India’s Covaxin Trial (Part 1 of Phase 1) Shows ‘Encouraging Results’

India’s Covaxin Trial (Part 1 of Phase 1) Shows ‘Encouraging Results’

July 26, 2020, 4:17 p.m.

India’s Covaxin( COVID-19 Vaccine) shows encouraging results in part first of the phase 1 trial. In an interview to Sputnik, Serum Institute of India Chairman Adar Poonawalla said that his company would manufacture 100 crore doses of the vaccine in the next one year and would provide 50% of them in India while providing the other half to other poorest nations.

Part 1 of phase-1 of Made in India Covaxin coronavirus vaccine trial (Covaxin) has been completed. As many as 50 people across India were administered the vaccine. The results were encouraging, news agency ANI reported Dr Savita Verma, Principal Investigator of vaccine trial team at PGI Rohtak, as saying. Six people were administered vaccine on Saturday under part 2 of phase-1.

With Coronavirus cases surging all across the globe including second waves of the virus spread in many countries, it has become clear that only a vaccine against the virus can help the world get rid of this scourge.

On Friday, a 30-year-old man was administered the indigenous Covid-19 vaccine Covaxin at the All India Institute of Medical Sciences, Delhi. Dr Puneet Misra, one of the investigators of the trial and a professor of community medicine at AIIMS told the Hindustan Times that the man was observed for an initial two hours to check for any adverse reaction of the vaccine on his body.

He also said that all the volunteers and their health will be under the scrutiny of the hospital for more than a year to check for any long term changes/reactions in their bodies. The vaccine, which has been developed by Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV) is undergoing clinical trial phase 1 round in three medical institutes across the country with AIIMS Delhi alone expected to inject over 100 healthy volunteers with the vaccine.

The other two institutes which had started the human trials of the vaccine some days ago are AIIMS Patna and Post Graduate Institute of Medical Sciences(PGIMS) Rohtak. Subsequently, the human trials will be commenced to nine other medical institutions in the country which have been selected by the Indian Council of Medical Research (ICMR).

It is pertinent to note that only those individuals who are fit and not suffering from any kind of comorbidities are allowed to become volunteers partaking in the human trials of the vaccines. After the completion of the first round of the clinical tests, the vaccine will be tested on more than 750 people between the age of 12 and 65, Dr Randeep Guleria was quoted as saying by news agency PTI. More than 3500 individuals have also evinced interest to become volunteers for the vaccine trials at Delhi AIIMS only for the Covaxin vaccine candidate.

ZyCov-D Update

Another indigenous vaccine which has made much headway in the fight against Covid-19 is the ZyCoV-D named vaccine candidate developed by Indian pharma Zydus Cadila. Along with the Covaxin, the vaccine developed by Zydus had also got regulatory approval to commence the human trials of the vaccine. The company has so far limited its trials to its Ahmedabad centre and expects to conclude all the phases of the human trial in about seven month’s time, Zydus Cadila Chairman Pankaj R Patel was quoted as saying in a Hindustan Times report.

The vaccine developed by the Oxford University which has already shown its potent efficacy in generating the antibodies against the virus in its phase 1 and phase 2 trials in different parts of the world will undergo clinical-stage trials in India as well.

The vaccine which was earlier tentatively named Covishield and estimated to cost less than Rs 1000 for a shot will be administered to over 5000 volunteers in the country, Pune based Serum Institute of India which is collaborating with its international manufacturer AstraZeneca was quoted as saying by the Sputnik.

Oxford Vaccine Update

On Saturday, the Serum Institute of India (SII) sought permission from the Drugs Controller General of India (DCGI) for conducting phase 2/3 human clinical trials of the potential vaccine, highly-placed sources said on Saturday, news agency PTI reported sources as saying.

They said that the Pune-based drug firm submitted its application to the DCGI on Friday seeking permission for conducting the trials of ‘Covidshield’. “According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ (COVID-19) in healthy Indian adults. The firm said that an around 1,600 participants of more than 18 years would be enrolled in the study,” PTI quoted a source as saying.

In an interview to Sputnik, Serum Institute of India Chairman Adar Poonawalla said that his company would manufacture 100 crore doses of the vaccine in the next one year and would provide 50% of them in India while providing the other half to other poorest nations in the world with the help of GAVI (Global Alliance for Vaccines and Immunisation). GAVI is a public-private partnership established by the Bill and Melinda Gates Foundation that helps the poor nations get equitable access to the medicines and vaccines.

Global Vaccine Update

On the global front, more than 140 candidates are involved in the development of the vaccine at several stages of human and animal trials. Among the frontrunners are Oxford University’s vaccine candidate, U.S drugmaker Pfizer’s vaccine candidate, China’s CanSino Biologics along with the vaccines developed by the Russian Gamaleya Institute of Epidemiology and Microbiology.

The first phase clinical trial of the first vaccine developed by the organisation were reported to be successful and the organisation is now going to commence from July 24 the clinical trial of another vaccine developed in the fight against Coronavirus disease.

According to a report by the Guardian, a total of 142 vaccine candidates are at the pre-clinical-stage around the world. Further classifying the vaccine candidates which are at various stages of clinical trials, the Guardian report said that a total of 17 vaccines are at the first phase, 13 at the second and only 5 candidates are at the phase 3 trial across the world respectively. It also said that no vaccine has been approved for mass use in the world and it will take several months before the world has a permanent solution to the Coronavirus pandemic.

Source: Financial Express

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