For everyone else: DOH, FDA warn vs use of unauthorized vaccine
This picture taken on November 17, 2020 shows a syringe and a bottle reading "Vaccine Covid-19". According to the World Health Organization, some 42 "candidate vaccines" against the novel coronavirus Covid-19 are undergoing clinical trials on November 17, 2020.
AFP/Joel Saget

For everyone else: DOH, FDA warn vs use of unauthorized vaccine

(Philstar.com) - December 28, 2020 - 3:30pm

MANILA, Philippines — The Department of Health and the Food and Drug Administration once again warned the public about the dangers of taking unauthorized vaccines after government officials confirmed that some military personnel have already been inoculated against COVID-19.

President Rodrigo Duterte himself said that many in the Philippines have received COVID-19 jabs from Chinese drugmaker Sinopharm. The Armed Forces of the Philippines confirmed that members of the Presidential Security Group were the first ones from the AFP who have been vaccinated.

Members of the Cabinet have also been vaccinated,  Interior Secretary Eduardo Año said.

This, despite the absence of regulatory approval in the Philippines. No COVID-19 vaccine has received emergency use authorization from the country’s Food and Drug Administration.

In a statement Monday, the DOH stressed that all vaccines should undergo the evaluation and regulatory processes of regulatory and expert bodies in the country.

“We also reiterate that the use of unregistered products poses harm to a person’s health and safety. This is why only vaccines which have been approved and found to be safe should be administered,” the DOH said in a message sent to reporters.

No liability for people vaccinated

FDA Director General Eric Domingo said those who receive unauthorized vaccine would not be held liable. But he stressed that the manufacture, importation, distribution and sale of unregistered products are not prohibited under the law.

“As for the rumors going around that people are getting vaccinated, the best I can do is warn them. I don’t know where these vaccines are coming from, I don’t know what they are. If I were you, I will think twice before having something injected on my arm,” Domingo said in an interview on ABS-CBN News Channel.

In justifying the vaccination of soldiers against COVID-19, presidential spokesperson Harry Roque also said it is not illegal to be inoculated with an unregistered vaccine. Uniformed personnel are fifth in the priority list to be given COVID-19 vaccine once available.

Regulatory process

The FDA has been conducting raids against the use of unregistered COVID-19 vaccines. But Domingo said he was caught by surprise with Duterte pronouncement last Saturday.

“I am as bewildered as you because there is a process, there is a way for us to make sure that we can get the most amount of certainty when it comes to safety and efficacy of the vaccine,” the chief of the regulatory body said.

“If our people are getting products outside of that system, I will be very wary, I will be very afraid for them. But what I can do for my part is to assure everybody that the products will be available to you, that will be sent to government hospitals, that will be used in public health centers, that will be given to frontliners and elderly will pass through the FDA,” he added.

Only the American pharmaceutical company Pfizer has so far applied for emergency use authorization of its COVID-19 vaccine in the country. The issuance of an EUA would shorten the process of regulatory approval from the usual six months to as fast as 21 days.

The DOH also said that the administration of approved vaccines is accompanied by strict monitoring of all the people who will receive them “in order to ensure proper management of possible effects.”

With nearly 470,000 COVID-19 cases and over 9,000 deaths, the Philippines is scrambling to secure vaccine supplies to help end Southeast Asia’s second worst COVID-19 outbreak.  — Gaea Katreena Cabico

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