Amid India drives through witnessing the third wave of the COVID-19 pandemic with a surge in the cases of Delta plus variant, the country has on Tuesday consented to the entry of the fourth COVID-19 vaccine even as the government carries out the measures to strengthen the vaccination drive of inoculating the doses to a major populace within this year.
The Drugs Controller General of India (DCGI) has on Tuesday granted permission to the Indian pharma giant Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country. The permission has given as per the provisions of the New Drugs and Clinical Trial Rules, 2019 under the Drugs and Cosmetics Act, 1940. The new entry is expected to strongly arm India's hand to beat the pandemic.
On Monday, Cipla has requested the Indian drug regulator for importing and marketing Moderna in India. A day after its petition, the DCGI has given its approval and awarded the authorization to the Indian pharma giant to bring the fourth vaccine to the country. According to PTI, an official said, "This permission is for restricted use in emergency situations in the public interest."
The official further said that Cipla has to submit seven days safety assessment of the vaccine in the first 100 beneficiaries before rolling out of the vaccine for further immunization programme, as per the approval order." Moderna has become one of the significant vaccines in the globe in its fight against the pandemic. The Moderna vaccine is also known as the mRNA- 1273 vaccine.
The Moderna Vaccine has shown to have an efficacy of around 94% in beating the pandemic and the US-made vaccine is approved by more than 40 countries including the United States, Japan, South Korea, Singapore, the United Kingdom, Switzerland, Italy, Sweden, Israel, Qatar, Spain, Ireland, Canada, France, and Germany. The two doses of the Moderna vaccine should be given to an individual in the time gap of 28 days.
On the front of the Moderna vaccine's fight against the COVID-19 variants, the experts say that based on the evidence so far, the new variants including the Alpha variant do not decrease the effectiveness of the vaccine. However, the impact and severity of the Delta plus variant are yet to be fully ascertained in India and the country will be studying the effects of the vaccines from the hundred beneficiaries.
According to the Centers for Disease Control and Prevention (CDC), the possible side-effects of Moderna's Covid vaccine could be a pain in the arm, inflammation, and redness. Apart from these, a vaccinated individual can also feel tiredness, fever, nausea, headache, and muscle pain. The American Disease Control Board has said that the side effects would happen within a day or two of receiving the dose and they would subside in following days.
The Moderna vaccine has been spelt to be safe and effective for adults over the age of 18. Currently, India has three COVID-19 vaccines as its shield against the pandemic - Serum Institute of India's Covishield, Bharat Biotech's Covaxin, and Russia's Sputnik V vaccines. Covishield and Covaxin are India's leading vaccine agents and most of the Indians are restoring to Covishield, given its effect of increasing immunity. The approval for the Moderna vaccine has come at a high time when India has said that pregnant women can also receive the vaccines.