Real-world evidence shows that the COVID-19 RNA vaccines are highly effective at preventing illness and death. There is evidence indicating that spike protein during infection can lead to damage, but this isn’t representative of the situation in vaccination. The level of spike protein generated through COVID-19 vaccination is much lower than the levels associated with damage during infection. The evidence so far doesn’t show that COVID-19 vaccination leads to a higher risk of adverse events during pregnancy or affects fertility.
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Myocarditis is a condition in which the heart muscle becomes inflamed. Viral infections are a leading cause of myocarditis, and COVID-19 itself is known to cause heart inflammation. Data from clinical trials and ongoing monitoring of COVID-19 vaccination campaigns show that the benefits of the COVID-19 RNA vaccines outweigh their risks. Health authorities recommend that everyone aged 12 and above get vaccinated, because the risks posed by COVID-19, such as health complications and death, are greater than that posed by the vaccines.
Pregnant women have an increased risk of serious illness or death from COVID-19 relative to non-pregnant women. As a result, pregnant people are included in vaccination priority lists in several countries, such as Belgium and Israel. Though the COVID-19 vaccines were not tested in pregnant people during clinical trials, preliminary results from both research and ongoing monitoring of people who have received the COVID-19 vaccines have not identified any safety concerns for pregnant people or their babies.
The spike protein of SARS-CoV-2 allows the virus to bind to and infect cells, making it an ideal target for vaccine development. Recent studies suggested that the spike protein produced during infection alone might cause cardiovascular damage in COVID-19 patients. While the three COVID-19 vaccines authorized for emergency use in the U.S. induce the cells to produce the spike protein, the protein generated through vaccination behaves differently from the spike protein produced in infection. Clinical trials and ongoing vaccination campaigns, which have vaccinated more than 890 million people worldwide, demonstrated that COVID-19 vaccines are very safe and effective at preventing the disease.
COVID-19 vaccines underwent preclinical testing in animals and clinical trials in tens of thousands of people, which established their safety and efficacy. Such testing is also a prerequisite for receiving emergency use authorization by the U.S. Food and Drug Administration. While deaths have occurred among vaccinated people, it is important to remember that more than 157 million people in the U.S. have been vaccinated, and that the rate of deaths among vaccinated people isn’t higher than that of unvaccinated people. This indicates that COVID-19 vaccines aren’t the cause of these deaths.
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.