Johnson & Johnson Seeks FDA Authorization For COVID-19 Vaccine Booster Shots
On Tuesday, Johnson & Johnson petitioned the U.S. Food and Drug Administration (FDA) to authorize a booster shot of its COVID-19 vaccine.
J&J had previously revealed an internal study Monday that showed a second shot administered two months after the first shot improved immunity against symptomatic moderate to severe symptoms to COVID to 94 percent.
“A booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94 percent,” said Mathai Mammen, who’s in charge of the global R&D division at J&J’s Janssen. “At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”
As the pharmaceutical company submitted its petition, the FDA’s independent vaccine advisory committee is set to meet on Oct. 15 to discuss whether to recommend the booster shot from J&J to the federal agency.
J&J’s single-dose vaccine has experienced several problems since FDA gave the Emergency Use Authorization to the company.
In April, the J&J vaccine was paused over rare blood clotting symptoms shown by dozens of women who got the single shot. The production was also disrupted for months due to the mistakes made by the Baltimore manufacturing plant.
On Tuesday, the Public Health Insider reported that another woman in her late 30s died from blood clotting symptoms last month after she was given a J&J shot.
“We at Public Health are saddened by this loss and offer condolences to the woman’s family and loved ones. The resident received her vaccination on August 26, 2021 and died on September 7, 2021. Her cause of death was determined to be thrombosis with thrombocytopenia syndrome (TTS), a condition that has been identified as a rare but potentially serious adverse event in people who received the J&J vaccine. The diagnosis was confirmed by the CDC’s Clinical Immunization Safety Assessment Project,” the statement read.