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FDA, CDC Lift Pause of Johnson & Johnson’s COVID-19 Vaccine
The agencies determined that the known and potential benefits of the COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age or older.
FDA and the CDC recently lifted the pause of the Johnson & Johnson COVID-19 vaccine in the US following a thorough safety review, including two meetings of the CDC’s Advisory Committee of Immunization Practices.
The agencies stated that they are confident that the vaccine is safe and effective in preventing the coronavirus and determined that the use of the vaccine should continue throughout the country.
Overall, the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older, the agencies said.
Healthcare providers administering the vaccine should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, FDA stated.
Both of these documents have been revised to include information about the risks associated with thrombosis-thrombocytopenia syndrome.
At this time, the available data suggests that the chance of thrombosis-thrombocytopenia syndrome is very low. But both FDA and CDC will continue to investigate the risk to avoid future complications.
“We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement.
“We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality,” Woodcock continued.
In mid-April, CDC and FDA paused Johnson & Johnson’s COVID-19 vaccine after six reported cases of a severe and rare kind of blood clot in individuals who received the vaccine. At this time, over 6.8 million doses had been distributed across the country.
The blood clot, known as cerebral venous sinus thrombosis (CVST), was observed in combination with low levels of blood platelets among women between the ages of 18 and 48.
Generally, symptoms occurred six to 13 days after vaccination.
During the pause, medical and scientific teams at FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses and other sites in the body, including large blood vessels of the abdomen and the veins of the legs.
Additionally, the agencies examined thrombocytopenia or low blood platelet counts and conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events.
This allows for providers to recognize and properly manage blood clots and low platelets in individuals.
Most recently, CDC’s Independent Advisory Committee on Immunization Practices met to discuss the latest data on thrombosis- thrombocytopenia syndrome. The committee heard from Janssen and the COVID-19 Vaccine Safety Technical Subgroup. It also received a risk benefit analysis.
“Above all else, health and safety are at the forefront of our decisions. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully,” said CDC Director, Rochelle P. Walensky, MD.
“We will continue to watch all signals closely as more Americans are vaccinated. There is a growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death,” Walensky continued.
FDA issued an emergency use authorization for Johnson & Johnson’s COVID-19 vaccine at the beginning of March.
The agency based its decision on trial results, which showed that a single dose of the vaccine was 67 percent effective in preventing moderate-to-severe and critical coronavirus 14 days after vaccination. The vaccine was also 66 percent effective 28 days after vaccination.
Following the resumption of its vaccine in the US, Paul Stoffels, chief scientific officer of Johnson & Johnson, said in a statement that the company believes its single-shot, easily transportable COVID-19 vaccine has demonstrated protection against multiple variants and can help protect the health and safety of people everywhere.
“We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively,” Stoffels concluded.
