American drugmaker Pfizer Inc, which had partnered with German biotech firm BioNTech to develop a vaccine candidate against Covid-19 earlier this year, has become the latest in the list of major movers in the vaccine race to move into the final stages of human trials. Right on the heels of Moderna Therapeutics, Pfizer announced that its vaccine candidate, called BNT162b2 for the time being, has progressed to phase II/III trials.
Like Moderna, Pfizer’s candidate belongs to a category called a messenger RNA vaccine. These types of vaccines involve modifying a messenger RNA to get the cells to recreate the part of the virus that is crucial to target. In this case, the Pfizer-BioNTech vaccine has modified the messenger RNA to instruct the cells in the body to produce the spiky outer surface of the SARS-CoV-2 virus–the spike glycoprotein.
The latest development means that Pfizer will be conducting two stages of clinical trials seamlessly, an approach that intends to shorten the time taken to conduct these tests. According to the protocol announced by the firm, the vaccine will be tested on up to 30,000 participants, the same number of volunteers that Moderna is targeting for its own vaccine candidate.
The trials will check for the safety and effectiveness of the vaccine in persons between the ages of 18 to 85 years and will be conducted not only in the US, but in 120 sites globally. The duo is targeting 39 states across the US, as well as countries like Argentina, Brazil and Germany.
Before this, Pfizer-BioNTech had conducted early stage phase I/II trials in the US and Germany.
If the late stage trials succeed in showing that the candidate is effective in preventing a person from getting Covid-19, Pfizer and BioNTech will be “on track” to approaching the American drug regulator for approvals as early as October this year.
If approval is given, the firm plans to supply up to 100 million doses by the end of 2020 and around 1.3 billion doses by the end of 2021.
BNT162b2 is one of four candidates that Pfizer and BioNTech were investigating as potential vaccines to protect people from getting Covid-19. This candidate, as well as another — BNT162b1 — were granted a “Fast Track” designation by the US Food and Drug Administration earlier this month. This would allow an expedited review and approval of their vaccine candidates when it approaches the regulator.
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The other Indian candidate vaccines
While candidate vaccines being developed by Hyderabad-based Bharat Biotech and Ahmedabad-based Cadila have moved into human trials earlier this month, there are at least six other novel Coronavirus vaccines being developed by Indian companies that are still going through pre-clinical trials. In the pre-clinical trials, the vaccines are tested on the animals, like mice.
Both Bharat Biotech and Cadila are testing one another candidate. Bharat Biotech has joined hands with Thomas Jefferson University in Philadelphia, United States for this other candidate vaccine. It is being developed at the university facilities.
Cadila’s other vaccine is of a different type than the one which has gone into human trials.
Besides these two, Pune-based Serum Institute of India is collaborating with Codagenix, a biotechnology company in New York, to develop a Coronavirus vaccine. Indian Immunologicals Limited, a public-sector company in Hyderabad which produces several animal and human vaccines, is working with Griffith University of Australia to develop a vaccine. Both these candidates are based on a similar strategy of trying to trigger immune response by injecting live but ineffective virus inside human bodies.
Biological E, another Hyderabad-based, company is also in the race, working on its own to develop a protein-based vaccine, in which proteins from the virus are injected into the human body to produce the immune response.
The other Indian company in the fray is Pune-based Gennova which is hoping to start human trials by October.
The story so far
- 25 candidate vaccines in human trials
- Five in Stage-III trials
- Pfizer-BioNTech vaccine to carry out Stage-II an Stage-III simultaneously
- 139 candidates in pre-clinical trial stage
- Two Indian candidates in Stage-I trials
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