There is finally some good news coming to battling this deadly coronavirus, AstraZeneca- the experimental COVID-19 vaccine which is being developed at Oxford University has been found to be safe and has also managed to produce an immune response, meaning antibodies in the early-stage clinical trial in healthy volunteers. However, it’s important to remember that this is only in its early phase and phase 3 trials are yet to be conducted for the real reliability of the vaccine to be known. Recently, the big leap in the vaccine race is taken by Pune based serum institute which is now partnered with AstraZeneca and with Oxford University to manufacture this potential vaccine here in Indian. Below are the significant takeaways from the report published given by the CEO of serum institute, Adar Poonawalla.
- The phase has established safety and no severe side effects and reaction were observed. So people can feel safe that this is not going to kill anybody or cause any major side effects, and all they got was headaches and fever which comes with normal vaccines that can be treated with paracetamol and all the patients took that and were fine. They tried to test T- cells response and the igG, and have found neutralizing antibodies in response which indicates in layman terms that this vaccine show protection against COVID. Now, how much protection and whether this will actually protect you against the disease will be established in phase 3, which is the next and final step. This has already started in many places and it is planned to start in August on Indians by serum Institute and they are hoping to conclude by October or November.
- Phase 1, Phase 2 as well as Phase 3, has to be done in thousands of people while also maintaining efficacy. During phase 1, it was done on 1000 people with 500 vaccinated and 500 not vaccinated to have the placebo. Now, the UK tracks have got about 10,000 patients for phase 3 and India will have to do half to that or similar to that because we have more of cases as it will be easier to establish the efficacy of a vaccine in a population where the disease is very infectious and prevalence. For this to happen it will typically take two and a half months to complete, so assuming that they start injecting patients by the end of August, we can see reliability by October or November.
- For citizens of India, the availability of the vaccine is going to be December and the first quarter of 2021, because to reach all parts of the country and all that logistics will take some time, including the internal testing. Always when the product is made, the first step is to have it tested yourself in your company and then it goes to CDL which is national in Kasauli, and only after that can a batch be released into the public. All these are being expedited in the serum institute. So when putting together- realistically large volumes for India will be quarter one twenty-one but a few million will be made available to the move for immuno compromised, the elderly and the health care workers as they are planning to have it was done by end of the year. They are wishing that at least the vulnerable populations in the main cities where the disease is are being protected from COVID.
- With the facilities at serum institute, the capacity of production is estimated to be about 700 to 800 million doses annually until new facilities are made and in the upcoming four months, the institute has planned to produce 300 million doses and scale up after that. Generally, most vaccines like pneumonia vaccine, rotavirus vaccine are given two to three shots and likewise, AstraZeneca is a two-dose vaccine. Serum institution announced that it might take three to four years for people on the entire planet to be vaccinated in realistic terms to the fullest extent with two does of any vaccine produce against coronavirus.
- Serum institute has decided that just like their other vaccines, this will be for a few dollars a dose. They are going to manufacture it and give the supply to the government of India and state government where the vaccine is bought from serum Institute and distributed in the most ethical and fair manner that they see fit. Serum Institute has taken this decision based on how healthcare experts and people on the ground has adequate knowledge of where the vaccines supply needs first (i.e.) vulnerable populations because if they were to take distribution up their sleeves then there is much possibility of missing out the vulnerable population or there might also be a chance of delay which could be dangerous. The CEO of serum institutes has added that there will be no need for a citizen of India to pay for the vaccine as this is a national security issue and they believe that the government will make it available free of cost for all people.
- Serum institute is betting big by spending 200 million dollars on OPEX and CAPEX dedicating to facilities and buying all raw materials for the AstraZeneca product. They are taking such a big risk because if it fails, they will be down more than two hundred million dollars. Serum institute terms taking such risk as their commitment to the cause of fighting this disease. They have started buying the raw materials to months back and will be going to spend the rest of the year in manufacturing thousands of millions of doses of this vaccine, hence if it fails there will be a big loss of revenue for them yet they want to take this risk.
- This sudden leap in decision making by serum institute has occurred after long research, for they want to manufacture a vaccine that is safest as well as gives you the longest term protection so there won’t be a need for coming back again and again. That’s the reason they have also bet on 5 other candidates, which include two Indian candidates as well. They are also planning to launch a new COVID 19 vaccine every three or four months starting with the AstraZeneca product because this is way ahead in the race of the vaccine. Plus in this way, they don’t have to bet on just one candidate and they believe that out of these, at least few will be successful.
Serum Institute is taking a very big step towards a vaccine production and they seem to have very high hope on AstraZeneca seeing how dedicated they are towards them. They also seem to be aware of both the positive and negative consequences this decision is going to have but serum institute is firm on their commitment and their role they have to play in this COVID stricken situation.
But Should we keep our hopes high on AstraZeneca? Can serum institute really produce a covishield for the world very soon? Was this the right step? Did serum institute make a big mistake? Or is this the start of putting an end to the disease this will remain to be found only after the phase 3 trials.