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COVID-19 vaccines received Emergency Use Authorization from the FDA after clinical trials demonstrated that they are safe and effective; COVID-19 vaccines aren’t experimental

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.

Pregnant women can decide whether to receive the COVID-19 vaccine; safety monitoring suggests that COVID-19 vaccines don’t pose any specific risk for pregnant women

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 don’t increase the incidence of poor outcomes during pregnancy, according to current safety data on COVID-19 vaccines

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”.

COVID-19 vaccines approved for emergency use prevent the disease and are generally safe based on rigorous clinical trials and ongoing monitoring

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.

Vaccines protect people from diseases, but don’t always prevent disease transmission; research ongoing to determine if COVID-19 vaccines stop transmission

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.

Nurse who fainted after getting Pfizer-BioNTech COVID-19 vaccine has a history of fainting episodes; does not mean the vaccine is unsafe

Fainting, also known as syncope, can occur after vaccination. It is usually harmless in itself, although it can lead to injuries if the affected person falls, which can happen if they are not sitting or lying down at the moment of fainting. Episodes of vasovagal syncope are often triggered by pain and/or anxiety, which can lead to changes in heart rate and blood flow, resulting in a temporary loss of consciousness. The sight of blood or a needle can also trigger vasovagal syncope. Fainting following vaccination is not necessarily indicative of problems with the vaccine itself.

A U.S. Food and Drug Administration panel validated Moderna’s COVID-19 vaccine; its authorization for emergency use should ensue

The U.S. Food and Drug Administration summoned a panel of scientific experts on 17 December 2020 to assess the efficacy and safety of the Moderna vaccine against COVID-19. After reviewing the clinical data, the FDA committee voted in favor of Moderna’s COVID-19 vaccine and recommended it for emergency use authorization, stating that its benefits far outweigh its potential risks. The data indicate a 95% reduction in symptomatic cases of COVID-19 in individuals who received the vaccine compared to those that did not. The clinical data also showed few serious adverse events in vaccinated individuals. The FDA should officially approve its distribution to the population in the next few days.

COVID-19 vaccine candidates are generally safe and effective at preventing disease; ongoing studies investigate whether the vaccine can also reduce transmission

The COVID-19 vaccine developed by Pfizer and BioNTech is the first COVID-19 vaccine to be administered to the general population, in particular healthcare workers, having received Emergency Use Authorization from the U.S Food and Drug Administration (FDA) on 11 December 2020. Since then, many posts and articles on social media have claimed alleged safety issues. … Continued

COVID-19 vaccine candidates show high efficacy and a safe profile in clinical trials, contrary to claims in viral video

COVID-19 vaccine candidates must pass the same safety standards as any other candidate to demonstrate their efficacy and safety before approval and public use. However, the pandemic situation has removed many of the usual handicaps that such trials face, including funding, recruitment, or bureaucratic red tape, which resulted in faster completion of safety tests. Phase 3 trial’s data from tens of thousands of participants show that COVID-19 vaccine candidates efficiently prevent the infection and are generally safe.

COVID-19 vaccine candidates are rigorously tested for safety during clinical trials, unlike thalidomide; misleading to equate the two

In spite of the expedited development timeline, COVID-19 vaccine candidates remain subjected to the same level of safety standards as any other vaccine, and must demonstrate clinical efficacy and safety before being approved for use. Thus far, COVID-19 vaccine frontrunners, such as those by Pfizer, Moderna, and AstraZeneca/Oxford, have demonstrated a high level of safety during clinical trials.