Moderna might apply for EUA of COVID-19 vaccine in ‘next few weeks,’ Novavax to follow: FDA

Kristine Sabillo, ABS-CBN News

Posted at Feb 09 2021 01:25 PM

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MANILA — The Food and Drug Administration (FDA) of the Philippines said Tuesday it expects two other COVID-19 vaccine frontrunners to soon apply for emergency use authorization (EUA) in the country.

“Baka posible na mag-apply in the next few weeks - baka Moderna (For Moderna, they might apply in the next few weeks). They have already asked us questions and we gave them information on the process,” FDA Director General Eric Domingo said during a Laging Handa briefing.

“Siguro, mga susunod natin, Novavax na galing sa Serum Institute of India,” he added.

(After that, we might have Novavax from the Serum Institute of India.)

The Philippines, which has lagged behind its Southeast Asian neighbors in the rollout of COVID-19 vaccines, is set to receive 20 million doses of Moderna’s product and 30 million doses from Novavax.

Currently, only American company Pfizer and United Kingdom-based AstraZeneca have EUA’s in the Philippines. This allows their vaccines to be used in the country’s national immunization program. An EUA does not allow the commercial selling of the vaccines.

The country expects the arrival this month of vaccine supplies from Pfizer and AstraZeneca under the COVAX facility, after which, inoculation of the target population may immediately begin, according to Presidential spokesman Harry Roque.

Both Moderna and Novavax are American companies as well, although the latter has a manufacturing agreement with the Serum Institute of India.

Other vaccine frontrunners (or those that already reached Phase III clinical trials) that have applied for EUA in the Philippines are China’s Sinovac and Russia’s Gamaleya Institute.

“(For) Sinovac at Gamaleya, we’re still waiting for some answers to queries by experts and some documents para sa side ng production and quality ng product,” Domingo said.

(For Sinovac and Gamaleya, we’re still waiting for some answers to queries by experts and some documents on the production and product quality.)

While Sinovac is reported to have already been approved for public use in China, it has not given the Philippines' FDA a copy of such authorization for general use, Domingo said.

“Ongoing ang evaluation ng Sinovac at hopefully matapos na sa lalong madaling panahon,” he said.

(The evaluation of Sinovac’s application is ongoing and hopefully it is completed soon.)

Sinovac has pledged 25million doses of its COVID-19 vaccine to the Philippines.

Domingo said Bharat Biotech from India, which also applied for EUA in the Philippines, still has not submitted its Phase III trial results, restraining the FDA from starting its evaluation process.

The Philippines' COVID-19 vaccine czar, Sec. Carlito Galvez, Jr., said last Sunday that the country expects to receive a total of around 152 million doses of vaccines against the coronavirus.

He said the country has so far signed term sheets with 5 drugmakers amounting to some 108 million doses of COVID-19 vaccine, on top of the 44 million that the World Health Organization said it would give under the COVAX Facility.

"More or less 152 million doses na po tayo. Kung titingnan po natin, ididivide po natin sa dalawa, meron na po tayong more than 75 million na mababakunahan," he said in an interview on ABS-CBN's TeleRadyo.

(More or less, we have 152 million doses. If we divide it to two, we can vaccinate more than 75 million people.)

The Philippines has logged 538,995 confirmed COVID-19 cases, as of Monday, including 27,992 active infections, 11,231 fatalities and 499,772 recoveries.