India’s Bharat firm applies for Philippines EUA

MANILA, Philippines — India’s Bharat Biotech has applied for emergency use authorization (EUA) for its COVID-19 vaccine, the Food and Drug Administration (FDA) reported yesterday.

“They submitted an application this (Thursday) morning and pre-evaluation is ongoing,” FDA director general Eric Domingo said.

Bharat’s local distributor, Ambica International Corp. and Family Vaccine (FVSC), filed the application for Covaxin, which previously secured EUA in India.

Aside from Covaxin, four other COVID vaccines have applied for EUA in the country.

India recently launched the world’s biggest vaccination drive using two locally developed vaccines, including Covaxin.

So far, only the vaccine developed by US company Pfizer has been granted EUA by FDA. The rest of the applications are still undergoing evaluation.

Health Undersecretary Maria Rosario Vergeire said authorities have to be strict in evaluating EUA applications to ensure that only safe and efficacious vaccines are used in the country.

On Wednesday, the Department of Health (DOH) said the country has received confirmation of participation in the COVID-19 vaccine-financing instrument, COVAX Facility-Advance Market Commitment (AMC).

“With the country’s participation in the COVAX Facility, the country is set to receive vaccines in the first quarter of this year,” DOH announced in a statement.

The COVAX Facility is a global procurement mechanism, which invests in a broad portfolio of promising vaccine candidates to support their research, development and manufacture.

The other day, Health Secretary Francisco Duque III and vaccine czar Carlito Galvez Jr. visited three cold storage facilities that can be used in the first wave of COVID-19 vaccine rollout.

The cold chain facilities visited were the First Pioneer Distribution Center of UNILAB located in Biñan City, Laguna, Research Institute for Tropical Medicine (RITM) in Muntinlupa City, and the Zuellig Pharma Corp. in Parañaque City.

According to UNILAB, their cold storage facility has a temperature range of +2 to +8 °C and can store a maximum of five million doses of vaccines while Zuellig Pharma reported that its facilities can accommodate pharmaceutical products with temperature requirements ranging between -80°C and +25 °C.

Zuellig further noted that its +2 to +8 °C cold rooms can store up to 629 million doses in various warehouses, while its -15 to -25 °C walk-in freezers can hold up to 40 million doses. The firm’s 14 ultra-cold freezers with -80 to -70 °C temperature range have the capacity to store up to 6.5 million doses.

RITM currently has four cold rooms with a +2 to +8 °C temperature range, one -20 °C walk-in freezer, and two borrowed ultra-low temperature freezers with a -70 to -80 °C temperature range. RITM has committed its ultra-low temperature storage facility.

Exclusive handling

Galvez has recommended the creation of another team at the RITM to exclusively handle the COVID-19 vaccine deployment, saying a separate team for EPI (Expanded Program of Immunization) vaccines would ensure uninterrupted focus on immunization programs.

Duque said the vaccine cluster is also in talks with third-party logistics providers to ensure efficiency of the entire supply chain management of COVID-19 vaccines from the receipt of vaccines from the COVAX Facility to its deployment.

“All of these preparations that we are undertaking are aimed at ensuring that the country is ready to receive, store and mobilize the COVID-19 vaccines that will come from the COVAX Facility,” Duque said.

At a briefing yesterday, Galvez said he expects the government’s vaccination program to begin in May.

“The best-case-scenario for the Covid-19 vaccination is May 2021. One of our indications for the COVID-19 vaccination is the supply and demand,” Galvez said at a press briefing yesterday.

He urged the public to continue adhering to health protocols and minimum health standards while waiting for the vaccine rollout.

“To be realistic, we have to see the worst-case scenario that the vaccine might be available by the end of the year… considering the constraint of the different supply chain wherein the demand of the vaccine is worldwide,” Galvez said.

“I’m thankful to the private sector for throwing their support to us, like what they did when we ramped up our testing capacity,” he said.

Galvez said that in its vaccination roadmap, the government could draw lessons from the COVID-19 testing program where “both the public and the private sector were mobilized together.”

“We will do the same here, the vaccination—we will make it available to the public, particularly for those most vulnerable people and the indigents,” Galvez said.

Let LGUs buy vaccines

Meanwhile, Sen. Christopher Go has expressed support for a Senate resolution allowing local government units to buy their own COVID-19 vaccines for constituents. With the guidance of the national government, Go said that this should expedite the process of procuring sufficient supply of safe and effective vaccines for all Filipinos.

He said giving LGUs authority to purchase FDA-approved vaccines would help the country undertake a massive vaccination program. He said many LGUs have enough funds to make their own purchase.

Go said the problem now is supply as some affluent countries have purchased more than what they need.

“They were able to make downpayment a few months ago because they wanted to make sure. We haven’t paid anything or signed any supply agreement, but there’s much fighting and mistrust,” he said in Filipino.

Go appealed to the executive and legislative branches of the government for greater unity so the country can start the rollout of its vaccination program.

Go also emphasized that the Senate, which is investigating the government’s vaccine program, wants to assure the public that there would be transparency in the procurement of vaccines.

“What we want is transparency, as a legislator, as a senator, we want transparency. We don’t want the people to doubt and we don’t want even a single peso to go to waste,” he said.  — Cecille Suerte Felipe, Jose Rodel Clapano