COVID Vaccines Now Limited to High-Risk Groups as Federal Health Policy Shifts
FDA restricts fall vaccines to seniors and those with underlying conditions amid broader changes to vaccination guidance
September 7, 2025
As respiratory virus season approaches, federal health officials have implemented a targeted approach to COVID-19 vaccination, prioritizing protection for those at highest risk while requiring additional safety data for broader population use.
The Food and Drug Administration's approval of updated COVID-19 vaccines from Pfizer, Moderna, and Novavax now restricts their use to adults 65 and older and individuals aged 5-64 with at least one underlying health condition that puts them at high risk for severe COVID-19. This represents a shift from previous years when vaccines were recommended for everyone 6 months and older.
The policy change reflects a risk-stratified approach that aims to maximize protection for vulnerable populations while addressing ongoing questions about the optimal risk-benefit profile for healthy younger adults and children. Health and Human Services Secretary Robert F. Kennedy Jr. stated that the new framework prioritizes "science, safety, and common sense" in vaccine recommendations.
Targeted Protection Strategy
The updated approach ensures continued access to vaccines for those who face the greatest risk from COVID-19, while requiring additional clinical trial data before expanding recommendations to populations where the risk-benefit calculation remains less certain. Adults 65 and older, who face a 17% case fatality rate from COVID-19, maintain full access to updated vaccines, as do individuals with conditions such as diabetes, heart disease, obesity, and immunocompromising conditions.
For healthy adults and children not in high-risk categories, vaccines remain available through physician prescription, though this creates additional barriers to access compared to previous years when vaccines were universally recommended.
Upheaval at CDC
The vaccine policy changes are part of broader upheaval at federal health agencies under Kennedy's leadership. In June, Kennedy removed all 17 members of the CDC's Advisory Committee on Immunization Practices (ACIP), the influential panel that makes vaccine recommendations.
"A clean sweep is necessary to reestablish public confidence in vaccine science," Kennedy said in a statement. "ACIP new members will prioritize public health and evidence-based medicine. The Committee will no longer function as a rubber stamp for industry profit-taking agendas."
The CDC's director, Dr. Susan Monarez, was also fired less than a month after her confirmation, followed by the resignations of several senior career staff including directors of key infectious disease centers.
Medical Groups Push Back
In an unprecedented break from federal guidance, major medical organizations have issued their own vaccine recommendations. The American College of Obstetricians and Gynecologists reaffirmed support for COVID-19 vaccination during pregnancy, recommending vaccines at any point during pregnancy, when planning pregnancy, or while breastfeeding.
The American Academy of Pediatrics published its own immunization schedule recommending COVID vaccines for all children ages 6-23 months and high-risk children up to age 18. AAP President Dr. Susan Kressly said pediatricians "know how important routine childhood immunizations are in keeping children, families and their communities healthy and thriving."
Pennsylvania's State Board of Pharmacy voted to allow pharmacists to follow vaccine recommendations from "trusted authorities" including ACOG, AAP, and other medical organizations, rather than being limited to CDC guidance.
Access and Coverage Concerns
The policy changes create new barriers for millions of Americans. People who don't meet age or risk requirements will need physician prescriptions for vaccines, and many pharmacists may be hesitant to administer shots beyond FDA approval due to state restrictions and liability concerns.
Insurance coverage remains uncertain, with vaccines potentially costing up to $140 without coverage. While some insurers say they plan to continue covering vaccines broadly, it's unclear how many will maintain this policy.
Congressional Scrutiny
Kennedy faced harsh questioning from both Republican and Democratic senators at a contentious hearing this week, with some Republicans accusing him of breaking promises made during his confirmation process.
Sen. Bill Cassidy (R-LA), who provided a key confirmation vote after receiving assurances that Kennedy wouldn't restrict vaccine access, criticized the health secretary for replacing ACIP members with "largely unscientific vaccine skeptics with vested financial interests in suing vaccine makers."
Democratic Sen. Ron Wyden said "I think Secretary Kennedy is dead set on making it harder for children to get vaccines and that kids are going to die because of it."
Trump's Mixed Messages
President Trump has offered mixed signals on vaccines, recently demanding that drug companies prove publicly that vaccines are effective while also praising Operation Warp Speed as one of his greatest achievements. Last week, Trump defended some vaccines as effective and non-controversial, saying "You have vaccines that work. They just pure and simple work."
Rising COVID Cases
The policy changes come as COVID cases have been rising in parts of the U.S., particularly in the South and California, driven by new variants. CDC data shows emergency room visits and hospitalizations related to COVID have increased slightly in recent weeks.
Comparing the Available Vaccines
Three COVID-19 vaccines are now available for the 2025-2026 season, each with distinct characteristics:
mRNA Vaccines (Pfizer-BioNTech and Moderna):
- Both showed similar effectiveness in clinical trials: 95% for Pfizer and 94.1% for Moderna
- Use mRNA technology to instruct cells to produce the spike protein
- Pfizer recipients reported more systemic symptoms (2.8 on average) compared to Novavax (1.7), with 43.8% experiencing moderate or higher side effects
- Storage and distribution widely established
- Both target the LP.8.1 strain for 2025-2026
Novavax (Protein Subunit):
- Showed 90.4% overall efficacy in clinical trials
- Uses traditional protein-based technology similar to hepatitis B and HPV vaccines
- Produces "somewhat fewer powerful, though transient systemic side effects" with only 24.2% experiencing moderate reactions
- Healthcare workers receiving Novavax reported 12.5% fewer local reactions and less work disruption (0.7 vs 1.4 hours of missed work)
- Targets JN.1 variant but demonstrates "broad cross-neutralizing antibodies against multiple variant strains, including JN.1, KP.2 and KP.3"
Key Differences: Medical experts emphasize that "all three vaccines have similar safety and protection against severe disease", but Novavax may cause fewer side effects than mRNA vaccines. The choice between vaccines often comes down to personal preference, with some individuals preferring Novavax's established protein-based technology over the newer mRNA approach.
Current EU Vaccination Strategy (2025)
No Travel Requirements
As of January 2023, EU COVID vaccine requirements have been lifted by all countries in the region. EU nations have reverted to the same entry measures that applied before COVID-19, with no European country currently requiring COVID-19 testing or vaccination before allowing entry.
2025-2026 Vaccine Campaign Updates
EMA Vaccine Recommendations: The European Medicines Agency (EMA) announced on May 16, 2025, that its Emergency Task Force would be recommending that COVID-19 vaccines be updated for the 2025-2026 vaccination campaign to target LP.8.1, a variant that is the most prevalent worldwide as of the first third of 2025.
Manufacturer Response: Pfizer and BioNTech submitted a regulatory application to the EMA on May 28, 2025, for approval of COMIRNATY for the 2025-2026 season, targeting the LP.8.1 strain, following the EMA's Emergency Task Force recommendation.
Target Groups and Coverage
ECDC Recommendations: ECDC issued public health considerations on September 7, 2023, highlighting that vaccination efforts should focus on protecting people at risk of progression to severe disease, including people aged over 60 years and other vulnerable individuals irrespective of age (such as people with underlying comorbidities or the immunocompromised).
Current Vaccination Coverage (2024-2025 Season): During the reporting period between August 2024 and January 2025, 20 out of 30 EU/EEA countries reported vaccination data. Approximately 13.6 million people aged 60 years and above received one COVID-19 vaccine dose. The median COVID-19 vaccination coverage among people aged 60 years and above was 8.7% (range: <0.1–52.8%).
Key Policy Features
Decentralized Approach: Each of the ten European nations surveyed reported different COVID-19 vaccination policies, with significant variations in vaccine formulations authorized for use, specific groups provided with priority access, and vaccination requirements implemented.
Continued Monitoring: The European Medicines Agency continues to monitor the safety of vaccines against COVID-19 and to ensure that they offer protection in the European Union, even though the public health emergency has ended.
Focus on Vulnerable Populations: The Commission is supporting Member States in securing access to vaccines to protect individuals, particularly those at risk of progression to severe disease. In July 2022, ECDC and EMA recommended a second booster dose for people between 60 and 79 years old and people with medical conditions putting them at high risk.
Key Differences from Other Regions
- No Universal Recommendations: Unlike some other regions, the EU focuses primarily on high-risk groups rather than universal annual vaccination
- Country Autonomy: Individual EU member states maintain significant autonomy in their vaccination policies
- High Previous Coverage: By summer 2023, roughly 84.8% of the EU's adult population had received primary vaccination against COVID-19
- Post-Emergency Approach: The EU has transitioned to treating COVID-19 as an endemic disease requiring targeted rather than mass vaccination campaigns
Bottom Line
The EU's 2025 approach emphasizes targeted protection for vulnerable populations (primarily those 60+ and immunocompromised), updated vaccines targeting current variants (LP.8.1), and country-specific implementation rather than unified mandates. The focus has shifted from mass vaccination to protecting those at highest risk while maintaining surveillance and vaccine effectiveness monitoring.
What's Next
The reconstituted ACIP is scheduled to meet September 18-19 to consider COVID-19 vaccine recommendations for 2025-2026. Kennedy is preparing to appoint up to seven new members to the panel, including several individuals who have been critical of COVID-19 vaccines.
The ultimate vaccine recommendations will determine insurance coverage and access, potentially creating a patchwork of different policies across states as medical organizations and state authorities chart their own courses in response to federal changes.
As respiratory virus season approaches, millions of Americans face unprecedented uncertainty about their ability to access vaccines that were routinely available just months ago, marking a fundamental shift in the nation's public health approach five years after the COVID-19 pandemic began.
SIDEBAR: Vaccination Guidance for Seniors 75+
If you're 75 or older with previous COVID vaccinations, here's what you need to know:
✓ You Still Qualify All adults 65 and older remain eligible for the new 2025-2026 COVID vaccines under current FDA approval, regardless of previous vaccination history.
When to Get Vaccinated
- The updated vaccines targeting the LP.8.1 strain are now available at pharmacies and clinics
- You can receive the shot even if you've had multiple previous doses
- Consider timing with other fall vaccines (flu, RSV if recommended)
What's Different This Year
- New formula targets currently circulating variants
- No waiting period required between doses
- Insurance coverage should continue for your age group
Talk to Your Doctor About:
- Optimal timing based on your last vaccine dose
- Coordination with other recommended vaccines
- Any specific health conditions that might affect timing
Where to Get Vaccinated
- Most pharmacies (call ahead to confirm availability)
- Your primary care provider
- Local health departments
- Some may require appointment scheduling
Cost Should be fully covered by Medicare and most insurance plans for adults 65+, but confirm with your provider.
Bottom Line Medical experts across organizations continue to recommend annual COVID vaccination for seniors, as this age group faces the highest risk of severe illness and hospitalization from COVID-19.
SIDEBAR: Current COVID Variant Landscape
How Variants Are Detected and Tracked:
Genomic Sequencing:
- CDC uses the National SARS-CoV-2 Strain Surveillance (NS3) program
- Clinical specimens undergo whole genome sequencing to identify viral lineages
- Results classified using Pango nomenclature system
- CDC provides variant proportion estimates every Tuesday using both empiric (real-world) and Nowcast (model-based) projections
Wastewater Surveillance:
- Detects variants 1-2 weeks before clinical samples in same area
- Uses tools like Aquascope pipeline to analyze sewage samples
- Tracks community-level transmission without individual testing
- Particularly useful for detecting asymptomatic spread
- National Wastewater Surveillance System (NWSS) monitors viral activity levels
Current Health Impact Metrics:
Emergency Department Visits:
- Rising among all age groups nationally
- Used to calculate reproductive number (Rt) for transmission trends
- Key early indicator of community spread
Hospitalizations:
- COVID-NET monitors laboratory-confirmed COVID hospitalizations
- Current rates relatively low compared to previous years
- 2024-25 vaccines estimated to have averted 68,000 hospitalizations
- Rates subject to reporting delays, especially around holidays
Deaths:
- Tracked through COVID-NET surveillance system
- Preliminary burden estimates updated weekly
- Data considered final within 2 years of initial estimates
Dominant Strains (September 2025)
XFG "Stratus" Variant:
- Now the dominant strain in the U.S., accounting for 75% of cases
- First detected in March 2025, surpassed previous "Nimbus" variant
- Highly contagious Omicron subvariant
- Global spread: 22.7% of worldwide sequences, detected in 38 countries
LP.8.1 Strain:
- Targeted by new Pfizer and Moderna vaccines
- Part of ongoing circulation alongside Stratus
- Member of JN.1 lineage family
Regional Hotspots:
- High Activity: California, Texas, Utah, South Carolina
- Southern Region: Nearly 18% positivity rate in Texas, Oklahoma, New Mexico, Arkansas, Louisiana
- National Average: 11% test positivity rate (down from 18% peak last year)
Variant Characteristics:
- Symptoms: Similar to previous strains - congestion, cough, fever, runny nose, fatigue, muscle aches
- Severity: No evidence of increased severity compared to previous Omicron variants
- Immune Evasion: Better at evading immunity from previous infection or vaccination
- WHO Assessment: Does not appear to pose additional public health threat
Current Trends:
- Cases growing or likely growing in 24 states as of September 2
- Emergency room visits rising among all age groups
- Summer wave began in July, peak timing uncertain
- Estimated 876,000 new daily infections nationally
Vaccine Coverage: Updated 2025-2026 vaccines expected to provide good cross-protection against circulating variants, including both Stratus (XFG) and LP.8.1 strains.
SIDEBAR: COVID Mortality and Morbidity by Age Group
Current Risk Profile (2024-2025):
Infants and Young Children (0-5 years):
- Highest risk: Children under 6 months have the highest pediatric hospitalization rates
- 6-11 months: Second-highest pediatric hospitalization rate at 2.7 per 100,000
- Emergency visits: 5.8% of ED visits among children under 5 were COVID-related as of August 2024
- Vaccine efficacy: 80% effectiveness against medically-attended COVID in children 6 months-11 years
Older Children and Adolescents (5-18 years):
- Lower hospitalization rates compared to infants
- Myocarditis risk varies by age, sex, and vaccine type
- Overall lower severe outcome rates than adults
Adults (18-64 years):
- 18-49 years: Historical case fatality ratio of 0.15%
- 50-74 years: Historical case fatality ratio of 2.3%
- Hospitalization risk increases with underlying conditions
Seniors (65+ years):
- 65-74 years: Elevated risk for severe outcomes
- 75+ years: Historical case fatality ratio of 17%
- 85+ years: Highest death rates - accounted for ~307,000 of total 1.1 million COVID deaths through June 2023
2023 Mortality Trends:
- COVID-19 deaths decreased 73.2% from 186,552 in 2022 to 49,932 in 2023
- COVID dropped from 4th leading cause of death in 2022 to 10th in 2023
- Age-adjusted COVID death rate fell 73.3% (from 44.5 to 11.9 per 100,000)
- Life expectancy increased 0.9 years from 2022 to 2023
Current Vaccine Protection:
- 2024-25 vaccines showed 44% effectiveness against hospitalization
- 28% effectiveness against death
- Estimated to have prevented 68,000 hospitalizations during 2023-24 season
- Protection particularly important for those 65+ and with underlying conditions
Key Risk Factors Across All Ages:
- Underlying medical conditions (diabetes, heart disease, lung disease)
- Immunocompromised status
- Pregnancy (for maternal and fetal outcomes)
- Lack of up-to-date vaccination
Note: Current hospitalization rates remain relatively low compared to previous years, but emergency department visits and hospitalizations have been rising across all age groups during the summer 2025 wave.
SIDEBAR: All-Cause Mortality Context and Vaccination Implications
Decade-Long Mortality Perspective (2014-2024):
Pre-Pandemic Trends (2014-2019):
- Steady mortality improvement across most age groups
- Working-age mortality declining 1-2% annually
- Life expectancy gains of 0.1-0.2 years per year
Pandemic Impact (2020-2022):
- Peak excess mortality: US reached 22.1% above baseline (Q4 2020)
- Working-age surge: Ages 25-44 saw 25-35% increases in death rates
- International comparison: US ranked among worst performers globally
- US: 15.1% excess mortality vs Nordic countries: 2-6%
- Total US excess deaths: ~1.2 million (2020-2023)
Insurance Industry Alerts:
- Society of Actuaries findings: Ages 35-44 reached 201% of expected deaths (Q3 2021)
- Persistent elevation: 2024 still showing 8.9% excess mortality in working ages
- Non-COVID causes: 15-20% above normal in under-45 age group (2023)
- Industry concern: Life insurers report sustained 40% claim increases
Unexplained Mortality Patterns (2024 vs 2019 baseline):
- Cardiovascular disease: +7% (Swiss Re notes "large, unexplained jump")
- Accidents/substance abuse: +12%
- Mental health/suicide: +13%
- Cancer (delayed diagnosis): +4%
- Diabetes complications: +6%
Vaccination Context and Implications:
Population-Level Benefits:
- Countries with higher vaccination rates generally showed faster recovery to baseline mortality
- 2024-25 vaccines estimated to prevent 68,000 hospitalizations
- Age-adjusted mortality improvements accelerated in highly vaccinated populations
Current Policy Implications:
- High-risk focus: New restrictions target groups with highest excess mortality (65+, underlying conditions)
- Working-age concerns: Persistent elevation in 25-64 age groups raises questions about broader access
- International disparities: Countries with universal vaccine access showed better mortality recovery
Risk-Benefit Analysis by Age:
- Ages 65+: Clear benefit given 17% case fatality rate and persistent excess mortality
- Ages 50-64: Moderate benefit, excess mortality still 5-10% above baseline
- Ages 25-49: Lower COVID risk but elevated all-cause mortality raises prevention questions
- Under 25: Minimal COVID risk but vaccine access important for community protection
Public Health Considerations:
- Excess mortality extends far beyond COVID deaths
- Multiple factors (delayed care, mental health, economic stress) contribute
- Vaccination represents one tool in broader mortality reduction strategy
- International data suggests comprehensive healthcare access crucial for recovery
Unanswered Questions:
- Role of long COVID in persistent excess mortality
- Optimal vaccination frequency for different age groups
- Impact of restricted access on community transmission
- Long-term cardiovascular and other health effects
- Relationship between mRNA vaccine side effects and all-cause mortality patterns
Clinical Trial and Safety Considerations:
- Myocarditis risk: Higher in young males, varies by vaccine type and dose interval
- Transmission reduction: Current vaccines not primarily studied or approved for preventing spread
- All-cause mortality: Limited long-term data on net mortality impact across age groups
- Risk-benefit calculation: Differs significantly by age, with unclear benefit in low-risk populations
- FDA acknowledgment: Current framework requires additional clinical trials for healthy adults/children
Evidence Gaps in Universal Vaccination:
- Transmission studies: Current clinical trials focus on preventing severe disease, not community spread
- Sterilizing immunity: Updated vaccines do not demonstrate prevention of infection or transmission
- Population benefit: No clear evidence that vaccinating low-risk groups reduces community transmission
- Duration of protection: Waning immunity requires frequent boosting with uncertain long-term effects
Policy Assessment: The broader mortality context reveals complex health impacts extending well beyond COVID deaths. However, the persistent elevation in all-cause mortality across age groups has multiple potential contributing factors, including delayed medical care, economic stress, and mental health impacts.
Critical Gap: Current evidence supports individual protection for high-risk groups but does not establish population-level transmission benefits that would justify universal vaccination policies, particularly for lower-risk groups where clinical trial data on net health benefits remains limited and potential risks exist.
Bottom Line for Policy: The mortality data supports targeted vaccination for high-risk groups where clinical benefits are well-established, while highlighting the need for comprehensive data on risks and benefits before expanding recommendations to populations where the risk-benefit calculation remains uncertain. The FDA's new requirement for additional clinical trials in healthy populations reflects this evidence gap.
Global COVID-19 Mortality Statistics
Confirmed COVID-19 Deaths
As of August 28, 2025, there have been 7,099,056 confirmed COVID-19 deaths reported to the World Health Organization (WHO) worldwide. However, this represents only the directly confirmed deaths and significantly undercounts the true pandemic toll.
Excess Mortality Estimates (2020-2021)
The WHO conducted the most comprehensive analysis of pandemic-related excess mortality for the critical first two years:
WHO Official Estimates: 14.9 million excess deaths globally between January 1, 2020 and December 31, 2021 (range: 13.3-16.6 million). This represents 2.74 times more deaths than the 5.42 million officially reported COVID-19 deaths for that timeframe.
Alternative Estimates:
- Institute for Health Metrics and Evaluation (IHME): 18.2 million deaths (17.1-19.6 million)
- The Economist model: 17.7 million deaths (13.9-21.1 million)
Key Distribution Patterns
Most excess deaths (84%) were concentrated in South-East Asia, Europe, and the Americas, with 68% concentrated in just 10 countries globally. Middle-income countries accounted for 81% of the 14.9 million excess deaths.
The global death toll was higher for men than women (57% male, 43% female) and disproportionately affected older adults.
Historical Context: Excess Mortality Over the Decade
Pre-Pandemic Trends (2015-2019)
Historical excess mortality calculations use baseline models fitted to death data from 2015-2019, capturing both seasonal variation and year-to-year trends in mortality. This period generally showed stable or improving mortality trends in most developed countries.
United States Long-Term Crisis
Research reveals that excess mortality extends far beyond the pandemic:
Decade-Long U.S. Trends: Between 1980 and 2023, there were approximately 14.7 million excess U.S. deaths relative to what would have been observed if the U.S. had mortality rates matching peer countries. In 2023, excess deaths accounted for nearly 23 percent of all deaths in the U.S.
Pandemic vs. Pre-existing Trends: While excess deaths peaked at 1,098,808 in 2021 during the pandemic height, they dropped to 820,396 in 2022 and 705,331 in 2023. However, the 2023 figure still exceeded the 2019 pre-pandemic total of 631,247.
"The 700,000 excess American deaths in 2023 is exactly what you'd predict based on prior rising trends, even if there had never been a pandemic," according to researchers.
Ongoing Excess Mortality (2024-2025)
Swiss Re Institute analysis shows that excess mortality persists today across multiple countries and may continue for the next decade. In 2023, excess mortality was estimated at 3-7% in the U.S. and 5-8% in the U.K.
Under optimistic scenarios, pandemic-linked excess mortality could disappear by 2028, but under pessimistic scenarios, it may remain elevated until 2033.
Methodological Considerations
Excess Mortality Definition
Excess mortality is defined as the difference between the total number of deaths that have occurred and the number that would be expected in the absence of the pandemic based on data from earlier years.
This includes deaths associated with COVID-19 directly (due to the disease) or indirectly (due to the pandemic's impact on health systems and society), minus any deaths averted due to pandemic-related changes like reduced traffic accidents.
Data Limitations
Many countries still lack functioning civil registration and vital statistics systems, with significant data gaps existing in African, Eastern Mediterranean, South-East Asian, and Western Pacific regions.
The World Mortality Dataset covers 94 nations out of approximately 200, with particularly sparse coverage in Africa, Asia, and the Middle East.
Global Impact Summary
The COVID-19 pandemic represents the most significant global health crisis of the 21st century:
- Direct confirmed deaths: Over 7.1 million as of late 2025
- True pandemic toll (2020-2021): Estimated 13.3-18.2 million excess deaths
- Broader context: The pandemic exacerbated existing mortality trends, particularly in the United States
- Ongoing impact: Excess mortality continues above pre-pandemic levels in many countries
As noted by researchers, "COVID-19 pandemic is the worst worldwide calamity experienced on a large scale (with an estimated 7 million deaths) in the 21st century", though the true toll when including indirect effects is likely more than double the confirmed figure.
These statistics underscore both the immediate devastating impact of the pandemic and longer-term challenges in global health systems and mortality patterns that preceded and continue beyond the acute crisis phase.
Africa: Massive Data Gaps and Modeling Controversies
Data Coverage Crisis
Only 16 of the 106 WHO Member States in African, Eastern Mediterranean, South-East Asian, and Western Pacific regions have sufficient data to make empirical calculations. A recent assessment found that the percentage of registered deaths ranged from 98% in the European region to only 10% in the African region.
In Africa, only eight of the 56 sovereign states compulsorily register deaths.
Disputed Excess Mortality Estimates
The inclusion of Africa in global estimates is highly controversial among researchers:
High Estimates (Contested): The Economist's model shows Sub-Saharan Africa has the highest excess mortality ratio of all regions at +700%, while Wang et al. claim actual deaths are 14 times higher than the 150,000 reported—more than 2 million excess deaths across the region in 2020-21.
Expert Pushback: However, African researchers consider this level of under-reporting implausible, noting "there is no evidence of such a huge death toll and COVID-19 particularly affected large cities where spikes in the mortality rate would be readily visible".
The WHO African region's own estimates suggest 430,000 COVID-19 deaths, corresponding to one in three deaths being reported in 2020-21, an under-reporting rate comparable with the rest of the world.
Methodological Concerns
Prominent excess mortality models "use data from developed countries to estimate excess deaths in Africa, despite clear differences in conditions" and "high excess death ratios are simply an artifact of high excess death estimates relative to low reported deaths".
Most estimates of mortality in sub-Saharan Africa "are made without reference to official mortality data on adults, making mortality estimates more reliant on external and researcher-defined parameters that may bias estimates up or down".
South America: Well-Documented Major Hotspot
South America is much better represented in global statistics and was indeed one of the worst-hit regions:
Strong Data Inclusion
Brazil, Colombia, Mexico, and Peru are among the 20 countries representing approximately 50% of the global population that account for over 80% of the estimated global excess mortality for January 2020 to December 2021.
The Region of the Americas (which includes South America) had 1.34-1.46 million excess deaths in 2020, representing about 60% more than reported COVID-19 deaths.
Extreme Impact Documented
South American countries showed some of the highest excess mortality rates globally:
Per Capita Impact: The highest excess mortality per 100,000 inhabitants was observed in Peru (590), followed by Mexico (360), Ecuador (350). When measuring relative increase (P-scores), it was by far the highest in Latin America: Peru (153%), Ecuador (80%), Bolivia (68%), and Mexico (61%).
Regional Studies: Studies of Brazil, Chile, Ecuador, Guatemala, Mexico, and Peru found that "from April 2020 on, mortality exceeded its usual monthly levels in multiple areas of each country. In Mexico and Peru, excess mortality was spreading through many areas by the end of the second half of 2020".
Life expectancy losses were severe: "Mexico, Ecuador, and Peru had losses of 5.5, 7.9, and 10.9 years, respectively".
Key Implications for Global Statistics
What This Means for Global Totals
- South America is well-represented in the 14.9 million WHO excess death estimate
- Africa is severely underrepresented, creating a major gap that could mean:
- If the high modeling estimates are correct, the true global toll could be substantially higher
- If the lower African expert estimates are correct, current global figures may be reasonably comprehensive
Data Quality Issues
Even in South America, "death registration coverage was below 80-90 percent in years preceding the COVID-19 pandemic" in several countries, though this is still much better than most African countries.
Bottom Line
Both regions should have been major hotspots. South America was and is well-documented as such in the global statistics. Africa remains a massive unknown due to data gaps, with global estimates potentially underestimating the true toll by millions of deaths if the high-end modeling estimates prove accurate, or potentially being reasonably complete if African-based research suggesting lower impacts is correct.
The controversy around African mortality estimates highlights one of the biggest uncertainties remaining in our understanding of the pandemic's true global impact.
Sources
- PBS NewsHour. "Can you get a COVID shot? Here's your fall vaccine guide." Available at: [Document provided]
- PBS NewsHour. "Fact-checking RFK Jr.'s claim that 'everybody can get' the COVID-19 vaccine." September 5, 2025. https://www.pbs.org/newshour/health/fact-checking-rfk-jr-s-claim-that-everybody-can-get-the-covid-19-vaccine
- The White House. "Fact Sheet: President Donald J. Trump Prohibits Federal Funding for COVID-19 Vaccine Mandates in Schools." February 14, 2025. https://www.whitehouse.gov/fact-sheets/2025/02/fact-sheet-president-donald-j-trump-prohibits-federal-funding-for-covid-19-vaccine-mandates-in-schools/
- Northeastern University. "Who is eligible for a COVID-19 shot this fall? Trump administration announces big change in policy." May 20, 2025. https://news.northeastern.edu/2025/05/20/covid-19-vaccine-2025-eligibility/
- CNBC. "Trump tells drugmakers to 'justify the success' of Covid meds after FDA limits vaccine approval." September 1, 2025. https://www.cnbc.com/2025/09/01/trump-covid-vaccines-cdc-rfk.html
- PBS NewsHour. "Trump officials say yearly COVID shots will no longer be approved for healthy adults and children." May 20, 2025. https://www.pbs.org/newshour/health/trump-officials-say-yearly-covid-shots-will-no-longer-be-approved-for-healthy-adults-and-children
- NPR. "The implications of the Trump administration's aggressive new vaccine policies." July 25, 2025. https://www.npr.org/2025/07/25/nx-s1-5474336/the-implications-of-the-trump-administrations-aggressive-new-vaccine-policies
- American Medical Association. "Sept. 5, 2025: National Advocacy Update." September 5, 2025. https://www.ama-assn.org/health-care-advocacy/advocacy-update/sept-5-2025-national-advocacy-update
- ABC News. "Trump admin live updates: Trump defends some vaccines after Florida moves to end mandates." September 5, 2025. https://abcnews.go.com/Politics/live-updates/trump-admin-live-updates/?id=125150863
- U.S. News & World Report. "Trump Administration Releases New COVID-19 Vaccine Plan: What to Know." May 20, 2025. https://www.usnews.com/news/health-news/articles/2025-05-20/trump-administration-releases-new-covid-19-vaccine-plan-what-to-know
- CNN Politics. "Trump raises fresh questions about Covid-19 vaccines that he says have 'ripped apart' CDC." September 1, 2025. https://www.cnn.com/2025/09/01/politics/covid-vaccines-trump-cdc
- ABC News. "FDA approves updated COVID vaccines with restrictions." August 27, 2025. https://abcnews.go.com/Health/fda-approves-updated-covid-vaccines-restrictions-receive/story?id=125032817
- NPR. "The latest COVID vaccines come with new FDA limits." August 27, 2025. https://www.npr.org/sections/shots-health-news/2025/08/27/nx-s1-5515503/fda-covid-vaccines-restricted
- NBC News. "FDA approves fall Covid shots, but with new restrictions." August 27, 2025. https://www.nbcnews.com/health/health-news/fda-approves-fall-covid-shots-new-restrictions-rfk-jr-rcna227569
- U.S. Food and Drug Administration. "COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025." https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025
- Pfizer. "Pfizer and BioNTech's COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19." August 27, 2025. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval
- CNBC. "FDA approves new Covid vaccines with limits under RFK Jr." August 27, 2025. https://www.cnbc.com/2025/08/27/fda-covid-vaccine-authorization--rfk.html
- CNN. "Covid vaccines: FDA approves updated shots for limited groups as US cases continue to rise." August 27, 2025. https://www.cnn.com/2025/08/27/health/covid-vaccines-fda
- NPR. "COVID vaccine guidance has changed — again. A doctor tackles your questions." September 1, 2025. https://www.npr.org/2025/08/29/nx-s1-5522273/health-cdc-covid-vaccine-hhs-fda
- PBS NewsHour. "FDA approves updated COVID-19 shots with some restrictions for kids and adults." August 27, 2025. https://www.pbs.org/newshour/health/fda-approves-updated-covid-19-shots-with-some-restrictions-for-kids-and-adults
- The Washington Post. "FDA approves covid vaccines for 'higher risk' people, restricting others." August 27, 2025. https://www.washingtonpost.com/health/2025/08/27/fda-approves-covid-vaccines/
- NPR. "RFK Jr. removes all members of the CDC's vaccine advisory committee." June 9, 2025. https://www.npr.org/sections/shots-health-news/2025/06/09/nx-s1-5428533/rfk-jr-vaccine-advisory-committee-acip
- Axios. "RFK Jr. removes all 17 members of vaccine committee for CDC." June 10, 2025. https://www.axios.com/2025/06/09/rfk-scraps-vaccine-advisory-committee
- ABC News. "RFK Jr. removes all 17 members of CDC's vaccine advisory committee." June 10, 2025. https://abcnews.go.com/Health/rfk-jr-removing-17-members-cdcs-vaccine-advisory/story?id=122670046
- NPR. "RFK Jr. faced tough hearing on vaccines, CDC changes." September 4, 2025. https://www.npr.org/sections/shots-health-news/2025/09/04/nx-s1-5528966/rfk-kennedy-hearing-covid-vaccines-cdc
- U.S. Department of Health and Human Services. "HHS Takes Bold Step to Restore Public Trust in Vaccines by Reconstituting ACIP." June 9, 2025. https://www.hhs.gov/press-room/hhs-restore-public-trust-vaccines-acip.html
- The Washington Post. "Kennedy defends CDC director firing, vaccine changes." September 4, 2025. https://www.washingtonpost.com/health/2025/09/04/rfk-vaccines-cdc-hearing/
- CNBC. "RFK Jr. removes all members of CDC panel advising U.S. on vaccines." June 10, 2025. https://www.cnbc.com/2025/06/09/rfk-jr-cdc-panel-vaccines.html
- CBS News. "RFK Jr. faces heated questions on CDC turmoil, vaccine changes at Senate hearing." September 4, 2025. https://www.cbsnews.com/live-updates/rfk-hearing-senate-finance-committee-cdc-vaccines/
- The Washington Post. "RFK Jr. purges CDC's vaccine advisory committee that recommends shots." June 10, 2025. https://www.washingtonpost.com/health/2025/06/09/rfk-ousts-vaccine-advisory-committee-acip/
- CNN. "RFK Jr. set to add new members to influential CDC vaccine advisory panel." September 4, 2025. https://www.cnn.com/2025/09/04/health/cdc-acip-members
- AARP. "What to Know About Up-To-Date COVID Vaccines This Fall." September 6, 2025. https://www.aarp.org/health/conditions-treatments/updated-seasonal-covid-vaccines/
- WBUR News. "What to know about Massachusetts' move to set its own vaccine rules." September 5, 2025. https://www.wbur.org/news/2025/09/05/massachusetts-covid-vaccine-insurance-guidelines-rfk-cdc
- CIDRAP. "Three states take steps to ensure COVID vaccine access." September 5, 2025. https://www.cidrap.umn.edu/covid-19/three-states-take-steps-ensure-covid-vaccine-access
- American College of Obstetricians and Gynecologists. "ACOG to Release Recommendations on COVID-19 Vaccine and Other Maternal Immunizations in Concert with the Vaccine Integrity Project." July 2025. https://www.acog.org/news/news-releases/2025/07/acog-to-release-recommendations-on-covid-19-vaccine-and-other-maternal-immunizations-in-concert-with-the-vaccine-integrity-project
- CNN. "Another major medical association breaks from CDC as ob/gyn group recommends Covid-19 vaccines during pregnancy." August 22, 2025. https://www.cnn.com/2025/08/22/health/covid-vaccine-pregnancy-acog-recommendations
- American College of Obstetricians and Gynecologists. "ACOG Statement on HHS Recommendations Regarding the COVID Vaccine During Pregnancy." May 2025. https://www.acog.org/news/news-releases/2025/05/acog-statement-on-hhs-recommendations-regarding-the-covid-vaccine-during-pregnancy
- Medscape. "Where Do We Stand on COVID Vaccine Recommendations in 2025?" August 21, 2025. https://www.medscape.com/viewarticle/where-do-we-stand-covid-vaccine-recommendations-2025-2025a1000m1w
- American College of Obstetricians and Gynecologists. "ACOG Releases Updated Maternal Immunization Guidance for COVID-19, Influenza, and RSV." August 2025. https://www.acog.org/news/news-releases/2025/08/acog-releases-updated-maternal-immunization-guidance-covid-influenza-rsv
- Public Health Insider. "COVID vaccines for this fall: What we know so far." September 4, 2025. https://publichealthinsider.com/2025/08/29/covid-vaccines-for-this-fall-what-we-know-so-far/
- CNN. "In break with current CDC recommendations, American Academy of Pediatrics recommends Covid-19 shots for young children." August 19, 2025. https://www.cnn.com/2025/08/19/health/covid-vaccine-recommendation-aap
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