Manila: The Food and Drug Administration (FDA) of the Philippines gave an emergency use authorisation (EUA) on Wednesday for Covovax vaccine manufactured by the Serum Institute of India.
The brand is manufactured by Serum Institute of India (SII). Covovax, a protein subunit vaccine, was developed by the US biotech company Novavax.
In approving the vaccine, FDA Director General Eric Domingo said Covovax has an efficacy rate of 89.7%. The EUA states Covovax may administered to individuals aged 18 years old and above.
“This is a new kind of vaccine, which is called a protein subunit vaccine. It will replicate a pure part of the antigenic portion of the virus. This will be then injected to elicit an immune response,” he told local media on Wednesday.
The FDA said Covovax will be given in two doses and should not be less than 21 days apart.
"Clinical trials show that it has very mild adverse effects. It also has a good safety profile,” said Domingo. Rollout for Covovax will be from the end of the year or in 2022, the official added.
The Covovax/Novavax vaccine is still under the WHO’s regulatory scrutiny. SII is expected to manufacture 1 billion doses of the Covovax vaccine for supply to low- and middle-income countries by the end of 2022, according to the India media reports.