COVID-19 Vaccine News: Arrival Before Time?


As per the reports available then we had maintained in our earlier post that the leading COVID-19 vaccine of the world Pfizer-BioNTech with a claimed efficacy of 95% was going to apply for Emergency Use Authorization (EUA) by mid-December and Moderna vaccine a few days later. However, with the rush for the first usable vaccine and the people of the worst-hit USA desperate for a vaccine, Pfizer-BioNTech had already applied for EUA with the Food and Drug Administration (FDA) in US, and following it up also applied for the European regulator, European Medicines Agency (EMA). In fact, United Kingdom has already placed orders for 40 million doses of Pfizer-BioNTech and it is likely to give approval in a matter of days now in which case UK could be the very first country in the world to officially approve a COVID-19 vaccine. The FDA is likely to examine Pfizer-BioNTech vaccine data by 10th December.


Moderna, the second leading vaccine being produced in the US, had said that it would apply to the FDA for its EUA on Monday, that is yesterday, after confirming its latest results. As per reports now it is going to apply today, and also to the EMA for a conditional approval as the agency has already been in the process of reviewing its data, and UK having placed orders for 20 million doses. After application is done the FDA is likely to examine its data on 17th December. Meanwhile, the efficacy of Moderna has been placed at 94.1% based on the latest results as against its earlier claim of 94.5%. Moderna’s experts say that this difference is statistically insignificant. On a more positive note Moderna has said that based on the latest results the vaccine has been proved to be 100% effective in preventing the severe strain of Coronavirus which is largely responsible for most of the 1.4 million deaths so far worldwide. The vaccine is also proved to be effective across people of all age, ethnicity and demographics.


Therefore, these two vaccines are set to arrive much before time, that is to say, within this year of 2020 that saw total cases of more than 63.5 million infections so far worldwide. The best thing about them is that their efficacy rates are much healthier and higher than the 50% benchmark set by the FDA and other regulators for consideration. Besides, both the vaccines use a new technology called synthetic messenger RNA (mRNA) whereas most others like UK’s AstraZeneca are using more traditional methods to develop the vaccines.

Back home, the government of India, directly under Prime Minister Narendra Modi, has been ramping up its preparations for the production and distribution of at least three leading vaccines in the country, namely Covishield, the Indian counterpart of the Oxford AstraZeneca developed by the Serum Institute of India in Pune, that is likely to apply for EUA with the Drugs Controller General of India (DCGI) in the coming two weeks; Covaxin developed by Bharat Biotech in Hyderabad is in the final stages; and ZyCov-D developed by Zydus Cadila in Ahmedabad is likely to complete clinical trials by February 2021. Apart from these, the Russian Sputnik V vaccine is also under final-phase human trials in India.


Therefore, vaccine could be available for distribution in India too from early next year. Health Minister, Dr. Himanta Biswa Sarma, of Assam, a state at the top now in terms of performance, has said that the government of India has marked out three priority categories to be vaccinated first, and accordingly his state, among all Indian states, is asked to submit estimates of numbers under these categories. The three categories are: doctors, nurses and frontline health workers; employees of the essential services like the police, municipalities, transport and administration who work on the field; and all citizens above the age of fifty. A fourth category, people with comorbidities, is also being considered next, the minister added. Dr. Sarma further informed that vaccination in the state would most probably start from the month of March 2021. Various states have also been asked to ramp up the cold storage facilities and infrastructure.


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