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Articles on FDA approval

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Research suggests that about 20% of all prescriptions are administered “off-label.” Hafakot/iStock via Getty Images Plus

Off-label’ use is common in medicine – a bioethicist and legal philosopher explain why the COVID-19 vaccines are different

The CDC’s COVID-19 vaccine provider agreement prohibits health care professionals from administering the vaccines in people for whom they are not yet authorized or approved. But this departs from longstanding norms.
Carter Giglio, 8, joined by service dog Barney of Hero Dogs, shows off the bandage over his injection site after being vaccinated at Children’s National Hospital in Washington. (AP Photo/Carolyn Kaster)

I’m an infectious disease doctor. Yes, I’m vaccinating our 5-year-old against COVID-19. Here is why you should too.

An infectious diseases doctor reviews the evidence, discusses hesitancy and concerns about side-effects and explains the overwhelming case for vaccinating five-to-11-year-olds, including his own son.
Ethics are important to vaccination decisions because while science can clarify some of the costs and benefits, it cannot tell us which costs and benefits matter most to us. THE CANADIAN PRESS/Frank Gunn

Ethical decisions: Weighing risks and benefits of approving COVID-19 vaccination in children ages 5-11

When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on sound ethics as well as sound science.
Pregnancy poses significant risks for severe illness or death from COVID-19, for both mother and baby. ArtMarie/E+ via Getty Images

Vaccination against COVID-19 supports a healthy pregnancy by protecting both mother and child – an immunologist explains the maternal immune response

In light of mounting research showing the serious risks of contracting COVID-19 during pregnancy, the CDC is re-upping its urgency that pregnant women get their shots.
Protesters gather at Indiana University in June 2021 to demonstrate against mandatory COVID-19 vaccinations for students, staff and faculty. SOPA Images/LightRocket via Getty Images

Forceful vaccine messages backfire with holdouts – how can it be done better?

Subtly shifting the crafting and delivery of public health messaging on COVID-19 vaccines could go a long way toward persuading many of the unvaccinated to get the shot.
FDA approval of Pfizer’s COVID-19 vaccine may boost vaccination rates among those who have been hesitant to get the shot. (AP Photo/Jessica Hill)

Pfizer’s COVID-19 vaccine now has full FDA approval. Here’s what that means for unvaccinated people, organizations and pharma

The U.S. FDA has approved the first COVID-19 vaccine. How is approval different from emergency use authorization, and what difference will it make to a vaccine that’s already in global use?

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