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FDA ’compassionate permit’ allows unregistered vax

Food and Drug Administration (FDA) Director General Eric Domingo said the agency can issue a "compassionate special permits" to allow the vaccination of small groups of people involved in critical missions such as President Rodrigo Duterte's bodyguards, even without a registered vaccine.

Domingo, also an undersecretary at the Department of Health (DOH), issued the statement when President Rodrigo Duterte asked him Monday night if the FDA can issue an authority for the use of the vaccines for emergency purposes.

“If it’s going to be a smaller group, like the Presidential Security Group (PSG) and of course, it’s their priority to protect you, then we can give a compassionate special permit, and a hospital can take care of it and a doctor can administer it safely,” Domingo said in a mix of English and Filipino.

Domingo said the emergency use authorization (EUA) is an "authorization issued for unregistered drugs and vaccines to be used in a public health emergency.”

The evaluation process of the product may be facilitated by reliance and recognition principles, but stricter conditions on the use and monitoring following authorization will be imposed, he said.

Public outrage grew last week over the early use of unauthorized vaccines against COVID-19 to vaccinate members of the PSG, ahead of the stated priorities of health care workers and the elderly.

Domingo earlier said a vaccine must be registered even if it is donated.

“For us, even if the drugs and vaccines are donated, they must go through the Department of Health, and the Department of Health asks us for an import permit and it is registered with the FDA,” Domingo said.

Meanwhile, researchers monitoring the pandemic said their study showed only 25 percent of Metro Manila residents are willing to be vaccinated against COVID-19.

The remaining 75 percent of respondents are mostly undecided (47 percent) or unwilling to be vaccinated (28 percent).

The non-commissioned scientific poll, which surveyed 600 people from Metro Manila aged 18 and above from Dec. 9 to 13, 2020, has a sampling error of ±4 percent.

Among socio-economic classes, those in classes ABC were more willing to be vaccinated. Meanwhile, a third of those unwilling to be vaccinated were from class E. More than half of class ABC are also undecided or “can’t say” if they will have themselves vaccinated.

The OCTA group, which has regularly released projections of COVID-19 case numbers, is composed of professors from the University of the Philippines, the University of Santo Tomas, and Providence College in the United States.

From the same Tugon ng Masa survey of the OCTA Group, majority (81 percent) of respondents said they approved of the national government’s COVID-19 response.

“This significant approval of the national government’s COVID-19 response is shared across different socioeconomic classes in Metro Manila (ABC at 70 percent, D at 83 percent and E at 82 percent),” the OCTA Group said in a statement.

The group noted that a minority of 6 percent of Metro Manila respondents were dissatisfied with the government response. Most of them are from the class ABC.

Senator Panfilo Lacson, meanwhile, called on the government to begin vaccination as soon as possible.

"We have to start the rollout of the vaccines soonest. It is embarrassing what is happening to us,” Lacson said in a mix of English and Filipino.

"We have had several loans for the vaccine, why until now do we still not have the vaccine?" he added.

He said it was high time the DOH and the FDA showed some urgency in obtaining vaccines.

Lacson said it was shameful that the prospective entry of vaccines stemmed from the initiative of the private sector instead of the government.

"Isn't it disgusting that the private sector is taking the lead to bring in vaccines? This should put the government to shame, especially considering that the Department of Finance has announced multimillion-peso loans for vaccines," he said..

Also on Tuesday, the Philippine Red Cross (PRC) said it was negotiating with Pfizer and AstraZeneca for its plan to roll out a “buy one, donate one” COVID-19 vaccine program.

“Our target initially is 1 million (doses), but I told AstraZeneca we cannot make it. Maybe around 200,000 to 250,000 we could make," Gordon said.

The senator said the PRC is still studying the possible cost of an anti-COVID-19 shot under this program but he added that it would most likely be under P1,500.

Meanwhile, Health Undersecretary Maria Rosario Vergeiere said the applications of Sinovac, Gamaleya, and Clover to conduct clinical trials of their COVID-19 vaccines in the country are still being processed.

Vergeire, in an interview on GMA News’ Unang Balita, said the manufacturers need to complete some documents.

According to Vergeire, only Janssen received approval to conduct clinical trials for its COVID-19 vaccines in the country so far.

She added that the Vaccine Expert Panel (VEP) has assigned five sites in the country for the conduct of Janssen’s clinical trial.

Aside from these, other potential vaccine products under the World Health Organization (WHO) Solidarity Trial are also expected to undergo clinical trials in the Philippines.

The DOH on Monday clarified that local government units cannot directly purchase COVID-19 vaccines approved for emergency use, but they can partner with the DOH for immunization of priority sectors.

Metro Manila LGUs have already allotted funds for the COVID-19 vaccination of their constituents.

Topics: Food and Drug Administration , Eric Domingo , COVID-19 , Rodrigo Duterte , Department of Health , Philippine Red Cross
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