Adverse event reporting systems, such as the Yellow Card scheme in the U.K. or VAERS in the U.S., are designed to help health authorities monitor the safety of medical products such as the COVID-19 vaccines. However, the databases contain unverified information and cannot demonstrate that COVID-19 vaccines caused adverse events. The reports can be a starting point for a detailed investigation into potential side effects, which happened for rare cases of blood clotting and anaphylaxis. Overall, the U.K. regulatory body, the MHRA, still concludes that the benefits of the COVID-19 vaccines outweigh their known risks.
Search Results for "covid-19 vaccine" "adverse events"
Both COVID-19 vaccines approved for emergency use by the U.S. Food and Drug Administration were thoroughly reviewed for safety and efficacy before approval. The U.S. Adverse Events Reporting System (VAERS) enables the public and healthcare providers to report adverse events that occur after vaccination. It serves as an early warning system for potential problems with vaccines. However, determining whether there is a causal link requires further investigation into these reports. VAERS data only tells us that an adverse event occurred after vaccination; on its own it cannot prove that vaccines caused the adverse event.
Multiple studies have shown that the benefits of COVID-19 vaccines outweigh their risks. One of the key reasons for the greater number of adverse event reports for COVID-19 vaccines compared to other vaccines is the mandatory requirement to report all serious adverse events regardless of causality. Other vaccines don’t carry this requirement.
Despite claims made on social media, a study published by the peer-reviewed journal BMC Infectious Diseases doesn’t actually provide the necessary scientific evidence for its claim that nearly 300,000 people died from COVID-19 vaccines. This estimate is based on a survey of about 2,800 people, but doesn’t involve verifying the accuracy of survey responses by examining medical records. As such, the study doesn’t offer a reliable estimate of deaths related to the COVID-19 vaccines.
Multiple peer-reviewed published studies have shown that the benefits of COVID-19 vaccination outweigh its risks. Benefits from vaccination take longer to appear compared to harms, which usually appear within the first six weeks following vaccination. Consequently, studies that aim to reliably compare the risks and benefits of vaccination require time to obtain a complete picture.
Certain COVID-19 vaccines, specifically the viral vector vaccines like the AstraZeneca and J & J vaccines, are associated with an increased risk of a blood clotting disorder called vaccine-induced thrombotic thrombocytopenia, which can be fatal. At the moment, there isn’t evidence indicating that mRNA COVID-19 vaccines are associated with the same risk. However, it’s important to also consider that getting COVID-19 itself increases a person’s risk of developing blood clotting problems to a greater extent than the viral vector COVID-19 vaccines.
While COVID-19 vaccines have indeed been associated with an elevated risk of certain adverse events like myocarditis, COVID-19 itself is associated with greater risks, including cardiac complications. To date, the scientific evidence shows that the benefits of COVID-19 vaccines outweigh their risks.
The emergence of the Omicron variant caused a spike in the number of COVID-19 cases and related hospitalizations among children aged six months to five years. Clinical trials involving thousands of participants showed that COVID-19 vaccines are safe and induce an immune response in children within this age group, which can prevent complications from the disease. Therefore, the American Academy of Pediatricians and the U.S. Centers for Disease Control and Prevention recommend that all children aged six months to five years receive the vaccine.
Manufacturers and healthcare providers must report all serious adverse events that occur after COVID-19 vaccination, regardless of whether they think the vaccine was the cause. This is mandatory under the Emergency Use Authorization that the FDA issued for the COVID-19 vaccines. In 2021 and 2022, clinicians administered over 600 million vaccines, an unprecedented number under such authorization, leading to a spike in deaths reported to VAERS. Taken together, this indicates that the spike is due to an increased reporting rate and not a genuine increase in deaths.
The American Academy of Pediatricians recommends that all eligible infants, children, and adolescents six months and older be vaccinated against COVID-19. Although the U.S. Advisory Committee on Immunization Practices (ACIP) voted to add the COVID-19 vaccine to the childhood immunization schedule, this addition doesn’t make the vaccine mandatory for attending schools. Whether a vaccine is mandatory to attend school is up to states.