Covishield, Covaxin get conditional market nod
The approval is an upgrade from the emergency use authorisation and largely represents a regulatory endorsement of the safety doses.
The Drugs Controller General of India (DCGI), India’s pharmaceuticals regulator, granted a conditional market authorisation for Covishield and Covaxin, the two coronavirus vaccines widely used in the country, officials said on Thursday.
The approval is an upgrade from the emergency use authorisation and largely represents a regulatory endorsement of the safety doses, which are now classified at par with pharmaceutical and biological products that take years of vetting to authorise.
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The development will not make a difference on the availability of doses just yet.
“The @CDSCO_INDIA_INF has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions,” announced the Union health minister Mansukh Mandaviya on Twitter soon after the approval was granted.
The Drugs Controller General of India (DCGI), India’s pharmaceuticals regulator, granted a conditional market authorisation for Covishield and Covaxin, the two coronavirus vaccines widely used in the country, officials said on Thursday.
The approval is an upgrade from the emergency use authorisation and largely represents a regulatory endorsement of the safety doses, which are now classified at par with pharmaceutical and biological products that take years of vetting to authorise.
The development will not make a difference on the availability of doses just yet.
“The @CDSCO_INDIA_INF has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions,” announced the Union health minister Mansukh Mandaviya on Twitter soon after the approval was granted.
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A person aware of the decision said the approval does not mean the vaccines can be sold over-the-counter by pharmacies, in the way that fully approved doses are. “Conditional access does not permit that; in fact, people wanting to take the shot will still have to approach a covid vaccination centre. Pharmacies will not be able to stock it just yet,” said this person, a senior government official, asking not be to named.
“Regular market authorisation may be granted later on probably once the entire eligible population is covered; for now, however, the sale and administration of doses will be closely monitored through the government system,” this person added.
One of the ways in which the access to these doses will continue to be how it has been is due to the condition that these doses will need to be delivered under the Co-WIN vaccine management system.
The health ministry said there authorisation was based on three preconditions: “firm shall submit data of overseas ongoing clinical trials of the product with due analysis on six monthly basis or as and when available, whichever is earlier; the vaccine shall be supplied for programmatic setting and all vaccinations done within the country to be recorded on Co-WIN platform; and Adverse Event Following Immunisation (AEFI), Adverse Event of Special Interest (AESI) shall continue to be monitored. The firm shall submit the safety data including AEFI and AESI with due analysis on six monthly basis or as and when available, whichever is earlier as per NDCT Rules, 2019.”
The vaccine will therefore continue to be supplied only through the vaccination programme, and the conditions on eligibility and timing of doses will continue to be as per the Co-WIN enforced policy. For instance, people under the age of 60 cannot take a booster, or “precaution” dose, unless they are in an at-risk job having completed nine months since their primacy vaccination.
As on Thursday, over 1.4 billion doses of Covishield and 229 million doses of Covaxin have been administered.
The key change will be for vaccine makers, who were previously required to submit to the drugs regulator rolling data from their clinical trial and adverse events during real-world vaccination follow-ups every 15 days. Now, they need to submit this data every six months. The conditions, however, will apply only for use of these vaccines within India.
“Conditional Market Authorisation 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,” said the health ministry statement cited above.
Lav Agarwal, joint secretary, Union ministry of health and family welfare, explained during the Covid media briefing that the vaccines will still have to be administered under the government programme.
“From monitoring point of view, it is pertinent to track each dose that’s being administered through the Co-WIN platform; and both AEFI and AESI data to be submitted after every six months to the national drugs controller,” he said.
Commenting on receiving the conditional market authorisation, Adar Poonawalla, chief executive of Serum Institute of India, which makes Covishield, said: “We are delighted to receive the Conditional Market Authorisation for Covishield from the DCGI. With this, our focus should be to reduce the gap between the 2nd and the 3rd dose to six months, as it is done globally. Our objective must be to get the population fully vaccinated to curb the spread of the pandemic.”
