Pfizer, Serum, and Bharat Biotech seek emergency approval; Government's review process also accelerated


Posted on 11th Dec 2020 02:31 pm by rohit kumar

The wait for the corona vaccine in India is about to end. After Russia and China, the UK has also secured the vaccine here. At the same time, three vaccines in India have also sought emergency approval for themselves. The Government of India has said that the regulator will make a decision on this soon and the process of vaccination will be expedited as soon as possible.

 

Among those seeking emergency approval in India is the US company Pfizer, which has made the mRNA vaccine made by German partner BioNotech. Pfizer's trials have not taken place in India. Because of this, the drug regulator may ask him for trials on some people in India. At the same time, on December 7, the Serum Institute of India (SII) and Bharat Biotech have also sought emergency approval for their vaccines. Both vaccines are in Phase-3 trials in India. SII has tied up with Oxford University / AstraZeneca to produce the vaccine. Its trials in the UK and Brazil have resulted.

 

According to the Vaccine Landscape of the Government of India, work is currently underway on 9 vaccines in India. There are three vaccines in the pre-clinical stage i.e. currently in labs. Besides, 6 vaccines are in the rough phase of clinical trials. Let's know about the vaccine being made in India ...

 

1. CoveShield: Decision on application of emergency approval of SII soon.

 

Who made it: Oxford University and AstraZeneca (UK) have made it together.

 

Status: AstraZeneca announced the results of its Phase-3 clinical trials on 23 November. Accordingly, when a half and a full dose were given, it was effective up to 90%. At the same time, giving two full doses was 62% effective. SII of Pune in India has signed an agreement to manufacture doses of this vaccine.

 

When to get and price: Poonawalla's company has applied for emergency approval of this vaccine on 7 December. The government will decide on this soon.

Around 10 million vaccines may be available by February. The government will get a dose of vaccine for 250 rupees and ordinary Indians for 500 rupees.

 

2. Covaxin: Bharat Biotech has also asked for emergency approval

 

Who created: Hyderabad-based company Bharat Biotech has created the vaccine in association with the National Institute of Virology (NIV) and the Indian Council of Medical Research (ICMR) and named it - Covaxin.

 

Status: There have been two phase trials of this vaccine and till now this vaccine has been effective. None of the volunteers has shown serious side-effects. The company has started its phase-3 trials in 25 locations at 25,800 volunteers in November itself. The company has sought emergency approval for the vaccine on 7 December.

 

When will I get this vaccine if everything happens according to the timeline? So far, the company has not said what its price will be.

 

3. Sputnik V: Dr. Reddy's Labs started Phase-2/3 trials

 

Who created: Gamalaya Research Institute of Russia has developed this vaccine with the help of the Russian Direct Investment Fund.

 

Status: Dr. Reddy's Laboratories Limited and the Russian Direct Investment Fund (RDIF) have started Phase-2/3 clinical trials of Russian Vaccine Sputnik V in India on 1 December. In November, RDIF presented a second interim analysis of Sputnik's clinical trials data. Accordingly, the vaccine remained 91.4% effective 28 days after the first dose and 95% effective 42 days after the first dose.

 

When to get it and the price: Phase-2/3 trials will take two to three months. The vaccine can be approved after March. The company has given the assurance of its single-dose being around 700 rupees.

 

4. ZyCov-D: Zydus Cadila Vaccine Ready to Go to Phase-3

 

Who Made: Ahmedabad-based company Zydus Cadila has created the plasmid DNA vaccine ZyCov-D to protect against Covid-19.

 

Status: The data of its phase-1 clinical trials has arrived and has given promising results. This has been confirmed by the Data Safety Monitoring Board (DSMB). Phase-2 trials are currently underway, the results of which will be announced soon. The company claims that the results in Phase-2 have also been good.

 

When to get it and the price: There is a plan to make the vaccine available in the market by the second quarter of 2021. So far, the company has not said what its price will be.

 

5. NVX-CoV2373: SII to start Phase-3 trials of Novavax vaccine

 

Who made it: The American company Novavax has built it using protein sub-unit technology. It will be made into the Serum Institute of India (SII) in India.

 

Status: Phase-3 trials of this vaccine are going on in some other countries including the US. So far it has succeeded in making antibodies. Phase-3 trials of this vaccine are being considered in India.

 

When to get and price: If everything goes well, then in 2021 this vaccine will be available. By the way, if the results of phase-3 trials in an external country are achieved before the results in India, then serum emergency may seek approval. It has also made similar demands for CoveyShield, an Oxford / AstraZeneca vaccine.

 

6. Biological E also started phase-1/2 clinical trials

 

Who created: American company Dynavax Technology Corporation and Houston's Baylor College of Medicine together have created a subunit vaccine candidate.

 

Status: Hyderabad-based company Biological E has tied up for this vaccine. In November itself, it has received approval from the Drugs Controller General of India (DCGI) to launch Phase-1/2 clinical trials of the Covid-19 subunit vaccine candidate in India. If the vaccine works, then there is a potential to make one billion doses in a year.

 

When to get and price: This vaccine is expected to be available only after July in 2021. So far, the company has not stated the price.

 

7. Currently in labs, Genoa Pharma and HDT Biotech vaccine from Pune

 

Who created: Pune-based Genova Biopharmaceuticals Ltd., in association with the US-based HDT Biotech Corporation, has developed the mRNA vaccine candidate (HGCO19).

 

Status: This vaccine has shown safety, immunogenicity, neutralization antibody activity in mice and primate models. The company has not yet applied for phase-1/2 clinical trials of its vaccine.

 

When to get it and the price: Its human trials have not started yet. This vaccine will be available in 2021 only after July. A decision on the price will be made later.

 

8. Inactivated rabies vector platform: American University has created a vaccine

 

Who created: Thomas Jefferson University of America has developed this inactivated rabies vector platform vaccine. It will be made in India by Bharat Biotech Company of Hyderabad.

 

Status: Pre-clinical trials are currently underway for this vaccine. This trial is in the advanced stage. It is expected that the vaccine will soon enter the Human Trials phase.

 

When to get and the price: Clinical trials have not started yet. In such a situation, it is impossible to tell the time and price.

 

9. Aurobindo Pharma vaccine currently in pre-clinical stage

 

Who Made: Hyderabad-based pharmaceutical company Aurobindo Pharma has developed this vaccine.

 

Status: Currently this vaccine is in the pre-clinical stage. That is, tests are going on in labs only. By the way, the company has reported that the company's vaccine manufacturing factory in Hyderabad may start functioning in May.

 

When to get and price: It is not possible to say anything at the moment.

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