NASSAU, BAHAMAS — The United States Food and Drug Administration (FDA) yesterday limited the use of Johnson and Johnson’s COVID-19 vaccine as a “last resort” for adults who cannot accept a shot from another vaccine manufacturer.
The decision comes after the agency completed an updated risk analysis of developing thrombosis with thrombocytopenia syndrome, a very rare and possibly fatal combination of blood clotting one to two weeks after receiving the jab.
While the FDA said the potential benefits of the vaccine still outweigh the risks, the agency noted that it has restricted the use of the J&J vaccines to individuals 18 and older; those medically ineligible for another approved vaccine, as well as those who only have access to the J&J vaccine and wish to take it.
Researchers with the FDA and Centers for Disease Control and Prevention determined that the J&J vaccine resulted in 60 confirmed cases of thrombosis with thrombocytopenia syndrome.
Nine of those cases died.
With a range of approved vaccines available in the US and The Bahamas, the FDA recommended only using Johnson and Johnson when other options were unavailable.
It remains unclear whether The Bahamas has supplies of the J&J vaccines; however, the brand of COVID-19 vaccine was being administered as a booster jab in recent months.
“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,” FDA’s Center for Biologics Evaluation and Research Director Peter Marks said in a statement.
“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.
He continued: “Today’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.
Marks said the agency will continue to thoroughly evaluate and monitor the safety of the J&J vaccine and all other vaccines, as it has done throughout the pandemic.
The J&J vaccine was approved for emergency use in February 2021.
On April 13, 2021, the FDA announced a recommended pause of the administration of the vaccine to investigate six reported cases of TTS and to help ensure that healthcare providers were made aware of the potential risk and could plan for “proper recognition and management due to the unique treatment required for TTS”.
Following a safety evaluation, the FDA and CDC lifted the recommended pause of the administration of the vaccine on April 23.
Last December, Minister of Health Dr Michael Darville said the government and its National COVID-19 Vaccine Consultative Committee are more than satisfied with the use and efficacy of its supplies of Johnson & Johnson vaccines.
At the time, the CDC expressed a preference for alternative mRNA COVID-19 vaccines.
As of the end of April, The Bahamas had administered a total of 342,304 vaccine doses, with more than 165,000 people fully vaccinated.
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