Credit to Author: Red Mendoza| Date: Fri, 20 Nov 2020 16:20:43 +0000
Another pharmaceutical firm wants to do clinical trials in the Philippines for the coronavirus disease 2019 (Covid-19) vaccine it is developing.
The British drug company AstraZeneca is the fifth vaccine developer to signify its intention to try out its drug locally.
It has informed both Vaccine Czar and National Task Force Covid-19 Chief Implementer Carlito Galvez Jr. and Health Undersecretary Maria Rosario Vergeire of its intention.
Vergeire said on Friday the entry of AstraZeneca was welcome since the Philippine government wants to test as many vaccine candidates as possible.
AstraZeneca’s vaccine, developed together with the University of Oxford, is waiting for the results of its late-stage phase three clinical trials to be released next month.
Phase two results published in the medical journal The Lancet indicated that the vaccine has shown tolerance and produced an immune response among volunteers aged 56 and above.
Already applying for clinical trials in the country are Sinovac Biotech Co. Ltd. of China, Gamaleya Research Institute of Russia, Clover Biopharmaceuticals also of China, and Johnson & Johnson-Janssen Pharmaceutica of the United States.
Food and Drug Administration (FDA) Director General Rolando Enrique Domingo said Sinovac needs only to submit a few more documents before the FDA and the joint ethics board can review its application.
Once the Vaccine Expert Panel endorses Sinovac’s phase one and two data, the FDA is ready to evaluate its application, Domingo said.
With President Rodrigo Duterte approving an executive order approving an Emergency Use Authorization (EUA) for a candidate vaccine, the FDA expects a vaccine may be acquired by the country by the second quarter of 2021.
Other vaccine manufacturers such as Pfizer and Moderna also aim to register their vaccines under an EUA with US regulators by December.
Once an EUA from the US is acquired, “we would be able to take a look at evaluations of mature and reliable regulatory agencies, that would hasten the process of making them available here,” Domingo said.
Vaccines and other therapeutic medicines that had been given Emergency Use Listing by the World Health Organization (WHO), or an equivalent EUA from a “mature” national health regulation agency such as the US FDA or the European Medicines Agency may be given an EUA in the country, he said.
Once the executive order is released, the FDA will issue the guidelines for vaccine manu-facturers on applying for a Philippine EUA.
Also on Friday, the Department of Health (DoH) said it would follow the WHO recommendation against the use of the antiviral drug remdesivir for treating Covid-19.
According to WHO’s Guideline Development Group Panel and published in The British Medical Journal, there is “currently no evidence” that remdesivir “improves survival or the need for ventilation.”
It based its recommendation on a new evidence review that compared the effects of treatments for Covid-19, which included four random trials involving 7,000 patients.
The review concluded that the antiviral drug, which is manufactured by Gilead, had “no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement.”
Remdesivir was included in WHO’s Solidarity Trial for Therapeutics, which aims to find a cure for the viral disease, together with the discontinued drugs hydroxychloroquine, lopinavir and ritonavir, and the still-on-trial drugs interferon-1a beta and acalabrutinib.
Vergeire said the department will abide by WHO’s recommendation since the country is part of the Solidarity Trial.
She said WHO has recommended continuing the trials for the drug for those patients who have been recruited for the trials to add more numbers of individuals to be studied to come up with a more accurate finding.