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To date, the vaccines in trial have been tested on tens of thousands of people and have passed safety requirements in Phase I and Phase II trials. As an additional layer of checks and balances, an external advisory board of medical and research professionals using additional public health data will review final COVID-19 vaccine data.
Clinical trials are an important part of determining vaccine safety and effectiveness. Currently, phase 3 clinical trials are underway for 4 vaccines involving thousands of participants. The purpose of clinical trials is to generate scientific data and other information for the Food and Drug Administration to review and base their recommendations on.
Vaccine safety monitoring systems are in place to collect side effect data. 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.
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 have 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. When it was proven safe and effective, the manufactured vaccines were deployed. If the vaccines don’t pass the approval process, which is verified by an independent committee of health experts, the unproven vaccines won’t be used.
You cannot get COVID-19 from the vaccine. Every day, a healthy immune system successfully fights off thousands of germs. Antigens are parts of germs that cause the body’s immune system to go to work to build antibodies, which fight off diseases. The antigens in vaccines come from the germs themselves, but the germs are weakened or killed so they cannot cause serious illness. Even if people receive several vaccinations in one day, vaccines contain only a tiny fraction of the antigens they encounter every day in their environment. Vaccines stimulate the immune system to produce antibodies to fight off serious vaccine-preventable diseases.
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.
COVID-19 vaccines were created using mRNA technology, which provides a set of instructions to your cells to create an immune response specific to COVID-19. Medical doctors independent of the vaccine development teams have verified that using mRNA will not alter the DNA of our body’s cells. They do not introduce DNA into your body. Learn more.
Pfizer’s vaccine was approved for ages 16 and older. Moderna’s vaccine has been approved for those 18 and older. The vaccines are not recommended for individuals who have experienced a serious reaction, such as anaphylaxis, to a prior dose of a COVID-19 vaccine or to any of its components. For information on vaccine components, refer to the manufacturers’ package inserts from Pfizer and Moderna.
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 any 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.
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.
Yes. We are seeing evidence of reinfection in patients. Early evidence suggests natural immunity from SARS-CoV-2 may not last very long, but more studies are needed to better understand this. Vaccination should not occur until the patient has met the criteria to discontinue isolation.
No, COVID-19 vaccines will not be mandated in Kansas at this time.