The COVID vaccine – 19 of Johnson & Johnson will have to be updated with a blood clot risk warning because the benefits outweigh the risks
Photo: PHILL MAGAKOE / AFP / Getty Images
Monday, November 18
CDC and FDA end Johnson & Johnson vaccine pause, states can now use it again
The Centers for Disease Control and Prevention (CDC and the Food and Drug Administration (FDA) lifted the recommended pause on the use of Johnson & Johnson’s coronavirus vaccine on Friday and they said that the label will be updated to warn of the risks of blood clots.
Agencies acted quickly after a vote of the CDC Advisory Committee on Immunization Practices recommended lifting the pause.
“We have concluded that the known and potential benefits of the Janssen COVID vaccine – 18 exceed their known and potential risks in people of 18 years of age or older, ”he said. in a comunity or the c Missed from FDA role, Dr. Janet Woodcock.
“We are confident that this vaccine continues to meet our standards for safety, efficacy and quality. We encourage people with questions about which vaccine is right for them to discuss with their healthcare provider. ”
The regulatory body’s decision comes shortly after an advisory committee of the Centers for Disease Control and Prevention (CDC, in English) advise this Friday suspend the pause and resume this vaccine, adding a warning about possible risks.
Single Dose Covid Vaccine – 19 by Johnson & Johnson is considered very convenient to get them to hard-to-reach places that may not have reliable cooling, such as tribal lands, poorer neighborhoods, and rural communities, as well as to people who may not be able to come back for a second dose, as assessed by U.S. health officials.
The two agencies have determined the following:
– The use of the COVID vaccine should be resumed – 19 of Johnson & Johnson in the United States
– FDA and CDC are confident that this vaccine is safe and effective in preventing COVID – 19
– The FDA has determined that available data shows that the known and potential benefits of the vaccine outweigh its known and potential risks in people older than 18 years.
– At this time, available data suggests that the likelihood of dangerous blood clots occurring is very low, but the FDA and CDC will remain vigilant to continue investigating this risk.
All cases reviewed by the expert panel of the Centers for Disease Control and Prevention (CDC), were women, including three who died and seven who remain in the hospital.
“Above all, health and safety are at the forefront of our decisions”, said Dr. Rochelle P. Walensky, Director of the CDC. “Our vaccine safety systems are working. We identified exceptionally rare events, out of millions of doses of Janssen COVID – 19 administered, and we stopped to examine them more closely. As we always do, we will continue to watch closely for all the signs as more Americans are vaccinated. ”
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