No safety concerns related to the Covishield vaccine trial: Serum chief

Adar Poonawalla, CEO of SII said preliminary results have shown that there are no immediate concerns pertaining to the Covishield vaccine. A total of 1600 people have been administered the first dose across 17 sites, and each participant is being followed up for six months to ensure safety of the vaccine.

The phase 2/3 human clinical trial for a vaccine against coronavirus has been running smoothly in the country with no safety concerns so far, and the entire recruitment process of 1,600 volunteers for the Covishield vaccine trial has been completed across 17 trial sites by October 31, according to the Serum Institute of India (SII).

Serum Institute, the world’s largest vaccine manufacturer by the number of doses produced, is working on several candidates for a vaccine against Covid-19, including one from AstraZeneca-Oxford University as well as developing its own.

Stating that there are no safety concerns related to the Covishield vaccine trial, SII’s CEO, Adar Poonawalla, said, “It is too early to comment on the vaccine’s availability, or the (chances of) trial completion by December 2020.”

There are more than 83 lakh reported cases of Covid-19 and over 1.23 lakh deaths recorded across the country until now, and the rollout of the vaccine may take a few months.

Poonawalla said: “Preliminary results have shown that there are no immediate concerns pertaining to the Covishield vaccine. So far, thousands of people have had it in India and abroad with no safety concerns.”

Poonawalla said prioritising the vaccine’s distribution lies with government agencies and the Health Ministry, but it is “likely” that frontline workers and young and old adults will be on the priority list.

He said that based on some initial reports of the trials in the UK, the AstraZeneca-Oxford vaccine has shown immune response. “However, it is too early and is dependent on trial’s success in proving the vaccine immunogenic and efficacious,” he said in an email interview with The Indian Express.

From the first volunteer for the Covishield trial enrolled on August 24 to a total of 1,600 recruited by October 31, each person has been administered the first dose across 17 sites, and each participant is being followed up for six months to ensure safety of the vaccine.

There are a few sites that are part of the immunogenicity cohort where participants are being randomly assigned in a 3:1 ratio to receive either Covishield or Oxford/AZ-ChAdOx1 nCov 19, respectively. The remaining 1,200 participants from the safety cohort are being randomly assigned in a 3:1 ratio to receive either Covishield or Placebo, respectively.

At some sites, several volunteers have received the second dose as part of the phase 2/3 observer blind, randomised, controlled study to determine the safety and immunogenicity of Covishield vaccine in healthy Indian adults.

The SII chief said that doses will be allocated proportionally across 92 countries in the COVAX AMC (Advance Market Commitment) and in accordance with WHO’s global allocation framework, which is currently under development. “As part of the alliance with GAVI and Gates Foundation, we will deliver 200 mn [million] doses of AstraZeneca-Oxford and Novavax vaccines in 67 and 92 countries, respectively,” Poonawalla said.

“As per our current agreement with AstraZeneca, GAVI Alliance, and the Gates Foundation, the vaccines will be distributed through them and as part of government immunisation programmes (once proven immunogenic) to low and middle-income countries (GAVI countries) and India,” Poonawalla said.

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