The regulator said market authorisation was conditional to submission of ongoing clinical trial data and safety data of the vaccine, at longer time intervals. All vaccinations have to be recorded on the CoWIN platform and all adverse events have to be strictly monitored.
Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin on Thursday received conditional market authorisation from the Drugs Controller General of India (DCGI).
Union health minister Mansukh Mandaviya said the permission for Covaxin and Covishield had been upgraded from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions. The conditions include supply for programmatic settings, including registrations on the CoWin platform and to continue to submit safety data on a six-monthly basis, the minister said.
The regulator said market authorisation was conditional to submission of ongoing clinical trial data and safety data of the vaccine, at longer time intervals. All vaccinations have to be recorded on the CoWIN platform and all adverse events have to be strictly monitored.
The firms also have to submit data of overseas ongoing clinical trials of the product with due analysis.
The Subject Expert Committee of the Central Drugs Standard Standard Control Oraganisation had on January 19 recommended upgrading the Covishield and Covaxin vaccines.
It advised grant of new drug status to the two vaccines from Emergency Use Authorisation permission granted earlier.
The country has administered 164.35 crore doses of these two main Covid-19 vaccines till Thursday, with 140.86 crore Covishield and 22.94 crore doses of Covaxin. Around 74.41% of the eligible population has been fully vaccinated and 95% have got their first dose.
The US Food and Drug Administration and the Medicines & Healthcare products Regulatory Agency of the UK have granted conditional market authorisation to Pfizer and AstraZeneca for their Covid-19 Vaccines.
‘Conditional Market Authorization’ is a new category of market authorisation that has emerged during the current global pandemic of Covid-19. The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.
SII CEO calls for reducing gap between 2nd, 3rd doses
Adar Poonawalla, CEO, Serum Institute of India (SII), has called for reduction of gap between the second dose and the third dose being administered in the country.
The gap mandated by the government for precautionary Covid-19 vaccine dose is nine months or 39 weeks after the second shot. Poonawalla wants the gap between the second and third dose to be six months as has been done globally. “Our objective must be to get the population fully vaccinated to curb the spread of the pandemic,” Poonawalla said after receiving conditional market authorisation.
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