In this file photo taken on July 21, 2020 a general view is pictured of the offices of British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca PLC in Macclesfield, Cheshire.
Paul Ellis / AFP
No more Philippine clinical trials for AstraZeneca
Sheila Crisostomo (The Philippine Star) - December 12, 2020 - 12:00am

MANILA, Philippines — The United Kingdom’s AstraZeneca has withdrawn its application to do clinical trials in the Philippines for its COVID-19 vaccine, the Food and Drug Administration (FDA) said yesterday.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 pulled out their application, because “they have enough data already.”

But Domingo emphasized the company can still supply vaccines to the Philippines even without having clinical trials in the country. It just has to apply for emergency use authorization with the FDA.

Earlier, 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 given 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 hold clinical trials in the Philippines.

The others are Sinovac and Clover Biopharmaceuticals, both of China; Gamaleya Center of Russia; and Janssen of Johnson & Johnson of United States.

As of Dec. 6, AstraZeneca’s application had already passed the Single Joint Ethics Review Board (SJERB) but it was still pending with the vaccine expert panel (VEP).

Health Undersecretary Maria Rosario Vergeire said Janssen has received “positive recommendation” from the VEP, bringing it closer to obtaining FDA approval of its application for clinical trial in the country.

“Janssen has already been approved by the (SJERB) so this means they can now go through the process of the FDA,” she noted at a briefing.

This means that Janssen, just like Chinese firm Clover Biopharmaceuticals, had already passed the evaluations of both VEP and SJERB.

But in an interview, FDA’s Domingo maintained that they have not received an application from Janssen to do a trial of its COVID-19 vaccine in the Philippines.

Domingo added the application of Clover, on the other hand, has been with the FDA since last week.

Vergeire earlier said the government was pursuing various “pathways” in securing vaccines for COVID-19 patients. One of them is through the clinical trials that may be held in the country and the other is by participating in the Solidarity Trial for Vaccines initiated by the World Health Organization (WHO). This trial is expected start in January 2021.

She added the government is also looking at the GAVI COVID-19 Vaccine Global Access (COVAX) Facility, a mechanism that aims to guarantee “rapid, fair and equitable access to COVID-19 vaccines worldwide.”

The government is also in talks with various vaccine firms, including Pfizer and Moderna, both from the US.

Health Secretary Francisco Duque III said the government is looking at “four to five” candidate vaccines that may be used to combat COVID-19.

Meanwhile, Duque said the government would be doing a “profiling” of the elderly who would be immunized against the disease as a precaution against the possible side effects of vaccines.

“We need to profile the elderly because we don’t know whether the vaccines might have some side effects (on them),” he told a press briefing.

Duque added that senior citizens are among the priorities for vaccination being readied by the government.

The other priorities are the health workers, poor families, barangay health workers and uniformed personnel from the police and the military.

He said local governments would take part in the vaccination program by having a registry detailing the “nitty-gritty” of information about potential vaccine recipients.

Reports showed that two British individuals have experienced severe allergic reactions after being given vaccines of Pfizer/BioNTech. The development has raised concerns regarding vaccine effect on people with pre-existing allergies.

At a separate briefing, Vergeire said allergies are “common” side effects of medicines and vaccines.

“Medicines and vaccines that are given to us by doctors are foreign materials. When they are injected into our body, there is a possibility that our body will react differently,” she maintained.

Vergeire added it would be a “critical thing” to have “exclusion and inclusion criteria” in every vaccination program.

She said this would be part of the “indication and contra-indication” should a vaccine for COVID-19 be rolled out in the country.

ASTRAZENECA
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