India fast-tracks EUA for foreign-produced COVID vaccines amid spike in cases: A look at all the options

India on Tuesday fast-tracked emergency use approval for eligible foreign-produced shots against COVID-19, in a move to expand its basket of vaccines amid the “highest” surge in infections in the country. The announcement by the Union health ministry by which the eligible manufacturers of the foreign vaccines are not required to undertake local clinical trials in India could clear the decks for imports of Pfizer, Moderna and Johnson & Johnson shots with certain conditions. The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country, it added. These are some of the options India may consider. Sputnik V Sputnik V from Russia’s Gamaleya Research Institute is the latest vaccine approved for emergency use in India. Sputnik V uses a cold-type virus vector. It is engineered to be harmless, as a carrier to deliver a small fragment of the coronavirus to the body. Safely exposing the body to a part of the virus’s genetic code in this way allows it to recognize the threat and learn to fight it off, without the risk of becoming ill. Sputnik V has been shown to have 92 percent efficacy. It is given in two doses, three weeks apart. It can be stored at temperatures between 2 and 8 degrees Celsius. Dr Reddy’s Laboratories is in the process of generating additional stability data for storing the Russia-made vaccine. This data will be available in a few months, after which we will make the necessary amendment request to the regulator and request for the storage condition to be modified to 2 to 8 degrees C," Deepak Sapra, Dr Reddy’s Chief Executive Officer, API and Services told reporters. He said necessary cold storage infrastructure is in place to distributeSputnik V vaccine in India, which will be available during the current quarter. Dr Reddy’s Laboratories on Tuesday said it has received approval from Indian drug regulator for restricted emergency use of COVID-19 vaccine Sputnik in the country. Moderna The mRNA vaccine by US-based company Moderna has been shown to have 94.1 percent efficacy. In this type of vaccine, the messenger RNA, or mRNA, acts as a blueprint for the production of the coronavirus spike protein. The cells of the vaccine recipient use this mRNA segment to produce the viral protein to train the immune system for a future encounter with the infectious coronavirus. Administered as two doses 28 days apart, the Moderna vaccine can be stored in the refrigerator at 2-8 degrees Celsius for up to 30 days. At -20 degrees Celsius it can be stored for up to six months. A study has found the vaccine to be 90 percent effective even after six months of inoculation. The company has also started testing new versions of the vaccine that target a concerning new variant of the coronavirus, which was first identified in South Africa and is known as B.1.351. So far there is no concrete development on the rollout of the vaccine in India. However, reports from February claimed that Moderna manufacturers were in early stages of talks with TATA Group’s newly launched medical venture Tata Medical & Diagnostics and with Council of Scientific & Industrial Research (CSIR) to carry out the necessary clinical trials of Moderna’s vaccine candidate in India. Pfizer The US-backed Pfizer-Biontech’s COVID-19 preventive, like the Moderna vaccine, is based on the segments of the genetic material of the novel coronavirus. Preliminary data from the clinical trials showed that two doses of the vaccine given three weeks apart provided efficacy of 94 percent. One limitation for the Pfizer vaccine has been its requirement for ultracold storage  upto -70 degrees Celsius. Johnson and Johnson The adenovirus vectored vaccine by the American company is provided as a single dose. The company had noted that the therapeutic can be stored for up to three months when refrigerated at 2-8 degrees Celsius, and up to two years when frozen at -20 degrees Celsius. The overall efficacy of the J&J vaccine was found to be 66 percent globally, and 72 percent in the US. NITI Aayog member VK Paul has said that India wants Pfizer, Moderna and Johnson & Johnson to seek licence for their COVID-19 vaccines as soon as possible.=- While Johnson & Johnson is keen to enter India and has held preliminary discussions for applying for an emergency approval recently, Pfizer withdrew in February from the race due to regulatory issues,  The Times of India reported.