FDA OKs ‘compassion’ use of Sinopharm vaccines for PSG

MANILA – The Food and Drug Administration (FDA) has granted the Presidential Security Group (PSG) a “compassionate” license for the use of 10,000 doses of the coronavirus disease 2019 (Covid-19) vaccine from China’s Sinopharm, Malacañang announced Thursday.

The announcement came nearly a month after Presidential Spokesperson Harry Roque urged the PSG to apply for special permits at the FDA so more of its personnel could receive Covid-19 vaccines.

“Nag-issue po ng compassionate use license ang ating FDA para sa 10,000 dosage ng Sinopharm. Ito po ay sang-ayon sa application ng ating Presidential Security Group or PSG (The FDA has issued a compassionate use license for 10,000 doses of Sinopharm. This is in accordance with the application or our Presidential Security Group or PSG),” Roque said in a virtual Palace press briefing.

Roque said the PSG had chosen Sinopharm vaccines since there was a delay in the arrival of Covid-19 vaccines from drugmakers Pfizer and AstraZeneca in the Philippines.

“The answer is obvious. Wala pa tayong nakukuhang supply pa sa ngayon ng Pfizer at saka ng AstraZeneca. Naantala nga po ‘yung pagdating ng inaasahan nating mid-February. At ngayon ay inaasahan nating either third or fourth week (We have yet to secure supply from Pfizer and AstraZeneca. It was delayed. We are expecting to arrive in mid-February but it would instead be delivered by either third or fourth week),” he said.

Roque said the family of PSG members might also get inoculated with Sinopharm vaccines.

He had no idea as to when the PSG would start the vaccination among its personnel.

He, nevertheless, expressed confidence that President Rodrigo Duterte would continue to be safe from Covid-19 following the FDA’s issuance of special permit for the inoculation of vaccines among the President’s security aides.

“Kinakailangang mabakunahan na yung ibang miyembro pa ng PSG dahil nga po sa kanilang trabaho na nagbibigay seguridad sa ating Presidente (Other members of PSG need to be vaccinated because their job is to give security to the President),” Roque said.

FDA Director General Eric Domingo has confirmed that the PSG has applied and complied with all requirements for the compassionate special permit.

“It was granted yesterday (Wednesday) and the PSG Hospital takes full responsibility for the vaccines and will report utilization and outcomes to FDA,” Domingo said.

Sinopharm has not yet applied with the FDA for an emergency use authorization which allows the use of unapproved medical products during a public health emergency.

Through the permit, the FDA can allow the use of unapproved or unregistered medical products through a certain licensed establishment for certain kind or type of patients, specific volume as stated in the Administrative Order No. 4 s. 1992.

The FDA noted that the PSG first applied for the permit on Jan. 18 and “recently completed all requirements”. The permit is for one-time importation only.

The PSG was criticized in December last year after some of its members got inoculated with a non-approved Covid-19 vaccine.

Critics and some lawmakers claimed the PSG’s use of unauthorized vaccine violates Republic Act (RA) 9711 or the Food and Drug Administration Act of 2009.

RA 9711 forbids the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of health products sans proper authorization.

The PSG defended its move, stressing that it needs to ensure that presidential guards are “not themselves threat to the President’s health and safety”.