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Explain the difference between FDA full approval and (EUA) Emergency Use Authorization for a vaccine.

December 28, 2022
Christopher R. Teeple

Required Reading

https://crsreports.congress.gov/product/pdf/R/R46745

Suggested Reading

https://jamanetwork.com/journals/jama/fullarticle/2781010

Please answer parts a,b,c,d below.

You are to assume that COVID is at pandemic levels and the CDC has rated the risk of COVID as VERY HIGH in your state.

A group of teachers (and the teachers’ union) approached the Mayor demanding that students in public schools (including elementary middle and High schools) have at least one COVID shot before being allowed to attend public schools in the city. They argue that they put themselves and their families at risk every day that they come to work and they deserve to be protected to the extent possible. Teachers also report that the children have a very hard time keeping their masks on in a proper fashion..and certainly not during lunch.

The City’s School Board has expressed concern for the children given that there have been recent reports of young children getting very sick with COVID something we had not seen previously with this epidemic.

Assume for the purpose of answering this exam that the FDA has given full FDA approval for a COVID vaccine for children 16 -18 and FDA Emergency Use Authorization (EAU) remains in place for children 5-15.
A voting member of a Food and Drug Administration (FDA) advisory committee admitted that whether or not the vaccine is safe for 5 to 11-year-old children won’t be known fully until its widely administered over an extended period of time.

Citing Justice Harlan’s language in the Jacobson v Mass case, the Mayor implemented a vaccine mandate noting that the city had the authority to compel students to receive the COVID vaccine if they wanted to attend the city’s public schools.

The Mayor’s mandate is simple: All elementary school children must take the COVID vaccine in order to be admitted to any public school in the city. No exceptions.

An anti-vaxer parent argued to the Mayor that the new law violated her daughter’s 14th Amendment right to due process.

A parent argued that the law discriminated against her child because they could not afford to avoid the law by sending their child to private school.

A religious sect argued that the new law violated their children’s religious freedom.

A mother of an autistic child argued that any vaccine would be harmful medically to her child.

(a) Explain the difference between FDA full approval and (EUA) Emergency Use Authorization for a vaccine. Be sure to include how suing for damages (if injured by the vaccine) differs for an FDA fully approved vaccine from a COVID countermeasure EUA approved vaccine.

(b) Analyze the Mayor’s proposed vaccine school mandate using Jacobson v Commonwealth of Mass . Cite to specific language in the Jacobson decision to support the Mayor’s proposal.

(c) Cite to specific language in the Jacobson decision that you think can be used to defeat the mandate as unconstitutional. What could be added to the proposal to make it meet constitutional requirements.

(d) How would your answers to (b) and (c) differ if the Mayor’s mandate was to apply to college students instead of elementary school children.

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