FDA and CDC Call for a Pause in Johnson & Johnson Covid-19 Vaccine

  • By cvbizz
  • April 13, 2021
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The FDA and CDC issued a joint statement calling for a pause in Johnson & Johnson Vaccinations while a rare blood clotting side effect was examined.

“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance,” the joint press release says. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” the press release says. “People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.”

Joint Media Call: FDA & CDC to Discuss Janssen COVID-19 Vaccine

Statement From South Carolina DHEC

The South Carolina Department of Health and Environmental Control (DHEC) released the following statement concerning this morning’s federal announcement about the Janssen vaccine, also referred to as the Johnson & Johnson vaccine:  

South Carolina public health officials received word this morning, like many throughout the nation and the state, that the CDC and FDA have recommended immediately pausing use of the Janssen vaccine due to concerns with blood clotting. Our top priority is protecting the health and safety of the public. This pause is evidence of very close safety monitoring as part of the strict quality assurance that is in place to ensure patient safety.  

DHEC has placed an immediate pause on our Janssen distribution and has contacted providers to alert them of this new development. In addition, we are currently in the process of rescheduling or changing planned vaccine types for events that were going to use Janssen.  

We recognize that this will impact our current supply of vaccines across the state and are awaiting to hear more information from the federal government. South Carolina, like most states, had been receiving a small amount of Janssen vaccine from the federal government — about 7,000 doses a week — compared to the more than 40,000 doses each of Pfizer and Moderna we receive each week. Because of this, the pause on Janssen vaccine is less of an impact in our state than we would experience if a pause occurred on Pfizer or Moderna vaccines. Millions of people in the United States have received doses of vaccines with very little side effects.  

We continue to encourage South Carolinians to get vaccinated against COVID-19 in order to best protect yourself and others and will keep everyone updated as we learn more about the Janssen vaccine.

Georgia Has Already Paused J&J Vaccinations

Recently the Georgia Department of Public Health paused administration of the Johnson & Johnson vaccine at the Cumming Fairgrounds “out of an abundance of caution” after eight people experienced adverse reactions. One person was evaluated at a hospital and released. The others were monitored on site and then sent home.

“The reactions were consistent with common reactions in adults being vaccinated with any vaccine, but due to the number of individuals affected, the site stopped the J&J vaccinations to evaluate,” the Georgia Department of Public Health says. “There were 425 J&J vaccines administered at the site [last] Wednesday, and tens of thousands of J&J doses have been given statewide with no adverse reactions.”

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