PHL distributor of Covovax expects EUA approval soon


After Novavax, a US biotechnology firm which received the Emergency Use Authorization (EUA) for its Covid-19 vaccine Covovax in Indonesia, the vaccine’s local distributor, Faberco Life Sciences Inc. (Faberco) announced on Thursday that they expect to receive similar approval in the Philippines in the next few weeks.

“We welcome this development and look forward to the start of the global rollout of Covovax,” said Faberco founding member and Board Chairman Vinay Panemanglor.

Panemanglor said that Covovax  has high efficacy and safety levels, adding he is anticipating an EUA approval from the Philippine Food and Drug Administration (FDA) shortly following the Indonesian EUA.

“We have completed all submissions and are ready to start shipment as soon as we get the approval,” the Faberco official added.

Novavax Inc. announced on October 31 that applications for approval of the vaccine have now also been submitted to Health Canada and TGA-Australia, in addition to previous submissions to the European Medicines Agency, UK-MHRA, India, Philippines, as well as for Emergency Use Listing with the World Health Organization.

“We expect regulators in India, the Philippines and elsewhere to make a decision within weeks,” Novavax Chief Executive Stanley Erck.

Phase 3 clinical trials for Covovax demonstrated a 93.2-percent efficacy rate on variants of concern and interest, including Delta. Studies also confirmed 90 percent overall vaccine efficacy seven days after the second dose and 100 percent efficacy against severe disease.

In another interview, Erck said Covovax is also “ideal for boosting.”

This is based on a Phase 2 study in the US and Australia conducted in August 2021 that demonstrated a booster dose of Covovax given six months after an initial two-dose regimen elicited a 4.6-fold increase in functional antibody titers.

Additionally, functional antibodies cross-reactive with the Delta variant were more than six-fold higher than the primary vaccination series.

Erck expects that breakthrough Covid infections will soar without boosters, and that Covovax could be a good option for those who had taken other shots. This is subject to approval by the FDA in the country and other regulatory authorities.

Faberco Life Sciences Inc. is a privately owned Philippine biopharmaceutical company that was established in 2017 aiming to be a leading provider of affordable, accessible, and quality pharmaceutical products from reputable international manufacturers at the forefront of innovative product platforms, always keeping in mind high-quality standards.

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