- 20 Jan 2021
As India prepares itself to welcome the festive season with the same grandeur and razzmatazz, staying well inside the 'Laxman Rekha', Subject Expert Committee (SEC) has recommended granting of permission to conduct Phase III clinical trials for indigenous Covaxin. Alongside, the Herculean efforts of scientists worldwide to develop a vaccine against Covid-19 are seeing positive results and a fast-tracked vaccine is very likely by mid 2021.
Things aren't the same anymore. In the New Normal, people have been more disposed to adopt despair and hopelessness in their daily lives and with an increase in the number of cases, the situation is turning more difficult with every passing day. In such trying times, every positive sign is enough to conjure up hope and belief, vast as a sky and coloured by matter in the shape of knowledge and information.
Where do Indian Vaccines lie?
Meanwhile, Union Health Minister Harsh Vardhan has added to the joy of festivities by saying that India is expected to have a Covid-19 vaccine in a few months and the country should be in the process of delivering it to people in the next six months. Tamil Nadu and Madhya Pradesh CMs have already announced that everyone in the two respective states would be given a vaccine free of cost. Delhi CM, Arvind Kejriwal proposed a provision for free vaccination across India, after acquiring necessary information on the cost of the vaccine.
The Drugs Controller General of India (DCGI) on Friday has permitted Bharat Biotech to conduct Phase 3 clinical trials of its indigenously developed Covid-19 vaccine, Covaxin with certain conditions. The news has come like the rising sun struggling through fog. Delhi Health staff may be considered for Phase 3 trials. Furthermore, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of the human clinical trials.
Ray of hope from foreign countries:
● The Oxford University COVID-19 vaccine is undergoing Phase III clinical trials with British pharma giant AstraZeneca . It is doing "everything expected" according to an independent analysis published on Thursday. The vaccine, ChAdOx1 nCoV-19 and also known as AZD1222, is considered among the most advanced in the worldwide hunt for a viable vaccine against the novel coronavirus.
● AstraZeneca is conducting human trials with up to 50,000 participants in total in the UK, US, Brazil, Japan and South Africa, Serum Institute is conducting the trial in India with 1,600 patients. Early results from both companies’ trials are expected by December. The respective authorities are highly hopeful of this particular vaccine because of its flawless performance till date
● Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamaleya Research Institute in Moscow – was approved by the Ministry of Health of the Russian Federation on 11 August. Experts have raised considerable concern about the vaccine’s safety and efficacy given it has not yet entered Phase 3 clinical trials. However, India has allowed the vaccine to get tested on 100 volunteers. DCGI has granted permission to pharmaceutical giant Dr Reddy's Laboratories for conducting the tests.
● A second vaccine in Russia, EpiVacCorona,is in line after Sputnik V and has also been granted regulatory approval without entering Phase 3 clinical trials.
● Moderna, an American biotechnology company based in Cambridge and Massachusetts, develops vaccines based on messenger RNA (mRNA) to produce viral proteins in the body. In January, they began developing a vaccine for the coronavirus and their assiduous efforts yielded results when they found that the vaccine protects monkeys from the coronavirus. In March, the company put the first Covid-19 vaccine into human trials which attained promising results. The vaccine has progressed into Phase 3 testing, which began on July 27. The final trial enrolled 30,000 healthy people at about 89 sites around the United States and Moderna expects an initial readout on whether the vaccine works by late November. Meanwhile, Canada has agreed to acquire 20 million doses.
● On July 27, the German company BioNTech along with collaborations from Pfizer, based in New York, and the Chinese drug maker Fosun Pharma announced the launch of a Phase 2/3 trial with 30,000 volunteers in the United States and other countries including Argentina, Brazil, and Germany. In an interim study, the companies reported that after getting the first dose, volunteers experience mostly mild to moderate side effects. On Sept. 12, Pfizer and BioNTech announced that they would seek to expand their U.S. trial to 43,000 participants. The following month, they gained permission to start testing the vaccine on children as young as 12 — the first American trial to do so.
● Imperial College,London researchers have developed a “self-amplifying” RNA vaccine, which boosts production of a viral protein to stimulate the immune system. They began Phase 1/2 trials on June 15 and have partnered with Morningside Ventures to manufacture and distribute the vaccine through a new company called VacEquity Global Health. The researchers expect to know if the vaccine is effective by the end of the year.
● On June 30, the Japanese biotechnology company AnGes announced they had started Phase 1 trials on a DNA-based vaccine, developed in partnership with Osaka University and Takara Bio. The company will present initial results of the trials in November and are planning for a Phase 3 trial by the end of the year.
Image Credits: nytimes.com
The world is full of hopeful analogies and handsome dubious eggs called possibilities~ George Eliot