'Hindi puwedeng pilitin': FDA says COVID-19 vaccination not compulsory

Davinci Maru, ABS-CBN News

Posted at Dec 03 2020 03:30 PM

'Hindi puwedeng pilitin': FDA says COVID-19 vaccination not compulsory 1
A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in this illustration taken Oct. 30, 2020. Dado Ruvic, Reuters/File

MANILA - The Food and Drug Administration (FDA) said Thursday they would not force people to take shots against COVID-19 amid safety concerns on the warp speed development of the vaccines.

"Ang isang tao ay mababakunahan (A person will be inoculated) after full disclosure of all the potential risks and the potential benefits of getting a vaccine," the state regulator's director general Eric Domingo said in a virtual forum.

"Hindi po kayo puwedeng pilitin at hindi po tayo puwedeng sapilitan."

(You can't be forced into it and this is not compulsory.)

But to allay fears about the vaccines, which are seen to help turn the tide of the global pandemic, Domingo assured the public they would not compromise their safety.

"We would like to assure the public we take it very seriously. We will make sure that the benefits will outweigh the risk more than anything before giving the emergency use authorization for any vaccine," he said.

To bolster public confidence, the Department of Health (DOH) is set to hold an education campaign about the vaccines to allow the public to make an informed decision, Domingo said.

President Rodrigo Duterte on Wednesday issued an executive order authorizing FDA to clear COVID-19 drugs and vaccines for emergency use.

The FDA can now issue emergency use authorization (EUA) if a drug or vaccine may be effective to prevent, diagnose or treat the novel coronavirus, which causes the respiratory disease.

The state regulator may also grant an EUA if there is no adequate, approved and available alternative to the drug or vaccine against COVID-19.

During the forum, Domingo bared the country may allow a coronavirus vaccine candidate for emergency use in January at the earliest following rapid developments in other countries.

The UK on Wednesday approved the emergency use of a vaccine developed by American drug maker Pfizer and German biotechnology partner BioNTech, which they said is 95 percent effective in preventing the illness. 

But the FDA director general stressed applicants should have an equivalent EUA from the country where they were developed or underwent a prequalification procedure with the World Health Organization (WHO).

Any public health program implementer can also apply for the EUA in which guidelines will be expected to be released next week, he said.

For its post authorization monitoring, Domingo said they would create a committee to track the possible effects of the vaccine.

"If there's any possible serious adverse events, like something happens within 24 hours of vaccination, whether or not connected sa bakuna o hindi, kailangan i-report agad 'yan (with the vaccines or not, it has to be reported immediately)," he said.

The FDA, DOH and other concerned agencies will investigate the incidents if the inoculation should be paused, halted or continued.

The Philippines, home to some 109 million people, is hoping to start immunization next year. With over 434,000 coronavirus infections, it has the second highest number of COVID-19 cases in Southeast Asia.

The country has been in talks with different vaccine makers for possible supply deals. It has so far secured 2.6 million COVID-19 shots developed by British drugmaker AstraZeneca and University of Oxford.

Watch more on iWantTFC  Courtesy of Department of Health