The announcement by Russia about the approval of a COVID-19 vaccine has set the alarm bells ringing around the world. Russia has approved the vaccine while WHO’s official database shows that this vaccine is only at Phase-1 trials. As per WHO’s database, a total of 29 vaccine candidates are at different stages of clinical trials while 6 of them are at Phase-3 clinical trials.
Across the globe, scientists and researchers are racing against time to find a vaccine for COVID-19 caused by the SARS-CoV-2 virus. As is evident from the data on number of cases across the world, COVID-19 is highly contagious and till a vaccine is available for large scale public use, the only way that one can stay safe is through social distancing, wearing masks, and personal hygiene. Since vaccine is essential to make a large section of the population immune to the infection, the entire world is waiting for a vaccine with bated breath.
Vladimir Putin announced the world’s first vaccine approved in Russia
The Russian President Vladimir Putin made an announcement on 11 August 2020 that the world’s first COVID-19 vaccine, named Sputnik V has been approved by Russia and that one of his daughters got vaccinated. The Government of Russia tweeted on the same day saying that- ‘the Russian Healthcare Ministry had given regulatory approval to the world’s first coronavirus vaccine. Its effectiveness and safety were confirmed in clinical trials.’ However, concerns have been raised on its ‘effectiveness’ and ‘safety’ since the vaccine has not completed large-scale clinical trials. Large-scale clinical trials on thousands of persons are necessary in order to study the side effects of a vaccine which may not be evident in smaller trials.
According to clinicaltrials.gov, the vaccine developed by Gamaleya Research Institute of the Russian Health Ministry, has been tested on 38 persons each in two early stage trials. Meanwhile, as per the World Health Organization’s list of vaccine candidates and status of trials, as on 13 August 2020, the Adeno based vaccine was at the Phase-1 of clinical trials.
Three phases of clinical trials need to be passed by vaccine candidates before approval
Phase-1 of clinical trials involves the testing of the vaccine among a small number of healthy adults, say around 20. During this phase, the properties of the vaccine and its tolerability are tested, and if found appropriate, its clinical laboratory and pharmacological parameters are also recorded. In phase-2, a target population based on certain parameters like age, and physical health is selected and preliminary information on vaccines ability to produce desired effect among the persons and general safety is recorded. The last stage, phase-3, is when thousands of persons are tested. A large number of people are given the vaccine to assess protective efficacy and safety on a larger scale. A detailed story by Factly on vaccines and their stages of development can be read here.
29 candidates are in the clinical evaluation stage
According to the WHO’s list as on 13 August 2020, there are 29 vaccines in the clinical evaluation stage, where at least phase-1 clinical trials have begun. Out of these, the following six (6) candidates in phase-3 trials
- University of Oxford- AstraZeneca backed vaccine from the UK
- Chinese vaccine maker Sinovac
- Wuhan Institute of Biological Products- Sinopharm backed vaccine from China
- Beijing Institute of Biological Products- Sinopharm backed vaccine also based in China
- Vaccine co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID) in the US
- BioNTech-Pfizer from the US.
There are two other candidates in phase-2 from China – CanSino Biological Inc. – Beijing Institute of Biotechnology and Anhui Zhifei Longcom Biopharmaceutical/Institute of Microbiology, Chinese Academy of Sciences.
Of the ten candidates in phase-1/2 trials, there is one candidate each from China, Japan, South Korea, and Belgium. In addition to two US based candidates in this stage, vaccine developed by Inovio Pharmaceuticals in collaboration with UNDP’s International Vaccine Institute also falls in phase 1/2 of trials. Bharat Biotech and Cadilla Healthcare Ltd, are two Indian candidates in phase 1/2 of trials. Bharath Biotech has developed Covaxin- which is India’s first indigenous COVID-19 vaccine in collaboration with Indian Council of Medical Research and National Institute of Virology. Zydus Cadilla’s vaccine is named ZyCoV-D.
There are 138 vaccine candidates in the pre-clinical stage
The pre-clinical stage of testing is when the vaccine is tested on animals. Currently, there are 138 vaccine candidates at this stage.
Mynvax, Indian Immunologicals Limited (in collaboration with Griffith University in Australia), Cadilla Healthcare Ltd.’s measles vector vaccine, are few other candidates from India which are in the pre-clinical trial phase. Bharat Biotech’s vaccine in collaboration with UW Madison and Flugen, and another in collaboration with Thomas Jefferson university are also in pre-clinical phase. Serum Institute of India is also collaborating with Codagenix and currently the vaccine is also in the pre-clinical phase.
Three vaccines are being tested in India
In his address to the nation on the eve of 74th Independence Day, Prime Minister Narendra Modi stated that testing for three different COVID-19 vaccines is taking place in the country and are at different stages. He said that once the scientists give a green signal, massive production of the vaccines will be launched. He further added that all preparations are in place, and an outline has been drawn to ramp up the production of vaccines and ensure that each and every person gets it in the shortest possible time.
Serum Institute of India has already prepared for mass production
Serum Institute of India, which is the world’s largest vaccine maker by number of doses produced and sold globally, has partnered with AstraZeneca to manufacture the vaccine being developed by the University of Oxford which is currently at Phase-3 of clinical trials. The Pune based company has already started preparation to manufacture millions of doses of the vaccine. The Bill and Melinda Gates foundation will also be providing a funding of USD 150 million to manufacture 100 million doses of the vaccine for India and other low- and middle-income countries so that the firm can charge a maximum of only $3 per dose of the vaccine.
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