NEXT year, all vaccines against coronavirus disease (COVID-19) may have full approval and will be made available in the market.
Food and Drug Administration (FDA) Director General Eric Domingo said He said most of the clinical trials of COVID-19 vaccines are set to be completed by this year. Completed clinical trials will enable drug makers to apply for full authorization.
“My prediction is by early next year, by the first quarter, not only Pfizer, but maybe several of the existing vaccines, will get full approval for marketing authorization,” said Domingo in a TV interview.
Vaccines being used by the Philippines have been issued only emergency use authorization (EAU). These are Pfizer-BioNTech, AstraZeneca, Sinovac, Sputnik V, Janssen, Bharat Biotech, Moderna, Sinopharm, and Novavax. All except Janssen are given in two doses.
Domingo expressed hope the vaccines will be made commercially available next year.
“Once they consolidate all of that data, most of these vaccines will probably start applying, not just in Philippine FDA, but in other FDAs all over the world,” he said.
Pfizer is the first COVID-19 vaccine to get full approval from the United States FDA. It was given last August.
Domingo said Pfizer is still completing requirements for full authorization.
“They haven’t applied yet. It’s probably because the company is not yet ready to supply. It is likely that they want to concentrate in one market at this time,” said Domingo.
Domingo also said Merck & Co Inc (MSD) has applied for EUA for its antiviral drug, Molnupiravir, to be used to treat COVID-19.
He said the US-based firm filed its application last week and is currently being evaluated.
Molnupiravir is not yet commercially available in the country. However, 31 hospitals have been granted compassionate special permit (CSP) for it by the FDA.
The first shipment of Molnupiravir arrived in the country through a partnership between MedEthix, one of the country’s major pharmaceutical importers and distributors, and JackPharma, a pharmaceutical distribution company. MedEthix is a member of the Ayala Healthcare Holdings, Inc. (AC Health), the healthcare arm of the Ayala Group.
The National Task Force against COVID-19 the country is set to receive 609,000 doses of government-procured Pfizer vaccines and another 609,000 doses today. — With Jocelyn Montemayor
