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.
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The U.S. Centers for Disease Control and Prevention (CDC) investigated the deaths that occurred among people who received a COVID-19 vaccine and found that the vaccines didn’t cause these deaths. The VAERS database helps health authorities to monitor the safety of vaccines. However, it is important to remember that the database contains unverified information and can’t be used on its own to suggest a causal link between vaccination and death. It is mandatory for healthcare providers to report any death occurring among COVID-19 vaccine recipients, which may be why more deaths are being reported among those who received a COVID-19 vaccine as compared to other vaccines.
To date, hundreds of millions of people around the world have received at least one dose of COVID-19 vaccine. Review of clinical trial data by regulatory agencies, in addition to continued monitoring of safety signals during the ongoing COVID-19 vaccination campaigns, show that vaccinated people aren’t more likely to die compared to unvaccinated people. While the COVID-19 vaccines are associated with certain side effects, the most common ones, like fever and pain at the injection site, are mild and short-lived. Their benefits outweigh their risks and it is safer to take the vaccine than to get the disease.
Millions of women in the U.S. received at least one COVID-19 vaccine dose. No significant safety concerns related to fertility or pregnancy have emerged in clinical trials or safety monitoring of COVID-19 vaccination campaigns. For the moment, there isn’t sufficient evidence to establish a causal relationship between the COVID-19 vaccines and menstrual irregularities that women observed after vaccination. More studies are needed to shed light on this subject.
Herpes zoster (shingles) is a viral infection caused by the varicella-zoster virus that also causes chickenpox. This virus doesn’t cause other types of herpes, such as genital herpes. Only people who had chickenpox in the past can develop shingles, which result from a reactivation of pre-existing virus in the body. One study reported six cases of shingles in patients with rheumatic diseases after receiving the Pfizer-BioNTech COVID-19 vaccine, suggesting that the vaccine might trigger viral reactivation in these patients. However, the study wasn’t designed to establish a causal association between shingles and the vaccine because it didn’t include a group of unvaccinated rheumatic patients.
Emergency Use Authorization (EUA) is a fast-track process for approving vaccines and drugs when their benefits outweigh the potential risks to a population. EUA is well-suited for addressing ongoing global health threats, such as the COVID-19 pandemic. Three COVID-19 vaccines received EAU from the FDA, after clinical data showed they were effective at protecting vaccinated individuals against the disease and had few risks for the general population. Continued monitoring of vaccinated populations is a standard procedure to increase our knowledge about a vaccine’s benefits and risk in a real world setting.
COVID-19 vaccines authorized for emergency use by the U.S. Food and Drug Administration demonstrated a high level of safety and efficacy in clinical trials. However, limited data is available regarding the safety and efficacy of these vaccines in pregnant women because they were excluded from initial clinical trials. Available evidence from animal studies and ongoing vaccine safety monitoring suggests that COVID-19 vaccines don’t pose any specific risk for pregnant women. In contrast, pregnant women have an increased risk of suffering complications from COVID-19, which may affect pregnancy outcomes.
COVID-19 vaccines authorized for emergency use by the U.S. Food and Drug Administration showed a high level of safety and efficacy in clinical trials. However, these trials excluded pregnant women. For this reason, data from clinical trials regarding the vaccines’ safety and efficacy in pregnant women is limited. However, current safety monitoring of pregnant women who received the vaccine hasn’t shown an increased incidence of pregnancy-related adverse events compared to unvaccinated pregnant women. The U.S. Centers for Disease Control and Prevention stated that “People who are pregnant and part of a group recommended to receive COVID-19 vaccine, such as healthcare personnel, may choose to be vaccinated”.
No vaccine can receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) unless clinical trials demonstrate that it is safe and can prevent the disease in vaccinated individuals. Data from Phase 3 trials and continued monitoring of vaccinated individuals show that the COVID-19 vaccines approved by the FDA have a high level of efficacy and are generally safe. This evidence indicates that the benefits of the COVID-19 vaccines in preventing the disease largely outweigh potential risks, such as allergic reactions in a small number of people who have previous histories of allergies.
According to the CDC and the FDA, a vaccine is a product that stimulates a person’s immune system to build defenses against a particular disease-causing microorganism, thereby preventing disease in the vaccinated individual. It is still unknown whether the COVID-19 vaccines developed by Pfizer-BioNTech and Moderna, which were approved for emergency use by the FDA, can stop transmission of the virus. Research is ongoing to address this question. Since it is currently unclear whether or not vaccinated people can still transmit the virus that causes COVID-19 to others, it remains important for people to follow preventative measures, such as washing hands frequently, wearing a face mask and practicing physical distancing.