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MANILA, Philippines – If everything goes according to schedule, the Food and Drug Administration (FDA) said that a COVID-19 vaccine could be available in the country starting in April next year.
But FDA Director General Eric Domingo noted that this schedule is totally dependent on manufacturers being able to complete clinical trials and analysis of their vaccine results this year and promptly submitting the requirements for evaluation and registration. of the product.
“As soon as possible, we believe [they] it could complete its phase 3 clinical trials in December. That means that there is a possibility that by the end of the year or towards the first quarter of next year, we will already have registrants, ”Domingo told reporters on Friday.
Once the clinical data and registration requirements are submitted to the FDA, it will take 45-60 days for the agency to process the registration.
Domingo said only applications from those who have completed their Phase 3 trials and have complete documents and records will be processed.
“If clinical trials are completed by December or January, and a company submits an application to the FDA, it is possible that by April 2021 we will have an approved vaccine,” Domingo said.
For more news on the new coronavirus, click here.
What you need to know about the coronavirus.
For more information on COVID-19, call the DOH hotline: (02) 86517800 local 1149/1150.
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