Once a vaccine has been approved for commercial sale by the FDA, how is its safety monitored over time? Select all that apply. Choose one or more: A. Issues with a vaccine's safety like an adverse reaction can be reported by patients, parents, and doctors for review. B. Facilities that manufacture the vaccine and the vaccines themselves are monitored and tested periodically. C. Three phases of clinical trials are performed on adult human volunteers. D. Data from various healthcare agencies on vaccines and their administration are collected and evaluated.
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These include: A. Issues with a vaccine's safety like an adverse reaction can be reported by patients, parents, and doctors for review. This is a form of post-marketing surveillance and is a crucial part of monitoring the safety of a vaccine. Show more…
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Which statement is TRUE about Preclinical trials: The safety and efficacy of a vaccine for humans is determined through preclinical trials. Safety concerns that are discovered at this stage could lead to a withdrawal of a licensed vaccine. Vaccine candidates are tested in animal models, first in mice or rats and then non-human primates such as monkeys. Preclinical trials can demonstrate whether a vaccine is protective against disease and safety is more fully assessed. During preclinical trials thousands of volunteers (30,000 to 45,000) that are randomized to receive the vaccine or a placebo.
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Putting It Together: Salk Vaccine On April 12,1955 Dr. Jonas Salk released the results of clinical trials for his vaccine to prevent polio. In these clinical trials, 400,000 children were randomly divided in two groups. The subjects in group 1 (the experimental group) were given the vaccine, while the subjects in group 2 (the control group) were given a placebo. Of the 200,000 children in the experimental group, 33 developed polio. Of the 200,000 children in the control group, 115 developed polio. (a) What type of experimental design is this? (b) What is the response variable? (c) What are the treatments? (d) What is a placebo? (e) Why is such a large number of subjects needed for this study? (f) Does it appear to be the case that the vaccine was effective?
Inferences on Two Samples
Inference about Two Population Proportions
Match each type of vaccine with the corresponding example. ___________inactivated vaccine ___________live attenuated vaccine ___________toxoid vaccine ___________subunit vaccine A. Weakened influenza virions that can only replicate in the slightly lower temperatures of the nasal passages are sprayed into the nose. They do not cause serious flu symptoms, but still produce an active infection that induces a protective adaptive immune response. B. Tetanus toxin molecules are harvested and chemically treated to render them harmless. They are then injected into a patient's arm. C. Influenza virus particles grown in chicken eggs are harvested and chemically treated to render them noninfectious. These immunogenic particles are then purified and packaged and administered as an injection. D. The gene for hepatitis B virus surface antigen is inserted into a yeast genome. The modified yeast is grown and the virus protein is produced, harvested, purified, and used in a vaccine.
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