Address Concerns About Safety and Effectiveness

COVID-19 vaccines are safe and effective and were evaluated in tens of thousands of participants in clinical trials. The vaccines met the U.S. Food and Drug Administration’s rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support Emergency Use Authorization (EUA). As of March 2024, more than 700 million doses of COVID-19 vaccines have been given in the United States. For latest statistics, click here.

The Pfizer-BioNTech, Moderna, and Novavax COVID-19 vaccines continue to undergo the most intensive safety monitoring in U.S. history. This monitoring includes using established and new monitoring systems to ensure that COVID-19 vaccines are safe.

Key Points

  • Hundreds of millions of people have safely received a COVID-19 vaccine, and the results of ongoing and vigorous safety monitoring are reassuring.
  • None of the COVID-19 vaccines contain the live virus that causes COVID-19, so a COVID-19 vaccine cannot make anyone sick with the disease.
  • Any vaccination can result in a severe allergic reaction (called anaphylaxis). Still, these events are very rare (roughly 1 case per 200,000 to 1 million vaccinations). Vaccine providers keep epinephrine (Adrenalin®) on hand to treat such rare reactions onsite.
  • COVID-19 vaccines are very effective. Several clinical trials of 40,000 volunteers each showed that these vaccines have high rates of efficacy for preventing COVID-19 infection and averting severe COVID-19 disease. Additional evidence gathered as hundreds of millions of people worldwide have been vaccinated (“real-world studies”) confirmed the findings of the clinical trials: the vaccines are very effective at reducing the risk of COVID-19 disease. The updated vaccine formulations have shown in multiple studies that vaccination reduces the risk of hospitalization, severe outcomes, and death in every age group studied.
  • Several monitoring systems continue to track outcomes from COVID-19 vaccines to ensure their safety.

Information for Pharmacy Teams

Listen to APhA’s podcast on COVID-19 Vaccine Safety and Effectiveness to hear a pharmacist talk frankly about the safety and effectiveness of the COVID-19 vaccines.
Review information from CDC about the Safety of COVID-19 Vaccines to learn about common side effects and rare adverse events associated with the COVID-19 vaccines.
Read CDC’s overview of the effectiveness of COVID-19 vaccines to learn how COVID-19 vaccines are working, how CDC measures COVID-19 vaccine effectiveness, and the possibility of COVID-19 illness after vaccination.
Read A Comprehensive Analysis of the Efficacy and Safety of COVID-19 Vaccines to review an analysis of data from the published trials of COVID-19 vaccines and the real-world data from the Vaccine Adverse Event Reporting System (VAERS).
Take APhA’s short quiz on COVID-19 Vaccines and Vaccine Confidence to test your knowledge about vaccine confidence basics, types of vaccine platforms (mRNA, protein subunit), myths about use in childbearing years, and vaccine efficacy and effectiveness.
Read CDC’s COVID-19 Vaccine Effectiveness Research to learn about the ways that COVID-19 vaccines were evaluated for effectiveness.
Read CDC’s Monitoring COVID-19 Vaccine Effectiveness to learn why and how the CDC monitors COVID-19 vaccine effectiveness.
Access CDC’s Vaccine Adverse Event Reporting System (VAERS) to learn how the monitoring system works, how to report adverse events using the system, and how to access data from the system.

Information for Patients

Share CDC’s Safety of COVID-19 Vaccines webpage that reviews common side effects and rare adverse events.
Share CDC’s COVID-19 Vaccines Work webpage that reviews why vaccines work, why boosters are needed, and what a breakthrough infection is.