New Delhi: The US Food and Drug Administration (FDA) has put a hold on Inovio, a Pennsylvania-based pharmaceutical company’s plans to start phase-2 and phase-3 clinical trials of its vaccine against the novel coronavirus. Notably, the US health regulator has raised questions over the technology the company was using to deliver the vaccine inside human body. Also Read - Israel to start human trials of COVID vaccine on Nov 1
Inovio has asserted that it would respond to FDA’s queries in October, after which the regulatory body, within 30 days, have to decide if the final trial should proceed. Also Read - Spain Declares Nationwide State of Emergency to Curb Second Wave of Coronavirus
“This partial clinical hold is not due to the occurrence of any adverse events related to INOVIO’s ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA’s notification”, the company reportedly said in a statement. Also Read - Pandemic Casts Shadow over Dussehra Festivities in India, Covid Effigies Become New Addition | See Visuals
Furthermore, it stated, “In addition, this partial clinical hold does not impact the advancement of INOVIO’s other product candidates in development. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA’s partial clinical hold and subject to the receipt of external funding to conduct the trial.”
Meanwhile, the overall number of global coronavirus has surpassed 33.2 million, while the deaths have increased to more than 1,000,820, according to the Johns Hopkins University. As of Tuesday, the total number of cases stood at 33,273,720 and the fatalities rose to 1,000,825.