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A comprehensive review of 20 years of data, recently published in the Annals of Internal Medicine, finds that U.S. vaccines are remarkably safe, thanks in part to ongoing safety surveillance after a vaccine hits the market.

The authors reviewed all vaccines that were FDA-approved between 1 January 1996 and 31 December 2015. Over this 20-year period, there were 58 safety-related changes to labels in 25 vaccines. Three of these changes were the removal of prior warnings and precautions, while 55 involved the addition of safety information. The most common safety issues were allergies, mostly due to the packaging which contains latex. Only one vaccine was withdrawn for safety reasons – a rotavirus vaccine that was taken off the market because it was linked to bowel intussusception – a very rare condition.

Vaccines are, indeed, one of the greatest achievements in public health and are remarkably safe. The study confirmed that the process by which vaccines come to market and continue to be monitored afterwards is working. I will add that if you want to know what the world would look like without vaccines – we are living in it now. The current COVID-19 restrictions on our lives are just a taste of the way we would have to live all the time in the absence of vaccines. And, were it not for vaccines, each year we would be burying a larger percentage of our children than the population who succumb to COVID-19.

Unfortunately, the chimera virus of COVID-19, an animal coronavirus combined with RNA from the human HIV virus – creates unique challenges for vaccine developers. The speed with which the COVID-19 vaccine is needed, the challenges of developing a vaccine to combat an engineered virus and the unique effects of COVID-19 on the immune system combine to make the COVID-19 virus a different situation than any we have previously faced.

Read Dr. Carter’s recent post on COVID-19 vaccine development for more information.


Dr. Fife sees patients at the CHI St. Luke's Hospital Wound Clinic in The Woodlands, Texas. For an appointment call (936) 266-2150.



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