FDA clarifies donated vaccines require authorization, evaluation

Marje Pelayo   •   January 21, 2021   •   316

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

Duterte: I asked Chinese Pres. Xi Jinping for help on COVID-19 vaccines but no talks on WPS

Robie de Guzman   •   May 11, 2021

MANILA, Philippines – President Rodrigo Duterte on Monday disclosed that he asked help from his Chinese counterpart Xi Jinping in obtaining COVID-19 vaccines but insisted that they did not discuss issues on the West Philippine Sea.

During his Talk to the People public address on Monday night, Duterte recalled how he called Xi when the Philippines had yet to get any supply of COVID-19 vaccines.

“Let me just also say na itong history na… for public consumption na ito. Tumawag ako kay President Xi Jinping, sinabi ko kasi noong kasagsagan ng walang dumating talaga, walang makapkap si Secretary (Carlito) Galvez (Jr.), tumawag ako, sabi ko, ‘Mr. President (Xi), I would like to ask for your help until now Philippines is at a loss on how to get vaccines,’” he said.

“Sabi niya, ‘it’s okay we will help you.’ Ganoon lang. Hindi naman sinabi na kalimutan mo yung Scarborough Shoal, bigyan kita… Sinabi niya lang as simple as that,” he added.

The Philippines first received 600,000 doses of Sinovac COVID-19 vaccines that were donated by the Chinese government on February 28. The national government used this supply to roll out its vaccination program on March 1.

In total, the Philippines has received 1 million donated Sinovac vaccine doses from China, including the 400,000 doses that were delivered in March.

Duterte stood by his earlier statement that the Philippines owes a debt of gratitude to China for all its help but emphasized that there would be no compromise on the West Philippine Sea issue.

“It’s never, never wrong to say that I owe you a debt of gratitude. Totoo eh, binigyan tayo, tinanggap natin, ginamit natin,” he said.

“But it does not mean na tanggapin ko ang bakuna tapos sabihin ko kalimutan ko na yung claim diyan sa West Philippine sea, okay na yun dahil sa bakuna… It was never like that, the world does not operate like that,” he added.

He said there would be no compromise on the issue and that China knows it.

“Maski bahain tayo dito ng vaccine, gagamitin ko pa rin pero sabihin ko ‘hindi ito kabayaran’. Iba ito. This is a Philippine national interest, this is not a health issue that nagpasalamat ako,” he said.

Correction:
An earlier version of this article misstated that “they did discuss issues.” 

DOH: NCR Plus to get most of newly-delivered AstraZeneca COVID-19 vaccine doses

Robie de Guzman   •   May 10, 2021

MANILA, Philippines — The National Capital Region (NCR) and nearby provinces of Cavite, Bulacan, Rizal, and Laguna – collectively called NCR Plus – will get the highest allocation of AstraZeneca COVID-19 vaccine doses that were delivered to the country over the weekend.

In an online briefing, Health Undersecretary Maria Rosario Vergeire said a quarter of the additional two million doses of AstraZeneca vaccines will be distributed in Metro Manila followed by areas in the Central Luzon and Calabarzon regions.

“Nasa NCR Plus bubble po yung pinakamataas na alokasyon dahil alam naman po natin yung focus natin so we can be able to have herd containment here in this epicenter of this disease,” she said.

The health official said the allocations have been prepared and the vaccines will be distributed starting Monday.

“Nagawa na yung allocation list and ready to deploy na tayo starting today,” she said.

Other regions will also receive AstraZeneca vaccines but Vergeire did not specify the allocation breakdown.

The additional doses of AstraZeneca vaccines from the World Health Organization (WHO)-led COVAX Facility arrived in the country on Saturday.

The fresh vaccine supply was delivered after Philippine health authorities announced last Friday the official resumption of AstraZeneca vaccine administration for eligible populations.

The DOH previously suspended the use of AstraZeneca vaccines following the recommendation of the local Food and Drug Administration (FDA) to temporarily halt its use on persons below 60 years old after reports of “very rare” cases of Vaccine-Induced Thrombosis and Thrombocytopenia (VIIT).

VITT is a very rare condition of blood clots associated with low platelet counts that can occur 4 to 28 days after receiving a viral vector vaccine such as AstraZeneca, the DOH said.

“After discussions with the DOH All Experts Group and the Philippine College of Hematology and Transfusion Medicine (PCHTM), it was concluded that there are currently no known risk factors for VITT and that the benefits of receiving the vaccine against COVID-19 still outweighs the risk,” the department said in an earlier statement.

The DOH, however, said that specific guidelines and measures will still be enforced to mitigate the risks of vaccination.

Healthcare workers (HCWs) in vaccination sites will also be trained to detect and manage possible symptoms of VITT and refer them accordingly to the appropriate health facility for definitive workup and management.

WHO approves Sinopharm COVID-19 vaccine for emergency use

Robie de Guzman   •   May 10, 2021

China’s Sinopharm COVID-19 vaccine will now be rolled out globally after it was approved for emergency use listing (EUL), the World Health Organization (WHO) said.

In an announcement, WHO director general Tedros Adhanom Ghebreyesus said the EUL granted for Sinopharm COVID-19 vaccine will expand the list of vaccines that the COVAX facility can provide to poor countries in need of vaccine supply.

“This expands the list of COVID-19 vaccines that COVAX can buy, and gives countries confidence to expedite their own regulatory approval, and to import and administer a vaccine,” Tedros said in a briefing on May 7.

WHO’s emergency use listing is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products said in a separate statement.

The WHO said the EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements.

The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions, it added.

In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility, the health body said.

The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). Its easy storage requirements make it highly suitable for low-resource settings. It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.

This is the first vaccine developed by a non-Western country to receive WHO backing. It is also the first time the WHO has given emergency use approval to a Chinese-made vaccine for any infectious disease.

The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a unit of Sinopharm subsidiary China National Biotec Group.

Following the approval, the WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks.

On the basis of all available evidence, the WHO said the vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79%, all age groups combined.

The WHO, however, noted that only few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group.

“Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons,” it said.

“There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations.  WHO therefore recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust,” it added.

Other COVID-19 vaccines included in WHO emergency use listing are those produced by Pfizer/BioNTech, AstraZeneca, Janssen (Johnson& Johnson) and Moderna.

REACH US

The Philippine Broadcast Hub

UNTV, 915 Barangay Philam,

EDSA, Quezon City M.M. 1104

(+632) 8396-8688 (Tel)

info@untv-newsandrescue.com (General inquiries)

ABOUT UNTV

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.