American biotechnology company Novavax has applied for emergency use authorization of its COVID-19 vaccine in the Philippines, Food and Drug Administration Director General Eric Domingo confirmed to Rappler on Friday, August 6.
“They have but requirements not yet complete,” Domingo said in a text message to Rappler, when asked if Novavax has filed an application for EUA.
Rappler also asked Domingo for the exact date of Novavax’s application but he has yet to respond as of posting time.
If approved, the Novavax COVID-19 vaccine would be the ninth vaccine to become available for Philippine use. The filing with the FDA is a significant step in allowing Filipinos access to its vaccine within the year.
Vaccine czar Carlito Galvez announced in May that the Philippines signed a supply agreement securing 30 million doses of the Novavax vaccine. The agreement was the fruit of his trip to India last March 12. Serum Institute of India, the world’s largest vaccine manufacturer, produces vaccines of American pharmaceutical firm Novavax.
In July, Cavite Governor Jonvic Remulla said that he expected the arrival of 1.5 million doses of the Novavax vaccine by the third week of August or first week of September.
The FDA is expected to take at least 21 days to review the vaccine’s trial data and other information to determine the quality, safety, and efficacy of the shot on the Philippine population.
Promising clinical data
Despite promising clinical data, the Maryland-based company has lagged rival vaccine makers such as Pfizer Incorporated and Johnson & Johnson. It has repeatedly delayed regulatory filings and the timeline for ramping up production as it struggled to access raw materials and equipment needed to produce the vaccine.
Novavax earlier claimed that its protein-based vaccine was more than 93% effective against the more easily transmissible predominant coronavirus variants, such as Alpha, Beta, and Gamma, that have caused concern among scientists and public health officials.
Protein-based vaccines are a conventional approach that use purified pieces of the virus to spur an immune response, such as those used against whooping cough and shingles.
The vaccine was 91% effective among volunteers at high risk of severe infection and 100% effective in preventing moderate and severe cases of COVID-19. It was roughly 70% effective against virus variants that Novavax was unable to identify, its head of research and development, Dr. Gregory Glenn said.
Novavax said a single booster shot of its vaccine given six months after an initial two-dose regimen, elicited a 4.6-fold increase in antibodies.
Clearing Novavax’s vaccine will provide another option for the Philippines, which is battling one of the worst outbreaks in Southeast Asia driven by the Delta variant.
The country earlier cleared the vaccines of Pfizer and BioNTech, AstraZeneca, Sinovac, Gamaleya Research Institute, J&J, Bharat Biotech, Sinopharm, and Moderna for emergency use in the country. – With reports from Reuters/Rappler.com