Research suggests that about 20% of all prescriptions are administered “off-label.”
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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.
Nearly 80% of participants in FDA-reviewed research trials live in foreign countries.
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Regulatory loopholes for research conducted off US soil allow for questionable trials and misleading data to slip under the FDA’s radar.
A new study suggests the market alone will not deter or punish pharmaceutical companies whose products turn out to have adverse effects after they have been approved.
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.
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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.
Regulators are currently reviewing the safety and efficacy data of the Pfizer vaccine for five to 11 year olds before deciding whether to approve its use in this age group.
Ceci n'est pas un Magritte.
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Three tobacco-flavored cartridges and a vaping device have been approved by the FDA for sale in the US. It comes after a decadelong debate over e-cigarettes.
Pregnancy poses significant risks for severe illness or death from COVID-19, for both mother and baby.
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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.
No third dose for now.
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An FDA panel has voted against recommending approval of a booster COVID-19 shot for the general population – disappointing some public health officials.
Protesters gather at Indiana University in June 2021 to demonstrate against mandatory COVID-19 vaccinations for students, staff and faculty.
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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.
Rapid antigen COVID-19 tests, designed for use at home, can show results in 15 minutes.
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Making rapid antigen tests for COVID-19 cheaper and more accessible can catch the infectious cases before they spread and help everyone resume normal activities safely.
COVID-19 vaccines have been proved safe and effective. But it’s understandable to have questions.
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An infectious disease doctor explains the science behind COVID-19 vaccines at a level that children – and adults – of all ages can understand.
FDA approval of Pfizer’s COVID-19 vaccine may boost vaccination rates among those who have been hesitant to get the shot.
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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?
More than half of Americans regularly take supplements.
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The FDA has largely lost its ability to regulate the myriad pills, powders and potions that promise to grow muscle, shed body fat and improve your focus.
Full FDA approval of the COVID-19 vaccines may help people feel more secure in its safety and effectiveness.
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While emergency use authorization gets vaccines out to the public more quickly, it doesn’t skip any steps that full approval requires.
Ticks can carry bacteria that cause Lyme disease.
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Researchers are testing an antibody shot to protect people from Lyme disease-causing bacteria.
Put into context, the benefits of vaccination still far outweigh the risks of rare adverse events.
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Ongoing tracking is meant to spot very rare risks – like the connection between the Johnson & Johnson shot and Guillain-Barré syndrome. And it relies on public reporting.
Alzheimer’s disease is characterized by progressive memory loss, spatial disorientation and many other cognitive and behavioural disorders that ultimately lead to a state of total dependence.
The new drug is based on the idea that a build-up of amyloid in the brain leads to the disease. But that hypothesis has been under scrutiny lately.
Do the benefits of approving a drug before confirming it works outweigh the potential costs?
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The FDA approved Alzheimer’s disease drug aducanumab despite minimal evidence of its efficacy. Whether this decision ultimately hurts or helps patients depends on data researchers don’t yet have.
Exterior of the Pfizer World headquarters building. Pfizer produced the first COVID-19 vaccine to gain emergency use authorization.
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The FDA receives almost half its funding from companies it regulates, such as drug and medical device makers. Is this something you should be concerned about?
Most children don’t get severely ill from COVID-19, but they can still spread the virus.
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With a third of adults saying they likely won’t get the vaccine, the US has a herd immunity math problem.