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SEC asks Panacea Biotec to submit revised protocol for phase III trials of dengue vaccine

Gireesh Babu, New Delhi
Thursday, September 30, 2021, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC) for Vaccines, under the Central Drugs Standard Control Organisation (CDSCO), has asked Panacea Biotec Ltd to submit a revised protocol for its dengue live-attenuated tetra agent vaccine prior to considering its proposal to conduct phase III clinical trial.

The SEC meeting, to review proposals and advice the Drugs Controller General (India) in matters for biologicals and Post Approval Change (PAC) proposals, held on September 21, deliberated the proposal submitted by Panacea Biotec for conduct of phase III clinical trial of dengue tetravalent vaccine, live along with the phase I and II clinical trial report.

The committee recommended that the firm needs to clarify and revise the protocol to bring in changes such as the definition for seroconversion should be revised by including the day at which it is assessed, virological diagnosis of dengue should be defined, specification of criteria for severity of the dengue infection and number of cases of severe dengue cases requiring hospitalisation and number of deaths must be included as secondary end points, it said.

Panacea Biotec, in September 2020, had announced successful completion of phase I/II study of its novel, single-dose live-attenuated tetravalent vaccine, DengiAll, which induced robust, balanced neutralising antibody responses against all the four dengue virus serotypes. The vaccine has been found to be safe and well-tolerated with no serious adverse effects and after a single-dose, more than 80 per cent of participants showed more than tri-valent response and around 95 per cent showed a multitalented response.

Rajesh Jain, managing director, during then, said that DengiAll's phase I/II study results are even more important in the context of the Covid-19 pandemic. Co-infection of dengue and Covid-19 in a Dengue endemic India may complicate approach to treatment and strain healthcare infrastructure.

“Panacea Biotec has already approached the DGCI to seek accelerated review of its data to bring DengiAll to market quickly and reduce burden on our healthcare infrastructure,” he said during the time. With more than 3.9 billion people living in dengue endemic areas and over 390 million infections per year, DengiAll targets a global market of over $3 billion.

Panacea Biotec has supplied more than 10 billion doses of polio vaccines and over 150 million doses of innovative fully-liquid vaccines to national governments, UN agencies and others.


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