Corona Vaccine News And Updates | Expert panel recommends vaccine and covishield know what will happen after this | Coveshield vaccine on the way for early approval, know what will happen next after the recommendations of the committee? » India News
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Corona Vaccine News And Updates | Expert panel recommends vaccine and covishield know what will happen after this | Coveshield vaccine on the way for early approval, know what will happen next after the recommendations of the committee?



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9 minutes agoAuthor: Ravindra Bhajani

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The battle against Corona has brought big news on the very first day of the new year. The Subject Expert Committee of the Central Drug Standards Control Organization (CDSCO) has recommended conditional approval of the coviShield vaccine. This has increased the expectation that vaccination will start in India on a large scale in January itself. Come, let us know how the vaccine journey will be from here.

First, which companies had asked for emergency approval?

  • CoveShield or AZD1222 is made by Oxford University in association with the British pharma company AstraZeneca. Adar Poonawala’s Serum Institute of India (SII) is conducting trials in its India. The expert committee has recommended conditional approval.
  • The second vaccine to seek emergency approval, Kovaxin, is indigenous. It is jointly formed by the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) by Hyderabad-based company Bharat Biotech. The committee has not taken any decision on this.
  • The third vaccine to seek emergency approval with both of these vaccines was from American company Pfizer, which it has developed in collaboration with BioNotech. Pfizer’s vaccine has been approved by the World Health Organization (WHO) for Emergency Use for the whole world. Even after this, the SEC of India has not taken any decision on it. The reason is that there are complaints of allergic reactions to Pfizer’s vaccine. Similarly, people of Indian origin were not involved in its trials. Because of this, the company has sought more time to present the data to the SEC.

What will happen after the recommendation of the SEC?

  • Many countries, including the US, have strict rules for emergency approval of medicines and vaccines under the Emergency Use Authority (EUA). The guideline is also fixed for this. But there is nothing like this in India. This does not mean that the regulator does not approve medicines or vaccines without completing trials here. Medications against corona were quickly approved. Similar emergency approvals have been given to Remedesivir in June and iTolizumab in July.
  • According to Dr. Gagandeep Kang, India’s Top Vaccine Scientist and Professor at Christian Medical College, Vellore, only in the last year, new clinical trials have been made in India. In this, the regulator has been given the authority to approve medicines or vaccines for emergency use even in emergency situations without trial.
  • According to Dr. Kang, monitoring of emergency use is similar to clinical trials even after being granted permission. Details of every patient are necessary. They are monitored. The company that has got the license for its product elsewhere, has to submit the complete data of pre-clinical and clinical trials to the regulator.
  • When the company asks for permission for Emergency Restricted Use, it is processed in two stages at the regulator level. The Subject Expert Committee considers that application. After its approval, the matter goes to the Apex Committee. This committee also has secretaries of departments associated with the Ministry of Health.
  • Currently, the CoveShield vaccine has been subject to the Subject Expert Committee’s conditional approval. In the meantime, the Apex Committee will consider that. The drug regulator will then approve it. By the way, the decision is made only after thorough assessment of the data in the subject expert committee meetings. Therefore, there does not seem to be any problem in the approval of the Apex Committee.

What is the risk of emergency approval?

  • It depends on the individual drug and vaccine. It may be that the emergency approvals are removed in the future and the entire project is closed. The same happened with hydroxychloroquine and remadecivir in the treatment of corona. The WHO also first withdrew the drugs that were found to be effective in Corona.
  • Dr. Avinash Bhondway, President of the Maharashtra Chapter of the Indian Medical Association, says that emergency approval is like eating half-baked food. It is better to eat it only when the food is fully cooked. It is better to be late by accident.
  • According to the FDA, people are required to tell about a drug, vaccine, or medical product that they have received emergency approval and that their safety and efficacy have not been fully proven so far. A similar process is being followed in all countries including India.

How long will the vaccine be available?

  • The preparations for KoviShield making SII are complete. The company has sent the vaccine for testing at Central Drugs Laboratory in Kasauli. This is an important process in which the vaccine produced in the manufacturing facility, rather than the laboratory vaccine, is sent for examination.
  • Adar Poonawala of Serum says that he has kept 5-6 crore doses at his risk. The delivery process of the vaccine will begin as soon as the formal process is complete.
  • The government has kept a dry run of vaccination across the country on 2 January. Earlier, the government had done such a dry run in two districts of four states. It had 25-25 health workers selected at each center. The process of registering health workers to access the vaccination site on the COVIN platform as well as the vaccine from the cold chain site to the vaccination site was tested. Similar preparations are being conducted throughout the country.
  • If all goes well, vaccination will begin within two weeks. That is, this year, Vaccination can start as soon as the sun is on Uttarayan on Makar Sankranti. The Serum Institute prepares to provide 100 million doses by March. In the first phase in India, 300 million people in priority groups are to be vaccinated.