THE Food and Drug Administration (FDA) will soon be able to approve in less than a month the local use of vaccines and any drugs for the novel coronavirus disease (Covid-19).
The new issuance is expected to further speed up the implementation of the proposed government Covid-19 vaccination drive next year.
On Tuesday, President Duterte finally issued Executive Order (EO) 121, which gave FDA the power to issue 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 revisit or revoke the same, as may be appropriate, to protect the general public health and safety,” Duterte said in his three-page issuance.
Faster approval
The EUA aims to reduce the processing time for the approval of Covid-19 drugs and vaccine from six months to just 21 days.
Duterte said the EUA can only be issued to drugs and vaccines, which have evidence of preventing Covid-19; have benefits which outweigh its potential health risks; and there is no adequate or approved at available alternative for it.
Manufacturers of Covid-19 vaccines and drugs, which would like to apply for an EUA “should demonstrate compliance with current Good Manufacturing Practices and accompanied by an undertaking by the manufacturer to complete the development of the drug and vaccines, among others.”
EUA applications will be first evaluated by the government’s vaccine expert panel, before they could be approved by FDA.
The approval of the EUA may 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 clinical trials and except in cases where a Compassionate Special Permit is issued, no unregistered Covid-19 drug and vaccine may be manufactured, sold imported, exported, distributed, or transferred without EUA,” Duterte said .
EO 121 will take effect immediately after being published in the Official Gazette or in a newspaper of general circulation.
On track
In an interview with PTV on Wednesday, Chief implementer of the government’s national policy on Covid-19 Carlito G. Galvez may be able to secure its supply of vaccine by the first quarter of next year if they can conclude the necessary agreements this month.
“If we will succeed in negotiating with two to three vaccines from different countries, we might be able to get it during the first quarter,” Galvez said.
He noted this will allow them to be on track with the national Covid-19 vaccination road map.
Currently, the vaccine czar said among the manufacturers that may start selling their Covid-19 vaccines by early next year are those from two Chinese manufacturers: Sinovac and Sinopharm.
He said they are also closely monitoring the Covid-19 vaccine from Moderna and Pfizer, which may soon get advance clearance through the US-FDA for emergency use authorization.
In the United Kingdom, the vaccines from Pfizer and AstraZeneca may also soon be approved by regulators, Galvez said.
Acute supply
But even if the said vaccines do become available in the global market earlier than anticipated, which is on May 2021, Galvez admitted the government may only be able to secure a small portion of the said items.
He explained why: 80 percent of the doses of Covid-19 vaccines to be produced by the said manufacturers have been procured in advance by rich countries.
Two percent of the said supply will be secured by the Covid-19 Vaccine Global Access (Covax), where the country is a participant.
This leaves developing countries like the Philippines only 18 percent of the Covid-19 vaccines supply worldwide to purchase, Galvez said.
With the “acute” scarcity in the sources or supply of vaccine, “the realistic scenario is we will be able to roll out [a] vaccine [in] the middle of the second quarter,” Galvez said.
But, he added, “we are trying hard to get vaccines especially from our diplomatic friends like China, Australia and other countries like US during the first quarter [of 2021],” he added.
He explained the government is rushing to launch its Covid-19 vaccination drive 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.
Image credits: University of Oxford/John Cairns via AP