New Delhi:
India's drug regulator may soon grant restricted emergency use authorization for Moderna's COVID-19 vaccine, official sources said on Tuesday.
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 USFDA for EUA, the vaccine can be granted marketing authorization without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization program.
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 the 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 newly revised rules.
According to the sources, approval is likely anytime as the Central Drugs Standard Control Organisation (CDSCO) is in favor of granting permission to Cipla for import of Moderna's COVID-19 vaccine for restricted emergency use in India considering the pandemic situation in the country and the public interest.
Moderna through a separate communication has 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 has 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.
In a bid to expedite the rollout of vaccines, the DCGI on June 1 decided to waive off testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK's MHRA, or the WHO.
The Centre had in April issued detailed guidelines and proactively eased the entry of foreign-made COVID-19 vaccines approved by the US FDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India.
According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.