SII to US: Need raw materials for Covovax, not Covishield

SII WAS PLANNING TO START AT-RISK MANUFACTURING OF COVOVAX IN LATE APRIL, BUT COULD NOT DO SO DUE TO LACK OF RAW MATERIALS

Serum Institute of India (SII) has approached the US government to clarify that it requires the supply of raw materials for Covovax and not Covishield, as was announced by the White House earlier this week since the lack of raw materials is holding back the vaccine maker from starting at-risk manufacturing of Covovax.

“SII is in talks with top officials from the US government directly. They are trying to understand why they were given raw materials for Covishield when they asked for help for Covovax. That has been their position constantly because they need to start production of Covovax, but are facing a shortage of raw materials,” a person aware of the development said on condition of anonymity.

SII had earlier indicated it was planning to start at-risk manufacturing of Covovax—mass production of a medical product even before it gets regulatory clearance—in late April, but has not yet started it due to lack of raw materials, the person said.

A senior government official, on condition of anonymity, said that India is hopeful that the US government will allow the supply of raw materials for Covovax as well after they had allowed supply for Covishield.

Covovax is the next vaccine that SII, the world’s largest vaccine maker, will manufacture after Covishield. The vaccine, which has only the spike protein part of SARS-COV2, was originally developed by US-based Novavax, which had signed a pact with SII, wherein the latter would manufacture about 1 billion doses of Covovax for supply to India and other low- and middle-income countries. SII chief executive officer Adar Poonawalla had earlier indicated that, like Covishield, about half of

Covovax produced by it will be reserved for India.

Novavax has shown efficacy of 96% against the original strain of the virus and 89.7% efficacy overall in a phase 3 trial of 15,000 participants in the UK. The efficacy against the original strain is the highest for any vaccine. In another trial in South Africa, where the mutant strain was dominant, it showed an overall efficacy of 48.6%, lower than the threshold of 50%, but still higher than some other vaccines, including Covishield.

Novavax is conducting another 30,000-participant phase 3 trial in the US and Mexico and has applied to the US Food and Drug Administration for emergency use authorization (EUA) based on available efficacy data from the UK and South Africa trials. SII is conducting a phase 2 and 3 bridging study to prove that Covovax produces the same immune response as Novavax’s jab. While currently, the company has set a September date for the launch of Covovax, it is considering applying for emergency clearance from the drugs controller early once the USFDA grants an EUA, Poonawalla said last week.