FDA Lifts Pause On Johnson & Johnson's COVID-19 Vaccine

(RTTNews) - The U.S. Food and Drug Administration lifted the pause and will now allow to resume vaccinations with Johnson & Johnson's single-shot COVID-19 vaccine following a thorough safety review by health regulators.

The FDA in mid-April temporarily halted the usage of the vaccine after six recipients developed a rare blood clotting disorder following the administration of more than 6.8 million doses.

All six recipients who developed the rare blood clotting disorder were women aged between 18 and 48. All of them developed the symptoms within one to three weeks of vaccination. One woman died and a second woman in Nebraska is in critical condition. The United States Centers for Disease Control (CDC) and the FDA's decision to resume the vaccination for all adults aged 18 years and older in the U.S., under Emergency Use Authorization, is based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP).

The ACIP conducted rigorous evaluation of data relating to a very rare adverse event involving blood clots in combination with low platelet counts. However, the agency will issue a fact sheet to medical providers warning them of the potential for extremely rare but serious blood clots. The FDA and CDC have confidence that the vaccine is safe and effective in preventing COVID-19.

The FDA has determined that the available data show that the vaccine's known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

At this time, the available data suggest that the chance of thrombocytopenia syndrome occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk, the regulators said.

Last Tuesday, European Medicines Agency said it found a possible link between the Johnson & Johnson's Covid-19 vaccine and rare blood clots. However, the Europe's medicines regulator pointed out that the overall benefits of getting the vaccine outweigh the risks.

The Johnson & Johnson COVID-19 Vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, received emergency use authorization from the FDA on February 27, 2021, to prevent COVID-19 in individuals 18 years of age and older.

The decision was based in part on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 66.1 percent effective in preventing moderate to severe/critical disease and 85 percent effective in preventing severe/critical disease across all regions studied, 28 days post-vaccination. The vaccine showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.