For the first time in India, the Phase 2 and 3 of clinical trials for children from 2-18 age group is cleared for Bharat Biotech’s Covaxin. The clearance came from Drugs Controller General of India (DCGI) on May 13. Covaxin is developed by Hyderabad based Bharat Biotech in association with Indian Council of Medical Research (ICMR).

Background

India is coming closer to the peak of the deadly wave of COVID-19 that has accounted for a daily caseload of 3.5-4 L and all the stakeholders in this matter has agreed that vaccination is the best defence and offence against the virus.

Although most states of the nation are under complete lockdown, the inoculation drive is under full swing. Currently, all individuals above the age of 18 are eligible to be vaccinated (if they can get their hands on vaccine as there are shortages in many states).

Details

On Thursday morning, it was announced that the Bharat Biotech’s Covaxin has been cleared for its second and third phase of clinical trials for children from age 2-18. According to the official statement by the government, the trials will be conducted on “525 healthy volunteers”.

The development was confirmed after the Subject Expert Committee on COVID-19 of India’s drug regulatory body Central Drugs Standard Control Organization (CDSCO) pondered upon the permission sought by Bharat Biotech to start its phase 2 and phase 3 clinical trials on children aged 2 to 18.

The vaccine maker from Hyderabad wants to conduct the trials to evaluate the safety, immunogenicity and reactogenicity of the Covaxin vaccine. After careful deliberation, the subject expert committee gave a nod for the trials.

Trials to be conducted across Delhi, Nagpur, Patna

These trials will be conducted at various sites across the country including the Delhi AIIMS, Nagpur’s Meditrina Institute of Medical Sciences and the Patna AIIMS. According to a source from Press Trust of India, it was reported that the Subject Expert Committee has put forward one condition that Bharat Biotech should submit all the safety data of the phase 2 trials before they start with the third phase.

Earlier, the SEC meeting deliberated on the proposal in late February and asked Bharat Biotech to come up with a revised clinical trial protocol and make submission of that accordingly.

The Covaxin is an ‘inactivated’ vaccine meaning it uses a killed SARS-CoV-2 virus that is injected in a person. Once the virus is injected, it enhances the person’s immune system response to the original virus.

Centre approves production of Covaxin at Bulandshahr

Meanwhile, as more and more states claim shortage of vaccines, the Centre decided to approve the manufacturing of Covaxin at Bulandshahr, Uttar Pradesh. The Centre’s decision comes at a time when its pertinent to meet the growing demand of vaccine doses, especially after the Centre earlier liberalized its vaccination policy to include all individuals above the age of 18. Reports suggest that Bharat Biotech will now be producing Covaxin at its Bulandshahr plant of Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL).

2 Crore doses of Covaxin to be produced at BIBCOL

Further it was also announced this week that Bharat Biotech will be able to produce as many as 2 crore doses of Covaxin each month. The BIBCOL plant of Bharat Biotech has in the past produced polio vaccines and other immunization drugs. The Ministry of Health will provide BIBCOL a sum of Rs. 30 crores for the production of Covaxin.

SII & Bharat Biotech submits vaccine production plan for next 4 months to Centre

In another development, Serum Institute of India that produces Covishield and Bharat Biotech, the producer of Covaxin have submitted their vaccine production plan for the next 4 months. The move comes after the Supreme Court had asked the Centre if the vaccine makers have actually come up with a plan for ramping up vaccine’s production.

According to the plan that’s submitted, Hyderabad based Bharat Biotech will raise its vaccine production to up to 3.32 crores by July and 7.82 crores by August. On the other hand, Pune’s Serum Institute will be increasing the production to 10 crore doses by August.