Doctors giving unregistered vaccines to lose license

MANILA, Philippines — Doctors illegally administering unregistered COVID-19 vaccines face sanctions including revocation of license, the Department of Health (DOH) and Food and Drug Administration (FDA) warned on Thursday.

In a joint statement, Health Secretary Francisco Duque III and FDA director general Eric Domingo said offenders “will be dealt with accordingly.”

“We will investigate the illegal administration of unauthorized smuggled vaccines, specifically doctors and other medical professionals who administer them. We will have their medical licenses revoked. We doctors have an oath. Do no harm. In a pandemic, we need to be more circumspect,” Duque said.

Both the DOH and FDA have received reports that legislators are meeting up in posh hotels for coffee and going to a room for their COVID-19 vaccines.

“I’m not buying the explanation that the doctors administering the shots are being pressured by lawmakers. Someone is peddling the service and it is unacceptable,” Duque stressed.

Domingo further noted that the DOH and FDA are working closely with the Bureau of Customs to prevent the entry of unauthorized vaccines and other drugs in the country.

“We have sent our enforcement unit to the field and we are awaiting the report. We are fully committed to monitoring this,” Domingo said.

Duque said illegal use of unregistered vaccine may only worsen the situation and may even prove fatal to some.

The FDA is evaluating the application of US pharmaceutical firm Pfizer for emergency use authority (EAU) to supply COVID vaccines in the country.

“We understand the urgency of the situation and we are carefully reviewing the documents they submitted and taking into account the possible risks to the public. We will make a decision at the soonest possible time,” Domingo said.

The DOH also denied receiving a letter of request from Chinese firm Sinopharm to do clinical trials for its candidate vaccine in the Philippines.

In a joint statement issued with the Department of Science and Technology (DOST) and FDA, the DOH said there was no truth to reports that it failed to act on Sinopharm’s request.

“The DOH categorically denies these baseless accusations and clarifies that the country’s participation in several clinical trials, including that of Sinopharm’s, was approved by the Inter-Agency Task Force on Emerging Infectious Diseases (IATF) as early as May,” the statement reads.

The DOH noted that this approval is contained in IATF Resolution No. 39 dated May 22, 2020.

The FDA has reiterated that Sinopharm “has not submitted any application for clinical trials nor Emergency Use Authorization.”

According to the DOST, upon the IATF’s approval of the country’s participation in the clinical trials, Sinopharm reached out to DOST with “two proposals for collaboration.” One is for the conduct of clinical trial which “will be funded by the Philippines.” The second is for the Philippines to “recognize the approval/authorization from their country.”

“In response, DOST wrote back to them to say that the Philippines only funds trials under the WHO Solidarity Trial. The DOST notes that Sinopharm never responded to this letter,” the statement added.

Dangerous

House Deputy Minority Leader Janette Garin, a medical doctor and former health secretary, said the use of unauthorized Sinopharm COVID-19 vaccines was dangerous.

“Vaccines that are not tested and smuggled into the country are dangerous,” the Iloilo congresswoman stressed.

“Whether these vaccines were donated or purchased, (they) should be approved by FDA. Vaccines and medicines for use, even in clinical trials, also need FDA clearance. Even donations need FDA clearance,” she pointed out.

Garin also urged the government to be careful in choosing vaccines to be used for mass vaccination.

“With the variety of vaccines like Pfizer, Moderna and AstraZeneca to name a few, let us not endanger our countrymen by using vaccines with no guarantee and uncertain origin. Let us remember that public health and lives of our people are at stake here,” she argued.

The minority lawmaker made the comment amid growing concerns over Chinese vaccine Sinovac, which is the primary choice of the administration despite its low 50 percent efficacy.

Garin herself is currently facing criminal charges over the deaths of schoolchildren allegedly due to Dengvaxia, the vaccine for dengue.

The previous administration implemented in 2016 the use of Dengvaxia, the world’s first dengue vaccine that was still undergoing clinical trials. More than 830,000 children were vaccinated.

In November 2017, manufacturer Sanofi Pasteur disclosed that those without prior dengue infection were at risk of having “severe disease” if immunized with Dengvaxia.

The DOH said around 10 percent or 80,000 of vaccinated children were at risk. The DOH has since stopped the dengue vaccination program.

AFP probes PSG vaccination

Meanwhile, Armed Forces of the Philippines chief Gen. Gilbert Gapay has ordered a “thorough investigation” on the inoculation of Presidential Security Group (PSG) members using unauthorized Chinese-made COVID-19 vaccines, according to AFP spokesman Maj. Gen. Edgard Arevalo.

The military has tried to distance itself from the issue and said that it was not aware of the unauthorized procurement and inoculation of PSG personnel.

“We maintain our previous declaration that the chief-of-staff of the AFP was not part of or privy to the circumstances involving the procurement of these vaccines, its source and the administration thereof to PSG troopers,” Arevalo added.

Defense Secretary Delfin Lorenzana earlier admitted that the vaccines used on PSG personnel were smuggled, as they had no authorization from the FDA.

Still, Arevalo continued to defend the PSG and said that they understand the supposed good intentions of the PSG personnel to protect President Duterte.

“We stand by the previous statement of PSG Commander (Brig. Gen.) Jesus Durante that the President’s close-in security had themselves inoculated with the COVID-19 vaccine 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 added.

Aside from the AFP, several agencies have launched their own investigations on the controversial issue, including the FDA, Bureau of Customs and National Bureau of Investigation. –  Sheila Crisostomo, Edu Punay, Romina Cabrera