[ad_1]
The vaccine for coronavirus disease 2019 (Covid-19) developed by Sinovac Biotech Ltd. (Sinovac) of China has approached a clinical trial in the country.
The Director General of the Food and Drug Administration (FDA), Rolando Enrique Domingo, confirmed that Sinovac has requested permission to test its CoronaVac vaccine here after passing the preselection of the Vaccine Expert Panel (VEP).
Domingo said Sinovac presented the panel with its phase one and two clinical data containing the vaccine’s safety profile and effects, as well as the study design, which had been reviewed by the VEP before being submitted to the FDA.
“In phase one and phase two trials of pong seen by the vaccine expert panel, the side effects were found to be mild, not serious at all, so they overcame them (The vaccine expert panel found that [Sinovac’s] the phase one and phase two trials had only mild side effects, nothing serious, that’s why it passed their scrutiny), ”Domingo said during a briefing on Thursday.
He said Sinovac has yet to submit other information, including the CoronaVac labeling and its proposed study design, to the FDA before moving on to a technical and regulatory review.
Sinovac will be reviewed by the Single Joint Research Ethics Board to ensure the safety of trial participants, Domingo said.
“Once those requirements are completed and they’ve already submitted approval, then they can get started (once they complete their requirements and we approve them, they can get started),” he said.
Once Sinovac completes your documentation, you could begin testing after a two to three week review.
The Undersecretary of Health, Maria Rosario Vergeire, said the VEP would also request additional evidence from Sinovac after the manufacturer’s phase three clinical trials demonstrated success in Brazil.
Vergeire also said the Health Department has begun informing local government units and communities about the trials to be conducted by the World Health Organization and independent vaccine manufacturers.
On Thursday, the country registered 1,664 new cases of Covid-19, bringing the total to 363,388 cases.
Recoveries amounted to 312,233 and the death toll rose to 6,783.
[ad_2]
