Give full authorisation to Covishield: Serum
NEW DELHI: Pune-based Serum Institute of India (SII) on Friday announced it has applied to India’s drugs regulator for full market authorisation to Covishield, its anti-covid vaccine, citing adequate availability of the required data.
“Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @Seruminstindia has applied to the @CDSCO_INDIA_INF (DCGI) and @MOHFW_INDIA for this permission,” Adar Poonawalla, chief executive officer, Serum Institute of India, tweeted on Friday.
Full market authorisation is granted when there is enough data to demonstrate that the vaccine is safe and effective for most people who receive it.
Serum Institute of India locally manufactures the Oxford-astrazeneca Covid-19 vaccine under the brand name Covishield.
“The company has applied for full market authorisation a couple of days ago; the safety and efficacy data (if and when submitted) by the company will be analysed by the Central Drugs Standard Control Organisation, and subsequently a decision would be taken on this,” said a senior official aware of the matter in the Union ministry of health and family welfare, requesting anonymity.
Another central government official, on condition of anonymity, added, “There is a proper process that needs to be followed through before full market authorisation is granted. The data quality is of paramount importance in such situations. It is entirely the call of experts; they should be satisfied with the data present before them.”
The recombinant chimpanzee adenovirus vector vaccine encoding the SARS-COV-2 Spike (S) glycoprotein, with an efficacy of nearly 70%, was approved for restricted use in emergency situations by the Drugs Controller General of India (DCGI), VG Somani, on
January 3 this year. The approval was a part of accelerated approvals granted to Covid-related vaccines and drugs.
Along with Bharat Biotech’s anti-covid vaccine, Covaxin, Covishield has been the mainstay of India’s coronavirus immunisation programme that was launched nationwide on January 16 this year. At least 90% of the doses administered so far are of Covishield.
If the national drugs regulator grants approval to Covishield, then it will be the second anti-covid vaccine in the world to have received full market authorisation, making it eligible for retail sale, albeit with certain conditions.
On August 23, this year, the US Food and Drug Administration (USFDA) approved the Pfizer-biontech vaccine, which is now being marketed as Comirnaty, for the prevention of Covid-19 disease in individuals 16 years of age and older.
“…While this and other vaccines have met the FDA’S rigorous, scientific standards for emergency use authorisation, as the first Fda-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said acting FDA commissioner, Janet Woodcock, after granting authorisation.