Moderna granted emergency use approval for import of COVID-19 vaccine by DCGI

India's drug regulator Drug Controller General of India (DCGI) has granted permission to the US-based pharmaceutical company Moderna's COVID-19 vaccine. According to permission notice, the Moderna vaccine can now be imported for use in emergency use in India. Mumbai-based pharmaceutical company Cipla has been granted permission to import Moderna's COVID-19 vaccine.

Moderna's vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik V. The Moderna can be used for restricted use in an emergency situation for active immunization to prevent COVID-19.

The two-dose vaccine is now allowed to anyone above the age of 18 and both doses have to be taken 28 days apart. The emergency use permission to Moderna comes at a time when fears regarding a possible outbreak of COVID third wave is high. There are also several reports of vaccine shortage from across the country. 

India Offered 7.5 million Doses of Moderna COVID-19 Vaccine

Earlier in a big development, India was offered 7.5 million doses of Moderna's COVID-19 vaccine through the COVAX programme. On June 29, the Drug Controller General of India accepted the recommendations of the Subject Expert Committee of the Central Drugs Standard Control Organisation, paving way for the approval of Moderna. 

The Moderna COVID vaccine

After Moderna published its peer-reviewed Phase 3 data, the U.S. Food and Drug Administration issued an emergency use authorization for its vaccine on December 18, 2020. The evidence from the Phase 3 clinical trial involving nearly 30,000 participants aged 18-95 showed that the Moderna vaccine was 94.1% effective at preventing COVID-19 infection in people who received two doses and had no evidence of being previously infected. The possible side effects include pain, redness and swelling in the arm where a person gets the shot and tiredness, headache, muscle pain, fever and nausea throughout the rest of the body. 

The US-based company’s vaccine was approved by the European Medicines Agency throughout the European Union in January. However, it received emergency validation from the WHO on April 30. The vaccine is survivable for 30 days in a standard medical refrigerator after the vial is opened while it can be stored for 7 months at -25 to -15 degrees Celsius. 

IMAGE: AP