Advisory committee recommends RSV vaccine for seniors

long talks

The advisory committee approved the recommendation for adults 60-64 by a 13-0 vote with one abstention, for adults 65 and older by a 9-5 vote.

The votes followed by long discussions by committee members on clinical trial size, pricing, and delivery of RSV vaccines as well as seasonal influenza and COVID-19 vaccines. As a result, the original wording of the recommendations has been changed from “may” to “should”.

Vaccines must still receive approval from the CDC director before being made available to the general public. Rochelle Walensky, MD, MPH, the current director, is expected to accept the committee’s recommendations and approve the vaccines before officially resigning from the agency on June 30.

Arexvy And Abrysvo, both indicated for the prevention of lower respiratory tract disease caused by RSV, received FDA approval in May. The manufacturers intend to have the vaccines available in time for this year’s RSV season.

Learn more about RSV

RSV season usually begins in the fall and peaks in the winter. However, evidence suggests that the COVID-19 pandemic changed seasonal activity respiratory viruses in 2020 and 2021, and it remains uncertain whether the typical models will return.

Although most people who develop an RSV infection have mild illness and recover in less than two weeks, some people — especially the elderly, infants, and young children — are at increased risk of serious illness or complications that may require hospitalization.

It should also be noted that the ACIP reviewed data on the use of RSV vaccines in pregnant women to protect infants against RSV in the first six months of life, as well as clinical considerations for combination of RSV vaccines and nirsevimab, a monoclonal antibody developed by AstraZeneca and Sanofi to provide broad protection against RSV disease. However, the committee did not vote on these matters. FDA Antimicrobial Drug Advisory Committee voted in June to recommend approval of nirsevimab to protect infants from RSV, and a decision from the agency is expected this fall.

other actions

Although RSV vaccines received a lot of attention at the ACIP meeting, the committee took other important steps, including unanimous approval several recommendations relating to pneumococcal disease vaccines:

• use of 15-valent or 20-valent pneumococcal conjugate vaccine for all children aged 2-23 months, according to recommended PCV dosage and schedules;
• for young children with incomplete PCV vaccination, use of PCV15 or PCV20 vaccine, in accordance with recommended PCV dosage and schedules for healthy children 24-59 months of age and children with specified risk conditions aged 24 to 71 months;
• for children 2-18 years of age with an at-risk condition who completed their PCV vaccination series before age 6, no additional doses of any pneumococcal vaccine if they received one or more doses of PCV20 ; but one dose of PCV20 or 23-valent polysaccharide pneumococcal vaccine, using previously recommended doses and schedules, if they received PCV13 or PCV15 (but not PCV20); And
• for children aged 6 to 18 with a risk indication who have never received a dose of PCV13, PCV15 or PCV20, a single dose of PCV15 or PCV20. When PCV15 is used, it should be followed by a dose of PPSV23 at least eight weeks later, if it has not been given before.

The committee also added moderate persistent or severe asthma, chronic liver disease and chronic kidney disease (excluding maintenance dialysis and nephrotic syndrome) to the list of conditions that put children at risk. increased, to be more consistent with the conditions listed for adults.

ACIP also made the following recommendations:

• Adults 18 years of age and older who are known or suspected to be unvaccinated or incompletely vaccinated against poliomyelitis should complete a primary series with inactivated poliomyelitis vaccine.
• Adults who have received a primary series of trivalent oral polio vaccine or inactivated polio vaccine in any combination and who are at increased risk of exposure to poliovirus can receive another dose of inactivated polio vaccine. The data do not indicate the need for more than a single lifetime booster dose with inactivated poliomyelitis virus for adults.
• It is no longer necessary for people with egg allergies to get a flu shot in a medical setting. Any influenza vaccine appropriate for the age and condition of the recipient can be used, whether egg-based or not.

Finally, the advisory committee reviewed submissions and received updates on dengue, chikungunya, Mpox, meningococcal disease and COVID-19 vaccines, including clinical advice on the use of the Jynneos vaccine during Mpox outbreaks, and updates on COVID epidemiology -19 and vaccine efficacy.

“It is clear from the data presented that vaccinating people of all ages against communicable diseases helps the whole community with direct and indirect effects,” Rockwell said.