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

Marje Pelayo   •   January 14, 2021   •   815

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.

Bulk of COVID-19 vaccine deliveries expected to arrive in PH starting June — Galvez

Robie de Guzman   •   April 20, 2021

 

MANILA, Philippines – The Philippine government expects to receive the bulk of COVID-19 vaccine deliveries from June to August, which could speed up the country’s mass vaccination drive, vaccine czar Secretary Carlito Galvez Jr. said.

In his report to President Rodrigo Duterte during a meeting in Malacañang on Monday, Galvez said they are expecting around 10 to 15 million vaccine doses by August.

Galvez also reported that he has secured five contracts with different drug makers and that the financing schemes are currently being ironed out.

These firms include Sinovac, AstraZeneca, Moderna, Novavax, and Gamaleya Institute, he said, adding that Johnson & Johnson already received an emergency use authorization (EUA) for its Janssen COVID-19 vaccine from the Food and Drug Administration (FDA).

“‘Yong Sinovac, ito ang pinaka-steady supply natin at saka po ‘yong Gamaleya. Pagka nagkaroon na tayo ng initial delivery, magiging steady na,” he said, adding he expects Moderna and AstraZeneca to also make their vaccine deliveries soon.

For this quarter, the government is eyeing to receive two million doses of COVID-19 jabs. Around 500,000 vaccine doses of these will come from Sinovac, 20,000 doses from Gamaleya and 195,000 doses from Pfizer through the COVAX facility.

Philippine Ambassador to Russia Carlos Sorreta said at least 20,000 doses of Gamaleya Institute’s Sputnik V vaccine will be delivered in the next few days.

According to Galvez, the Sputnik V vaccine doses will be a mini rollout as the Russian pharmaceutical company conducts testing in the Philippines.

Galvez also reported that once the bilateral agreements are completed, Pfizer could make an early delivery of 2.4 million doses in the second quarter.

“And then sa May mayroon tayong ini-expect na four million; two million po sa Sinovac. Ito nabayaran na po ‘to natin, mahal na President, ‘yong 3.5 million na 1.5 million sa April at saka two million sa May,” he told the Duterte.

The vaccine czar also disclosed that the Philippine government expects to sign a contract with Gamaleya on Tuesday after ordering around one to two million doses from the Russian drug manufacturer.

Galvez added that he is also looking at getting 194,000 doses from Moderna.

The Philippines has so far vaccinated over one million Filipinos against COVID-19.

Some 965,960 healthcare workers have received the first doses of the jab. There are 132,948 senior citizens and 180,315 persons with co-morbidities who also received the shot.

20K Sputnik V COVID-19 vaccine doses to arrive in PH ‘in next few days’ – envoy

Robie de Guzman   •   April 20, 2021

 

MANILA, Philippines – Around 20,000 doses of Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Institute are expected to be delivered within the next few days, the Philippine ambassador to Russia announced Tuesday.

“My understanding is that we have complied with their requirement because they would not deliver unless they are satisfied with our logistics,” Ambassador Carlos Sorreta said during a Palace briefing.

Sorreta said the initial batch of Sputnik V vaccine doses would be used to “fine-tune” logistics to ensure that the vaccines’ temperature requirement will be met.

Sputnik V vaccine needs to be stored at a temperature of -18 degrees Celsius.

Sorreta also reported that an additional shipment of nearly 500,000 doses will arrive in the Philippines before end of April or early May.

“Over the next few months, we’re going seven figures, about 20 million doses before the end of the year,” he said.

“I think there will be delivery as scheduled based on the agreement signed by (vaccine czar) Secretary (Carlito) Galvez,” he added.

Galvez earlier said that the government is expecting to receive 20 million doses of Sputnik V this year.

Sorreta said the delivery of Sputnik V vaccines to the Philippines took a while due to some issues that needed to be addressed.

“We are happy about this development, although it took a while. It was unavoidable. The FDA, ginagawa nila ang kanilang trabaho ngunit merong konting differences sa terminologies, sa technologies so that those have been overcome,” he said.

He also expressed optimism that the Philippines will get the vaccine supply that the government requires to meet its target inoculation despite the global supply shortage.

“We have to be cognizant of the realities, the demand is very high for the vaccine and the best we can do it to try to lock in the supplies,” he said.

“Of course, we have to manage expectations. There could be problems in production. Many things can come up,” he added.

The country has so far received over 3 million COVID-19 vaccine doses made by Sinovac and AstraZeneca firms. More than 1.4 million of these doses have been administered to healthcare workers, senior citizens and persons with co-morbidities.

The government rolled out its COVID-19 vaccination program on March 1 and is targeting to inoculate 70 million people this year.

Philippines approves emergency use of J&J, Bharat Biotech COVID-19 vaccines

Marje Pelayo   •   April 20, 2021

MANILA, Philippines – The Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the COVID-19 vaccines of Bharat Biotech International and Janssen Pharmaceuticals, FDA Director General Eric Domingo confirmed Monday (April 19).

The agency, however, has not released details on the indication and contraindication of the vaccines as well as the procedure of administration and to whom it should be prescribed.

India’s Bharat Biotech is known for its Indirab rabies vaccine while Janssen Pharmaceuticals is the medical research and pharmaceutical product development arm of the New Jersey-based American corporation Johnson & Johnson.

To date, six pharmaceutical companies have applied and have been granted EUA for their vaccines in the Philippines.

These are Pfizer Biontech, Gamaleya, Astrazeneca ,Sinovac , Bharat Biotech and Janssen.

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