Responsible for ensuring safety-effectiveness of vaccines

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The Food and Drug Administration (FDA) is responsible for ensuring the safety and effectiveness of vaccines. The typical requirements before the FDA licenses a vaccine include: careful testing in clinical trials by the manufacturer; peer review; and final review by FDA scientists.

At the same time, the prevailing law in many states is that a vaccine manufacturer is not liable for harm caused by a non-defective product due to its inherent or unavoidable dangerousness. But this legal position has it limits; such as, what if the rush to approve the vaccine misses serious side effects like loss of smell, shortness of breath for asthma suffers, memory loss, racing heartbeats, joint pain and/or ineffective warning labels because the long term side effects are not well studied.

Assume that the principal manufacturers of a COVID-19 vaccine, such as Pfizer, Johnson & Johnson, and so forth, balk at actually releasing a vaccine to the public unless they are assured of absolute products liability protection whether under negligence or strict liability theories. They are fearful in a rush to bring a vaccine to the public in light of a second wave of the virus embracing the United States, Europe and other parts of the world that the manufacturers don't know all the potential side effects that may arise as suggested in the paragraph above.

Here are the three graded in-class questions for your consideration.

Should the federal government grant the manufacturers and sellers of a COVID-19 vaccine absolute immunity from any harm whether foreseeable or not?

Should the federal government mandate that young adults and college age students between 15 and 25 and all adults over 60 years of age must take a COVID-19 vaccine?

Should the vaccine be free for those who are mandated to take it?

Does the answer differ whether Biden or Trump is elected president?

Reference no: EM132691414

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