Editor's note: The CDC director approved both recommendations Oct. 26.
A panel of vaccine experts on Wednesday recommended including a new pentavalent meningococcal vaccine as an option for adolescents and young adults in limited circumstances.
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) also recommended routine vaccination of certain adults at high risk of mpox (formerly known as monkeypox) and allowing vaccination of high-risk adolescents.
The CDC director approved both on Oct. 26.
Pfizer’s new pentavalent meningococcal vaccine (MenABCWY; Penbraya) combines its MenACWY vaccine (Nimenrix) used in other countries and its MenB vaccine (Trumenba) used in the U.S.
ACIP members deliberated over multiple options for how the pentavalent vaccine could be incorporated into the current meningococcal vaccine schedule. The routine schedule calls for doses of MenACWY at 11-12 years and 16 years and two doses of MenB vaccine at 16-23 years if desired following a discussion between a health care provider and patient or the patient’s parent/guardian.
The committee weighed issues, including cost-effectiveness, unnecessary antigen exposure from broad use of the pentavalent vaccine and the number of vaccines providers would have to keep on hand.
“I do feel like the benefit-risk balance in minimizing unnecessary exposure to antigens is an important one, and I think the reason it’s complicated for us is due to the way the current schedule is set up,” said ACIP Chair Grace M. Lee, M.D., M.P.H., associate chief medical officer for practice innovation at Lucile Packard Children’s Hospital in Palo Alto, Calif.
The group voted 10-4 in favor of allowing use of the pentavalent vaccine as an option when both MenACWY and MenB are indicated at the same visit. This occurs for healthy individuals ages 16-23 years who choose to receive MenB vaccination and individuals 10 years and older who are at increased risk of meningococcal disease due to health conditions (persistent complement deficiencies, complement inhibitor use or functional or anatomic asplenia) and are due for both vaccines.
“I would frame it not as the recommendation but rather that it’s a choice for people to make,” Dr. Lee said. “And they could stick with the original schedule.”
Some of the choices include off-label uses but all still incorporate shared clinical decision-making for MenB (see slide 23).
Those voting against the proposal said they preferred broader use of the pentavalent vaccine or wanted to delay a vote until after ACIP conducts an in-depth evaluation of the meningococcal vaccine schedule. That evaluation is scheduled to take place over the coming year and will look at issues like whether the MenACWY dose given at 11-12 years should be eliminated or if the series should begin at an older age. The committee also will explore whether the recommended ages or dosing intervals for the MenB series should be changed to provide better protection for those ages 18 and 19. In addition, ACIP will revisit whether administration of the MenB vaccine should be based on shared clinical decision-making between providers and families.
ACIP members also voted 14-0 Wednesday to recommend routine mpox vaccination with Jynneos for people 18 years and older with certain risk factors. It also recommended allowing vaccination of adolescents and pregnant people who are considered to be at risk.
People considered at risk are those who are gay, bisexual, males who have sex with males, transgender or nonbinary people and who in the past six months have had one of the following: a new diagnosis of sexually transmitted disease, more than one sex partner, sex at a commercial sex venue or sex in association with a large public event in a geographic area where mpox transmission is occurring. Sex partners of people with these risk factors also are considered to be at risk as well as people who anticipate experiencing these risk factors.
The vaccine is given as two doses 28 days apart. The interim recommendations approved Wednesday will be revisited in two to three years. While the vaccine is licensed for people 18 years and older, clinical trials are underway in adolescents ages 12-17 years.
There have been more than 30,000 mpox cases in the U.S. since May 2022 with a peak in August 2022. While cases have decreased this year, there still have been one to four new cases a day in recent months.
Jynneos vaccine effectiveness is about 36%-75% with one dose and 66%-89% with two doses. The most common adverse events reported to the Vaccine Adverse Event Reporting System have been injection site symptoms like redness, swelling, pain and itching. Myocarditis and pericarditis rates are consistent with expected background rates. However, the CDC said providers should review guidance on coadministration of Jynneos and COVID-19 vaccines to reduce risks of these conditions.