FDA approves 10K China vaccine doses for PSG use

The Food and Drug Administration (FDA) has issued a compassionate use license for 10,000 doses of the COVID-19 vaccine of the China National Pharmaceutical Group (Sinopharm) at the request of the Presidential Security Group (PSG), Malacañang announced on Thursday.

The FDA granted the permit two months after the commander of the presidential bodyguard, Brig. Gen. Jesus Durante III, admitted that his troops had been inoculated against COVID-19 using an unauthorized vaccine that had been donated to it, though he did not identify the donor.

Durante’s admission followed President Duterte’s disclosure in a televised address in mid-December that many Filipinos had already been vaccinated against COVID-19, including soldiers. He said the vaccine was the one made by Sinopharm.

Unauthorized

The FDA, however, said it had not authorized any of the candidate COVID-19 vaccines, kicking up a controversy that saw the PSG facing a legislative investigation, with allegations of breaking the country’s drug regulations.

The investigation would have become part of the Senate committee of the whole’s inquiry into the government’s vaccination program, but President Duterte, invoking executive privilege, barred Durante from appearing at the hearings.

On Thursday, presidential spokesperson Harry Roque said the presidential guard had applied for a special permit to use the Sinopharm vaccine as part of its job of protecting the President.

“It is for compassionate use, because the other members of the PSG have to be vaccinated since their job is to provide security to the President,” Roque said in a press briefing.

FDA chief Eric Domingo, in a message to reporters, confirmed the grant of the special permit. He said Durante’s command applied for the permit on Jan. 18.

“The PSG applied and complied with all the requirements,” Domingo said. “It was granted on Wednesday.”

Domingo said the presidential bodyguard would report use of the vaccine and the outcome to the FDA.

He said the permit was for “future use” and covered a one-time importation.

Roque said he did not know how the presidential guard would procure vaccines.

He also announced that the Philippines would receive 600,000 doses of China-donated vaccines on Feb. 23, a portion of which will be used to inoculate military personnel.

He said the date of arrival of the COVID-19 vaccines made by Sinovac Biotech was “set in stone,” and 100,000 doses would go to the Department of National Defense, donated by China to the Philippine military.

The rest would be given to medical staff in Metro Manila hospitals, the top priority group on the government’s vaccination list.

The donated Sinovac shots would be on top of the 25 million doses that the Philippine government would buy from the Chinese drugmaker.

Sinovac Biotech has applied for an emergency use authorization for its vaccine with the FDA.

Should the vaccines arrive before the permit is issued, they will be stored until they are allowed to be used, Roque said.

If a permit is not issued, the vaccines will be sent back to China, he said.

Roque reiterated that President Duterte stood firm on his preference for a Chinese vaccine.

He, however, said he was not at liberty to disclose which Chinese vaccine Mr. Duterte had chosen for himself.

Roque also said it was uncertain which vaccine, Sinovac or Pfizer, would arrive first in the country.

The Pfizer vaccines from the global procurement pool COVAX were initially expected to arrive in mid-February, but would now be delayed.

Vince Dizon, deputy chief of the National Task Force Against COVID-19, said the delay in the delivery of the initial batch of 117,000 Pfizer vaccines was due to the need to process certain documents with COVAX and the World Health Organization.

“But we are confident that these would arrive in the coming weeks, within the month of February,” Dizon said.

The Department of Health is preparing the required documents, he said.

Once the vaccines are delivered, these will be distributed first to four COVID-19 referral hospitals in Metro Manila—Philippine General Hospital in Manila, Lung Center of the Philippines and East Avenue Medical Center in Quezon City, and Dr. Jose Natalio Rodriguez Memorial Medical Center (Tala Hospital) in Caloocan City.

First recipient

PGH spokesperson Jonas Del Rosario, a COVID-19 survivor, will be the first employee of the hospital to receive a shot, according to hospital director Gerardo Legaspi.

Del Rosario also lost his parents to the disease, Legaspi said.

“It would be better for people to see that the first [to get the vaccine] would be those who offered their strength and intelligence and were affected by COVID severely. It would be a symbolic gesture of the final phase of their fight, their personal fight, against COVID,” Legaspi said.

Next to get the vaccines are staff working in COVID-19 wards, who number around 1,000, Legaspi said.

He said 5,134 PGH personnel had registered for vaccination, out of the 6,300 the hospital expected to sign up.

Legaspi said the decision of the rest not to register may be related to their choice of vaccine.