Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as effectiveness, and it has often been used synonymously, although in pharmacology a distinction is now often made between efficacy and effectiveness. Efficacy can be defined as the performance of an intervention under ideal and controlled circumstances, whereas effectiveness refers to its performance under ‘real-world’ conditions.
Adequate testing of any new drug is mandatory. What are the side effects and how likely are they to occur?
Pulled from the market in 1961, thalidomide caused approximately 10,000 children to be born with deformed limbs, brain defects, or other developmental deformities. In July of 1962, president John F. Kennedy and the American press began praising their heroine, FDA inspector Frances Kelsey, who prevented the drug’s approval within the United States despite pressure from the pharmaceutical company and FDA supervisors. Kelsey felt the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness. Among her concerns was the lack of data indicating whether the drug could cross the placenta, which provides nourishment to a developing fetus. While thalidomide is not a vaccine the message seems obvious to me.
My own wife started taking Tumeric on advise from her doctor to ease her arthritis pain. The non-prescription drug is advertised as a potent anti-inflammatory and antioxidant and may also help improve symptoms of depression and arthritis. The doctor did not warn her about any side effects. But there are some: stomach upset, nausea, dizziness, or diarrhea. She suffered from diarrhea even after she stopped taking the medication for four months. That led to her having a colonoscopy that found nothing but an irritation to her colon.
Pascal Soriot, CEO of AstraZeneca, confirmed to Bloomberg on Thursday the British pharmaceutical giant was likely to run an additional global trial to evaluate the efficacy of its Covid-19 vaccine.
In our rush to obtain a vaccine for Covid-19 (Warp Speed) will side effects be known? Side effects may not be known for many months. We may want the vaccination but I will be standing at the back of the line.
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