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GAO-21-342SP 1 (2021-02-24)

handle is hein.gao/gaobaecms0001 and id is 1 raw text is: Science, Technology Assessment, and Analytics SCIENCE & TECH SPOTLIGHT: VACCINE SAFETY What is it? A vaccine is generally considered safe when the benefits of protecting an individual from disease outweigh the risks from potential side effects (fig. 1). The most common side effects stem from the body's immune reaction and include swelling at the injection site, fever, and aches. Headache, tiredness, fever, death- Meningitis (inflammation of membranes of brain and spinal cord) Sore throat-- Nausea, stomach pain Paralysis (arms, legs, or both) Paresthesia (feeling of pins and needles in the legs) Redness, swelling, or pain at injection site Source: GAO. I GAO-21-342SP What is known? Vaccine developers assess safety from early research, through laboratory and animal testing, and even after the vaccine is in use (fig. 2). Researchers may rely on previous studies to inform future vaccine trials. For example, safety information from preclinical trials of mRNA flu vaccine candidates in 2017 allowed for the acceleration of mRNA COVID-19 vaccine development. Vaccine candidates shown to be safe in these preclinical trials can proceed to clinical trials in humans. In the U.S., clinical trials generally proceed through three phases of testing involving increasing numbers of volunteers: dozens in phase 1 to thousands in phase 3. Although data may be collected over years, most common side effects are identified in the first 2 months after vaccination in clinical trials. After reviewing safety and other data from vaccine studies, the Food and Drug Administration (FDA) may license a vaccine to be marketed in the U.S. There are also programs to expedite-but not bypass-development and review processes, such as a priority review designation, which shortens FDAs goal review time from 10 to 6 months. Safety monitoring continues after licensing. For example, health officials are required to report certain adverse events-such as heart problems- following vaccination, in order to help identify potential long-term or rare side effects that were not seen in clinical trials and may or may not be associated with the vaccine. Figure 1. Symptoms of polio and side effects of the polio vaccine. A vaccine is generally considered safe if its benefits (preventing disease) outweigh its risks (side effects). In rare cases, some vaccines may cause more severe side effects. For example, the vaccine for rotavirus-a childhood illness that can cause severe diarrhea, dehydration, and even death-can cause intestinal blockage in one in 100,000 recipients. However, the vaccine is still administered because this very rare side effect is outweighed by the vaccine's benefits: it saves lives and prevents an estimated 40,000 to 50,000 childhood hospitalizations in the U.S. each year. The two messenger RNA (mRNA) vaccines authorized for COVID- 19-a disease that contributed to more than 415,000 American deaths between January 2020 and January 2021-can cause severe allergic reactions. However, early safety reporting found that these reactions have been extremely rare, with only about five cases per 1 million recipients, according to data from January 2021 reports by the Centers for Disease Control and Prevention. In general, side effects from vaccines are less acceptable to the public than side effects from treatments given to people who already have a disease. Exploratory research Identify vaccine candidates and potential safety risks Post-licensure Ongoing monitoring of suspected side effects following vaccination - Purity testing of every lot manufactured Source: GAO. I GAO-21-342SP Preclinical trials Identify side effects in laboratory and animal testing - Assess whether safe to test in humans Clinical trials Test diverse groups of human volunteers - Assess suspected side effects and other reactions in humans Vaccine safety is assessed at every stage: development through post-licensure. Following a declared emergency, FDA can also issue emergency use authorizations (EUA) to allow temporary use of unlicensed vaccines if there is evidence that known and potential benefits of the vaccine GAO-21-342SP Vaccine Safety

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