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One COVID-19 vaccine gets FDA restriction

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WASHINGTON, D.C. -- A restriction is in place today by the federal government to limit U.S. usage of one vaccine against coronavirus.

The U.S. Food and Drug Administration (FDA) is limiting authorized use of the Janssen COVID-19 vaccine to adults only whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to adults who choose the Janssen COVID-19 vaccine because its their only COVID-19 vaccine option.

The restriction is in effect today after the FDA took action yesterday to limit the Janssen COVID-19 vaccine.

It says it issued the limitation after an updated analysis, evaluation and investigation of reported cases showed the FDA the risk of thrombosis with thrombocytopenia syndrome (TTS).  FDA says the, "syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine."

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FDA says benefits of the vaccine for prevention of COVID-19 outweigh its risks for people 18 years of age and older for whom Janssen COVID-19 vaccine is their only viable COVID-19 vaccine option.

FDA's Fact Sheet for Healthcare Providers Administering Vaccine reflects its revised Janssen COVID-19 vaccine usage authorization with a warning at the start of the fact sheet to note the risk for TTS.  FDA says information about its revised Janssen COVID-19 vaccine usage authorization and updated information about blood clots risks with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers

FDA’s Center for Biologics Evaluation and Research Director Dr. Peter Marks says, "We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals."

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The Janssen COVID-19 vaccine was authorized for emergency use February 27, 2021, and 45 days later on April 13, 2021, the FDA and the Centers for Disease Control and Prevention (CDC) announced a recommended pause in administration of the vaccine to investigate six reported cases of TTS and to help ensure health care providers were made aware of the potential for TTS to plan for proper recognition and management due to unique treatment required for TTS.  

On April 23, 2021, the FDA and CDC lifted the recommended pause regarding Janssen COVID-19 vaccine usage. FDA says, "The agencies confirmed a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS), including the original six reported cases, out of approximately 8 million doses administered."

FDA says at that time the data helped FDA’s assessment that Janssen COVID-19 vaccine benefits outweighed its known and potential risks for adults.

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In December 2021 the CDC’s Advisory Committee on Immunization Practices (ACIP) made "a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine for adults in the United States. The ACIP recommended and CDC endorsed that the Janssen COVID-19 vaccine may be considered in some situations: when a person has a contraindication to receipt of mRNA COVID-19 vaccines, when a person would otherwise remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines, and when a person wants to receive the Janssen COVID-19 Vaccine despite the safety concerns identified."

The FDA says with the CDC they "have continuously monitored for and investigated all suspected cases of TTS reported to VAERS. In an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered."

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FDA says in its decision to limit authorized use of the Janssen COVID-19 vaccine the agency considered that reporting rates of TTS and TTS deaths following administration of the Janssen COVID-19 vaccine are not appreciably lower than previously reported, and "Furthermore, the factors that put an individual at risk for TTS following administration of Janssen COVID-19 Vaccine remain unknown."

This week's revised Emergency Use Authorization for the Janssen COVID-19 vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.

Marks says FDA's action, "demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information."

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