(Eagle News) — The Philippine Food and Drug Administration (FDA) said that the validation of the World Health Organization WHO) of the Pfizer and BioNTech vaccine against COVID-19 for emergency use was “very significant” for a possible grant of emergency use authorization (EUA) in the country.
FDA Director General Eric Domingo said that Pfizer submitted its application for EUA on December 23, and so far was the only vaccine maker which had applied for EUA.
Domingo said the FDA is currently studying Pfizer’s application and may issue an authorization after the completion of “all regulatory requirements.”
“The WHO emergency use listing is very significant. Our experts are currently evaluating the documents submitted by Pfizer as outlined in our guidelines. I will issue a decision on the application as soon as all the regulatory requirements and procedures are completed,” he said in a statement.
-2 to 3 weeks of evaluation-
Domingo said that the FDA would take about two to three weeks to finish its evaluation.
WHO had “listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago.”
“The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need,” WHO said in a release.
WHO said that the vaccine had met its requirements and criteria for safety and efficacy. After a thorough review, it said that the benefits for the use of the Pfizer vaccine far outweighed the potential risks.
Both the United States and the United Kingdom had already issued emergency use authorization for the Pfizer vaccines which had since been administered among health workers and the sectors who are most at risk, including the elderly.
-EUA by January?-
In previous television interviews in December last year, Domingo had said that the study on the EUA application of Pfizer could be finished within a month.
The validation given by WHO including the Pfizer vaccine in its emergency use listing (EUL) is “very significant”, giving it an added boost for the possibility of this being granted EUA in the Philippines by the FDA.
According to WHO, the EUL “involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan.”
“These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies,” it said.
Once WHO has listed a vaccine for emergency use, it then “engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.”
“In addition to the global, regional, and country regulatory procedures for emergency use, each country undertakes a policy process to decide whether and in whom to use the vaccine, with prioritization specified for the earliest use. Countries also undertake a vaccine readiness assessment which informs the vaccine deployment and introduction plan for the implementation of the vaccine under the EUL,” WHO explained.
WHO had earlier said that the requirement of the Pfizer vaccine for ultra cold storage facilities in its storage and transportation would make it very challenging for countries to transport and disribute the vaccines, especially those countries with no such ultra cold storage facilities and supply chain.
The Philippines, which has a warm tropical clinmate, has earlier said that it lacks such ultra cold storage facilities.
“The Comirnaty vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible,” WHO noted.
“For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible,” it said.
(Eagle News Service)