AFP starts own probe of PSG use of China vaccine

MANILA, Philippines — The Armed Forces of the Philippines said it would launch its own investigation of the clandestine inoculation of President Rodrigo Duterte’s close-in security detail with a vaccine for COVID-19 not yet authorized by local regulators.

The inoculation had prompted accusations that the Presidential Security Group (PSG) and Malacañang may have violated the law in their desire to protect Duterte from SARS-CoV-2, the virus that causes COVID-19.

The secret vaccination was criticized by the public for undermining more vulnerable sectors, particularly health workers, who should have been the first to be vaccinated during the pandemic.

In a statement on Thursday, Maj. Gen. Edgard Arevalo, the AFP spokesperson, said Chief of Staff Gen. Gilbert Gapay ordered a “thorough investigation on the factual circumstances surrounding the incident.”

The AFP, however, supported the statement made by PSG commander Brig. Jesus Durante III justifying the inoculation of Duterte’s bodyguards “to greatly reduce the possibility of being the source and carrier of this virus and consequently infect the President, whose good health and well-being are the PSG’s primordial concern,” Arevalo said.

It said that Gapay “was not part of or privy about the circumstances involving the procurement of these vaccines, its source, and the administration thereof to PSG troopers.”

Durante had said that the PSG members inoculated each other in September and October, but he refused to identify the donor or the manufacturer of the “donated” vaccine.

Separate investigations

The Food and Drug Administration (FDA), Bureau of Customs and the National Bureau of Investigation are conducting separate investigations on how the unregistered vaccine was brought into the country and administered to presidential guards.

The Senate will convene as a committee of the whole to open its own inquiry. Senators will summon Durante to shed light on how the vaccine doses were procured.

Government officials eventually admitted the the vaccine for COVID-19 was developed by the Chinese pharmaceutical company Sinopharm.

Sinopharm’s vaccine has not yet been approved by the FDA for use in the country.

Durante said he would take “full responsibility” for the vaccination of PSG members with an unauthorized vaccine.

Critics and some lawmakers said the PSG violated Republic Act No. 9711, or the FDA Act of 2009, which prohibit the manufacture, importation, exportation, sale, distribution, transfer and non-consumer use of unregistered products. Violators may face jail time of one year to 10 years.

Defense Secretary Delfin Lorenzana himself said the Sinopharm vaccine was “smuggled” into the country.

Under the government’s vaccination priority list, the military was fifth among priority recipients, behind front-line health workers, workers of select government offices, senior citizens and indigents.

Distributor denies involvment

In a radio interview on Friday, two representatives of a company claiming to be the sole distributor of the Sinopharm vaccine in the country denied its involvement in the inoculation of the PSG members.

The two men told DZBB radio that their Makati City-based company, MKG Universal Drugs Trading Corp., would follow the law in distributing the Sinopharm vaccine. They refused to reveal their identities for security reasons.

They said they had secured an FDA application and had sent it to Sinopharm in China, which would then apply for an emergency use authorization (EUA) from the FDA.

The FDA said only US-based Pfizer/BioNTech has so far applied for EUA for its vaccine for COVID-19.

An EUA is a mechanism intended to expedite the availability of a drug or vaccine to the public in times of a health emergency, such as the current pandemic.

Even if the vaccine development process is still ongoing, an EUA may be issued if there are available and “convincing” safety and efficacy data.

This authorization, however, does not exempt the manufacturer from completing the development of its product and applying for prequalification once it is licensed.

The Chinese government approved only on Thursday the use of Sinopharm’s COVID-19 vaccine for general use on its population.

This came after it announced that the vaccine it developed had an efficacy rate of 79 percent based on an analysis of its Phase 3 clinical trials.

Sinopharm had not released data of its clinical trials, saying they would be published “later” in Chinese and foreign medical journals.