Covaxin phase 3 trial results to be out in July: Bharat Biotech
Hyderabad-based vaccine maker Bharat Biotech said on Wednesday it will release the results of phase 3 clinical trials of its coronavirus shot only in July, a month later than the previously announced timeline of June.
The Bharat Biotech shot, Covaxin, is one of the three vaccines currently approved in India for emergency use owing to the pandemic. It was given a go-ahead in January without having carried out phase 3 trials at the time. The company released interim data in April that showed the vaccine was very effective.
The firm told news agency ANI on Wednesday it will release its data to the public in July, submit it to the Central Drugs Standard Control Organisation (CDSCO) for a full license application, and give the results for a peer-review.
The interim analysis of the trials has shown an efficacy of 78% against symptomatic disease, and 100% protection from serious illness, according to the company.
“It is critical to understand, and further emphasise the phase-3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier, COVAXIN phase 3 results full trial data will be made public during July. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN,” Bharat Biotech told ANI on Wednesday. At the time of releasing the interim data, the company said the data was likely to be released in June.
The company’s project head for Covaxin, Raches Ella, made a similar statement on Twitter.
But usually, companies do publish data much before they apply for full licensure. Moderna, for instance, whose vaccine was approved in the US under the same emergency use authorisation, published its peer-reviewed preliminary results 12 days later in late December. AstraZeneca/Oxford published peer-reviewed efficacy results earlier in December, ahead of its approval in the UK.
People aware of the matter also said Bharat Biotech will further collate real-world data from people who are being administered the shot in the country.
Experts say the data should be put in public domain for independent analysis. “Trial data should ideally be published in peer-reviewed top medical journal so that those people who are not a part of the clinical trial can study it, question it and cross-check the legitimacy of the trial,” said CM Gulhati, editor, Monthly Index of Medical Specialities (MIMS), pharmaceutical reference guide.
The phase 3 study held this year enrolled 25,800 participants between 18-98 years of age, with analysis conducted 14 days post second dose. Covaxin was developed with seed strains received from the National Institute of Virology under the Indian Council of Medical Research (ICMR).