“Our actions reflect our updated risk analysis [thrombosis with thrombocytopenia syndrome] “After the introduction of this vaccine and the restriction of the use of the vaccine to certain individuals,” – said Peter Marx, Director of the FDA Center for Biological Assessment and Research. The statement reads. “We recognize that Jansen’s COVID-19 vaccine still plays a role in the ongoing pandemic response in the United States and throughout the global community. The agency will continue to monitor the safety of Jansen COVID-19 vaccine and all other vaccines.”
A statement from Johnson & Johnson said they would continue to work with regulators around the world to ensure consumers are “alerted and fully informed about TTS reports”.
“The Johnson & Johnson COVID-19 vaccine plays a crucial role in the global battle to end the COVID-19 pandemic,” J&J said. “The company continues to focus its efforts on ensuring that its vaccine is available during a pandemic where people need it most.”
Wallpaper: Updated figures from March 18 through the Vaccine Adverse Event Reporting System show that 60 people developed TTS Johnson & Johnson after receiving a stroke, nine of whom died. The updated TTS rates are similar to the previous rates; The FDA said in December that about 15 percent of TTS cases were fatal after J&J vaccination.
The FDA and the Centers for Disease Control and Prevention were unable to determine the risk factors for developing TTS, although the highest reporting rates were observed in women aged 30 to 49 years.
What does it mean: A former FDA official, who spoke on condition of anonymity because he was not authorized to speak to the media, said the agency’s renewed authorization of the J&J vaccine “puts it in third place” compared to other products available to US adults.
Although the CDC Independent Vaccine Advisory Panel made a preferential recommendation on mRNA vaccines over the J&J product in December, an FDA update substantially fixed this advantage on the vaccine label.
An administration official, speaking on condition of anonymity because he was not authorized to speak to the FDA, said that if mRNA vaccines were not available, the J&J risk-benefit profile would justify its existence in the market. The FDA Emergency Authorization Standard allows the agency to allow targeted marketing of medical treatment when “there are no adequate, approved, and affordable alternatives” to a public health emergency.
“If there were no mRNA vaccines, it would still be a very effective option. “It can save lives,” said a spokesman for the administration. “But in places where there is an abundance of mRNA vaccines, such as the US, the risk-benefit profile is changing because there are other options. I think you have to look globally where it is not. ”
TTS is a rare side effect, but the condition can be soothing and life-threatening, said Walid Gelad, director of the Center for Pharmaceutical Policy and Subscription at the University of Pittsburgh.
“This is a fact of how serious the side effects are – not that it is very common in any form,” he said.
Რa is the following: The J&J Covid-19 vaccine will remain available for those who have developed a severe allergic reaction to the mRNA vaccine, for those who do not have access to the mRNA vaccine, and for those who do not wish to receive the mRNA vaccine and otherwise remain unvaccinated.
J&J has not yet received an application for a full license for its vaccine in the US, and a former FDA official has suggested that the product will receive even greater scrutiny if it moves forward with the application.
The vaccine is an “area of opportunity,” said the former official. Recent restrictions may prevent full approval, but the vaccine may also receive approval with restrictions or monitoring requirements. The FDA may instruct J&J to better detect subpopulations that may be prone to blood clots, they said.
The renewed authorization will not remove the J&J vaccine from the market, the former official said, meaning the FDA still sees benefits in making it available to Americans.
“But given the risks here, they say people should consider other options before approaching this option,” they said.
David Lim contributed to this report.
The FDA severely restricts the use of the Johnson & Johnson Covid-19 vaccine
Source link The FDA severely restricts the use of the Johnson & Johnson Covid-19 vaccine