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Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals
Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals
Dear International Colleague,
Today, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.
The agency amended the emergency use authorizations as follows:
A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”
Today’s action applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups.
The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s). Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax are authorized to provide the authorized booster dose(s).
Information to Support Authorization of a Second COVID-19 Booster Dose
The FDA has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations. The evidence considered for authorization of a second booster dose following primary vaccination and first booster dose included safety and immune response information provided to the agency as well as additional information on effectiveness submitted by the companies.
A summary of safety surveillance data provided to the FDA by the Ministry of Health of Israel on the administration of approximately 700,000 fourth (second booster) doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 4 months after the third dose in adults 18 years of age and older (approximately 600,000 of whom were 60 years of age or older) revealed no new safety concerns.
The safety of Moderna COVID-19 Vaccine, when administered as a second booster dose, is informed by experience with the Pfizer-BioNTech COVID-19 Vaccine and safety information reported from an independently conducted study in which the Moderna COVID-19 Vaccine was administered as a second booster dose to 120 participants 18 years of age and older who had received a two-dose primary series and a first booster dose of Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior. No new safety concerns were reported during up to three weeks of follow up after the second booster dose.
Immunogenicity data from an ongoing, open-label, non-randomized clinical study in healthcare workers at a single center in Israel were reported in a publication provided to the FDA. In this study, individuals 18 years of age and older who had received primary vaccination and a first booster dose with Pfizer-BioNTech COVID-19 Vaccine were administered a second booster dose of Pfizer-BioNTech COVID-19 Vaccine (154 individuals) or Moderna COVID-19 Vaccine (120 individuals) at least four months after the first booster dose. Among these individuals, increases in neutralizing antibody levels against SARS-CoV-2 virus, including delta and omicron variants were reported two weeks after the second booster as compared to 5 months after the first booster dose.
The amendments to the EUAs to include a second booster dose for these populations were granted to Pfizer Inc. and ModernaTX Inc.
Additional Resources:
Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
Spikevax and Moderna COVID-19 Vaccine
COVID-19 Vaccines
Emergency Use Authorization for Vaccines Explained
Projected | CMS
Projected | CMS
CMS Office of the Actuary Releases 2021-2030 Projections of National Health Expenditures
Report shows slower projected national health spending growth after the rapid 2020 growth associated with the COVID-19 pandemic
Today, the Centers for Medicare & Medicaid Services (CMS) released the 2021-2030 National Health Expenditure (NHE) report, prepared by the CMS Office of the Actuary, that presents health spending and enrollment projections for the coming decade. The report notably shows that despite the increased demand for patient care in 2021, the growth in national health spending is estimated to have slowed to 4.2%, from 9.7% in 2020, as supplemental funding for public health activity and other federal programs, specifically those associated with the COVID-19 pandemic, declined significantly.
The NHE has been published annually since 1960, and is often referred to as the “official” estimates of U.S. health spending. The historical and projected estimates of NHE measure total annual U.S. spending for the delivery of health care goods and services by type of good or service (hospital, physician, prescription drugs, etc.), type of payer (private health insurance, Medicare, Medicaid, etc.), and type of sponsor (businesses, households and federal/state governments). The NHE report also includes spending on government public health, investment in structures and equipment, and noncommercial research, as well as information on insurance enrollment and uninsured estimates.
The report finds that annual growth in national health spending is expected to average 5.1% over 2021-2030, and to reach nearly $6.8 trillion by 2030. Growth in the nation’s Gross Domestic Product (GDP) is also projected to be 5.1% annually over the same period. As a result of the comparable projected rates of growth, the health share of GDP is expected to be 19.6% in 2030, nearly the same as the 2020 share of 19.7%.
Near-term expected trends in health spending and insurance enrollments are significantly influenced by the COVID-19 public health emergency (PHE). In 2021, spending for other federal programs and public health activity (the NHE Accounts categories that include the federal COVID-19 supplemental funding) is expected to have declined from $417.6 billion in 2020 to $286.8 billion. Additionally, following the declines observed in 2020, health care utilization is expected to rebound starting in 2021 and then normalize through 2024. As COVID-19 federal supplemental funding is expected to wane between 2021 and 2024, the government’s share of national health spending is expected to fall to 46% by 2024, down from an all-time high of 51% in 2020.
The average annual growth in national health spending over the latter half of the next decade (2025-2030) is projected to be 5.3% and is expected to be driven primarily by more traditional elements, including economic, demographic, and health-specific factors. During this time, upward pressure on spending growth for Medicaid is expected, in part due to the expiration of Disproportionate Share Hospital payment cap reductions statutorily scheduled to end in 2027. Conversely, downward pressure on spending growth is expected for Medicare (related to the end of the Baby Boomers’ enrollments), as well as for private health insurance and out-of-pocket spending in lagged response to slowing income growth earlier in the period.
The percentage of the population with health insurance is expected to be 91.1% in 2021 and 2022 (mainly due to gains in Medicaid enrollment that are, in large part, due to special rules in effect only during the COVID-19 PHE). After the end of the COVID-19 PHE, enrollments are projected to begin returning to pre-pandemic distributions. The 2030 insured rate is projected to be 89.8%.
Selected highlights in national health expenditures by major payer include:
Medicare: Medicare spending growth is projected to average 7.2% over 2021-2030, the fastest rate among the major payers. Projected spending growth of 11.3% in 2021 is expected to be mainly influenced by an assumed acceleration in utilization growth, while growth in 2022 of 7.5% is expected to reflect more moderate growth in use, as well as lower fee-for-service payment rate updates and the phasing in of sequestration cuts. Spending is projected to exceed $1 trillion for the first time in 2023. By 2030, Medicare spending growth is expected to slow to 4.3% as the Baby Boomers are no longer enrolling and as further increases in sequestration cuts occur.
Medicaid: Average annual growth of 5.6% is projected for Medicaid spending for 2021-2030. Medicaid spending growth is expected to have accelerated to 10.4% in 2021, associated with rapid gains in enrollment. Over 2022 and 2023, Medicaid spending growth is expected to slow to 5.7% and 2.7%, respectively, as a result of projected enrollment declines, after the end of the COVID-19 PHE, when the continuous enrollment condition under the Families First Coronavirus Response Act expires and states begin to disenroll beneficiaries no longer eligible for Medicaid. Over 2025-2030, spending growth is projected to increase an average 5.6%, in part due to the expiration of Disproportionate Share Hospital payment cap reductions set for late-2027. Spending is projected to exceed $1 trillion for the first time in 2028.
Private Health Insurance and Out-of-Pocket: For 2021-2030, private health insurance spending growth is projected to average 5.7%. A rebound in utilization is expected to primarily influence private health insurance spending growth over 2021 (6.3%) and 2022 (8.3%), and then normalize through 2024. Over 2025-2030, as health spending trends by private payers tend to be influenced on a lagged basis by changes in income growth, average growth for private health insurance spending is then expected to slow to 4.8% by 2030 in response to slowing income growth earlier in the projection period. Out-of-pocket expenditures are projected to grow at an average rate of 4.6% over 2021-2030 and to represent 9% of total spending by 2030 (ultimately falling from its current historic low of 9.4% in 2020).
Selected highlights in projected health expenditures for the three largest goods and services categories are as follows:
Hospital: Hospital spending growth is projected to average 5.7% for 2021-2030. In 2021, hospital spending growth is expected to be 5.7%, a deceleration from 6.4% in 2020, largely due to declining federal supplemental payments. However, growth in hospital spending for Medicare, Medicaid, and private health insurance are expected to have grown faster compared to 2020 due to a partial rebound in utilization. Demand for care is expected to remain elevated in 2022, along with a projected acceleration in price growth; as a result, hospital spending growth is likewise expected to accelerate to 6.9% in 2022. Over 2023 and 2024, growth is expected to normalize (5.6% per year) and transition away from pandemic-related impacts on utilization, federal program funding, and changes in insurance enrollment, and remain similar on average through 2030 (5.5% per year). Key factors influencing hospital spending growth over 2025-30 is faster projected growth in Medicaid spending due to the scheduled expiration of Disproportionate Share Hospital payment cap reductions, as well as slower expected growth in Medicare spending (slower enrollment growth and larger sequestration-based cuts) and private health insurance spending (in lagged response to slowing income growth).
Physician and Clinical Services: Physician and clinical services spending is projected to grow an average of 5.6% per year over 2021-2030. In 2021, growth in physician and clinical services spending is expected be 5.1%, which is slower than growth of 5.4% in 2020, mainly due to declines in supplemental funding more than offsetting expected utilization increases among Medicare and private health insurance enrollees. Consumers are expected to return to more typical use patterns in 2022 resulting in 6.2% growth. Pandemic-related effects are expected to diminish through 2024. Through 2030, average total physician and clinical services spending growth of 5.5% is expected to primarily reflect decelerating spending growth for private health insurance enrollees in lagged response to projected slower growth in incomes earlier in the period.
Retail Prescription Drugs: Spending growth for retail prescription drugs is projected to increase over 2021-2030 at an average rate of 5%. In 2021, growth is expected to accelerate (4.7%) compared to 2020 (3%) due to faster growth in utilization by Medicaid beneficiaries and those enrolled in private health insurance. In 2022, however, overall retail prescription drug spending growth is projected to slow to 4.3%, as declines in Medicaid enrollment are expected to lead to slower drug spending for that program and more than offset faster Medicare spending for drugs in that year. New drugs expected to be approved from 2021-2026 are expected to influence retail prescription drug spending utilization and prices over the remainder of the projection period; over 2025-2030, retail prescription drug spending growth is anticipated to average 5.2%.
The Office of the Actuary’s report will appear at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsProjected.html
An article about the study is also being published by Health Affairs and is available here:
https://www.healthaffairs.org/
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Registration for March 2022 Virtual Meeting for the AHRQ Software Developers Meeting - Common Formats
Registration for March 2022 Virtual Meeting for the AHRQ Software Developers Meeting - Common Formats
Join Patient Safety Organization Representatives for a March 31 Virtual Meeting on AHRQ’s Common Formats
Software developers, vendors, and other users interested in improving ways to collect and analyze patient safety data using AHRQ’s Common Formats are invited to join a free virtual meeting on Thursday, March 31 from 1 to 2:30 PM ET. Representatives from two Patient Safety Organizations that currently use Common Formats in their work with healthcare providers will share their experiences and challenges. Register by Wednesday, March 30: https://cma.ahrq.gov/cma/registration.jsp?eventid=157
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