Vaccine Race! - Who will win the race?
In our country, more than 86 lakh people already infected and companies have joined hands to develop a vaccine for the deadly virus covid-19. Actually, the vaccine takes years of research & testing to induce a vaccine ready & produce it on an oversized scale, but as a result of the pandemic situation, scientists are working tirelessly to launch a vaccine as soon as possible for us.
Right now, There are eight pharma majors are working towards Covid-19 vaccine in India.
- Bharat Biotech
- Serum Institute of India
- Panacea Biotech
- Dr. Reddy’s
- Indian Immunologicals
- Zydus Cadila
- Mynvax
- Biological E
Some of the local players namely Hester Biosciences, Premas Biotech, Gujarat Biotechnology Research Centre, Auro Vaccines, Genova Biopharma, and Christian Medical College, Vellore have recently become a part of the race. The newly joined players would perform a vital role in scaling-up the manufacturing of the vaccine.
If an Indian firm becomes a frontrunner in arising with a covid vaccine, it might not only aid in speeding up the healthcare process but would also transform the Indian pharma industry's reputation from being a mass producer of generics to a drug innovator.
Sujay Shetty, Chairman- Partner Oversight Committee- PwC India, reportedly said “India’s excellent at the D side, the event side. It’s more like incremental innovation, so in terms of broad innovation or [research], it’s relatively small.”
Before entering into the details analysis of the varied stages at which each of those firms is, let’s get an understanding of what function a vaccine performs and the way it comes into existence.
How does a Vaccines work - Protect against disease.
A vaccine is a type of medicine that trains the body's immune system so that it can fight against the disease it has not come into contact with before. It generates antibodies (protective proteins) specific to the disease-causing virus and destroys the virus. this fashion the body’s system remembers the virus and the way to kill it.
Deadly Coronavirus has spikes surrounding it that attach to human cells like Velcro and form strong bonds, which causes infections. With the assistance of a vaccine, a sort of drugs, harmless copies of the virus is introduced into the body in an exceedingly safe way.
If you are exposed to the identical virus in next time, your system is ready to quickly kill the virus or foreign antigen, before it gets an opportunity to create you ill. During this manner, your body develops resistance power or immunity power to the actual virus.
So what does it take to produce a vaccine?
It can take up to a decade to manoeuvre from the invention of a vaccine to its development and approval and take 5 broad stages to provide life-saving vaccines:
Preclinical Stage:
This is a research-initial stage that aims to look out natural or synthetic antigens which may trigger the identical reaction because the original virus would. Antigens are foreign substances that elicit a response in your body.
Phase 1/2a and 2b:
In Phase 1, the vaccine is tested for the 1st time on a little group of 20-80 adults to assess its safety & gauge the immune system’s response to that. Then,
Phase 2a determines the dosage that may be simplest and also aims to reinforce the protection experience with the vaccine. Researchers may rummage around for adverse reactions like headache, fever, muscle aches, among others.
Phase 2b trial involves administering the vaccine to a bigger number of humans.
Phase 3:
In this 3rd stage, so many volunteers are joining the clinical test & receive the vaccine so as to look at whether it's effective or not.
Regulatory approval:
After a successful trial of phase 3. The vaccine manufacturing company applies to the regulatory bodies for approval. The regulator reviews the trial data to confirm that the vaccine is safe & effective for the human body. After the vaccine gets approved, the pharma company proceeds with its production.
Phase 4:
Even post the vaccine approval and licensure stage, the regulator continues to remain involved, monitors its production, inspects manufacturing facilities; & conducts vaccine tests to make sure its potency, safety, & purity for the human body.
At which stage are our pharma companies are standing?
Serum Institute of India (SII) our Leading pharma company reported that “it has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI. Also, the corporate has completed the enrolment of phase-3 clinical trials for the novel coronavirus vaccine-Covishield-in India.” The firm aims to supply the vaccine for India and other middle & low-income countries.
Adar Poonawalla, CEO – SII, said “Based on this situation and most up-to-date updates on the clinical trials, we hope that the AstraZeneca Oxford vaccine are available towards the top of this year. other than Astra Zeneca Oxford vaccine and Codagenix, we've related to multiple institutions worldwide as manufacturing partners for vaccine candidates that are being developed. These include Austria’s Themis together with two others,”.
Next pharma giant Zydus Cadila hopes that clinical trials of ZyCoV-D (its Covid-19 vaccine candidate) would pass through in 7 months. the corporate had begun clinical trials of its Covid-19 vaccine candidate in July 2020.
Pankaj R Patel, Chairman-Zydus Cadila, said: “Depending on the study outcomes and if the info is encouraging and therefore the vaccine is found to be effective during the trials, it could take a complete of seven months for the trials to be completed and for the vaccine to be launched”.
The Hyderabad-based Bharat Biotech had got approval to conduct Phase 1 & Phase 2 clinical trials of its vaccine named Covaxin at Rohtak’s Post-Graduate Institute of Medical Sciences after its pre-clinical studies exhibited safety and immune reaction. it's collaborated with the Indian Council of Medical Research (ICMR) and also the National Institute of Virology (NIV) to develop the vaccine.
Now Dr Reddy’s, another Hyderabad-based pharma company, has the regulatory nod to conduct the adaptive phase 2/3 human trial for the Russian Sputnik V vaccine in India. The firm confirmed that the vaccines have reached & clinical trials will begin shortly. Also, Gamaleya National Research Institute of Epidemiology and Microbiology & therefore the Russian Direct Investment Fund has announced that the vaccine was found to be 92% effective in safeguarding humans against the deadly coronavirus.
National Dairy Development Board (NDDB) Indian Immunologicals, a subsidiary has partnered with Australia’s Griffith University to develop the deadly Covid-19 vaccine. Other pharma companies like Mynvax and Biological E, too, are endeavouring to develop deadly Covid-19 vaccines.
At the same time, Pfizer Inc., the US-based pharma giant, reported that its first set of Phase 3 clinical trials of the deadly Covid-19 vaccine provides the fledgeling evidence that its covid vaccine is 90% effective to forestall Covid-19. Similarly, Moderna, another US-based pharma giant, announced that its Phase 3 data of clinical trials state that its Covid-19 vaccine is 94.5% effective in preventing deadly Covid-19 virus.
Are there any limitations?
In India, the manufacturing cost of covid medicine, including covid vaccines, is comparatively low due to inexpensive labour and therefore the presence of in-depth manufacturing facilities. From a distribution standpoint, it's necessary to supply the vaccine at reasonable prices in order that even the people at the ground level could get its benefit.
Chandrakant Lahariya, a vaccinologist & public health expert, commented that “A [deadly coronavirus] vaccine developed in India would be far cheaper than a vaccine developed anywhere else. The affordability of a Covid-19 vaccine is paramount; if doses are prohibitively expensive, it could hamper distribution, prolonging the pandemic & costing lives.
Serum Institute of India (SII) envisages that it'll offer one dose of vaccine at $3 to India & other emerging economies. As against this, Pfizer vaccine, which is getting manufactured within the USA and Germany, would be offered at $19.50 per dose and Moderna would charge within the range of $32-$37 for one dose of covid vaccine.
Apart from the value considerations, the storage of the Covid vaccine is another impediment in its widespread adoption. The Pfizer vaccine for coronavirus incorporates a complicated super-cold storage requirement i.e. it must be stored at 70 degree Celsius. this may become a challenge not only in poor countries or rural missions in India where cold chain facilities are limited but also become a constraint for the foremost advanced hospitals within the USA. As compared to the present, Moderna’s vaccine may be conveniently stored at -20 degrees celsius.
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Conclusion
As per the US FDA norms, a vaccine has to be a minimum of 50% effective to fulfil the approval. Compare that with the 90% effective Covid vaccine, which is incredibly promising and a good achievement in a very record-breaking time, that too for the whole humanity. However, any conclusive evidence would be drawn only after the scientific peer-review of the Phase 3 results gets over.
Currently, it’s too early to develop any conclusion. at the same time as researchers still race through clinical trials, they may soon come up with a version that needs less or no refrigeration in the least.
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