Addressing the cost of insulin continues to be at the forefront of policy discussions around prescription drugs. Legislation has been introduced in Congress that would cap monthly copayments for insulin products at $35 for people with Medicare and private insurance, require the federal government to negotiate insulin prices, and encourage insulin manufacturers to lower list prices. To inform discussions about these proposals, this analysis updates prior work from KFF on out-of-pocket spending on insulin products by Medicare beneficiaries enrolled in Part D drug plans, along with state-level use and spending data, based on prescription drug event claims data through 2020 from the Centers for Medicare & Medicaid Services (CMS) Chronic Conditions Data Warehouse. Available claims data predate the 2021 introduction of the CMS Part D Senior Savings Model in which enhanced Part D drug plans charge a monthly copayment of no more than $35 for selected insulin products. Therefore, this analysis does not reflect any potential cost savings for Part D enrollees who have enrolled in these plans since 2021.

In the aggregate, Part D enrollees spent $1 billion out of pocket on insulin in 2020, more than four times the amount spent in 2007

Aggregate out-of-pocket spending by people with Medicare Part D for insulin products quadrupled between 2007 to 2020, increasing from $236 million to $1.03 billion (Figure 1). The number of Medicare Part D enrollees using insulin doubled over these years, from 1.6 million to 3.3 million beneficiaries, which indicates that the increase in aggregate out-of-pocket spending was not solely a function of more Medicare beneficiaries using insulin.

Average out-of-pocket spending per insulin prescription was $54 in 2020 – over 50% more than the proposed $35 monthly copay cap for insulin – but spending on many insulin products was higher

Among Medicare Part D insulin users who do not receive low-income subsidies, average out-of-pocket costs per prescription across all insulin products was $54 in 2020 – over 50% more than the proposed $35 monthly copay cap for insulin. The $54 per-prescription average in 2020 is an increase of 39% since 2007.

Among all insulin products available in 2020, out-of-pocket spending per prescription by non-LIS Part D enrollees ranged from $16 for Humulin N, an intermediate-acting insulin used by 74,000 non-LIS enrollees in 2020, to $116 for Humulin R U-500, a short-acting concentrated insulin used by 3,600 non-LIS enrollees in 2020 (Figure 2). Some of the more commonly used insulin products with above-average per prescription costs in 2020 include Novolog Mix 70-30 Flexpen ($77 per prescription; used by 32,900 non-LIS enrollees); Tresiba Flextouch U-200 ($70 per prescription; used by 93,700 non-LIS enrollees); and Levemir ($67 per prescription; used by 43,000 non-LIS enrollees).

Among insulin users, Part D enrollees without low-income subsidies spent $572 per person for insulin in 2020, on average, but a small share of insulin users spent considerably more

Among insulin users without Part D low-income subsidies (LIS), average annual out-of-pocket spending on insulin per user increased by 76% between 2007 and 2020, from $324 to $572 (Figure 3; see Table 1 for 2020 insulin use and spending by state). Average annual growth in out-of-pocket costs between 2007 and 2020 was 4.5%, which exceeded the 1.7% average annual rate of growth in inflation over these same years.

Some Part D insulin users spent considerably more than the average in 2020. For example, 10% of non-LIS insulin users spent more than $1,300 on insulin in 2020 and 1% spent more than $2,300 (Figure 4). Higher-than-average out-of-pocket spending is due to a greater number of prescription fills for insulin products and higher out-of-pocket costs per insulin prescription. In other words, taking more than one insulin product and taking more expensive formulations leads to higher out-of-pocket costs.

If insulin copays were capped at $35, Part D enrollees would save 35% on average, based on spending of $54 per prescription in 2020

Policymakers have introduced proposals to cap monthly copayments for insulin products, building on the Part D insulin model. If a $35 monthly copay cap for all insulin products had been in place in 2020, Part D enrollees without low-income subsidies would have saved $19 per insulin prescription, on average—a reduction of 35% based on average out-of-pocket costs of $54 per insulin prescription in 2020.

Under the current Part D insulin model, participating plans are not required to cover all insulin products at the $35 monthly copayment amount, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting). Absent a requirement to cover all insulin products at no more than a $35 copay, insulin users might need to switch from one insulin product to another to save on their out-of-pocket costs, or switch to a plan that covers their insulin product at the $35 copayment.

With the Omicron wave of COVID-19 sweeping the country, we previously calculated the number of people who were not up to date with vaccination in vulnerable areas as of June 2, 2022. Specifically, we looked at counties classified by the Centers for Disease Control and Prevention (CDC) has having “medium” or “high” COVID-19 community levels, signifying not only that new COVID cases were on the rise but also strains on hospital capacity. Since then, the BA.5 Omicron variant, which appears to be even more contagious and is able to evade prior immunity, has become dominant, driving up cases and hospitalizations even further.

Now, less than two months later, the share of the population living in medium or high community level counties and the number of people in those counties who are not up to date on vaccination have grown significantly; in addition, most who are not up to date are now living in counties with high community levels. We provide an update here, as of July 21, 2022.

Findings

• The share of the U.S. population living in counties with medium or high COVID-19 community levels is 87% or 283 million people. This is up from 55% of the population (180 million people) in early June. Also, in contrast to early June, most people are living in high community level counties (61% of the total population now compared to 21% in early June).
• The number of people not up to date on vaccination in vulnerable counties has jumped to 198 million, up from 120 million. This represents a 65% increase since June 2. Most of these individuals (139 million) live in counties with high community levels, representing an increase from just 46 million people in such counties in early June. The share of those not up to date on vaccination living in high level counties has also grown, from 20% in early June to 70% now.

• Of the 198 million not up to date on vaccination in medium and high community level counties:
  • 73 million are unvaccinated, including 50.4 million living in counties with high COVID-19 community levels (up from 14 million in high level counties in early June).
  • 29.8 million are partially vaccinated, including 20.9 million who are in high level counties (up from 8 million).
  • 95.4 million are vaccinated but not yet boosted, including 67.7 million in high level counties (up from 25 million).

Most Americans are not up to date with their COVID-19 vaccines. As of July 21, 2022, 227.8 million Americans (70%) were unvaccinated, had not completed their primary series, or had not gotten a booster dose. In each state, at least half the population is not up to date on COVID-19 vaccines. In Alabama, North Carolina, and Virginia, over 80% of people are not yet up to date on COVID-19 vaccines.

Implications

In just a short time, with the spread of the latest COVID-19 Omicron variant, the number of people in the U.S. who are particularly vulnerable to the impacts of COVID-19, because they are not up to date on vaccination and live in vulnerable counties, has grown considerably, rising from 120 million in early June to 198 million now. Moreover, an even greater share of people now live in counties with high community levels. The most vulnerable among them – those who remain unvaccinated and live in counties with high community levels – has grown from 14 million to 50.4 million.

CDC recommends that all people mask indoors in areas that have high COVID-19 community levels, and that people living in medium-level counties mask based on their personal risk, but most jurisdictions and facilities do not require masking. These updated data illustrate how quickly the current wave is spreading and increasing risk across the country. These data underscore the significant vulnerability to COVID-19 illness that still exists at this time, more than a year since vaccines became widely available in the U.S. to most people. As such, they point to the importance of other public health measures, such as masking and testing, in addition to vaccination, in many parts of the country.

The Senate Finance Committee recently released legislative text to be included in a forthcoming reconciliation bill that includes several provisions to lower prescription drug costs for people with Medicare and private insurance and reduce drug spending by the federal government. The prescription drug provisions in the Senate reconciliation legislation would reduce the federal deficit by $288 billion over 10 years (2022-2031), according to CBO. It would also reduce out-of-pocket spending by Medicare beneficiaries and limit increases in drug prices for Medicare and private insurance. The provisions would be implemented over several years beginning in 2023 (Figure 1). This brief examines the potential impact of these provisions for Medicare beneficiaries nationally and by state, based on legislative text released on July 27, 2022.

The Senate Finance Committee legislation includes two policies that are designed to have a direct impact on drug prices, both of which are similar to provisions included in legislation passed in the U.S. House of Representatives in November 2021:

• Requires the federal government to negotiate prices for some high-cost drugs covered under Medicare. Top-spending brands and biologic drugs without generic or biosimilar equivalents that are covered under Medicare Part D (retail prescription drugs) or Part B (administered by physicians) and are nine or more years (small-molecule drugs) or 13 or more years (biologicals) from FDA approval would be eligible for negotiation. The number of negotiated drugs would be limited to 10 Part D drugs in 2026, 15 Part D drugs in 2027, 15 Part B and Part D drugs in 2028, and 20 Part B and Part D drugs in 2029 and later years. CBO estimates $101.8 billion in Medicare savings from the drug negotiation provision.
  • The number of Medicare beneficiaries who would see lower out-of-pocket drug costs in any given year under this provision, and the magnitude of savings, would depend on which drugs were subject to negotiation under the legislation and the price reductions achieved through the negotiation process relative to current prices.
• Imposes rebates on drug manufacturers that increase prices faster than inflation to limit annual increases in drug prices for people with Medicare and private insurance. From 2019 to 2020, half of all drugs covered by Medicare had price increases above the rate of inflation over that period (1%, prior to the recent surge in the annual inflation rate), and among those drugs with price increases above the rate of inflation, one-third had price increases of 7.5% or more, the inflation rate in early 2022. The inflation rebate provision would be implemented beginning in 2023, using 2021 as the base year for determining price changes relative to inflation. CBO estimates a net federal deficit reduction of $100.7 billion over 10 years from the inflation rebate provision due to both reductions in spending and new revenues.
  • The number of Medicare beneficiaries and privately insured individuals who would see lower out-of-pocket drug costs in any given year under this provision would depend on how many and which drugs had lower price increases and the magnitude of price changes relative to baseline prices.

The Senate Finance Committee legislation also includes several provisions that would reduce out-of-pocket spending for Medicare beneficiaries:

• Eliminates the 5% coinsurance requirement above the Medicare Part D catastrophic threshold in 2024 and adds a $2,000 cap on Part D out-of-pocket spending in 2025, along with other Part D benefit design changes. In 2022, the catastrophic threshold is set at $7,050 in out-of-pocket drug costs, which includes what beneficiaries themselves pay and the value of the manufacturer discount on the price of brand-name drugs in the coverage gap (sometimes called the “donut hole”), which counts towards this amount. Under current law, beneficiaries who use only brand-name drugs in 2022 have to spend about $3,000 out of their own pockets (rising to around $3,500 in 2025) before qualifying for catastrophic coverage, and then face 5% coinsurance. CBO estimates the Part D benefit design changes would increase federal spending by $25.1 billion over 10 years.
  • 1.3 million Medicare Part D enrollees without low-income subsidies had spending above the catastrophic coverage threshold in 2020 (the most recent data available), which was $6,350 that year, and would be helped by the elimination of the 5% coinsurance requirement above the catastrophic threshold. (See Table 1 for state-level estimates)
  • 1.4 million Medicare Part D enrollees without low-income subsidies had annual out-of-pocket drug spending of $2,000 or more in 2020 and would be helped by the proposed $2,000 hard cap on out-of-pocket drug spending. This group includes the 1.3 million enrollees without LIS who had spending above the catastrophic threshold in 2020. (See Table 1 for state-level estimates)
  • These estimates of how many beneficiaries could be helped by these changes are conservative because they do not account for expected increases in average annual out-of-pocket spending since 2020 that would increase the number of beneficiaries with spending above the catastrophic threshold or above $2,000.
  • Capping out-of-pocket drug spending under Medicare Part D would be especially helpful for beneficiaries who take high-priced drugs for conditions such as cancer or multiple sclerosis. For example, in 2020, among Part D enrollees without low-income subsidies, average annual out-of-pocket spending for the cancer drug Revlimid was $6,200 (used by 33,000 beneficiaries); $5,700 for the cancer drug Imbruvica (used by 21,000 beneficiaries); and $4,100 for the MS drug Avonex (used by 2,000 beneficiaries).
• Eliminates cost sharing for adult vaccines covered under Medicare Part D, as of 2023, and improves access to adult vaccines under Medicaid and CHIP. CBO estimates these provisions would increase federal spending by $4.4 billion and $2.5 billion, respectively, over 10 years.
  • 4.1 million Medicare beneficiaries received a vaccine covered under Part D in 2020, including 3.6 million who received the vaccine to prevent shingles, and would benefit from the elimination of cost sharing for Part D vaccines. (See Table 1 for state-level estimates)
  • The Medicaid and CHIP provision would require vaccine coverage for all Medicaid-enrolled adults. Under current law, vaccine coverage is optional for many adults and coverage varies by state. According to a recent survey, half of states (25) did not cover all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) in 2018–2019, and 15 of 44 states responding to the survey imposed cost sharing requirements on adult vaccines.
• Expands eligibility for full Part D Low-Income Subsidies (LIS) in 2024 to low-income beneficiaries with incomes up to 150% of poverty and modest assets and repeals the partial LIS benefit currently in place for individuals with incomes between 135% and 150% of poverty. Beneficiaries receiving partial LIS benefits typically pay some portion of the Part D premium and standard deductible, 15% coinsurance, and modest copayments for drugs above the catastrophic threshold, while those receiving full LIS benefits pay no Part D premium or deductible and only modest copayments for prescription drugs until they reach the catastrophic threshold, when they face no cost sharing. CBO estimates this provision would increase federal spending by $2.2 billion over 10 years.
  • 0.4 million Medicare beneficiaries received partial LIS benefits in 2020 and could potentially be helped by the expansion of income eligibility for full LIS benefits. Annual out-of-pocket costs for these beneficiaries could fall by close to $300, on average, based on the difference between average out-of-pocket drug costs for LIS enrollees receiving full benefits versus partial benefits in 2020. (See Table 1 for state-level estimates)
  • This provision would benefit low-income Black and Hispanic Medicare beneficiaries in particular, who are more likely than white beneficiaries to have incomes between 135% and 150% of poverty.

The Senate Finance reconciliation legislation also includes a provision that would repeal the Trump Administration’s drug rebate rule, currently slated to take effect in 2027. The rebate rule would eliminate the anti-kickback safe harbor protections for prescription drug rebates negotiated between drug manufacturers and pharmacy benefit managers (PBMs) or health plan sponsors in Medicare Part D. If implemented, this rule would increase Medicare spending and premiums paid by beneficiaries. CBO estimates this provision would save $122.2 billion between 2027 and 2031.

Discussion

High and rising drug prices remain a top health care affordability concern among the general public, with large majorities of Democrats and Republicans favoring policy actions to lower drug costs. The prohibition against the federal government negotiating drug prices was a contentious provision of the Medicare Modernization Act of 2003, the law that established the Medicare Part D program, and lifting this prohibition has been a longstanding goal for many Democratic policymakers. The pharmaceutical industry has argued that allowing the government to negotiate drug prices would stifle innovation. CBO estimates that 15 out of 1,300 drugs, or 1%, would not come to market over the next 30 years as a result of the drug provisions in the reconciliation legislation.

The Senate Finance legislation would limit annual increases in drugs price for people with Medicare and private insurance, a response to public concerns about rising drug prices. While it is possible that drug manufacturers may respond to the inflation rebates by increasing launch prices, overall, this provision is expected to limit out-of-pocket drug spending growth for people with Medicare and private insurance and put downward pressure on premiums by discouraging drug companies from increasing prices faster than inflation.

The $2,000 hard cap on out-of-pocket prescription drug spending would be the first major change to the Medicare Part D benefit since 2010, when lawmakers included a provision in the Affordable Care Act to close the so-called Part D “donut hole.” A cap on out-of-pocket drug spending for Medicare Part D enrollees would provide substantial financial protection to people on Medicare with high out-of-pocket costs. This includes Medicare beneficiaries who take just one very high-priced specialty drug for medical conditions such as cancer, hepatitis C, or multiple sclerosis and beneficiaries who take a handful of relatively costly brand or specialty drugs to manage their medical conditions.

A new report from KFF (Kaiser Family Foundation) and The Joint United Nations Programme on HIV/AIDS (UNAIDS) finds that donor governments disbursed US$7.5 billion in 2021 to combat HIV in low- and middle-income countries, largely flat amid the COVID-19 pandemic and essentially matching 2008 levels, against a backdrop of growing inflation and shrinking funding from other sources.

While the total is less than in 2020, that largely occurred due to the timing of payments from donor nations to the Global Fund to Fight AIDS, Tuberculosis and Malaria, and not a reduction in support.

Donor governments’ bilateral aid – provided directly to specific countries, rather than to the Global Fund or other multilateral organizations – was US$5.5 billion in 2021, a slight decline compared to US$5.6 billion in 2020, continuing a decade-long trend of decreasing bilateral support.

The United States continues to be the largest donor to HIV, providing US$5.5 billion in support (73% of all donor government funding), followed by the United Kingdom (5% or US$385 million). Other major donors include, Germany (US$246 million), the European Commission (US$232 million), and France (US$231 million).

“This report confirms a decade of decline in donor aid for HIV. As the COVID-19 and Ukraine crises have dramatically increased the needs of low and middle-income countries and decreased the domestic revenues for the coming years, a stepping up of donor aid is even more vital,” said Winnie Byanyima, Executive Director of UNAIDS. “Aid for the AIDS response is a smart and effective investment. Now is the time for donors to be courageous and deliver on the common pledge to end AIDS by 2030.”

“While donor government funding for HIV has been relatively stable during the global COVID-19 pandemic, there’s a lot of uncertainty about whether funding will keep pace with global inflation amid other priorities,” KFF Senior Vice President Jen Kates said.

The funding supports HIV care and treatment, prevention, and other services in low- and moderate-income countries. The data are included in a broader UNAIDS global report, which examines all sources of funding for HIV relief, including local governments, non-governmental organizations, and the private sector.

The new report, produced as a long-standing partnership between KFF and UNAIDS for more than 15 years, provides the latest data available on donor government funding based on data provided by governments. “Donor government funding” refers to disbursements, or payments, made by donors.

Background

Monkeypox is an infectious disease caused by the monkeypox virus, in the Orthopoxvirus genus, and is related to smallpox. The first human case was identified in 1970, and historically, it has primarily been found on the African continent, except in cases related to travel or imported animals. However, in May 2022, multiple cases were identified in several countries where monkeypox has not been endemic, including the United States (U.S.). This current outbreak is the largest ever in the U.S. and globally and marks the first time substantial local transmission has been reported in non-endemic countries across multiple continents. (See Box 1 for an overview of monkeypox illness, transmission and testing, prevention, and treatment.)

In the U.S., the first monkeypox case in the current outbreak was identified on May 18, 2022. As of July 26, 3,591 cases in 46 states, Puerto Rico, and Washington, D.C., have been diagnosed (see Figure 1); this represents 19% of 19,188 confirmed global cases. This number is likely a significant undercount due to a number of factors including: limited access to testing, particularly in the first few months of the outbreak; lag time between seeing a provider and having a case confirmed; knowledge gaps among providers; and stigma that may make individuals reluctant to seek medical care, especially when sores are in the genital or anal region and transmission may be associated with same-sex sexual encounters. Given the growing number of cases and considering other factors, on July 23, 2022, the World Health Organization (WHO) declared the monkeypox outbreak to be a Public Health Emergency of International Concern (PHEIC), and provided a set of recommendations on actions that governments and others can take to address the outbreak. Whether or not the U.S. follows suit and declares the outbreak to be a domestic public health emergency (PHE), remains to be seen. Doing so would allow for a range of flexibilities and potential access to funding, should this be needed. Confirmed cases are expected to continue to rise in the coming weeks, likely due to both an actual increase in the number of cases from ongoing transmission as well as improvements to testing and surveillance that capture more cases.

Almost all reported cases in the current U.S. outbreak (99% as of June 28, 2022) have been among gay, bisexual, and other men who have sex with men, who are considered most at risk at this time. However, monkeypox can be a risk to anyone, regardless of sexual orientation or sex/gender of sexual partners, and in the current outbreak, cases have been identified among transgender men and cisgender women. A few recent cases among children have also been identified.

This brief answers key questions about the U.S. outbreak to date and identifies issues that may affect the response going forward.

Key Questions About the U.S. Response

When did the U.S. federal response to the outbreak begin?

After the first cases of monkeypox in this outbreak were identified (in the United Kingdom on May 6, 2022, and in the U.S. on May 18, 2022), the CDC and other agencies took initial response steps such as developing an updated case definition for monkeypox, providing advice to local, state, tribal, and territorial health departments on surveillance, reporting, and contact tracing, supporting diagnostic testing, and coordinating with international authorities and other countries. On June 28, 2022, 6 weeks after the first reported U.S. case, the White House announced a government-wide strategy and approach to scaling up vaccination and expanding testing capacity for monkeypox, and the CDC activated its Emergency Operations Center to enhance operational support including monitoring and coordination.

Some public health experts and advocates have criticized the administration’s response, saying the government did not act quickly enough or at sufficient scale and are now playing “catch up” in key response areas such as messaging and expanding access to vaccinations, testing, and treatments. Some expressed concern the federal government is repeating the missteps of its early response to the COVID-19 pandemic and warned the monkeypox outbreak could quickly grow even larger without additional testing, vaccinations, and particular focus on addressing equity issues. The administration has said it would continue to adapt the nation’s response as the situation develops.

What areas are the main focus of the U.S. response?

The federal government and state and local governments share responsibilities for responding to outbreaks such as monkeypox.  The federal government’s response to date has been focused on several areas, including:

• securing and distributing vaccines and treatments;
• conducting and improving surveillance;
• increasing testing capacity and access;
• educating health care providers and the public;
• supporting research and development;
• coordinating with and supporting state, local and territorial responses;
• developing and pursuing research priorities; and
• engaging with affected communities and other stakeholders.

State and local jurisdictions also support many of these activities, with federal support and assistance. For example, some jurisdictions are working to facilitate health care providers’ access to testing, treatment, and vaccination, playing a role in communicating key information about the outbreak, and developing on-the-ground response networks. These responses, however, are variable across the country and more robust in some places than others. (See below discussion for more detail.)

What agencies are involved in the federal response?

The federal response is coordinated by the White House National Security Council’s Directorate on Global Health Security and Biodefense (also known as the White House Pandemic Preparedness Office) and involves the U.S. Department of Health and Human Services (HHS) and several of its operating divisions and offices. These include the Office of the Assistant Secretary for Preparedness and Response (ASPR, which includes the Strategic National Stockpile under the Office of Operations and Resources as well as the Biomedical Advanced Research and Development Authority (BARDA), the CDC, the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). The White House Office of Science and Technology Policy (OSTP) also plays a role.

What is the status of monkeypox testing in the U.S.?

Testing for monkeypox (clinical samples taken from patients’ lesions and tested for the presence of an Orthopoxvirus or in some cases, specifically the monkeypox virus) currently takes place only in a set of authorized laboratories, and testing capacity has ramped up slowly. Initially, testing was done primarily at the CDC and other public health laboratories. More recently, testing has been expanded to commercial laboratories:

• As of June 28, 2022, 78 laboratories (mostly public health laboratories) in 48 states had the testing capacity to handle 10,000 Orthopoxvirus tests per week, up from 67 labs with a weekly capacity of 8,000 tests a week earlier.
• On June 22, 2022, HHS announced it had begun shipping CDC Orthopoxvirus tests to five commercial laboratory companies – Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare – with the aim of increasing testing capacity and improving accessibility for providers and patients.
  • As of July 18, Aegis Science, Labcorp, the Mayo Clinic Laboratories, and Sonic Healthcare had all begun testing using the CDC Orthopoxvirus test, with each of these labs providing a capacity of up to 10,000 tests per week.
  • Since then, Quest Diagnostics announced they developed their own monkeypox-specific test (compared to the general Orthopoxvirus test) and expected to be able to run 30,000 of those tests per week by the end of July. Quest has stated that it would continue to work towards validating the general CDC Orthopoxvirus test as well, which would provide another testing option, and they expect that additional capacity to be available in August.

• Combining the public health laboratories and commercial sector, the total U.S. Orthopoxvirus or monkeypox virus testing capacity is currently 80,000 tests per week.

There have been some reports of access challenges to monkeypox testing, particularly prior to the commercial labs partnering with the CDC to offer tests. And now even with commercial labs offering the tests, not all providers are equipped or willing to perform specimen collection which contributes to ongoing barriers. Additionally, whereas testing performed at public health laboratories does not carry a cost for patients, tests performed by a commercial laboratory may have costs, which could be an issue particularly for patients who are under- or un-insured.

What is the status of the monkeypox vaccine supply in the U.S.?

Monkeypox vaccines can be used following a known or likely exposure (i.e., post-exposure prophylaxis or PEP) or as a preventive measure before an exposure occurs (i.e., pre-exposure prophylaxis or PrEP) (see Box 1 for more details).

Monkeypox vaccines are being made available through the Strategic National Stockpile. The U.S. currently has a limited supply of such doses, with just 65,000 JYNNEOS doses in the stockpile in late June. Additional doses have been ordered for delivery in the coming months, with 6.9 million doses of JYNNEOS expected to be available by mid-2023 (enough to vaccinate 3.5 million people), including approximately 1.9 million doses in 2022 (enough to vaccinate 950,000 people).

Of these, 5.5 million of the JYNNEOS doses were recently ordered by the U.S. government and come from an existing bulk vaccine order that HHS/BARDA has with vaccine-maker Bavarian Nordic though an existing ten-year contract. The contract allows the U.S. government to request that Bavarian Nordic “fill and finish” the equivalent of more than 15 million vaccine doses that the U.S. government purchased. Still, it is unclear whether the U.S. government plans to order more JYNNEOS doses through this contract beyond the 5.5 million doses already announced.

HHS also reported that the strategic national stockpile has more than 100 million doses of the ACAM2000 vaccine (a smallpox vaccine considered effective for monkeypox as well) available, though the JYNNEOS vaccine is preferred and recommended for most individuals.

Where and how have vaccine doses been distributed?

HHS reports that it began shipping JYNNEOS doses on May 21, 2022, and that as of July 22, 2022, it had allocated 333,218 doses (93% of which had been shipped) to all 50 states and seven jurisdictions/groups (American Samoa, Washington, D.C., Guam, the Northern Mariana Islands, Tribal Entities, Puerto Rico, and the U.S. Virgin Islands) from the strategic national stockpile. In addition to state-specific allocations, several large cities received additional doses. The largest number of doses have been allocated, thus far, to New York, followed by California, and then Florida. See Figure 2.

JYNNEOS doses are being allocated based on a “four-tier distribution strategy that prioritizes jurisdictions with the highest case rates of monkeypox. Within each tier, doses of JYNNEOS will be allocated based on the number of individuals at risk for monkeypox who also have pre-existing conditions, like HIV. Jurisdictions with higher cases counts and greater numbers of highly affected populations have been prioritized in initial allocation of the vaccines. Specifically, allocations in the current phase have been based on transmission (current and projected monkeypox cases) and prevalence of high risk populations, (i.e. men who have sex with men with HIV or who are eligible for HIV PrEP). To receive vaccine, jurisdictions must make requests to the CDC and draw down from their allocations, in most cases. The CDC has recommended that vaccines be provided to individuals with confirmed and presumed monkeypox exposure (as PEP and PEP++, respectively; see Box 1) while vaccine supply is limited, but some localities, such as New York City and Washington, DC, have made vaccination available more broadly to higher risk groups, such as gay and bisexual men and other men who have sex with men.

In addition, the ACAM2000 vaccine can be requested by jurisdictions. As of July 1, HHS reports that more than 800 doses of ACAM2000 have been distributed based on these requests.

What is the status of monkeypox treatment in the U.S.?

There are no available treatments that specifically target the monkeypox virus. However, because the smallpox and monkeypox viruses are similar, smallpox treatments may be effective for treating monkeypox. Currently, Ticoviromat (TPOXX), an antiviral approved for smallpox, is the treatment most likely to be prescribed for monkeypox infection in the U.S. under an expanded access Investigational New Drug (EA-IND) protocol. On July 1, 2022, HHS reported that the strategic national stockpile had over 1.7 million TPOXX antiviral treatment courses, and that it had deployed 300 courses from the strategic national stockpile by the end of June (it is unclear where these doses have been distributed).

Because TPOXX is only available under an EA-IND protocol for the treatment of monkeypox, its use has to be approved by the CDC. Partly for this reason, there have been many reports of providers facing lengthy and burdensome procedures for accessing treatment for their patients, creating a barrier for patients and a challenge for provider. In response to these challenges, on July 22, 2022, the CDC announced revisions to this process. While the CDC must still approve use of this treatment, the approval process has been somewhat streamlined by reducing “the number of required forms, patient samples, and photos & [giving] patients the option to see their doctor virtually.”

What federal funding is available for jurisdictions to respond to monkeypox?

So far, Congress has not provided any additional or emergency funding specifically for the monkeypox response. However, CDC has stated that several of their existing grants have flexibility to allow local jurisdictions to use funding for monkeypox as needed. These include four funding streams to date:

• Public Health Emergency Preparedness (PHEP) Cooperative Agreement: PHEP funding allows public health departments to “build and strengthen their abilities to effectively respond to a range of public health threats, including infectious diseases, natural disasters, and biological, chemical, nuclear, and radiological events.”
• Strengthening STD Prevention and Control for Health Departments (STD PCHD) Cooperative Agreement: STD PCHD funds support grantees efforts in addressing STDs including among priority populations including “adolescents and young adults, men who have sex with men, and pregnant women.”
• Epidemiology and Laboratory Capacity (ELC) Building for the Prevention of Emerging Infections Disease Cooperative Agreement: ELC funding supports grantee efforts “to detect, respond to, control, and prevent infectious diseases.”
• Community Health Workers for COVID Response and Resilient Communities (CCR): CCR funding provides “opportunities intended to put more trained [community health workers] CHWs in communities that have been hit hardest by COVID-19 and among populations at high risk for COVID-19 exposure, infection, and illness.”

What public communication and messaging efforts are being conducted about the outbreak?

Because this monkeypox outbreak has disproportionately affected gay, bisexual, and other men who have sex with men, messaging directed at this community is especially important, particularly when it accounts for the stigma and discrimination these communities experience. Accordingly, HHS has been reaching out to public health and provider communities as well as journalists working on LGBTQ issues to inform them about the evolving monkeypox outbreak and provide guidance on disease presentation, progression, testing, and treatment. The CDC is providing consultations with health departments on local epidemics, testing, vaccination, and treatment. The Biden administration has also met with advocates to elicit input and share information with trusted messengers. Additionally, CDC is providing messaging support to be shared with dating apps to raise awareness about monkeypox among gay, bisexual, and other men who have sex with men.

Public-facing messaging from the CDC and other public health authorities has focused on the fact that anyone can get monkeypox while acknowledging that the current outbreak has been concentrated among men who have sex with men. The agency has exercised caution in an effort not to marginalize those at increased risk, notably gay and bisexual men. One suggestion the CDC makes for partners engaging in monkeypox messaging is to “emphasize that anyone [emphasis theirs] can get monkeypox and promote it as a public health concern for all. Focusing on cases among gay and bisexual men may inadvertently stigmatize this population and create a false sense of safety among those who are not gay and bisexual men.” Some in the LGBTQ+ community have expressed concern that the efforts made to avoid stigmatizing this group have actually meant the true risk has been downplayed, resulting in the community not being adequately informed about monkeypox.

In addition to messaging from the federal government, some state and local health departments are reaching out to local providers and highly impacted communities (though the extent to which this is happening is varied), and some national efforts such as Greater than AIDS (operated by KFF) have developed targeted messaging for those at risk.

What key factors might impact the U.S. outbreak response going forward?

As the current monkeypox outbreak in the United States continues to unfold with reported cases climbing, a number of factors could impact the success of the federal approach to contain and address it, including: access to testing, vaccination, and treatment; funding and cost issues; community education and messaging; variation in responses across states/jurisdictions; and equity challenges.

Access to Testing

While testing is now scaling up, early on some criticized the federal government for not standing up widescale testing and engaging with national pharmacy and other partners. Testing plays a key role in tracking the outbreak and allowing those testing positive to take risk reduction measures, such as preventing ongoing transmission, accessing PEP (if possible) and notifying close contacts. It is also a first step towards accessing treatment, if needed and possible. Successful scale-up of testing means that patients and providers are aware of it and that barriers such as costs and stigma are managed. It is also important to note that while there is now commercial laboratory capacity, not all providers may be willing or able to conduct sample collection which could limit access for some. More broadly, whether the current scale-up of testing can keep pace with demand amidst the expanding outbreak is not yet known.

Access to Vaccination

Vaccine distribution has also been limited to date, and it is not yet clear how vaccine distribution will evolve over the coming months.

• Because jurisdictions are being prioritized for distribution based on certain factors, as discussed above, some will gain quicker access to vaccination than others. While the federal government distribution algorithm plays a central role in this, jurisdictional decisions about when and how many doses they request from the CDC may also be a factor. To the extent that some jurisdictions are slower to request vaccines compared to other jurisdictions, it could lead to delayed or restricted vaccine access.
• Federal and jurisdictional vaccine prioritization and allocation approaches also affect the speed and consistency of vaccine access across jurisdictions. The current emphasis on PEP/PEP++ is largely due to the supply of the preferred vaccine being highly limited at the moment and meeting the needs of those likely already exposed being considered more urgent. However, this approach limits access for high-risk individuals without a known exposure, which may be a missed opportunity for preventing disease and helping curb new infections. While some jurisdictions, such as New York City and Washington, D.C., have offered a limited supply of PrEP to persons at higher risk, many jurisdictions have not yet done so.
• Demand for vaccination currently seems to be far outpacing supply in various jurisdictions. In Washington, D.C., for example, on multiple occasions, the D.C. Department of Health opened vaccination appointments at a certain time with a limited number of spots (300 in the first instance) and seen those spots filled within a matter of minutes. Similar challenges, including traffic crashing the city website, were reported in New York City. However, once vaccination is more widespread, there may be a larger role for federal and local officials to play in encouraging uptake.

Available Funding and Coverage of Costs

It is unclear how much funding may be available for monkeypox under existing grants or how much more might be needed. Transparent tracking and reporting of how much funding is being used for this purpose may be useful and inform discussions if additional funding is needed.

Likewise, in the early weeks of the outbreak, certain costs of testing, treatment, and vaccination are being covered by the federal government, but it is possible this could shift over time. At this time, there is no cost to individuals for testing that occurs within public health laboratories or at the CDC. However, individuals may face costs for tests conducted through commercial sector labs, with actual amount determined by insurance coverage. Those without insurance or with high-cost sharing associated with their coverage could face more limited access to testing. Currently, vaccinations are being deployed from the strategic national stockpile and the vaccine itself is provided at no cost. Similarly, the cost of TPOXX is also currently covered. However, individuals may face costs for provider visits, hospitalization, and other lab tests run as part of treatment or diagnosis.

Variation in Local Responses

States and jurisdictions will likely see various levels of success in their ability to contain localized outbreaks due to differences in how they are responding (in some cases, for reasons outside their control) to the ongoing monkeypox outbreak. The differences include their access to and ability to distribute vaccines, approaches to distribution (e.g. as PEP or PrEP and to which priority groups), access to local public health testing – especially for the uninsured - robustness of local response networks, and the availability of funding. Jurisdictional success in addressing the outbreak may also vary based on their ability to communicate effectively with highly affected populations.

Equity Challenges

Health equity is a stated priority for the Biden administration, and working to limit disparities in access to health information, vaccination, and treatment will help curb the outbreak evenly across groups and reach those across sociodemographic lines (e.g., race, ethnicity, income, etc.). As with both HIV and COVID-19, health disparities have persisted, and there is a risk to see that repeated here. Anecdotal evidence suggest that this occurring with vaccinations in at least some settings already. With monkeypox vaccination and treatment now underway, monitoring vaccination and treatment data by race/ethnicity and other demographic characteristics will help to identify any emerging disparities early on, but thus far this data has not been made publicly available. Efforts to counter potential disparities could also be made at the outset through targeted outreach, including to people of color and transgender people, tailored messaging, ensuring broad access to testing, treatment, and vaccination, and leaning on trusted messengers.

Summary

While the U.S. response to monkeypox has ramped up over time, after early criticism, the outbreak is expanding significantly, and challenges remain. In particular, testing, vaccination, and treatment supply and access remain limited and varied across the country and among different population groups. The ability of the federal government to respond to these challenges over the next few months will be an important determinant in whether the U.S. is able to bring about an end to the outbreak or face the potential of monkeypox becoming an entrenched endemic disease domestically. While WHO has now designated this monkeypox outbreak as a PHEIC, the U.S. has so far not declared it a domestic public health emergency, though the administration is reportedly weighing the option. Whether the administration will elect to use this lever in the future is unknown, but doing so would allow for a range of flexibilities and potential access to funding, should be it be needed.

Key Findings

This report provides an analysis of donor government funding to address HIV in low- and middle-income countries in 2021, the latest year available, as well as trends over time. It includes both bilateral funding from donors and their contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), UNITAID, and UNAIDS. Donor government funding for HIV declined between 2020 and 2021, primarily due to the timing of payments rather than decrease in support in the past year. Still, this means that funding was largely flat in 2021 compared to the prior year, even as 1.5 million people were newly infected with HIV, 650,000 died from AIDS, and global progress is slowing and well below targets.¹  This also occurred amid the ongoing impacts of COVID-19 and the war in Ukraine, and against a backdrop of growing inflation as well as shrinking HIV support from other sources.²  Moreover, donor support is not keeping pace with inflation, as funding in 2021 essentially matched 2008 levels in nominal terms, and several donors have reduced their support for HIV over the past decade. As such, there is significant uncertainty about the future, as the COVID pandemic continues to effect economies around the world and donors face other global pressures. Key findings include the following:

• DONOR GOVERNMENT FUNDING FOR HIV DECLINED IN 2021 COMPARED TO THE PRIOR YEAR. Disbursements were US$7.5 billion in 2021, a decrease of US$670 million below 2020 (US$8.2 billion), in current U.S. dollars (funding declined even after accounting for inflation and exchange rate fluctuations).³  Still, looking more broadly, funding in 2021 is approximately at the same level as 2008, in nominal terms, and has fallen over that period after accounting for inflation.
• THE DECLINE BETWEEN 2020 AND 2021 WAS PRIMARILY DUE TO THE TIMINING OF PAYMENTS RATHER THAN A DECREASE IS SUPPORT IN THE PAST YEAR. Contributions to the GF were US$1.8 billion in 2021 (after adjusting for an HIV-share), compared to US$2.3 billion in 2020, a decline of approximately $500 million, with disbursements decreasing from the U.S., Japan, and the U.K. However, these declines were part of regular fluctuations in three-year pledged contributions over the 2020-2022 period and do not reflect actual reductions in funding commitments. For instance, Japan and the U.K., provided a large share of their pledge at the beginning of the pledge period and the U.S. provided a large disbursement last year; all are on track to fulfill their funding commitments.^4 ,5 
• HOWEVER, THERE WAS SOME DECLINE IN BILATERAL FUNDING, CONTINUING A LONGER-TERM TREND IN DECLINING BILATERAL SUPPORT FROM DONOR GOVERNMENTS OTHER THAN THE U.S., WHICH BEGAN OVER A DECADE AGO. Bilateral funding in 2021 was US$5.5 billion compared to US$5.6 billion in 2020, a decline of approximately $100 million. Most of this was due to reduced funding from the U.K. and was not unexpected due to the U.K. government’s decision to reduce overall official development assistance (ODA).⁶  More broadly, since 2011, bilateral funding from donor governments other than the U.S. has declined by almost US$1.3 billion, reductions not fully compensated for by increases in multilateral support.
• THE U.S. IS THE LARGEST DONOR TO HIV, EVEN AFTER ADJUSTING FOR THE SIZE OF ITS ECONOMY, AND ACCOUNTS FOR A GROWING SHARE OF BILATERAL SUPPORT. In 2021, the U.S. disbursed US$5.5 billion, accounting for 73% of total donor government HIV funding (bilateral and multilateral combined). The U.K. was the second largest donor (US$385 million, 5%), followed by Germany (US$246 million, 3%), the European Commission (US$232 million, 3%), and France (US$231 million, 3%). The U.S. also ranked first when standardized by the size of its economy, followed by the Netherlands, Sweden, and the U.K. Largely due to declines by all other donors, the U.S. now accounts for 92% of bilateral support whereas it accounted for 70% a decade ago.
• THE OUTLOOK FOR 2022 AND BEYOND IS UNCERTAIN, GIVEN THE ONGOING EFFECTS OF COVID-19, THE WAR IN UKRAINE, AND OTHER GLOBAL PRESSURES ON DONOR GOVERNMENT BUDGETS. While donor government funding for HIV in low and middle income countries does not seem to have been negatively impacted by COVID-19 thus far, support has stayed flat and has not kept pace with inflation, and some donors have reduced their support for HIV over the past decade.⁷  In addition, the economic and health effects of the COVID-19 pandemic are still being felt around the world, and there remains significant uncertainty about the future course of COVID itself.⁸  More generally, several donors have announced plans to cut ODA funding in order to support in-country costs associated with refugees from the war in Ukraine, and inflationary pressures are threatening budgets further.⁹  One of the biggest markers ahead for future HIV funding will be the Global Fund’s 7th replenishment conference this fall¹⁰ , which will be hosted by the U.S. government, the outcome of which will likely set the stage for donor support for years to come.

1. UNAIDS, “Global AIDS Update Report”, July 2022. ↩︎
2. UNAIDS, “Global AIDS Update Report”, July 2022. ↩︎
3. In 2021, some donor governments provided COVID-specific emergency contributions to the Global Fund and UNITAID in addition to their contributions for core activities. Specifically, Canada, France, Germany, Italy, Japan, and Norway provided COVID-specific funding to UNITAID, while Canada, Germany, Luxembourg, the Netherlands, Norway, Switzerland, and the U.S. provided COVID-specific funding to the Global Fund. For the purposes of this report, these COVID-specific amounts have been excluded as they cannot be attributed to a specific area, such as HIV. ↩︎
4. Donor government contributions to the Global Fund and UNITAID have been adjusted for an HIV-share to account for the fact that these multilateral organizations address other diseases and areas (see Methodology). ↩︎
5. In 2021, the U.S. Congress appropriated an additional $3.5 billion in funding (beyond its regular contribution supporting HIV, TB, and malaria activities, which was flat in 2021 compared to the 2020 amount) to support the Global Fund’s efforts to address the COVID-19 pandemic. This funding is not included because it is for COVID-specific activities and cannot be attributed to HIV. ↩︎
6. U.K. Foreign Commonwealth & Development Office (FCDO), “Statistics on International Development: Provisional UK Aid Spend 2021,” April 2022. ↩︎
7. UNAIDS, “Global AIDS Update Report”, July 2022. ↩︎
8. OECD, “COVID-19 assistance to developing countries lifts foreign aid in 2021”, April 2022. ↩︎
9. United Nations Secretary-General, “Deputy Secretary-General’s statement on cuts to Official Development Assistance (ODA)”, May 2022. ↩︎
10. Global Fund, “Seventh Replenishment Investment Case: Fight for What Counts”, 2022. ↩︎

Most Parents Open to Getting Their Young Child Vaccinated Haven’t Yet Spoken to Their Pediatrician

Most parents of young children newly eligible for a COVID-19 vaccine are reluctant to get them vaccinated, including 43% who say they will “definitely not” do so, a new KFF COVID-19 Vaccine Monitor survey finds

The survey – KFF’s first since the U.S. Food and Drug Administration authorized two COVID-19 vaccines for use in children from 6 months through 4 years old in June – shows that just 7% of parents of children in that age range say they’ve already gotten them a vaccine.

Another 10% say they want to get them vaccinated as soon as possible, while others are less eager, including a quarter (27%) who want to “wait and see” how it works in other young children and one in eight (13%) who say they would only get their child vaccinated if it were required for school or childcare.

As with other age groups, the survey finds a big partisan divide in how parents of children from 6 months through 4 years old are approaching vaccination. A larger share of parents who are or lean Democratic (15%) say they’ve already gotten their newly eligible child vaccinated than parents who are or lean Republican (3%). Republican parents are three times as likely as Democratic parents to say they will “definitely not” get their child vaccinated (64% v. 21%).Not surprisingly, nearly two-thirds (64%) of parents who are unvaccinated say they will “definitely not” get their newly eligible child vaccinated. Even among parents who are vaccinated themselves, about one in four (27%) say they will “definitely not” get their young child vaccinated.

Many young children who have tested positive for COVID-19 have had mild cases, and those experiences may be shaping some parents’ views about the benefits and risks of vaccination.

A narrow majority (53%) of parents with children under 5 eligible for the vaccine say it poses a greater risk to their child’s health than a COVID-19 infection. That share rises to two-thirds (67%) among parents whose young child previously tested positive for COVID-19.

Overall, large majorities of parents with unvaccinated children in this age range say they are concerned that their child might experience serious side effects from the vaccine (81%), that not enough is known about the vaccine’s long-term effects in children (81%), and that the vaccine will not protect their child from getting sick from the virus (70%). 

Fewer parents say they are concerned about economic and access issues. This includes more than four in ten Black parents (44%) who say they are concerned about taking time off work to get their child vaccinated or care for them if they experience side effects, and a similar share of Hispanic parents (45%) who say they are concerned about not being able to get their child the vaccinated at a place they trust. In addition, about a third of Hispanic parents also say they are concerned about having to pay out-of-pocket to get their child vaccinated (36%).

Most parents (70%) of these young children say they haven’t spoken to their pediatrician or another health care provider about getting the vaccine for their child, suggesting an opportunity for further education about its benefits that could boost vaccination rates slowly over time. Among parents who are open to getting their young child vaccinated, most (70%) say they will wait until their child’s regular check-up to talk to their pediatrician while a quarter (27%) say they will make a specific appointment.

The new Vaccine Monitor also provides updated data on people’s vaccination status and intentions in other age groups:

• Children ages 5-11 became eligible for a vaccine in late October. Among parent of these children, 40% say their child has gotten vaccinated. A similar share (37%) say they will “definitely not” get their child a vaccine.
• Among parents of adolescents ages 12-17, 57% say their child has been vaccinated, similar to the share reported earlier this year. About a quarter (28%) say they will definitely not get their adolescent vaccinated.
• Most parents of vaccinated children over age 5 say their child has already gotten or are likely to get a recommended booster dose.
• Three-quarters (76%) of adults say they have gotten at least one dose of a COVID-19 vaccine, a share that has held relatively steady since September. This includes around half of adults who say they’ve gotten fully vaccinated and received a COVID-19 booster dose (49%).
• When those who are vaccinated but have not gotten a booster are asked about some reasons why, 57% say they feel they have enough protection from their initial vaccination or a prior infection, 52% say they just don’t want to get it, and 48% say they don’t think the boosters are effective, since some vaccinated people are still getting infected.

Designed and analyzed by public opinion researchers at KFF, the Vaccine Monitor survey was conducted from July 7-17, 2022, online and by telephone among a nationally representative sample of 1,847 U.S. adults, in English and in Spanish. The survey included an oversample of 471 parents with a child under the age of 5. The margin of sampling error is plus or minus 4 percentage points for the full sample and plus or minus 8 percentage points for parents with a child under 5. For results based on other subgroups, the margin of sampling error may be higher.

The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public’s attitudes and experiences with COVID-19 vaccinations. Using a combination of surveys and qualitative research, this project tracks the dynamic nature of public opinion as vaccine development and distribution unfold, including vaccine confidence and acceptance, information needs, trusted messengers and messages, as well as the public’s experiences with vaccination.

Children between the ages of 6 months and 5 years of age finally became eligible for COVID-19 vaccination in the U.S. on June 18, after the Director of the Centers for Disease Control and Prevention (CDC) recommended their use for this population, following emergency use authorization granted by the Food and Drug Administration. We recently wrote about some of the issues to consider in vaccinating young children, ranging from fewer access points and more reticence among their parents, compared to their 5-11 year-old counterparts. Here, we examine the status of vaccine uptake in this group, one month into their eligibility. Our analysis is based on data obtained from CDC’s Data Tracker on the number of first COVID-19 doses administered by age as of July 20, 2022 nationally and by jurisdiction (see methods below for more information). Overall, we find that vaccination has already peaked in the youngest age group, and is far below where 5-11 year-olds (who became eligible in November of last year) were at this point in their eligibility:

• As of July 20, approximately 544,000 children under the age of 5 had received at least one COVID-19 vaccine dose. This represents 2.8% of the approximately 19 million children in this age group. At a similar point in their vaccine roll-out, more than 5.3 million children ages 5-11 (18.5% of 5-11 year-olds) had received their first dose. (See Figure 1).
• Vaccinations peaked among those under 5 about two-weeks into their eligibility, even before the July 4 holiday. After a quick rise in vaccinations soon after they became eligible, the rate of vaccination (as measured by the 7-day rolling average of new doses administered) peaked at just over 28,000 on July 1. It then began to decrease and was about 13,000 on July 20. (See Figure 2).
• This peak is significantly below where their 5-11 counterparts were at a similar stage. While vaccinations also peaked among 5-11 year-olds about two-weeks into their eligibility, they peaked at 271,000 average daily doses; at that point, almost 2.7 million 5-11 year-olds, or 9.3% of the age group, had received their first dose. This compares to about 283,000 children under age 5, or 1.4%, at their July 1 peak. (See Figure 1).
• While still in the early stage, there is already significant variation by jurisdiction. The highest share of children under age 5 who have received their first COVID-19 vaccine dose is in Washington DC (14.4%) followed by Vermont (10.3%) and Massachusetts (7.2%). The top 10 states have vaccinated 4.5% or more of their under 5 year-olds with their first dose. The bottom 10 states have vaccinated 1% or fewer children under age 5; Mississippi has vaccinated the lowest share (0.4%), followed by Alabama (0.6%). (See Table 1).

These data suggest that achieving vaccination coverage of the youngest age group will likely take some time, may require more intensive and ongoing efforts, and may lag behind even their slightly older peers (even among 5-11 year-olds, just 30% have been fully vaccinated, eight months since they became eligible; vaccine coverage jumps to 60% of 12-17 years-olds and 77% of those 18 and older). This slow uptake likely reflects a range of factors. In addition to there being fewer access points for those under the age of 5, our prior COVID-19 Vaccine Monitor Surveys, fielded before children under 5 became eligible for vaccination, found that most parents were cautious about getting their young children vaccinated; soon-to-be released survey data will show that this caution has continued even after the CDC recommended vaccination for those 6 months and older. As a result, many parents may not encounter an offer of a vaccine until they go in for a routine visit to a pediatrician at some point in the year. More broadly, the sense of COVID-19 as an emergency has diminished among the public. Still, the country is in the midst of another COVID wave, due to the latest Omicron variant, and while children generally fare much better than adults if they do get COVID-19, some do get quite sick, suffer longer-term health issues, and even die from the disease. Vaccination against COVID-19 is safe and effective, can protect them from illness, and minimize disruptions to childcare, camp, school, and other needed services.

An important component of most private insurance plans is the out-of-pocket (OOP) limit. These limits place an annual cap on the amount of cost-sharing (deductibles, copayments, and coinsurance) an enrollee can face for in-network covered services each year. By doing so, OOP limits provide significant financial protection for individuals who face substantial health care use in a year. Even so, these limits are typically several thousand dollars for covered workers enrolled in single coverage; families in which multiple people have health spending may face significant cost-sharing before reaching the limit.

This analysis uses economic projections to look at how the maximum allowable OOP limits may change for different types of private health insurance plans over the next decade. It finds that the ACA’s maximum out-of-pocket limit is likely to grow faster than wages and salaries, and is also expected to grow faster than the maximum out-of-pocket limit for HSA-qualified health plans.

The analysis is available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.