Vaccines Access

ACIP Recommendation by Product and Age

Routine versus risk-based versus shared clinical decision. Coverage design is the demand switch. 2026 childhood-schedule edits are stayed.
ProductPopulationACIP postureWhy it matters
Influenza (seasonal)Everyone 6 months+Routine annualCoverage benchmark. 2025-26 adult uptake 46.5% (NIS-FRVM).
COVID (seasonal)Adults; narrower than pandemicSeasonal; age and risk rules have tightenedCoverage 17.5% of adults 18+ in 2025-26. Recommendation design is the demand switch.
RSV vaccines (Arexvy, Abrysvo, mRESVIA)75+; 50-74 at increased riskSingle dose, not annual. No product preference.The 2024 vote killed the annual-booster TAM. Arexvy fell from £1.238B (2023) to about £0.6B.
Beyfortus (nirsevimab)Infants entering first RSV seasonRoutine infant preventionCompetes with maternal Abrysvo. Sanofi said Beyfortus was not hit by the 2026 childhood-schedule edit.
Enflonsia (clesrovimab)Infants entering first RSV seasonFDA approved Jun 2025; ACIP vote is in the stayed setCRS notes the June 2025 infant-RSV vote may not currently sit on the CDC schedule. Coverage is unsettled.
Abrysvo (maternal)Pregnancy, 32-36 weeksMaternal indicationOnly RSV vaccine with a pregnancy label. Not split out in Pfizer's product table.
ShingrixAdults 50+RoutineIRA $0 Part D copay. US immunization 44%; ex-US is now 66% of GSK sales.
Prevnar family / Capvaxive / VaxneuvancePediatric routine; adult pneumococcal by age and riskRoutine pediatric; adult share fightVFC catalog is the public-sector price. Adult is pharmacy and Part D.
Gardasil 99-26 routine; 27-45 shared clinical decisionRoutine through 26Shared decision-making is a coverage binary. China destock is a tender risk, not an ACIP risk.

CDC Posted Immunization Schedule, July 2025

The child and adult tables CDC currently labels as live under the 16 Mar 2026 stay. Not uptake. Not a stayed ACIP vote. Enflonsia's June 2025 vote is omitted on purpose.
AntigenCDC posted postureAges on the posted tablesRoster P&L
Hepatitis BRoutine childhood series. Adult table: 2, 3, or 4 doses depending on vaccineBirth dose, then 1 to 2 months and 6 to 18 months on the child tableHEPLISAV-B is the 2-dose adult product in the Sanofi-Dynavax deal. Pediatric HepB sits in combination books.
RotavirusRoutine infant2 and 4 months (RV1) or 2, 4, and 6 months (RV5)Merck RotaTeq $673M in 2025. GSK Rotarix is inside established and Gavi volume.
DTaP / TdapRoutine childhood plus adolescent boosterDTaP on the infant table (2, 4, 6, 15 months). Tdap: 1 dose at 11 to 12 years (CDC child notes)Sanofi PPH and GSK established. Not a single SKU P&L.
HibRoutine infant2, 4, then 12 to 15 months (third or fourth dose per notes)Inside Sanofi PPH.
Pneumococcal conjugateRoutine pediatric. Adult 50+ if never received a PCV (MMWR 2025 adult schedule)Infant 2, 4, 6, and 12 to 15 months (PCV15 or PCV20) on the child table. Adult table: see notes; MMWR 2025: universal at 50+ if no prior PCV15/20/21Pfizer Prevnar family $6.494B. Merck Vaxneuvance and Capvaxive.
IPVRoutine childhood2, 4, 6 to 18 months, and 4 to 6 yearsInside Sanofi PPH.
InfluenzaRoutine annual from 6 months1 or 2 doses annually by age and prior doses. Adult 65+ prefers HD, recombinant, or adjuvantedSanofi flu/COVID bundle (unsplit). CSL Seqirus. GSK influenza £303M.
COVID-19Seasonal; see notesPosted child and adult tables point to notes, not a fixed annual age bandPfizer Comirnaty and Moderna Spikevax. Recommendation design is the demand switch. This row is the posted schedule, not uptake.
MMR and varicellaRoutine two-doseFirst dose 12 to 15 months. Second dose 4 to 6 yearsMerck ProQuad / M-M-R II / Varivax $2.451B.
Hepatitis ARoutine childhood two-dose12 to 23 monthsTender and travel adjacency. Not a named 2025 franchise line here.
HPVRoutine adolescent; adult catch-up through 26; 27 to 45 shared clinical decisionCDC child notes: routinely recommended at 11 to 12 years (can start at 9); catch-up through 18. Adult table: 19 to 26 (2 or 3 doses); 27 to 45 shared clinical decisionMerck Gardasil. Shared decision-making is a coverage binary.
MenACWYRoutine adolescent two-doseCDC child notes: 2-dose series at 11 to 12 years and 16 yearsGSK Menveo / Penmenvy. Sanofi MenQuadfi sits inside the unsplit meningitis/travel/endemic bundle.
MenBShared clinical decision at 16 to 23, not a routine seriesCDC child notes: healthy adolescents 16 to 23 (preferred 16 to 18), 2 doses 6 months apart based on shared clinical decision-making. Increased-risk: 3-dose seriesGSK Bexsero. Shared decision is the demand switch, not a second COVID.
RSV infant (nirsevimab)Routine infant prevention on the child table1 dose depending on maternal RSV vaccination status, with 8 to 19 months notesSanofi/AZ Beyfortus. Merck Enflonsia is FDA-approved; the June 2025 ACIP vote is in the stayed set and is not treated as coverage here.
RSV vaccine (Abrysvo, adults)Maternal seasonal; adult 75+ and 50 to 74 at increased riskChild table: seasonal in pregnancy. Adult table: 75+ and 50 to 74 (see notes). Single dose, not annualPfizer Abrysvo. GSK Arexvy and Moderna mRESVIA share the adult row. The 27 Apr 2026 adult-page amendment added the April 2025 RSV language as adopted by HHS.
Shingles (RZV)Routine adult 50+2 doses at 50 to 64 and 65+GSK Shingrix. No 2026 US commercial competitor.

CDC VFC Catalog Prices, April 2026

What the US public sector pays versus private list. Gardasil $275, Prevnar 20 $200, Beyfortus $444 at CDC cost.
ProductManufacturerCDC cost / dosePrivate sector / dose
Gardasil 9Merck$275.01$328.24
Prevnar 20Pfizer$200.13$299.25
VaxneuvanceMerck$184.19$239.87
ProQuadMerck$194.95$286.17
VaxelisMerck$108.72$167.36
PentacelSanofi$78.39$130.53
BexseroGSK$159.12$251.31
MenQuadfiSanofi$117.77$177.11
Beyfortus 50mg / 100mgSanofi$443.78$595.06
EnflonsiaMerck$422.04$556.00
AbrysvoPfizer$240.04$319.07
JynneosBavarian Nordic$232.71$264.56
RotaTeqMerck$87.35$101.99
M-M-R IIMerck$26.93$95.74

WHO 2024 Dose Volume vs Value

7.2 billion doses and $66 billion of value. DCVMN and SII win volume. IFPMA wins the P&L. UNICEF and self-procuring MICs buy most doses.
2024 global market
7.2B doses
$66B financial value. Volume +7%, value -13% vs 2023 on COVID decline.
DCVMN share of doses
~2/3
Developing-country manufacturers, led by Serum Institute. Not the USD P&L.
IFPMA share of value
~80%
GSK, Merck, Pfizer, Sanofi, Moderna. Same order as 2023.
R21 Gavi price
$2.99
Nov 2025 SII/Gavi/UNICEF deal. Contrast with VFC Gardasil at $275.

BARDA and SNS: Freeze-Dried Jynneos

Option exercises, not pharmacy demand. $156.8M bulk in 2024 through $97M remaining freeze-dried doses for 2027.
2017
DealBavarian Nordic

BARDA awards Bavarian Nordic a 10-year freeze-dried Jynneos contract

Stockpile, not a retail schedule. Freeze-dried formulation is for long-term SNS storage. Contract HHSO100201700019C.

2022-23
ProcurementBARDA / SNS

US draws down liquid-frozen Jynneos for the mpox outbreak

Outbreak demand consumes bulk that was meant for freeze-dried replenishment. That bulk has to be rebuilt.

8 Aug 2024
DealBavarian Nordic

BARDA orders $156.8M of Jynneos bulk replenishment

$139.7M bulk invoiced in 2024 plus storage services into 2027.

24 Sep 2024
DealBavarian Nordic

Additional BARDA order $63M for bulk and freeze-dried doses

Supports 1 million freeze-dried doses for 2026 delivery and more bulk for the freeze-dried conversion.

Mar 2025
ApprovalBavarian Nordic

FDA approves freeze-dried Jynneos

Longer shelf life and easier storage than liquid-frozen. The SNS product, not the 2022 outbreak SKU.

6 May 2025
DealBavarian Nordic

BARDA exercises $143.6M of options for 2026 delivery

Public-preparedness revenue is option exercises, not ACIP retail.

11 May 2026
DealBavarian Nordic

BARDA exercises $97M more; remaining 11.5M-dose freeze-dried order for 2027

Company raised 2026 public-preparedness guidance to DKK 2.3B-2.5B after this option. Bulk invoiced in 2026; finished doses in 2027.

US Vaccine Policy Timeline, 2025 to 2026

ACIP reconstitution, the 17-to-11 childhood-schedule rewrite, Sanofi's US warning, and the March 2026 stay. Live litigation.
9 Jun 2025
ACIPHHS / CDC

HHS removes sitting ACIP members and reconstitutes the committee

The committee that writes US coverage rules is itself a policy risk. Subsequent votes and the new charter have been litigated.

Jan 2026
ACIPCDC / HHS

CDC narrows childhood schedule (17 routinely recommended diseases to 11)

Issued outside the usual ACIP process. Sanofi and peers flagged US pediatric softness. Count is diseases, not shots.

29 Jan 2026
ProcurementSanofi

Sanofi: 2026 vaccine sales 'slightly negative' on US weakness

Issuer primary. Management tied the dip to US coverage and public debate, with Beyfortus called out as not hit by the childhood-schedule edit.

Q1 2026
ProcurementSanofi / Pfizer / Merck

Issuers report weaker US meningitis, COVID, pneumococcal, and flu

Policy risk showed up in the P&L, not only in headlines. Ex-US mix (Shingrix, Beyfortus rest of world) is the hedge.

16 Mar 2026
ACIPAAP v. Kennedy

Massachusetts district court stays the 2026 childhood-schedule rewrite and post-June 2025 ACIP votes

Preliminary stay, not a final judgment. Government appealed 29 Apr 2026. Do not treat the 11-disease schedule as current CDC law.

IRA Part D Zero Cost-Share Uptake

10.3 million Part D enrollees vaccinated at $0 in 2023 versus 3.4 million in 2021. Shingles +42%. RSV was a launch-year print, not an annual franchise.
Metric2021 (cost-sharing)2023 ($0 copay)
Part D enrollees vaccinated3.4 million10.3 million (~20% of Part D)
Enrollee OOP for ACIP adult vaccines$234 million$0 (>$400 million saved)
Shingles recipients2.7 million3.9 million (+42%)
RSV recipientsNot yet licensed6.5 million (launch year)
Share of 2023 mix (ASPE)n/aRSV 63%, shingles 38%, Tdap/Td ~15%

China Gardasil Destock

International sales fell from $6.158B to $2.592B. WHO: China was half of 2024 HPV financial value, all private sector.
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