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The Food and Drug Administration (FDA) will soon be able to approve in less than a month the local use of vaccines and any drug for the new coronavirus disease (Covid-19).
The new issue is expected to further accelerate the implementation of the government-proposed Covid-19 vaccination campaign next year.
On Tuesday, President Duterte finally issued Executive Order (EO) 121, which gave the FDA the power to issue an Emergency Use Authorization (EUA) for Covid-19 vaccines and drugs.
“An EUA issued pursuant to this Order shall be valid only within the duration of the declared public health emergency due to Covid-19, without prejudice to the discretion of the FDA Director General to review or revoke it, as appropriate. , to protect public health and safety in general, ”Duterte said in his three-page post.
Faster approval
The EUA aims to reduce the processing time for approval of Covid-19 drugs and vaccines from six months to just 21 days.
Duterte said that the EUA can only be issued for drugs and vaccines, which have evidence of preventing Covid-19; have benefits that outweigh its potential health risks; and there is no suitable or approved alternative for it.
Manufacturers of Covid-19 vaccines and drugs who wish to apply for an EUA “must demonstrate compliance with current Good Manufacturing Practices and be accompanied by a commitment by the manufacturer to complete the development of the drug and vaccines, among others.”
US applications will first be evaluated by the government’s panel of vaccine experts, before they can be approved by the FDA.
EUA approval can make use of the decision of international regulatory authorities such as the World Health Organization (WHO) and the United States Center for Disease Control (US-CDC).
“Outside of clinical trials and except where a Special Compassionate Permit is issued, no unregistered Covid-19 drug and vaccine may be manufactured, sold, imported, exported, distributed or transferred without the US,” Duterte said.
EO 121 will take effect immediately upon its publication in the Official bulletin or in a newspaper of general circulation.
On time
In an interview with PTV on Wednesday, the government’s chief executor of the government’s national policy on Covid-19, Carlito G. Galvez, could secure his vaccine supply for the first quarter of next year if they can conclude the necessary agreements this month.
“If we can negotiate with two or three vaccines from different countries, we could get it during the first quarter,” said Gálvez.
He noted that this will allow them to be on track with the national Covid-19 vaccination roadmap.
Currently, the vaccine czar said that among the manufacturers that may start selling their Covid-19 vaccines early next year are those from two Chinese manufacturers: Sinovac and Sinopharm.
He said they are also closely monitoring Moderna and Pfizer’s Covid-19 vaccine, which could soon gain advance approval from the US FDA for emergency use authorization.
In the UK, the Pfizer and AstraZeneca vaccines could also soon be approved by regulators, Gálvez said.
Acute supply
But even if such vaccines are available on the global market earlier than expected, which is in May 2021, Gálvez admitted that the government may only be able to insure a small portion of such items.
He explained why: 80 percent of the doses of Covid-19 vaccines that these manufacturers will produce have been purchased in advance by rich countries.
Two percent of said supply will be insured by Covid-19 Vaccine Global Access (Covax), where the country is a participant.
This leaves developing countries like the Philippines only to buy 18 percent of Covid-19 vaccines worldwide, Gálvez said.
With the “acute” shortage in vaccine sources or supply, “the realistic scenario is that we will be able to implement [a] vaccine [in] in the middle of the second quarter, ”said Gálvez.
But, he added, “we are struggling to get vaccines, especially from our diplomatic friends like China, Australia and other countries like the United States during the first quarter. [of 2021]”He added.
He explained that the government is rushing to launch its Covid-19 vaccination campaign as soon as possible next year to address the growing “emotional fatigue” of Filipinos from months of quarantine, as well as to allow the country to recover from the pandemic.
