory Committee on Immunization Practices.
