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

Marje Pelayo   •   December 3, 2020   •   410

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)

Manila City allows walk-ins in all vaccination sites

Aileen Cerrudo   •   June 21, 2021

MANILA Philippines — The Manila City Government on Monday (June 21) now allow walk-ins in all vaccination sites.

According to Manila Public Information Office (MPIO), the directive of Manila Mayor Isko Moreno was after having a low turnout in vaccination sites. The mayor said he directed not to allow walk-ins in order to prove to critics the effect if the system would only be done through scheduling.

“I’m not a believer of scheduling but we tried it today para doon sa mga may mema, iyong  may masabi lang ang naggagaling-galingan lang (for those who just wanted to complain),” he said.

The Manila local government reported that only 4,210 doses were administered on Monday (June 21) from the 28,000 allocated doses. AAC

No favoritism in deployment of Pfizer COVID-19 vaccine doses – DOH

Robie de Guzman   •   June 21, 2021

MANILA, Philippines – The Department of Health (DOH) on Monday denied claims it is favoring certain areas when it comes to the distribution of COVID-19 vaccine manufactured by American drug firm Pfizer-BioNTech.

The DOH issued the statement following reports that Davao City has received a substantial number of Pfizer jabs.

Davao City is President Rodrigo Duterte’s hometown.

Health Undersecretary Maria Rosario Vergeire stressed that the national government is not giving any preferential treatment and that available vaccine doses in the country are allocated based on need and the prioritization framework.

“Wala pong paborito, base lang po sa pangangailangan, base lang po sa prioritization framework,” Vergeire said during a press briefing.

Reports claimed that Davao City got a huge number of Pfizer vaccine doses while other regions in Mindanao received fewer jabs.

But Dr. Adbullah Dumama Jr., DOH Undersecretary for the Visayas and Mindanao Field Implementation and Coordination team, said the 210,000 doses for Davao is for the whole region and not only for the City.

The same amount of Pfizer jabs were also allotted for Cebu Province, he added.

“Wala pong pagkakaiba yung doses na naibigay sa Cebu at sa Davao… Wala hong favoritism dito,” he said in the same briefing.

 “Hindi po ito pang Davao City lang. Sa Davao region po ito at yung mga karatig pook na merong mga pangangailangan sa Pfizer,” he added.

Dumama also said that Davao and Cebu areas were given Pfizer shots because they have ultra-low freezers that are capable of storing the vaccine.

“Nabigyan lang ito ng ganun kalaki [na allocation], kung sa palagay ninyo ay malaki, ay dahil sa tayo ay mayroong capability, meron po tayong ultra-low temperature freezers dito. Doon ho sa ibang lugar, wala pa pero dahil sa dito lang ito, maaari kaming magbigay as ibang lugar na nangnangailangan,” he said.

According to Vergeire, there are only five areas in the country that have yet to receive Pfizer vaccines due to lack of appropriate vaccine storage capability. There are the Bangsamoro region, Caraga, Regions 12, 5 and Mimaropa.

The Bangsamoro government earlier said it will pass a resolution that would authorize the procurement of ultra-low freezers and increase its vaccination centers in the region.

The national government has announced it has inked a deal with Pfizer-BioNTech for the purchase of 40 million doses, which may be delivered starting August this year.

The DOH said it is now preparing to capacitate all regions in the country to handle the storage of Pfizer vaccines.

 

PH, Pfizer ink deal for 40M doses of COVID vax, delivery starts in August

Marje Pelayo   •   June 21, 2021

MANILA, Philippines – The Philippine government and American multinational pharmaceutical company Pfizer signed a supply agreement for 40 million doses of Pfizer-BioNTech COVID-19 vaccine.

Vaccine Czar Secretary Carlito Galvez Jr. said big nations are no longer strict when it comes to vaccine supply after vaccinating most of their population.

This leads to manufacturers opening delivery arrangements with other countries.

“The vaccine demand has begun to ease up for many big and rich countries, as most of them have already acquired more than enough vaccines for their population and have vaccinated many of their citizens. This has allowed the manufacturer to commit to us that deliveries, though still to be made in tranches, will be in bulk,” Galvez said.

The initial delivery for this particular deal will happen in August.

The payment for the supply will be made through a multilateral arrangement with the Asian Development Bank.

This is the biggest vaccine procurement for this year.

To date, the Philippines has secured a total of 157 million doses of COVID-19 vaccines and these include those donated through the COVAX facility.

The first delivery of the Pfizer vaccine will coincide with the kick off of the national immunization program for the general public including children aged 12 to 15 years old. MNP (with reports from Rosalie Coz)

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