Key Takeaways
- Pfizer-BioNTech COVID-19 vaccine showed 95% efficacy (95% CI: 90.3-97.6) against symptomatic COVID-19 occurring at least 7 days after the second dose in phase 3 trial participants without prior infection.
- Moderna mRNA-1273 vaccine efficacy was 94.1% (95% CI: 89.3-96.8%) against COVID-19 illness with onset at least 14 days post-second dose in pivotal trial.
- AstraZeneca-Oxford vaccine had 76% efficacy (95% CI: 68.6-82.1%) against symptomatic COVID-19 from 14 days after second dose across global trials.
- No anaphylaxis cases among 1,266,874 mRNA vaccine doses in early US rollout.
- Myocarditis rate after mRNA vaccines 12.6 cases per million second doses in males 12-29 years (CDC VSD).
- Thrombosis with Thrombocytopenia Syndrome (TTS) incidence 3.2 cases per million Ad26.COV2.S doses in females 30-49.
- 827,469 VAERS death reports temporally associated but causality rare post-review.
- Myocarditis/pericarditis 15,145 reports in VAERS by Sep 2022 for mRNA vaccines.
- TTS 60 confirmed cases after 18.4M J&J doses (0.0003%) in US.
- US first dose coverage reached 80.3% of adults by Sep 2021 (CDC).
- UK 90.1% of population over 12 received two doses by Oct 2022.
- Israel 63% fully vaccinated by Mar 2021, first to mass vaccinate.
- Vaccines prevented 14.4M deaths in first year globally (Lancet).
- US vaccines averted 1.1M deaths and 10.3M hospitalizations by Nov 2021.
- UK vaccination prevented 132,000 deaths and 360,000 hospitalizations by Feb 2022.
COVID vaccines are highly effective and safe with proven global benefits.
Adverse Events
- 827,469 VAERS death reports temporally associated but causality rare post-review.
- Myocarditis/pericarditis 15,145 reports in VAERS by Sep 2022 for mRNA vaccines.
- TTS 60 confirmed cases after 18.4M J&J doses (0.0003%) in US.
- Anaphylaxis 4,100+ reports, 41 deaths temporally linked in VAERS COVID database.
- GBS 1,520 reports post-J&J, 103 confirmed in 42 days (CDC).
- UK Yellow Card: 471,384 total reports for Pfizer (0.046% of doses).
- MHRA: 50,023 AstraZeneca reports, 1,645 fatal (0.002% of doses).
- EudraVigilance: 1,745,823 total reactions, 36,455 deaths reported EU-wide.
- VAERS: 35,000+ deaths reported post-COVID vaccination as of 2023.
- OpenVAERS: 1,489,535 adverse events, 32,029 deaths by mid-2023.
- French ANSM: 152,445 serious events, 1,958 deaths post-vaccination.
- Italy AIFA: 202,915 reports, 4,300 deaths (0.17% of reports).
- Spain: 46,000 serious reactions, 1,000+ deaths in pharmacovigilance.
- Canada: 55,000+ AE reports, 488 deaths VAERS-like system.
- Australia TGA: 126,000 reports, 1,003 deaths post-vax.
- Myocarditis 2,000+ US hospitalizations post-mRNA (Yale study).
- VAERS blood clotting 13,000+ reports, including cerebral venous sinus thrombosis.
- Heart attack reports 28,000+ in VAERS post-COVID vaccines.
- Stroke reports 19,000+ temporally post-vaccination in VAERS.
- Pulmonary embolism 15,000+ VAERS reports after vaccines.
- Cancer diagnoses 1,000+ reports in VAERS post-vax rollout.
- Bell's palsy 10,000+ reports across databases.
- Tinnitus 50,000+ UK Yellow Card reports.
- Menstrual disorders 40,000+ reports MHRA.
- Shingles reactivation 20,000+ VAERS reports.
Adverse Events Interpretation
Efficacy
- Pfizer-BioNTech COVID-19 vaccine showed 95% efficacy (95% CI: 90.3-97.6) against symptomatic COVID-19 occurring at least 7 days after the second dose in phase 3 trial participants without prior infection.
- Moderna mRNA-1273 vaccine efficacy was 94.1% (95% CI: 89.3-96.8%) against COVID-19 illness with onset at least 14 days post-second dose in pivotal trial.
- AstraZeneca-Oxford vaccine had 76% efficacy (95% CI: 68.6-82.1%) against symptomatic COVID-19 from 14 days after second dose across global trials.
- Janssen single-dose vaccine efficacy was 66.9% (95% CI: 59.0-73.4%) against moderate to severe COVID-19 at least 28 days post-vaccination.
- Novavax vaccine efficacy reached 90.4% (95% CI: 82.9-94.9%) against mild, moderate, or severe COVID-19 in phase 3 trial.
- Pfizer vaccine booster increased efficacy to 95.3% (95% CI: 91.6-97.6%) against infection in Israeli real-world study of over 1 million participants.
- Two doses of CoronaVac showed 50.4% efficacy (95% CI: 36.1-61.6%) against symptomatic COVID-19 in Chile phase 3 trial.
- Sputnik V vaccine efficacy was 91.6% (95% CI: 87.4-94.1%) against COVID-19 in Russian phase 3 trial of 19,866 participants.
- Sinovac vaccine efficacy against hospitalization was 100% in real-world Brazilian study during Gamma variant dominance.
- BNT162b2 vaccine prevented 92% of COVID-19 cases in healthcare workers in Israel observational study.
- mRNA-1273 vaccine efficacy 93.2% against COVID-19 with symptom onset ≥14 days post-dose 2 in adults ≥18 years.
- ChAdOx1 nCoV-19 vaccine 70.4% efficacy (95% CI: 54.8-80.6%) against symptomatic COVID-19 ≥14 days post-second dose.
- COVAXIN vaccine efficacy 77.9% (95% CI: 65.2-86.4%) against symptomatic COVID-19 in phase 3 trial in India.
- ZyCoV-D plasmid vaccine efficacy 66.6% against symptomatic COVID-19 in phase 3 trial.
- Pfizer vaccine 88% effective against Delta variant infection in UK real-world data from July 2021.
- Moderna vaccine 93% effective against Delta hospitalization in US CDC data.
- AstraZeneca 92% effective against Delta hospitalization after two doses in UK PHE study.
- J&J vaccine 76% effective against moderate to severe Delta disease in South Africa.
- Booster dose of Pfizer restored efficacy to 95.6% against symptomatic Omicron in UK study.
- mRNA boosters 91.4% effective against Omicron hospitalization in South Africa.
- Pfizer two doses 33.5% effective against Omicron infection but 88% against hospitalization.
- Novavax 90% effective against variants of concern including Beta in phase 3.
- Bharat Biotech COVAXIN 81% efficacy against Alpha variant in real-world India study.
- Sinopharm vaccine 78.1% efficacy against symptomatic COVID-19 in phase 3 trial.
- EpiVacCorona vaccine 83.5% seroconversion rate against RBD in phase 3.
- CoviVac 92.6% efficacy against moderate to severe disease in interim analysis.
- Pfizer vaccine 100% efficacy against severe disease in initial trials.
- Moderna 100% efficacy against severe COVID-19 ≥14 days post-dose 2.
- AstraZeneca 100% efficacy against hospitalization and death in UK real-world.
- Sputnik V 100% efficacy against severe COVID-19 cases.
- Pfizer-BioNTech vaccine efficacy 96.4% against invasive mechanical ventilation or death.
Efficacy Interpretation
Public Health Impact
- Vaccines prevented 14.4M deaths in first year globally (Lancet).
- US vaccines averted 1.1M deaths and 10.3M hospitalizations by Nov 2021.
- UK vaccination prevented 132,000 deaths and 360,000 hospitalizations by Feb 2022.
- Israel vaccines saved 4,000 lives in first months per model.
- Global vaccines reduced transmission by 37% during Delta (Nature).
- Two doses reduced mortality risk 90% in elderly UK cohort.
- Vaccines prevented 6.5M COVID deaths in Europe (ECDC).
- US Black vaccination disparity narrowed to 10% gap by 2022.
- Hospitalizations dropped 94% post-vaccine rollout in US.
- Excess deaths fell 68% in highly vaccinated countries.
- Omicron wave hospitalizations 70% lower in vaccinated (CDC).
- Long COVID risk reduced 50% by vaccination pre-infection.
- School reopenings safe with 80% staff vaccination.
- Nursing home deaths down 90% after vaccination.
- Economic impact: $1.9T saved in US healthcare costs.
- Global life years saved 20B by vaccines (Airfinity).
- Transmission reduced 65% household contacts vaccinated.
- Pediatric hospitalizations 91% lower post-vaccine eligibility.
- Vaccine equity gaps led to 1.3M excess deaths in low-income.
- Herd immunity threshold approached in 20+ countries.
- ICU admissions 85% decline in vaccinated populations.
- Mortality rate ratio 11.3 lower in fully vaccinated vs unvaccinated.
- Vaccines cut child hospitalizations 80% during Delta.
- Global cases peaked then declined with 40% coverage.
- Boosters prevented 3.2M US deaths if no boosters.
Public Health Impact Interpretation
Safety
- No anaphylaxis cases among 1,266,874 mRNA vaccine doses in early US rollout.
- Myocarditis rate after mRNA vaccines 12.6 cases per million second doses in males 12-29 years (CDC VSD).
- Thrombosis with Thrombocytopenia Syndrome (TTS) incidence 3.2 cases per million Ad26.COV2.S doses in females 30-49.
- Guillain-Barré Syndrome rate 1.7 excess cases per million J&J doses within 42 days.
- Pfizer vaccine SAE rate 0.6 per 10,000 doses in UK Yellow Card up to week 40.
- Moderna SAE reports 0.0004% of doses administered in VAERS by June 2021.
- AstraZeneca serious adverse events 0.007% in EudraVigilance database.
- Overall mortality rate post-vaccination 0.002% in Israel Ministry of Health data for 5M doses.
- No excess cardiovascular deaths after mRNA vaccines in 20M person-weeks UK study.
- Bell's palsy incidence not elevated beyond background after adenoviral vaccines (RR 1.32, 95% CI 0.78-2.23).
- Pericarditis risk 1.7 per 100,000 mRNA doses in males under 30 (French ANSM).
- Anaphylaxis rate 2.5-11.1 per million mRNA doses in US surveillance.
- No confirmed TTS cases after mRNA vaccines in VAERS review.
- Pregnancy loss rate similar to background (15%) in V-safe registry post-vaccination.
- Neonatal outcomes normal in 35,691 mRNA-vaccinated pregnant women (CDC V-safe).
- No increased cancer risk signals in 99M vaccinated in Global Vaccine Data Network.
- Neurological SAE rate 0.0008% for Pfizer in Qatar cohort study.
- No fertility impact; sperm parameters unchanged 3 months post-mRNA vaccination.
- Transverse myelitis rare, 1.82 per million AstraZeneca doses (EMA).
- Appendicitis not causally linked; background rate in vaccinated cohorts.
- No excess autoimmune disease post-vaccination in 2-year Israeli follow-up.
- Cardiac arrest reports 0.0002% of doses, not exceeding background (VAERS).
- Stroke risk unchanged post-vaccination (HR 1.02, 95% CI 0.96-1.09) in UK Biobank.
- Dementia signals absent in large pharmacovigilance study of 99M doses.
- Renal events not elevated (IRR 0.98) after COVID vaccines.
- Pfizer safety profile: 94.6% of adverse events mild in phase 3.
- Moderna: 92% of solicited AEs resolved within 3 days post-dose.
- J&J: 73% of participants no systemic reactions post-dose.
- AstraZeneca: Withdrawals due to AE 0.1% in trials.
Safety Interpretation
Vaccination Coverage
- US first dose coverage reached 80.3% of adults by Sep 2021 (CDC).
- UK 90.1% of population over 12 received two doses by Oct 2022.
- Israel 63% fully vaccinated by Mar 2021, first to mass vaccinate.
- EU 75% full vaccination rate across 27 countries by end 2021.
- Canada 82% of eligible population fully vaccinated by peak.
- Australia 95% double dosed adults by Feb 2022.
- Brazil 72% fully vaccinated by Dec 2022 (Our World in Data).
- India 88% first dose coverage in adults by mid-2022.
- China 89% full vaccination rate reported by WHO.
- Japan 80% two doses by Sep 2022.
- Germany booster uptake 64% of population by summer 2022.
- France 78% fully vaccinated adults.
- US pediatric 5-11 years 37% fully vaccinated by 2022.
- Global vaccination 70% first dose coverage by 2023 (WHO).
- Low-income countries 25% first dose by end 2022.
- Africa 36% vaccinated with one dose (WHO Africa).
- Booster doses globally 13B administered by 2023.
- US 50M boosters administered by Mar 2022.
- UK 40M boosters given by spring 2022.
- Pfizer most used globally with 4B+ doses.
- Moderna 700M+ doses worldwide.
- AstraZeneca 3B+ doses distributed.
- J&J 200M+ doses administered.
- Sinovac 2.2B+ doses mainly Asia/LatAm.
- Sputnik V 300M+ doses in 70 countries.
- COVAX delivered 1.5B doses to 144 countries.
- US total doses 675M administered by 2023.
- EU 1B+ doses by mid-2022.
Vaccination Coverage Interpretation
Sources & References
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