Philippines approves emergency use of Pfizer-BioNTech’s COVID-19 vaccine

Marje Pelayo   •   January 14, 2021   •   842

MANILA, Philippines — The Food and Drug Administration (FDA) on Thursday (January 14) granted emergency use authorization (EUA) for the coronavirus disease (COVID-19) vaccine developed by US pharmaceutical giant Pfizer Inc. and its German partner BioNTech SE.

The approval followed issuance of Executive Order No. 121 s. 2020, which grants vaccines under development an EUA “where there is no adequate, approved and available alternative to a vaccine for preventing COVID-19 during this present public health emergency.” 

The FDA clarified, however, that the EUA does not mean that the vaccine would be available for use as the country has yet to settle an agreement for its supply.

“The granting of the EUA is not a marketing authorization or a Certificate of Product Registration, hence this cannot be used to market the vaccine commercially,” the FDA explained.

Pfizer-BioNTech’s COVID-19 vaccine, which boasts a 95% efficacy rate, is expected to arrive in the country by February according to vaccine czar Carlito Galvez Jr., in a meeting with President Rodrigo Duterte on Wednesday evening (January 13).

“After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine,” Director General Eric Domingo said.

“The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups,” he added.

Domingo noted the adverse events that happened in other countries following the inoculation of the vaccine. 

Thus, he said, close monitoring of the COVID-19 immunization programs is necessary to ensure adverse reactions will be properly addressed.

“The roll out of the vaccine and use in more than five million people worldwide has identified severe allergic reaction in a few individuals,” Domingo said.

“Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond,” he added.

The FDA noted also that reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented.

No need for vital signs screening before COVID-19 vaccination, DOH says

Robie de Guzman   •   May 14, 2021

MANILA, Philippines – The vital signs screening will no longer be included in the vaccination process against COVID-19 as part of efforts to expedite the immunization in the country, the Department of Health (DOH) said Friday.

In an online press briefing, Health Undersecretary Maria Rosario Vergeire said they have already issued guidelines regarding the matter after DOH advisors and vaccination experts approved the recommendation from the Philippine Heart Association and the Philippine Society of Hypertension.

She said the new policy was approved after a DOH time and motion study found that walk-in vaccine recipients and the vital signs screening were causing long queues in vaccination sites.

“Meron na ngayong patakaran here in Metro Manila ang ating mga local government, only those master listed should go to the vaccination site kaya lang ngayon siyempre ang mga kababayan natin, very eager sila na magpabakuna na kahit hindi sila yung scheduled for that day, they go to the vaccination site, so that’s one,” Vergeire said.

“Pangalawa, nakita natin na there are certain processes within our system na nakakatagal talaga and one of those would be the vital signs screening, yung pag-BP (blood pressure), pagkuha ng temperature, pagkuha ng pulse rate, ng heart rate,” she added.

Under the new guidelines, Vergeire said that healthcare workers only need to closely monitor individuals with established hypertension or organ damage prior to their vaccination.

“Ang kailangan lang nating bantayan, especially for the blood pressure, would be yung blood pressure na 180/120 or more. Pero yung iba, kahit tumataas yung presyon, maaari pa rin naman natin silang bakunahan,” she said.

“Naglagay rin tayo sa guidelines natin na there should be a separate lane para sa mga taong gusto nating obserbahan because of their established history ng kaniang mga sakit para hindi po sila nakakadagdag doon sa pila,” she added.

Vergeire also said that the DOH is eyeing to expand vaccination sites to help speed up the rollout.

The health official also noted that the public confidence in COVID-19 vaccines has increased citing a survey they conducted in March.

Vergeire said the poll showed that 75 percent of respondents said that they are willing to get immunized if a vaccine was available, and 85.8 percent said they would get inoculated if they knew that the vaccines were safe and effective.

“Nakita po natin yung pagtaas talaga ng kumpiyansa ng ating mga kababayan noong nakita nilang marami na ring nababakunahan,” she said.

The Philippines has so far administered over 2.5 million doses of the COVID-19 vaccine, with over 500,000 who are fully vaccinated.

No wastage: Galvez assures soon-to-expire AstraZeneca vax doses will be used up by June 15

Robie de Guzman   •   May 13, 2021

MANILA, Philippines – Vaccine czar Carlito Galvez Jr. on Thursday allayed public concern that the two million doses of AstraZeneca COVID-19 vaccine from the COVAX facility will expire before they could be used in the government’s mass vaccination program.

Galvez said the deployment and administration of these doses have been planned and that vaccination sites have already been advised to use up these jabs by June 15.

The vaccine czar issued the statement following reports that the British-Swedish vaccine doses that recently arrived in the Philippines are nearing expiration.

“We believe iyong AstraZeneca, we can manage that considering that our daily inoculation right now is 83,000, and it will further increase over the days considering we are increasing our capacity,” he said in an event in Makati Medical Center.

“When we computed on the daily output that we have, kaya natin imanage ang Astrazeneca. By June 15, we are expecting matatapos po lahat po iyon,” he added.

Galvez said that based on the plan of the Department of Health, the 1.5 million doses of AstraZeneca vaccine expiring on June 30 will be used as first doses while the over 500,000 doses set to expire in July will be administered as second doses of those previously vaccinated.

The Department of Health (DOH) earlier said that its vaccine operations center has prepared mechanisms for the immediate rollout of COVID-19 vaccines.

The DOH also said that vaccine candidates against coronavirus have a relatively short shelf life.

“We’ll be giving these vaccines as first dose because WHO (World Health Organization) has committed that they will be providing the vaccine for the end of May or first week of June,” Health Undersecretary Mari Rosario Vergeire said.

“Almost all vaccines ngayon walang mahahabang expiry date,” she added.

15K second doses of Sputnik V COVID-19 vaccine arrive in PH

Robie de Guzman   •   May 13, 2021

MANILA, Philippines – Another batch of Sputnik V COVID-19 vaccines manufactured by Russia’s Gamaleya Research Institute was delivered to the Philippines on Wednesday.

The 15,000 doses of vaccines arrived past 9 p.m. at the Ninoy Aquino International Airport (NAIA) Terminal 3.

The National Task Force (NTF) against COVID-19 said the newly delivered doses were Component 2 or the follow-up dose of the initial batch of Sputnik V vaccines that arrived in the country last May 1.

It can be recalled that the first batch of Sputnik V vaccines were used in a logistical run to prepare for the arrival of additional doses.

The Food and Drug Administration earlier said that Sputnik V vaccines must be stored at a temperature around -18 degrees Celsius.

Five cities in Metro Manila received the initial batch as they have the cold storage facilities required for the vaccines.

NTF against COVID-19 and vaccine czar Carlito Galvez earlier said that this shipment is part of a 10-million dose agreement between the Philippine government and Gamaleya Research institute that are expected to arrive in the next four months.

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