Faberco Life Sciences Inc. , Philippine distributor of Covovax, said it will proceed with the application for the emergency use authorization (EUA) of the vaccine with the Food and Drug Administration (FDA).
In a statement, Faberco said it will use published data and other relevant information provided by Serum Institute of India (SII) in applying for the EUA.
This follows the global announcement last Tuesday of the final efficacy analysis of the UK Phase 3 trials of the said vaccine.
Faberco also said Novavax in the US yesterday announced the vaccine provides 100 percent protection against severe cases of the new coronavirus disease 2019 (COVID-19) and 96.4 percent efficacy against original strain of the virus.
The UK Phase 3 trials concluded that Covovax registered a 90.9 percent efficacy in adults with high-risk medical comorbidities and 88.9 percent. efficacy in adults over the age of 65 years old.
Faberco said trials results confirmed the vaccine provides 100 percent protection against severe diseases caused by the South Africa and UK variants of COVID 19. It also showed 86.3 percent efficacy against B.1.1.7 UK variant and 55.4 percent efficacy among HIV-negative participants, with the vast majority of cases due to the B.1.351 South Africa escape variant.
“The UK Phase 3 results are now submitted for publication. South Africa Phase 2b results were published in the prestigious New England Journal of Medicine,” Faberco said.
Due to the encouraging results, numerous studies have been expanded to include adolescents (12-17 years old), pregnant women, as well as on its potential use as booster and in combination with other COVID-19 vaccines, and for seasonal revaccination.
With new developments announced by Novavax, Novavax has expanded its manufacturing capacity, with several partners including world’s largest vaccine manufacturer, SII, to meet the global demand to fight COVID-19 pandemic.
Faberco and SII target to commence delivery of the vaccines in the third quarter of this year.
Faberco added Covovax is anchored on its basic strengths which make it ideal for rollout in the Philippines: high efficacious, highly adaptable platform, stability at two- to eight- degree Celsius, and its favorable safety profile.
