New Delhi: India on Tuesday made way for fourth coronavirus vaccine in its drug basked after Mumbai-based pharmaceutical company Cipla got a nod from India’s drug regulator DCGI to import the vaccine for restricted emergency use in the country, officials told HT.
Cipla filed an application on Monday seeking permission for import of Moderna’s COVID-19 vaccine referring to DCGI notices dated April 15 and June 1 as per which if the vaccine is approved by the US Food and Drug Administratio (USFDA) for Emergency Use Authorization (EUA), the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
Also, the requirement of testing of every batch by the Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin. However, summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release as per standard procedures, Cipla said referring to the DCGI’s new revised rules.
Moderna through a separate communication had informed that the US Government has agreed to donate a certain number of doses of the Moderna COVID-19 Vaccine, mRNA-1273, through COVAX to the Government of India for use in India and had submitted the dossiers through e-mail. “This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines,” Moderna said.
Moderna’s method to protect against COVID-19 relies on messenger RNA (mRNA) to programme cells to generate immunity to the coronavirus. Many experts have said that this lends the vaccines a high efficacy in its fight against the novel coronavirus.