Phase-2 trials of both indigenous vaccines of India started; Serum Institute to create 2 billion vaccine doses for Novavax


Posted on 16th Sep 2020 02:38 pm by rohit kumar

The second wave of coronavirus all over the world is hunting people more frighteningly. Not only are the cases increasing day by day, but the death toll is also increasing rapidly. This has made the race for the vaccine even faster. After China and Russia, now the UAE has also approved the vaccine. This vaccine is made by the Chinese company Sinopharm. Phase-3 trials of this vaccine are still ongoing. Meanwhile, both indigenous vaccines of India have completed Phase-I trials. Volunteers for Phase-2 have also been recruited. The Serum Institute has been granted permission to reintroduce trials of Kovishield, a Covid-19 vaccine from Oxford / AstraZeneca.

 

Coveshield: Trials resumed in England, India, stopped in the US

 

After England, India has also permitted to resume the trial trials of the Oxford / AstraZeneca vaccine. The Serum Institute of India (SSI) in India has started Phase-2 and Phase-3 trials of this vaccine. At the same time, the Drug Regulator Food and Drug Administration in the US has not taken a decision yet. At the same time, the National Institute of Health has started investigating the reasons for stopping the trials.

 

A woman's health worsened during the Phase-2 and Phase-3 trials of Coveshield, the Oxford / AstraZeneca vaccine in England. After this, his trials were banned all over the world including India. The Independent Expert Committee and the UK's Drug Regulator have permitted for the trials to be resumed after investigation. The woman, who was ill, has also been discharged from the hospital.

 

Phase-1 trials of both indigenous vaccines were successful.

 

Director-General of ICMR, Dr. Balaram Bhargava said that both indigenous vaccine candidates (Kovaxin of Bharat Biotech and Candidate of Zydus Cadila) have completed Phase-1 trials. So far both have been safe and effective.

Dr. Bhargava said that Zydus Cadila has completed recruitment for Phase-2. Three doses will be given at a difference of 28 days. Similarly, phase-2 recruitment has also been done for Bharat Biotech's Kovaxin. Volunteers will be given two doses in this phase.

 

Dr. Bhargava says that the Serum Institute of India has completed Phase-2 trials. Vaccine doses have been given to 100 volunteers for this. After a seven-day gap, Phase-3 trials will start at 1,500 volunteers at 14 sites.

Discussions are being held between the Russian government, diplomats, and high-level Indian expert committee on the issue of phase-3 trials of the Russian vaccine in India. Dr. Bhargava said that not much can be said in this regard at the moment. Russia has also started phase-3 trials of the vaccine.

 

Novavax will now make 2 billion vaccine doses in India

 

In August, the US company Novavax signed a deal with the world's largest vaccine producer Serum Institute of India to manufacture at least one billion vaccine doses. Now he has doubled this deal to two billion vaccine doses.

 

Under the new agreement, Serum Institute will also manufacture vaccine antigen component NVX ‑ CoV2373. This will enable the production of two billion doses by June 2021. Novavax vaccine has been safe and effective in the initial stage. The company is scheduled to start Phase-3 trials in October.

Trump claims - vaccine will be available in a month

 

US President Donald Trump has claimed that the coronavirus vaccine may be available within a month. It also said that this epidemic will end by itself.

 

During a Q&A session with voters in Pennsylvania, Trump said, "We are very close to getting the vaccine." We will have the vaccine in a few weeks. It may take four weeks and 8 weeks.

 

Democrats have voiced concern over Trump's statements. He says Trump is pressurizing the government health regulator by making such promises that he approves the coronavirus vaccine as soon as possible. This makes him want to strengthen his turn against Joe Biden, a Democrat candidate in elections.

 

Scientists not satisfied with Russian vaccine data, sought and data

 

The results of the initial trials of the Russian vaccine SPUTNIK V, despite appearing in the medical journal Lancet, have not convinced his safety. A group of international scientists have questioned the data published in the study. They have drawn attention to potential flaws.

 

40 scientists have demanded original data by writing an open letter to Gamalaya Institute, the developer of the Russian vaccine. The study published in the Lancet does not contain complete data. The developers have claimed that their vaccine has been completely safe and effective in Phase-1 and Phase-2.

 

UAE approves Chinese vaccine

 

The UAE has become the third country in the world to approve the use of the coronavirus vaccine. It has approved the vaccine of Chinese state-run Sinoform. The company had been doing vaccine trials in the UAE for the past six months.

 

Phase-3 trials of Sinopharm are not over yet. The UAE government said that this vaccine would first be given to defense heroes who are at the highest risk of infection with the virus.

 

This Covid-19 vaccine from Sinopharm was approved by China on July 22, even before the phase-3 trials began. China has also approved two other vaccines, but their Phase-3 trials have not yet been completed. Similarly, Russia has already approved SPUTNIK V before the results of Phase-3 trials.

 

Now Pfizer will conduct vaccine trials on 44,000 people

 

Pfizer, which is among the leading companies in the race for the Covid-19 vaccine, said its vaccine is safe and the company hopes to get the data next month. Pfizer CEO Albert Baurla said that to make the process open and transparent, they are sharing information as quickly as possible.

 

The company has said that now it has increased the scope of trials from 30 thousand to 44 thousand people. The 16 to 18-year-old teenager will also be included in this. Besides, patients suffering from HIV, Hepatitis A, B, or C will also be enrolled.

 

WHO Says Vaccine Landscape…

 

180 vaccines are currently being developed all over the world.

35 vaccines are undergoing clinical trials.

9 vaccines are in Phase-3 ie final round trials. There are also four vaccines being developed in China.

145 vaccines are in the phase of pre-clinical trials. That is, their evaluation is still going on in the labs.

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