Pregnant women are usually excluded from clinical trials. Two of these 23 women reported adverse events, but both were in the placebo group. There were 12 in the vaccine group and 11 in the placebo group. Food and Drug Administration for review, 23 pregnancies were reported after the clinical trial began. It is just telling health care providers how to document and track various types of potential adverse events.Īccording to the data submitted to the U.S. It also is not actually reporting adverse events. This document is not discussing viral shedding, or even indicating that there’s a potential for viral shedding. And “study intervention” refers to the vaccine itself – the medicine (intervention) being studied. “Exposure” just means that someone somehow came in contact with the substance being studied. In this section, the document lists events that should be reported, including various types of exposure. On page 67 of this document, there’s a section titled “Regulatory Reporting Requirements for SAEs.” SAEs stands for Serious Adverse Events. The protocol outlines the goal of the study, explains how it’s designed and provides instructions for the health care providers conducting the study. All clinical trials must have a clinical trial protocol before they begin. There are some fake versions floating around, so here is a link to the original document listed on .Ī clinical trial protocol is a document that describes the rules for a clinical trial. There’s a lot of confusion about what the information in that document means. Links to the clinical trial protocol document for phases 1, 2 and 3 of the Pfizer clinical trial are spreading on social media. Learn more about how adenovirus vaccines work. (Again, they do NOT contain the coronavirus.) But the adenovirus in both the Johnson & Johnson and AstraZeneca vaccines can’t replicate, so there’s no way they can shed. The Johnson & Johnson and AstraZeneca vaccines are considered live vaccines because they both contain adenovirus. The mRNA vaccines – Pfizer and Moderna – are not live vaccines and do not replicate. Shedding can’t happen without a live vaccine. “We know that people with COVID-19 shed large amounts of virus from respiratory secretions,” says Dr. If someone has tested positive for COVID-19, though, they are shedding virus, including the spike protein, and contagious. "But it should not be shed in significant quantity in respiratory or other secretions.” “Spike protein is primarily made locally in muscle where the vaccine is administered and may possibly be seen in low levels in the blood," says Dr. Vaccines do not contain SARS-CoV-2, the virus that causes COVID-19. “We have no data to indicate that contact with somebody who has been vaccinated affects menstrual cycles,” says infectious diseases expert James Lawler, MD, MPH. The idea is that someone who has been vaccinated is shedding spike protein to those around them who have not been vaccinated. There have been rumors of “vaccine shedding” causing side effects to people who have not been vaccinated. Can “vaccine shedding” cause side effects in unvaccinated people? Call 800.922.0000 to schedule an appointment with an OB-GYN who can help. If you’re experiencing persistently abnormal periods, seek care. See why it helps to schedule your mammogram around a vaccine. These side effects often go away in a few days. Often people report fevers, body aches, headaches and pain at the site of injection. Vaccines sometimes do create an immune response that you can feel. “When millions of menstruating women are receiving the vaccine, the timing could certainly be coincidence.” “It’s not uncommon for women to experience an atypical cycle over the course of a year,” says Dr. They could be related, but it’s too soon to say for sure. That doesn’t necessarily mean the vaccine caused the abnormal period. Oral contraceptives and other medications can also change periods, especially if they change hormone levels.Ībnormal periods will also happen by chance after people receive the COVID-19 vaccine. Nebraska Medicine OB-GYN Karen Carlson, MD, writes about how pandemic stress can affect periods. Your period can fluctuate for many reasons, including diet, stress, exercise, illness and pregnancy. There’s also no biological mechanism, based on how the vaccines work, that would explain these occurrences.” ![]() “This was not identified in the clinical trials of the vaccines. “Some women have reported on social media that the period after a COVID-19 vaccine was different, or changed in some way from what they usually expect,” says OB-GYN Jennifer Griffin Miller, MD, MPH. Right now, there’s no scientific evidence that suggests COVID-19 vaccines are making periods irregular. Are irregular periods a side effect of COVID-19 vaccines? Irregular periods include heavier bleeding than normal, early periods, late periods and similar changes.
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