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FDA Limits Use of Johnson & Johnson COVID-19 Vaccine
In other COVID news, FDA approves Eli Lilly's COVID-19 treatment and Novavax submits variations to expand its vaccine approval in Australia and New Zealand.
FDA recently limited the authorized use of Johnson & Johnson's COVID-19 vaccine to include individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible or appropriate.
The agency based its decision on an updated analysis, evaluation, and investigation of reported cases, which found that the risk of thrombosis with thrombocytopenia (TTS) one to two weeks following administration of the vaccine warrants limited authorized use.
Therefore, FDA determined that the known and potential benefits of the vaccine to prevent COVID-19 outweighed the known and potential risks for adults.
Notably, the Fact Sheet for Healthcare Providers Administering Vaccines now reflects the revision of the vaccine and includes a warning statement at the beginning of the fact sheet for prominence that summarizes information on the risks for TTS.
"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," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in the announcement.
"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," Marks continued.
TTS is a syndrome of rare and potentially life-threatening blood clots combined with low levels of blood platelets with the onset of symptoms. In August 2021, a study found that AstraZeneca's COVID-19 vaccine was associated with TTS in 3/100,000 vaccinations with high fatality rates.
Researchers found that 20 COVID-19 deaths occurred in individuals under 60 years of age compared to 890 deaths over 60 years. And vaccine-related deaths ranged from 17 to 153 if 80% of adults 18–59 years were vaccinated.
FDA Approves Eli Lilly's COVID-19 Treatment, Olumiant
FDA recently approved Eli Lilly and Company's Olumiant to treat COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The agency based its approval on results from two randomized, double-blind, placebo-controlled Phase 3 studies, which found that Olumiant helped hospitalized COVID-19 adults and did not elicit any safety concerns.
FDA recommended 4 mg of Olumiant once daily for 14 days or until hospital discharge, whichever comes first.
"I'm encouraged by the FDA's full approval of OLUMIANT for the treatment of these patients based on results from the rigorous, placebo-controlled, double-blind, randomized trials. There’s still an urgent need for more options to help improve outcomes for patients hospitalized due to COVID-19," Andre Kalil, MD, MPH, professor of medicine at the University of Nebraska Medical Center and principal investigator of the Adaptive COVID-19 Treatment Trial 2 (ACTT-2), said in the announcement.
FDA first granted Olumiant emergency use authorization in November 2020, which will remain in place for hospitalized pediatric patients 2–17 years old who require various degrees of oxygen support.
Novavax Submits Variations to Expand Approval of COVID-19 Vaccine
Novavax recently submitted variations to the Australian Therapeutic Goods Agency (TGA) and the New Zealand Medicines and Medical Devices Safety Authority, Medsafe, to expand the provisional approval of its COVID-19 vaccine in adolescents aged 12–17 years.
TGA granted provisional approval for the vaccine in January 2022, while Medsafe granted provisional approval in February 2022.
Novavax requested provisional authorization based on pre-clinical, clinical, and manufacturing-related (CMC) data, including clinical data from the ongoing pediatric expansion of the Phase 3 trial.
The PREVENT-19 trial enrolled 2,247 adolescents aged 12 through 17 years across 73 sites in the US to evaluate the safety, effectiveness, and efficacy of Novavax's COVID-19 vaccine. Researchers found that the vaccine demonstrated 80% efficacy overall.
Additionally, preliminary safety data from the pediatric expansion of PREVENT-19 showed the vaccine to be generally well-tolerated.
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