DOH, FDA to tap PRC in determining liability of doctors involved in unregistered vaccination

Robie de Guzman   •   January 4, 2021   •   166

MANILA, Philippines – The Department of Health (DOH) on Monday said it will coordinate with the Professional Regulatory Commission (PRC) in relation to the investigation on doctors involved in the administration of unregistered vaccines against novel coronavirus disease (COVID-19).

DOH spokesperson Undersecretary Maria Rosario Vergeire said they will be working with the PRC in determining the possible liability of medical professionals who participated in unauthorized COVID-19 vaccination.

Vergeire also stressed that the unauthorized inoculation of the COVID-19 vaccine to some members of the Presidential Security Group (PSG) is now being investigated by the Food and Drug Administration (FDA) and that the response of concerned agencies will depend on the agency’s findings.

“The FDA and DOH is also would be coordinating with the Philippine Regulatory Commission para nga doon sa mga involved professionals na sinasabing pagbibigay nitong unregistered vaccine na ito,” she said.

The vaccination of some PSG members came to light after President Rodrigo Duterte revealed last week that some military men had already received a COVID-19 vaccine.

PSG commander Brigadier General Jesus Durante had confirmed that his unit obtained the vaccine but refused to disclose its source. He also clarified that the president was only informed of their move after the fact.

Durante also stressed that their decision to inoculate some members sans the FDA approval is based on their mission to protect the president’s health and safety.

The PSG drew both criticisms and support from various quarters over the issue, while the Palace lauded the group’s bravery in taking unregistered and possibly smuggled vaccines.

But for Health Secretary Francisco Duque III, the incident is now being investigated by the FDA, as well as by the National Bureau of Investigation, and the Bureau of Customs.

“Nire-respeto po natin ang mga opinyon ng sinoman at ang mahalaga po rito ay kung ano po ang kakalabasan ng imbestigasyon na ginagawa ng FDA,” he said.

“Huwag po natin pangunahan ang anomang resulta na ilalabas ng FDA, NBI at Bureau of Customs sa naturang imbestigasyon… Sila po ang lead agency patungkol sa imbestigasyon na binanggit ko,” he added.

The DOH, meanwhile, urged local government units to coordinate with the agency and strictly observe protocols in rolling out their respective COVID-19 vaccination programs.

“So that we can have a unified effort at hindi tayo magkaroon ng technicalities and also we can be able to monitor as well.  We have to remember the National Immunization Program rests on the mandate of the Department of Health,” Vergeire said. – RRD (with details from Correspondent Aiko Miguel)

FDA clarifies donated vaccines require authorization, evaluation

Marje Pelayo   •   January 21, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) issued a statement on Wednesday (January 21) clarifying that donated COVID-19 vaccines still require FDA authorization in the form of Emergency Use Authorization (EUA) prior to use.

The statement came after some senators in a recent Senate hearing, raised concerns on the issue of donated vaccines from China.

The FDA said, “Entities which intend to donate vaccines to the government are required to coordinate with the Department of Health (DOH) which will facilitate the acceptance and processing of the donation.”

The agency further noted that the proposed donations will be evaluated by the DOH in consideration to the need of beneficiaries, reliability of the source shelf life and other relevant criteria.

“Only after authorization of the FDA may the DOH distribute the products to the intended beneficiaries,” FDA said.

FDA stressed that “the approval of the donated product does not mean free use thereof. FDA’s authorization is limited to the donated lot and carries conditions for use depending on the nature of the donated product.”

The DOH is also mandated to take full responsibility for the use of the donated vaccines, given that the product has been granted EUA by the FDA which ensures its safety, quality and efficacy. MNP/Raymund David

India’s Bharat Biotech applies for EUA in Phl for COVID-19 vaccines

Aileen Cerrudo   •   January 21, 2021

MANILA, Philippines — Indian biotechnology company Bharat Biotech has applied for Emergency Use Authorization (EUA) in the country for its COVID-19 vaccine.

The Food and Drug Administration, in a message, has confirmed that Bharat Biotech submitted their application for Covaxin on Wednesday (January 20) and pre-evaluation is already ongoing.

“They submitted an application this morning and pre-evaluation is going on,” according to FDA Director-General Eric Domingo.

Meanwhile, in a statement, the biotech company said that Covaxin is ideal for tropical countries because storage temperature only needs to be set by two to eight degrees celsius.

Bharat Biotech also said the Philippines is among the list of priority countries that will receive Covaxin supply.

“The Philippines is among the list of priority countries that Bharat Biotech will allocate supplies of Covaxin to. It was announced earlier this week that the Indian government has issued a letter of comfort covering this,” the company said in a statement.

Other companies seeking EUA in the country include Astrazeneca, Gamaleya Research Institute, and Sinovac Biotech. -AAC (with reports from Aiko Miguel)

PH to get COVID-19 vaccines from COVAX in Q1 2021 – DOH

Robie de Guzman   •   January 21, 2021

MANILA, Philippines – The Department of Health (DOH) announced that the Philippines has received confirmation of its participation in the COVID-19 vaccine financing instrument – COVAX facility – Advance Market Commitment.

The COVAX Facility, an initiative of the World Health Organization (WHO), is a global procurement mechanism which invests in a broad portfolio of promising vaccine candidates to support their research, development, and manufacturing.

This facility was setup to ensure fair and equitable access to COVID-19 vaccines.

“With the country’s participation in the COVAX Facility, the country is set to receive vaccines in the first quarter of this year,” the DOH said in a statement on Wednesday.

As part of the preparations for the COVID-19 vaccine deployment, Health Secretary Francisco Duque III and Vaccine Czar Secretary Carlito Galvez, Jr. on Wednesday visited three cold storage facilities that can potentially be used in the first wave of COVID-19 vaccine roll-out.

The cold chain facilities visited were the First Pioneer Distribution Center of UNILAB located in Biñan City, Laguna, the Research Institute of Tropical Medicine (RITM) in Muntinlupa City, and the Zuellig Pharma Corporation in Parañaque City.

“The inspection was carried out to ensure that the cold chain facilities will meet the storage requirement of vaccines prior to its distribution to identified vaccination sites,” the DOH said.

UNILAB’s cold storage facility has a temperature range of +2 to +8 °C and can store a maximum of five million doses of vaccines.

Meanwhile, Zuellig Pharma reported that its facilities can accommodate pharmaceutical products with temperature requirements ranging between -80°C to +25 °C. Its cold rooms with temperature ranging from +2 to +8 °C can store up to 629 million doses in various warehouses, its -15 to -25 °C walk-in freezers can hold up to 40 million doses, and its 14 ultra-cold freezers with -80 to -70 °C temperature range has the capacity to store up to 6.5 million doses.

“The vaccine cluster, on behalf of the government, is grateful to UNILAB and Zuellig Pharma for partnering with the government in further strengthening the country’s capacity to curb the pandemic. We also express our commitment to ensure continued support for RITM in its preparations to receive vaccines,” Galvez said.

RITM Director Dr. Celia Carlos said that RITM currently has four cold rooms with a +2 to +8 °C temperature range, one -20 °C walk-in freezer, and two borrowed ultra-low temperature freezers with a -70 to -80 °C temperature range. Presently, RITM commits its ultra-low temperature storage facility.

With this, the DOH said that Galvez has recommended the constitution of another team at the RITM exclusively handling the COVID-19 vaccine deployment, adding that a separate team for EPI (Expanded Program of Immunization) vaccines is ideal for an uninterrupted focus and roll-out of both immunization programs.

Duque, on the other hand, noted that aside from cold chain facilities, the vaccine cluster is also in talks with third-party logistics providers to ensure efficiency of the entire supply chain management of COVID-19 vaccines, from the receipt of vaccines from the COVAX Facility to its deployment.

“All of these preparations that we are undertaking are aimed at ensuring that the country is ready to receive, store, and mobilize the COVID-19 vaccines that will come from the COVAX Facility,” Duque said.

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