Covishield moves closer to roll-out; SII gets in-principle nod from panel

At a marathon meeting on Friday, the expert panel gave an in-principle nod to Serum Institute of India (SII), ending the country’s wait for a Covid-19 vaccine. The Subject Expert Committee (SEC), which is advising the Drug Controller General of India (DCGI) on the matter, recommended restricted emergency use authorisation for the Serum Institute vaccine. There was no official word from the DCGI—the regulator — till the time of going to press.

Bharat Biotech’s vaccine, which was also being considered by the committee for approval, has to wait. The expert committee has sought more data from Bharat Biotech on efficacy of their vaccine candidate. No fresh date has been set for the next meeting on the subject.

The green light for Covishield, a vaccine developed by the University of Oxford and British pharma major AstraZeneca, which will be made and marketed by Pune’s Serum Institute, came as a new year gift for India, a day ahead of a nationwide vaccination dry run.

India would need 30 million doses in the first phase when it vaccinates the essential services workers including health care professionals, municipal and police staff, etc. According to sources, Serum will have 100 million doses in stock within the first 10 days of January.

The expert committee has recommended that the vaccine be given restricted emergency use authorisation under certain conditions. “SII will have to closely monitor and also immediately report any adverse event once the vaccine is being given to Indian citizens. Also, informed consent (in the form of a signed document) is necessary from each one who receives the shots. Everyone would need to be explained the conditions under which the vaccine was developed and approved,” said a source in the know.

The DCGI is the final authority to consider these recommendations for a nod. The SEC has approved the two full doses regime for Covishield and the source revealed that it has 70 per cent efficacy for symptomatic people. US pharma giant Pfizer did not appear before the SEC on Friday to present its case.

SII had presented bridge trial data (on safety and immunogenicity or whether the vaccine induces the desired immune response against Sars-CoV-2 virus) from 1600 Indian volunteers apart from data from global trials from the UK and Brazil. The UK regulator had approved Oxford-AstraZeneca vaccine on December 30 for use by those 18 years or older. The SEC had met on Wednesday to discuss the same, but sought more time to review the UK MHRA approval, while asking for some more data from the firm on dosages etc.

The UK has already ordered around 100 million doses, and according to sources, SII will have a stock of 100 million doses within the first 10 days of January.

As for Bharat Biotech’s whole inactivated virus vector vaccine Covaxin, the firm had initially sought an accelerated approval based on data from phase 1 and phase 2 trials. Phase 1 and 2 trials measure the safety and immunogenicity of a vaccine candidate. “This data too has some indirect efficacy data known as surrogate marker as a person develops neutralising antibodies once the vaccine is administered and can be monitored if he catches an infection,” said a source close to the development.

Bharat Biotech also submitted some interim efficacy data from their ongoing phase 3 trials before the SEC and said that they would continue to do so while the vaccine can be given a restricted emergency use nod. The firm is conducting one of the largest efficacy trials in India and Asia on around 26,000 subjects and has already recruited more than half of its target number of volunteers. It began phase 3 trials on November 17.

According to a source, data from around 3,000 volunteers has been presented before the SEC. Bharat Biotech CMD Krishna Ella had said recently that since data from monkeys have shown the efficacy of the vaccine, and the phase 1 and 2 human trial data showed that it was safe, one could apply for marketing approval. He had said the vaccine was safe enough to be given to a six month old and a 60-year old.