Covid vaccine is expected to hit the Indian market by August 15. The Indian Council of Medical Research (ICMR) is partnering with Bharat Biotech International Limited (BBIL) in Hyderabad to launch the drug. If the vaccine really comes on the market as claimed on August 15, then India will be the first country to be recognized for inventing the corona vaccine. According to sources, Prime Minister Narendra Modi will announce the discovery of the vaccine from Red Fort on Independence Day. In the first phase, health workers like doctors and nurses, who are at the forefront of the fight against corona, will be vaccinated.
Today, ICMR chief Balaram Varghese wrote a letter giving clearance to 12 companies in the country to apply the vaccine on clinical trials or on humans before using it commercially. On the question of clinical application of the first indigenous antidote, dozens of organizations like ' SUM ' of Orissa, King George College of Visakhapatnam, PGIMS of Rohtak have been selected besides AIIMS in Delhi. The trial of the vaccine will begin on July 6. The ICMR said today that in order to prevent infections like Covid and to bring antidotes to the market quickly, those companies have been instructed to start work by getting all the necessary clearances quickly. Which means, the time at hand is only five weeks. India Biotech will have to release the antidote in the market by August 15 after judging its merits and demerits. Vargab wrote in the letter that the project is being monitored from the very top level of government. If they does not follow the instructions, government will take a strict attitude.
The question arises, there are at least a few steps in the question of discovering any antidote or vaccine. Whether the antidote is safe at all is checked at every step. Which is time consuming. In this case, virologist Pradeep Seth has questioned how it is possible to finish the episode in just five weeks. In the words of the former AIIMS doctor, "How can a vaccine be possible in just five weeks?", He said, it is believed that India Biotech has applied the vaccine to an animal. First of all, it has to be seen whether it has a negative or positive effect on the body of the animal. The decision of application to the human body will be on the basis of that report. In that case too, it remains to be seen whether the vaccine has been able to develop immunity in the human body in the first and second steps. It remains to be seen whether the vaccine is doing any harm. In some cases, it takes 2-3 years to understand the whole process, said Pradeep Seth, who administered his own HIV vaccine in 2003.
Test steps and timing :
Pre-clinical trials: Antibiotics in monkeys or rats
Step-1:
Safety Trial :- Applied to a very small number of people, to see if antibodies are being produced.
* Wait three months to understand what is harmful
Step-2:
Extended trial :- Antidote in 100 patients. It remains to be seen how safe and effective the vaccine is
** Usually wait three months. It is seen whether the victims are recovering or whether they are having harmful effects on the body.
Step-3:
Efficacy trial :- Application on thousands of people. It is seen how many people became infected and recovered. Wait three months
Step-4:
Seeing the results, the clearance for making the antidote is given .
• Many companies do steps 1 and 2 together. According to the experts, even if you do steps 1 and 2 together, you should wait for 6 months. It takes at least six months to reach the approval level from step 1 . But India is getting Covaxin within 5 weeks. (July 6 to August 15)
Oxford University gave experimental antidotes to about a thousand people last April. However, the antidote is not on the market before October
Q: Why hurry? What if Citizens have to pay compensation for this ?
Parthasarathy Roy, a professor of biological sciences at the Indian Institute of Science Education and Research, has been vocal in his criticism of the government's "We -have-done-this " attitude. "In the case of science, this attitude is not desirable," he said. Rather, the antidote should be released in the market by analyzing the aspects of human safety in a scientific way by judging good and evil. But in this case, the whole thing seems to be an irresponsible move. ” Many experts are considering this step of ICMR as a 'threat' According to them, research is not done at the gun point. The patient's condition should be monitored for at least three to six months after each step of the prophylaxis. After that you have to go to the next step. In this case, if there is a failure at any stage, then the whole matter has to be reviewed anew. Where is that opportunity here! If so, is the antidote already considered successful? Public health doctor Ananta Van also raised such a question.
"On July 2, it was said that all experimental applications should be started within five days," said Ananta, a bioethics researcher. If not, strict action will be taken. The question is, who will? ICMR? In what capacity? ”In this case, Anant also raised the question of whether the safety issues are being complied with after the application of the antidote. Although the ICMR source said in the guidelines, the final decision will depend on the report of the place where the clinical trial will take place. But a large portion of researchers say it is impossible to complete the entire process by August 15 and make a report. Vaccination is far away!
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