Bharat Biotech to commence Phase 2/3 trial of its COVID-19 vaccine on children

Summary

  • COVID-19 vaccine developed by Bharat Biotech has been recommended for the Phase 2/3 clinical trial on children.
  • The clinical trial will take place on 525 participants at various sites in India and evaluate the safety and immunogenicity of the vaccine.
  • Another hard-hit nation, Brazil, has entered into an agreement with Pfizer to secure additional 100 million shots of its COVID-19 vaccine.

India-based Bharat Biotech will evaluate its COVID-19 vaccine in a Phase 2/3 clinical trial on children in the 2-18 age group. According to PTI report, the study will be performed on approximately 525 participants at several sites in India.

Recently, the COVID-19 vaccine developed by Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) obtained the Emergency Use Authorization (EUA) in the US for children aged 12-15 years. With the approval, the two partners became the first manufacturers to get their vaccine approved for adolescents.

READ MORE: US gets first COVID-19 vaccine for adolescents as Pfizer-BioNTech’s shot wins emergency approval

Bharat Biotech to commence Phase 2/3 trials on 2-18 years children

On 11 May 2021, Bharat Biotech’s COVID-19 vaccine, Covaxin, was recommended for a Phase 2/3 clinical trial by an expert panel on children aged between 2 to 18.

The COVID-19 Expert Committee of the CDSCO (Central Drugs Standard Control Organization) has given approval to the Indian firm to conduct the clinical study.

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The trial will evaluate the safety, reactogenicity as well as immunogenicity of Covaxin shots in children.

ALSO READ: Are the Vaccines Working? When will Covid-19 end?

Earlier, the Company had submitted a proposal on 24 February 2021, and the firm was asked to submit a revised protocol for the clinical trial. 

Bharat Biotech and the ICMR (Indian Council of Medical Research) are developing Covaxin in collaboration. The vaccine is being administered in adults in the nation’s current COVID-19 vaccination drive.

As per the PTI report, experts have recommended that to start the proposed Phase 2/3 clinical trial, the Company should submit the interim safety data of Phase 2 clinical trial and recommendations of data and safety monitoring board to the CDSCO before going ahead with the Phase 3 part.

DID YOU KNOW: Experts warn of more COVID-19 variants as India reels under the deadly second wave

In another important update from a different part of the world, Brazil, one of the worst-hit countries, has secured further vaccine shots from Pfizer-BioNTech. Let us take a look:

Brazil secures more shots of Pfizer-BioNTech's vaccine

On 11 May 2021, the Health Ministry of Brazil updated that it had entered into an agreement with Pfizer to deliver an additional 100 million doses of its COVID-19 vaccine, as highlighted by Reuters. The country has doubled the number of shots from Pfizer, and the additional jabs will be provided between September and December.

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The new deal adds to the previous agreement, which was signed for the initial 100 million doses. So far, Brazil has only obtained 1.6 million.

ALSO READ: All you need to know about intranasal COVID-19 treatments and vaccines


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