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

Marje Pelayo   •   January 14, 2021   •   137

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.

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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