Emergency approval for COVID-19 vaccine possible in January 2021 – FDA

Marje Pelayo   •   December 3, 2020   •   269

MANILA, Philippines – The Food and Drug Administration (FDA) expects the availability of coronavirus disease (COVID-19) vaccines to be earlier than the initial plan following the approval of Executive Order No. 121.

President Rodrigo Duterte recently approved the order which authorizes the FDA to give emergency use authorization to COVID-19 drugs and vaccines.

FDA Director-General USec. Eric Domingo said the President’s decision was a surprise as they were expecting other major countries to move first.

“Nagulat din tayo sa bilis ng mga pangyayari. Ang inexpect po natin actually ay ang US at UK ay magbibigay ng EUA, end of the month ng December kaya ang ini-expect ko po talaga ay mga January pa magkakaroon tayo ng applications dito sa Pilipinas,” he said.

[We were also surprised as things happened so fast. We were expecting that the US and the UK will issue an EUA by the end of December so we were expecting applications here in the Philippines by January.]

“Pero mukhang accelerated po lahat. Ang UK nagbigay na ng EUA, ang US FDA ang balita po natin within one to two weeks magbibigay na rin sila ng EUA sa ilang kumpanya,” he added.

[But it seems everything has been accelerated. The UK already issued an EUA and the US FDA, for what we know, will issue an EUA within one to two weeks to several companies.]

Domingo said the FDA can expedite the approval process to 21 days instead of the initial plan of six months for the vaccine to be immediately available.

The official said it is possible that by the first quarter of 2021, a COVID-19 vaccine would be available because as soon as vaccine manufacturers submit their application for an EUA along with the required documents here in the Philippines, the agency will immediately process them.

Kapag nag apply po sila dito sa atin, then maaring by first few weeks of January ay meron na rin po tayong maibigay na emergency use authorization. At baka mapaaga ng kaunti or baka magkaroon ng chance na baka mga March ay magkaroon na ng bakuna dito sa Pilipinas,” Domingo said.

[Once they apply here, most likely in the first few weeks of January, we can issue the emergency use authorization. It may even be earlier, probably by March, we would have a vaccine available already here in the Philippines.]

Domingo said an approved COVID-19 vaccine will be given authorization for use in the public health program of the Department of Health (DOH).

He said the DOH will be among the agencies that will decide as to when and to whom the vaccine will be administered first. MNP (with reports from Aiko Miguel)

Marikina City eyes expansion of COVID-19 vaccine storage facility

Marje Pelayo   •   January 15, 2021

MANILA, Philippines — Marikina City may have been hit by a massive flooding in the last quarter of 2020 but the city government assures enough funding for its COVID-19 response.

In fact, the city already has a cold chain storage facility in time for the delivery of COVID-19 vaccines.

The storage, which can store up to 40,000 vials of vaccines, is fully air-conditioned and equipped with state-of-the-art vaccine refrigerators.

The city government also invested on carriers that will transport the vaccines to the vaccination sites.

The vaccines will be placed inside a specially designed package with a thermometer to ensure proper temperature while in transit. Even the syringes are exact in measurement and can only be used once.

“Ito ay may lock kaya auto disable,” Marikina City’s cold chain manager Lourdeliza de Guzman explained.

According to Mayor Marcy Teodoro, they are negotiating with two companies and the tripartite procurement for the vaccine is already in progress.

They expect the vaccines to arrive in February or within the third quarter of the year.

Also, the city government is also preparing other areas where additional vaccine storages can be established.

“Ine-expand pa rin namin ito para at least makapag hold kami ng up to 100,000 vials ng vaccine. Both 2-8 degrees and sub-zero cold storage ang aming objective,” he added.

Teodoro said Marikina City is targeting to inoculate around 270,000 or about 60 percent of its population.

It has also allotted around P80M budget in addition to the vaccines that the national government will provide.

“Iyong prioritization namin primarily one, health care workers, mga social workers, iyong mga non-medical (workers) iyong mga nasa PNP natin, barangay health workers, iyong essential workers natin na katulong natin,” Teodoro said.

“Pagkatapos (mga) senior citizens, PWD, iyong mga mahihirap, iyong mga nakatira doon sa mga settlement area ng Marikina. Tapos yung mga working population namin,” he added.

Teodoro said they are planning for a mobile vaccination which will make rounds in hospitals, resettlement sites or in other areas where vaccination is needed. MNP (with reports from Rey Pelayo)

FDA warns against purchase, use of AiDeLai face masks

Marje Pelayo   •   January 15, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Friday (January 15) warned against the purchase and use of AiDeLai face masks.

In an advisory dated January 8, the FDA said it cannot guarantee the safety and quality of the popular face mask brand because it has not gone through the agency’s evaluation process.

The regulator also warned establishments not to distribute, advertise, or sell the medical product until Product Notification Certificate is issued.

“Otherwise, regulatory actions and sanctions shall be strictly pursued,” the FDA mentioned.

The agency urges the public to always check certain products on their website www.fda.gov.ph before purchasing. MNP / Raymund David

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Gov’t eyeing to begin immunization program in February, says vaccine czar

Aileen Cerrudo   •   January 15, 2021

MANILA, Philippines — The national government is planning to begin the COVID-19 immunization program in February, according to vaccine czar Carlito Galvez Jr.

He said 50,000 of China’s Sinovac vaccines are set to arrive in the country on February 20. An additional 950,000 doses will arrive in March, and two million more in the succeeding months.

Galvez also reported that Pfizer may also provide more or less 25 to 40 million doses once negotiations are finalized. The government is also in the final stages of negotiation with drug maker Johnson & Johnson, the vaccine czar added.

“Kapag nagpirmahan po tayo baka, hopefully, kung mayroon silang excess from US at other countries pwede pong mai-deliver ito sa atin (Once the agreement has been signed hopefully, if there is excess from the United States and other countries, [the vaccines] can be delivered to us),” he told the President during a meeting in Malacañang.

Other vaccine companies that the government is in talks with include American biotechnology company Moderna, and Russia’s Gamaleya Research Institute. Gamaleya promised to deliver 50 to 100 million doses to the country.

Meanwhile, local government units have already inked a deal with Astrazeneca for a supply of around 17 million doses of COVID-19 vaccine. AAC


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