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Each vaccine company’s FDA application included two months of follow-up safety data from clinical trials conducted by universities and other independent bodies, during which tens of thousands of volunteers got a vaccine and were monitored to see if they developed side effects or became infected, compared with others who received a placebo.
Clinical trials revealed no severe outcomes attributable to the vaccine. The Pfizer and Moderna vaccines were found to prevent infection among 95% of the people who participated in their clinical trials. By September, Pfizer’s trial had ~44,000 participants and no serious safety concerns were reported. Similarly, Moderna’s trial had ~28,000 participants with no serious safety concerns, hospitalizations, or deaths. Since that time, millions of people have safely received these vaccines.
Vaccine safety monitoring systems are in place to collect side effect data (CDC). If an unexpected adverse event is seen, experts quickly study it further to assess whether it is a true safety concern that warrants changes in U.S. vaccine recommendations. This monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines.
As a result of this ongoing safety monitoring, the Johnson & Johnson vaccine administration was paused April 13 by the CDC and FDA following reports in the United States of people who developed a rare disorder involving blood clots and low platelets within about two weeks of receiving J&J vaccine. During the pause, the FDA and CDC examined available data to assess the risk of this rare condition. They also published protocols for identifying and treating individuals for this rare clotting disorder and communicated these to healthcare providers to ensure they were aware of the potential for these adverse events and could properly recognize and manage them. Following these reviews, the two agencies have recommended that Johnson & Johnson vaccine administration be resumed in the United States. As of April 26th, Kansas providers resumed administration of the J&J COVID-19 vaccine, following the CDC and FDA’s announcements.
America’s best medical and research professionals have been working for years on coronavirus vaccines for SARS and MERS. While SARS and MERS are different than COVID-19, they belong to the coronavirus family. The lessons learned through those developments are being applied today.
Although the timeline has been accelerated, the integrity of the trial and approval processes has remained. Scientists had a head start on developing the COVID-19 vaccine, using their experience from previous coronavirus vaccine efforts. Another way scientists preserved safety and saved time was by working on efforts simultaneously, rather than one after another like the traditional process. For example, COVID-19 vaccines were in Phase III clinical trials at the same time they were being manufactured. Once the vaccine was proven safe and effective and authorized for use after the FDA review process, the manufactured vaccines were deployed. If the vaccines don’t pass the authorization process, which is verified by an independent committee of health experts, the manufactured vaccine cannot be used.
The flu vaccine will not protect you from coronavirus.
Influenza and COVID-19 (SARS-CoV-2) belong to two different RNA virus families, so one vaccine is not interchangeable for another. Influenza belongs to the Orthomyxoviridae family, while SARS-CoV-2 is classified in the Coronaviridae family. Both Influenza and SARS-CoV-2 rely on different protein layers to initiate responses. Influenza uses two surface antigens, while SARS-CoV-2 uses spike proteins, so their immunization approaches are different.
The COVID-19 vaccines do not alter your DNA.
Medical doctors independent of the vaccine development teams have verified that using mRNA – technology underpinning the Pfizer and Moderna vaccines – will not alter the DNA of our body’s cells. These vaccines provide a set of instructions to your cells to create an immune response specific to COVID-19 without introducing DNA into your body. Learn more.
The Johnson and Johnson vaccine works more like a traditional vaccine. The vaccine is a viral vector vaccine that uses a harmless version of a different virus, called a “vector,” to deliver information to the body that helps to protect you. Learn more.
The ingredients used in the mRNA vaccines developed by Pfizer and Moderna are simple. They contain mRNA, as well as lipids to ensure safe delivery of the mRNA that will initiate an immune response. Although FDA approved adjuvants (aluminum salts) and preservatives (ethylmercury) have a history of safe use in vaccines, they were not used by Pfizer and Moderna in this vaccine technology. The vaccines do not include fetal tissue.
Among vaccine recipients during the Pfizer clinical trials, 8.8% reported experiencing a reaction they considered to interfere with daily activity; the most common symptoms were fatigue (4.2%), headache (2.4%), muscle pain (1.8%), chills (1.7%), and injection site pain (1.4%). More people experienced these side effects after the second dose.Among vaccine recipients during the Moderna clinical trials, 9.1% reported local injection site reaction and 16.5% reported side effects, with the most common including fever, headache, fatigue and muscle aches and pains. No specific safety concerns were identified for the Pfizer and Moderna vaccines in subgroup analyses by age, race, ethnicity, underlying medical conditions, or previous SARS-CoV-2 infection.
Johnson & Johnson administration was paused April 13 by the CDC and FDA following reports of recipients in the United States who developed a rare disorder involving blood clots within about two weeks of vaccination. During the pause, the FDA and CDC examined available data to assess the risk of the condition as well as conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events. Following these reviews, the two agencies have recommended that Johnson & Johnson be resumed in the United States. As of April 26th, KDHE announced that Kansas will resume administration of the J&J COVID-19 vaccine, following the CDC and FDA’s announcements.
Yes, it is recommended that even vaccinated individuals practice an abundance of caution by continuing to wear a mask, social distance, wash their hands and avoid large gatherings -- especially indoors.
COVID-19 is a deadly disease that causes severe illness – and in some cases, long-term symptoms that we have yet to fully understand. The COVID-19 vaccine has been created to decrease death and severe illness.
Although a high percentage of people recover from COVID-19, some are hospitalized and experience severe illness. It is also somewhat common to have the virus but never experience symptoms, and it’s possible to spread the virus to others even when symptoms are not present. When you make the choice to be vaccinated, you are protecting not only yourself but also those around you from the chance of death and severe illness.
No, COVID-19 vaccines will not be mandated in Kansas at this time. Documentation of COVID-19 vaccination will be required by some countries for international travel and may be required in some states to attend sporting events or other large events. If you have travel plans, please make sure you know where COVID-19 vaccination will be required.