A vaccine with an overall efficacy rate of 90.4% and a 93.2% efficacy against variants of interest and concern, developed by US biotechnology company Novavax, is expected to arrive in the country in the third quarter of the year. The vaccine’s trade name in the Philippines is CovovaxTM.
This was announced by Faberco Life Sciences Inc., the local pharmaceutical firm that has secured the distribution rights to the vaccine in the Philippines.
“Manufacturing for CovovaxTM has started at Serum Institute of India, which is the largest manufacturer of vaccines in the world,” said Dr. Luningning Villa, medical director of Faberco. “The target delivery to the Philippines of the first batch of CovovaxTM vaccines is within the 3rd quarter of this year.”
Serum Institute of India has an exclusive agreement to manufacture CovovaxTM for low- and middle-income countries such as the Philippines, using the latest Covid-19 vaccine technology developed by Novovax. CovovaxTM contains the NVX-CoV2373 recombinant nanoparticle protein-based Covid-19 vaccine that demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against variants of interest and concern, 91% efficacy in high-risk populations such as the elderly and those with comorbidities, and a 90.4% efficacy overall in the latest Phase 3 clinical study conducted in the US.
“These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. The company is testing a third dose as a six-month booster, and early data suggests it produces a strong immune response.
The US/Mexico study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate the efficacy, safety, and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.
The Phase 3 trials conducted earlier in the U.K. yielded a higher overall efficacy rate of 96.4% for the original Covid-19 strain. It also showed high efficacy against predominantly circulating variants and complete protection against moderate and severe disease.
“We are very pleased with the results of the trials and look forward to providing Filipinos a new high-quality vaccine soon,” Dr. Villa said. She added that Faberco has already submitted its documents for a rolling evaluation for Emergency Use Authorization to the Philippine Food and Drug Administration (PFDA) CovovaxTM. Review and completion of requirements is currently being coordinated between the company and the PFDA.
Novavax is also part of another study currently underway in the U.K. examining mixing different vaccines. Results could bode well for a broad booster use for NVX-CoV2373. In addition, Serum Institute is preparing to conduct clinical trials to determine the efficacy of CovovaxTM on children. The study could be launched as early as July in India.
Faberco Life Sciences Inc. is a privately owned Philippine biopharmaceutical company that was established in 2017 aiming to be a leading provider of premium pharmaceutical products from reputable international manufacturers at the forefront of innovative product platforms and high-quality standards. The company ensures strict compliance with national regulatory and international standards. Aside from immunization. Faberco is invested in the areas of HIV/AIDS and other infectious diseases, family planning, immunosuppressive therapy, neurology and psychiatry (including pain management), substance use disorders (tobacco, alcohol, drug addiction), and diagnostics.