Pediatricians soon may have new options for measles, mumps and rubella (MMR) vaccines and pneumococcal conjugate vaccines (PCV).
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted 15-0 in favor of the new vaccines Wednesday. It also recommended approval of an influenza policy for the 2022-’23 season.
The CDC director will review ACIP’s recommendations. Those that are approved will be published as official recommendations in the Morbidity and Mortality Weekly Report (MMWR). The Academy will review the CDC’s changes and make official policy recommendations of its own.
ACIP is supporting the use of Priorix from GlaxoSmithKline as an MMR vaccine option. It would be interchangeable for on-label and off-label use of the M-M-R II vaccine from Merck. Both are live attenuated vaccines with similar dosage and vaccine components, but Priorix does not contain gelatin.
Priorix was first licensed in Germany in 1997 and has been approved in more than 100 countries outside the U.S. Earlier this month, the Food and Drug Administration (FDA) approved it for use in children 12 months and older as a two-dose series. The first dose is given at 12-15 months, and the second dose is given at 4-6 years.
Studies show Priorix and M-M-R II have similar safety profiles. Rates of serious adverse events were 0%-0.2% and 0%-0.3%, respectively. Rates of febrile seizures also were similar among children ages 12-15 months. In the six to 11 days after dose 1, the rate was 9.5 per 10,000 doses for Priorix and 14.8 per 10,000 doses for M-M-R II, according to the CDC. Studies also showed no significant difference in immunogenicity.
There were 13 to 1,282 measles cases, 154 to 6,366 mumps cases and zero to four rubella cases in the U.S. each year from 2016-’21.
Patricia Stinchfield, R.N., M.S., CPNP, liaison from the National Association of Pediatric Nurse Practitioners, expressed concern about children missing routine vaccines like MMR during the pandemic and the impact of misinformation.
“The MMR additional option is so good and we have to put them to use,” she said. “ … I’m very concerned about the next outbreak being measles.”
ACIP also is recommending that Merck’s PCV15 Vaxneuvance be used as a PCV option for children under 19 years. The dosing and schedules for routine administration (2, 4, 6 and 12-15 months), catch-up options and for children with underlying medical conditions would be the same as PCV13. PCV15 contains two additional serotypes: 22F and 33F. The recommendation does not impact use of the 23-valent pneumococcal polysaccharide vaccine.
A Merck representative presented safety data Wednesday comparing PCV15 to PCV13 that showed rates of vaccine-related adverse events were similar at 89.1% and 86.4%, respectively. Serious vaccine-related adverse events were 0.1% for PCV15 and 0% for PCV13.
After dose four, 0.7% of children who received PCV15 had a fever of 104 degrees Fahrenheit or greater compared to 0.2% of the PCV13 group, a difference that is not statistically significant, according to Merck. Among the 19 children with a fever after dose four of PCV15, there were no febrile convulsions and no vaccine-related serious adverse events. Some of the fevers may have been caused by underlying infections or co-administration of other vaccines.
Immunogenicity data show that in children under 2 years, PCV15 is noninferior for all 13 shared serotypes and is significantly higher for serotype 3 and for the two additional serotypes in PCV15. The results were mixed when looking at children ages 2-18 years with underlying conditions, and the CDC said it had low certainty in the evidence.
ACIP members chose not to express a preference for PCV15 over PCV13 due to uncertainty about the potential for higher reactogenicity after PCV15 and a lack of efficacy data. The CDC also anticipates licensure of PCV20 for children next year.
“We don’t have the same degree of knowledge of clinical efficacy of the miracle of how good will these vaccines be for these serotypes I tend to think of as stragglers more than things obviously causing invasive disease in children under 2,” said ACIP member Sarah Long, M.D., FAAP, professor of pediatrics at Drexel University College of Medicine. She added there’s “some oddness about the numbers of temperatures over 104” after PCV15 but not enough data to explore them further.
For the 2022-’23 flu season, the CDC will continue to recommend everyone 6 months and older without contraindications get vaccinated. All flu vaccines will be quadrivalent, and the influenza A(H3N2) and influenza B/Victoria components have been updated.
The CDC’s recommendations next season will include using Flucelvax Quadrivalent for children as young as 6 months, after the FDA lowered the eligible age from 2 years last fall.
ACIP on Wednesday also voted to recommend adults 65 years and older preferentially receive one of three higher-dose or adjuvanted influenza vaccines.
For the current season, overall vaccine effectiveness against medically attended influenza was 34% for any influenza A virus and 35% for influenza A(H3N2), the CDC reported Wednesday. Effectiveness against influenza A(H3N2) was 44% for children under 18 years.
A study of 73 participants ages 12 years and older during the 2021-’22 season found no safety concerns with co-administration of mRNA COVID-19 vaccines and quadrivalent inactivated influenza vaccines.
- Information from the AAP Red Book on measles, mumps, rubella, influenza and pneumococcal infections
- Information for parents from HealthyChildren.org on flu vaccine, MMR vaccines and pneumococcal vaccines