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No more clinical trials in the Philippines for AstraZeneca
MANILA, Philippines – The UK’s AstraZeneca has withdrawn its application to conduct clinical trials in the Philippines for its COVID-19 vaccine, the Food and Drug Administration (FDA) said yesterday.
FDA Director General Eric Domingo said in a text message that AstraZeneca had withdrawn its application because “they already have enough data.”
But Domingo stressed that the company can still supply vaccines to the Philippines even without having clinical trials in the country. All you have to do is apply for emergency use authorization from the FDA.
Previously, the Philippine government and the private sector signed an agreement with AstraZeneca for the supply of some two million doses of vaccines.
Half of the doses would be delivered to the private sector and the rest to the Department of Health.
AstraZeneca is one of five vaccine manufacturing companies that applied for approval to conduct clinical trials in the Philippines.
The others are Sinovac and Clover Biopharmaceuticals, both from China; Gamaleya Center of Russia; and Janssen from Johnson & Johnson in the United States.
As of December 6, AstraZeneca’s application had already been approved by the Single Joint Ethics Review Board (SJERB), but was still pending with the Vaccine Expert Panel (VEP).
The Undersecretary of Health, María Rosario Vergeire, said that Janssen received a “positive recommendation” from the VEP, moving her closer to obtaining FDA approval for her clinical trial application in the country.
“Janssen has already been approved by (SJERB), so this means that they can now go through the FDA process,” he said in a briefing.
This means that Janssen, like Chinese firm Clover Biopharmaceuticals, had already passed the VEP and SJERB evaluations.
But in an interview, Domingo from the FDA maintained that they have not received a request from Janssen to test their COVID-19 vaccine in the Philippines.
Domingo added that the Clover app, on the other hand, has been with the FDA since last week.
Vergeire previously said that the government was following several “avenues” to secure vaccines for COVID-19 patients. One of them is through clinical trials that can be carried out in the country and the other is by participating in the Solidarity Trial of Vaccines initiated by the World Health Organization (WHO). This test is expected to start in January 2021.
He added that the government is also considering GAVI’s global access facility to COVID-19 (COVAX) vaccine, a mechanism that aims to ensure “rapid, fair and equitable access to COVID-19 vaccines around the world.” .
The government is also in talks with several vaccine companies, including Pfizer and Moderna, both from the US.
Health Secretary Francisco Duque III said the government is studying “four to five” candidate vaccines that can be used to combat COVID-19.
Meanwhile, Duque said the government would be making a “profile” of the elderly who would be immunized against the disease as a precaution against possible side effects of the vaccines.
“We need to profile the elderly because we don’t know if the vaccines might have some side effects (on them),” he told a news conference.
Duque added that older people are among the priorities for vaccination that the government is preparing.
The other priorities are health workers, poor families, barangay health workers, and uniformed police and military personnel.
He said local governments would participate in the vaccination program by having a registry detailing the “nitty-gritty” information on potential vaccine recipients.
Reports showed that two British people have experienced severe allergic reactions after receiving vaccines from Pfizer / BioNTech. The development has raised concerns regarding the effect of the vaccine in people with pre-existing allergies.
In a separate briefing, Vergeire said that allergies are “common” side effects of medications and vaccines.
“The medicines and vaccines that doctors give us are foreign materials. When they are injected into our body, there is the possibility that our body will react differently, “he said.
Vergeire added that it would be “essential” to have “exclusion and inclusion criteria” in each vaccination program.
He said this would be part of the “indication and contraindication” if a vaccine for COVID-19 were to be launched in the country.
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