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Another pharmaceutical company wants to conduct clinical trials in the Philippines for the coronavirus disease 2019 (Covid-19) vaccine it is developing.
British pharmaceutical company AstraZeneca is the fifth vaccine developer to express its intention to test its drug locally.
He has informed both the Vaccine Czar and the Chief Implementer of the Covid-19 National Working Group, Carlito Gálvez Jr., and the Undersecretary of Health, María Rosario Vergeire, of his intention.
Vergeire said Friday that AstraZeneca’s entry was welcome as the Philippine government wants to test as many vaccine candidates as possible.
The AstraZeneca vaccine, developed in conjunction with the University of Oxford, is waiting for the results of its final phase phase three clinical trials to be released next month.
Phase two results published in The Lancet medical journal indicated that the vaccine has shown tolerance and produced an immune response among volunteers aged 56 and over.
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 are already requesting clinical trials in the country.
The CEO of the Food and Drug Administration (FDA), Rolando Enrique Domingo, said that Sinovac only needs to submit a few more documents before the FDA and the joint ethics board can review his application.
Once the Vaccine Expert Panel backs up Sinovac’s phase one and two data, the FDA is ready to evaluate its application, Domingo said.
With President Rodrigo Duterte passing an executive order approving an Emergency Use Authorization (EUA) for a candidate vaccine, the FDA expects the country to be able to procure a vaccine 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 a US is acquired from the US, “We could take a look at the assessments from mature and reliable regulatory agencies, which would speed up the process of making them available here,” said Domingo.
Vaccines and other therapeutic drugs that have received an emergency use list from the World Health Organization (WHO), or an equivalent EUA from a “mature” national health regulatory agency, such as the US FDA. OR the European Medicines Agency, can receive an EUA in the country, he said.
Once the executive order is published, the FDA will issue the guidelines for vaccine manufacturers to apply for a Philippine EUA.
Also on Friday, the Department of Health (DoH) said it would follow the WHO recommendation against using the antiviral drug remdesivir to treat Covid-19.
According to the WHO Guidelines Development Group Panel and published in The British Medical Journal, “there is currently no evidence” that remdesivir “improves survival or the need for ventilation.”
He based his recommendation on a new evidence review comparing the effects of treatments for Covid-19, which included four randomized trials with 7,000 patients.
The review concluded that the antiviral drug, manufactured by Gilead, “had no significant effect on mortality or other important patient outcomes, such as the need for mechanical ventilation or the time to clinical improvement.”
Remdesivir was included in the WHO Solidarity Trial of Therapeutics, which aims to find a cure for the viral disease, along with the discontinued drugs hydroxychloroquine, lopinavir and ritonavir, and the drugs still under trial interferon-1a beta and acalabrutinib.
Vergeire said the department will comply with the WHO recommendation as the country is part of the Solidarity Trial.
He said the WHO recommended continuing trials of the drug for those patients who have been recruited for trials to add more numbers of individuals to study to arrive at a more precise finding.
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