IATF approves Phl participation in COVID-19 vaccine clinical trials
Maris Federez • May 24, 2020 • 894
MANILA, Philippines — Upon the recommendation of the Department of Science and Technology (DOST), the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-MEID) has approved the proposed participation of the Philippines in clinical trials that seek to formulate a potential vaccine against coronavirus disease 2019 (COVID-19).
Based on IATF Resolution No.39 dated May 22, 2020, the task force has also ordered the creation of a sub-technical working group which will be led by the DOST.
The group will be coordinating with the four collaborating organizations composed of the Department of Health (DOH), the Food and Drug Administration (FDA), the Research Institute for Tropical Medicine (RITM), and the World Health Organization (WHO) with regard to the said clinical trials.
The IATF has also issued a directive to the FDA to facilitate the processing of necessary permits for the conduct of the clinical trials in the country.
The collaborating organizations for the clinical trials are the Adimmune Corporation, Academia Sinica, Chinese Academy of Science- Guangzhou Institute of Biomedicine and Health, the Sinopharm – Wuhan Institute of Biological Products, and the Beijing Institute.
Once the clinical trials are undertaken, these will be included in the FDA’s requirements for the registration process for the vaccine and the application for certificate of registration to make the vaccine available in the market.
The Philippines has initially participated in the WHO’s clinical trials, which include the testing of off-label drugs that show potential of being effective against COVID-19.
Meanwhile, the IATF has also approved the plans of the DOST to construct research centers for the local vaccine research development.
These include the Virology S&T Institute at the New Clark City in Tarlac and the reactivation of the Pharmaceutical Development Unit of the DOST-Industrial Technology Development Institute. —(from the report of Rosalie Coz) /mbmf
MANILA, Philippines – Senator Panfilo Lacson on Friday sought simplified procedures for the entry of donated COVID-19 vaccines, especially those with emergency use authorization (EUA) from countries or territories with stringent regulatory agencies.
Lacson made the call during the third hearing of the Senate, convening as a Committee of the Whole, on the government’s COVID-19 vaccination program.
“This is critical because there are many associations abroad that may donate vaccines to their sister cities in the Philippines. Would it not be more practical to ensure the goods reach the intended recipients directly under strict supervision and guidance by health authorities, instead of coursing the goods through the Department of Health and having the DOH distribute them?” he said.
“Besides, many local government units like Baguio City already have their own cold storage facilities for the vaccines, as their local leaders had the foresight to act accordingly. Allowing such donated vaccines to go directly to the LGUs instead of having to go through the logistical requirements of the DOH and Inter-Agency Task Force on COVID-19 would also avoid the prospect of double handling and additional costs,” he added.
Lacson pointed out that the pandemic involves an emergency where authorities cannot afford to have vaccines go through the bureaucratic processes that could delay its distribution.
In response to Lacson’s recommendation, Vaccine czar Carlito Galvez Jr. said they will make the necessary simplification of processes. They may also conduct a time and motion rehearsal in the logistical process.
“Tama kayo, Sir. Yan din ang gagawin namin. Kaya magkakaroon ng time and motion rehearsal para in case capable ang LGU, pwede idiretso para wala nang double handling,” Galvez told Lacson.
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
MANILA, Philippines – Senator Panfilo Lacson on Thursday said he has accepted the apology of vaccine czar and National Task Force against COVID-19 chief implementer, Secretary Carlito Galvez Jr. for his previous remark accusing some senators of politicizing the government’s COVID-19 vaccination program.
“I accepted his apology. He promised to be more careful in issuing statements,” Lacson said in a statement.
The senator said Galvez apologized during a meeting with him, Senate President Vicente Sotto III, Senator Ronald dela Rosa, and contact tracing czar Baguio City Mayor Benjamin Magalong on Wednesday.
But prior to their meeting, Lacson said he received a message from Magalong, relaying Galvez’s request to meet with him to apologize for his remarks during virtual meeting last week.
“He also promised to brief me and disclose all the details of their vaccine procurement, including the prices of the different brands,” he said.
“Then came the instruction of President Rodrigo Duterte to Sec. Galvez to brief Senate President Vicente Sotto III. I suggested to them that SP Sotto and I just go together, along with Sen. Ronald de la Rosa,” he added.
During the meeting, Lacson said that Galvez was able to clarify “a lot of issues and concerns raised by senators that have remained unresolved until last night.”
“We advised him to explain in tomorrow’s hearing the same way that he did last night, without violating the terms of the agreement with the vaccine suppliers,” he added.
The Senate is set to resume its inquiry on Friday, January 22 on the government’s nationwide immunization plan.
Lacson said he was satisfied with Galvez’s briefing but advised the official to be vigilant against any irregularity that may be taking place without his knowledge.
“We were shown the documents. And we have no doubt about Sec. Galvez’s integrity and his sincerity to accomplish his task,” he said.
“That said, we advised Sec. Galvez to mind his back, front, left and right sides. He may have the best of intentions but there may be people pushing him out front to do the talking and explaining to take advantage of his credibility while pursuing their own interests,” he added.
Lacson said that Galvez has assured senators that he will make it “very hard for those people to even have an opening for that opportunity.”
UNTV is a major TV broadcast network with 24-hour programming. An Ultra High Frequency station with strong brand content that appeal to everyone, UNTV is one of the most trusted and successful Philippine networks that guarantees wholesome and quality viewing experience.