It takes 18 months to develop good vaccine: Ex-ICMR chief


By Sumit Saxena

New Delhi, Jul 4 (IANS): A good vaccine usually takes at least 18 months, before it could be rolled out for production after fast-tracking all the mandatory regulatory approvals, said N.K. Ganguly, former director general of Indian Council of Medical Research (ICMR).

It is expected that India's first indigenous Covid-19 vaccine, Covaxin may be released on August 15 under a fast-track mechanism. According to the government's top medical research body, a dozen institutes have been selected for clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID vaccine). Ganguly said the strain of the virus was given to BBIL in May end, and in July, human trials have been scheduled.

Elaborating on the lengthy process involved in vaccine development, he insisted that after spending many months and infusing a lot of funds, the uncertainty continues to linger. "It may be difficult to say whether the vaccine is successful or not", he added.

The ICMR in a letter said, "It is envisaged to launch the vaccine for public health use latest by August 15, after completion of all clinical trials. BBIL (Bharat Biotech International Limited) is working expeditiously to meet the target, however the final outcome will depend on the cooperation of all clinical trial sites involved in this project."

Before the vaccine is tested on humans, challenge studies are done on mice and monkey, then a toxicology report is prepared, to check if the developed vaccine produces harm to cells, and it takes at least three to four months to finalize this report, said Ganguly. After this phase, the vaccine is tested on two rodents and a large animal and after successful completion of this stage the vaccine is ready for human trials.

"In Phase 1, the age group profiling is done (wherein vaccine study is done on people in different age groups). In Phase 2, nearly 600 to 700 people are vaccinated, and if the vaccine performs successfully in this phase then it progresses into Phase 3, which is called the efficacy study (in this phase, thousands of people are enrolled). Even after fast tracking regulatory approvals, it will take at least 18 months to develop a good vaccine", said Ganguly.

He insisted that the vaccine being developed by Moderna (RNA vaccine is set to begin Phase 3 trials later this month and targets a vaccine by 2021) and BioNTech-Pfizer (Phase 3 trial is expected to begin in July). Gennova biopharmaceutical is also working on a vaccine and it looks positive, Ganguly added.

 

  

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Comment on this article

  • Langoolacharya., Belman / Washington, DC.

    Sat, Jul 04 2020

    Satish, Mangalore,

    Perhaps you are exposing your ignorance here by writing this comment on behalf of Hat...

    Astrozenica is NOT in forefront of COVID-19 Vaccination but Moderna is...just because they collaborate with NIH , where Anthony Fauci Works ( Getting free US Government research)... Regarding company Size and achievements Pfizer ,Merck and Johnson and Johson are far bigger than these two....perhaps their total budget could be half of total Indian budget!!! ...

    Astrozenica is a small Jewish Company having collaboration with some foreign drug companies, for manufacture of COVID-19 vaccine...

    I am 100% sure one of these 5 will be first company to get COVID-19 Vaccination approval by FDH before November ... 15th August is your Independence day not mine...my independence day is today 4th July...

    You know what? I know Astrozenica very well...and had been to their HQ for designing a Cell site there ....they are Good Company and people ...they distribute free medicine to people who cannot afford to pay...which is very rare in a Capitalist Country like US...

    I don't do internet research here and write here like Hat does ...whatever I write here is what I see and experience ...and I STAND BY IT....no matter you or people like you like it or not...

    Getting a COVID-19 Vaccine as soon as possible is good for HUMANITY....not only for drug Companies...Why some m*or*n's oppose it is beyond my comprehension...By the by, I am not even in Drug Industry or their sympathizer...

    ...Tak...Takk

    DisAgree [3] Agree [1] Reply Report Abuse

  • Satish, Mangalore

    Sun, Jul 05 2020

    Langoolacharya,

    I don't want to pretend to be an expert. I only quoted the news. As per the news, Astrozenica will commence phase 3 trials whereas others are still at Phase 1 or 2. Best possible release date may be somewhere in December 2020. That is it. I will not write more from the internet and get exposed like you. There is no need to boast when you are not from that field.

    I do not know Mr. Geoffrey but your reply to him was not gentleman like. We need to maintain minimum decorum while writing comments. Most of your comments goes in the direction of ridiculing people and such arrogance is not good.

    DisAgree Agree [3] Reply Report Abuse

  • smr, Karkala

    Sat, Jul 04 2020

    The Indian Council for Medical Research urgently backpedalled the deadline its director general had set for the release of a fully usable coronavirus vaccine by August 15.

    The WHO recommends that phase-3 trials, often considered the most important, should involve up to 20-30,000 people.

    Indian testing levels – which are 6,913 per million compared to 116,543 for Spain and 149,071 for UK – she said that when the test positivity rate falls under 5%, India will be testing enough. At the moment it is 8.34%.

    Scientific, ethical standards mustn't yield to speed. The August 15 ICMR deadline is nothing but a political motivated move under pressure from the ruling elite that wanted to take the credit from the untested drug for the upcoming 'Bihar' election.

    Jai Hind

    DisAgree [1] Agree [2] Reply Report Abuse

  • Langoolacharya., Belman / Washington, DC.

    Sat, Jul 04 2020

    Hat,

    Only m*r*ns like you can deny following companies passed their Phase-1 and Phase-2 Clinical tests for COVID-19 Vaccine on humans successfully and Currently going through Phase-3 / Final Clinical testing....

    1. Moderna
    2. Pfizer
    3.Merck
    4.Astrozanica
    5. Johnson and Johnson

    Not only that they are currently testing Vaccine on humans at Phase-3....they are so confident...they already manufactured Vaccine and kept it ready..in anticipation of its approval !!!...

    When whole world is looking for a Vaccine for this COVID-19 menace...so they can go for their normal work...ONLY silly and good for nothing people like you can say it takes 18 months to make a Vaccine....to make you,,, it took less than that for your parents!!!!....

    Regarding Trench???...You and many more will go there soon if a Vaccine is not found before that!!!!...


    ...Tak...Takk...

    DisAgree [4] Agree [1] Reply Report Abuse

  • Satish, Mangalore

    Sat, Jul 04 2020

    Don't pretend to be an expert by copying and pasting from internet. Astrozanica is in the forefront of the trials and the earliest it can release the vaccine is by December 2020 if trails go as per their expectations. Others are behind. In India we are yet to start the trial and it is difficult to say it will be ready by August 2020.

    Mr. Geoffrey has nowhere mentioned about 18 months and you try to twist the facts to corner him. It is natural that when people are cornered they go offensive to show their upmanship. Here in doing so you have exposed yourself.

    Take it easy my friend.

    DisAgree [1] Agree [3] Reply Report Abuse

  • praveen, mlore

    Sat, Jul 04 2020

    modiji want to take credit on new vaccine on Independece day speech...so evan if they half done..they wil release

    DisAgree [5] Agree [9] Reply Report Abuse

  • Charles D'Mello, Pangala

    Sat, Jul 04 2020

    "Gennova biopharmaceutical is also working on a vaccine and it looks positive, Ganguly added." Is it advertisement for Gennova where by he may be working after retirement....????????

    DisAgree [1] Agree [4] Reply Report Abuse

  • geoffrey, hat hill

    Sat, Jul 04 2020

    This is rather pragmatic and realistic speculation towards a vaccine development. But the gullible choose to repose their faith in rhetoric of desperate political leaders and adverts of unscrupulous pharmaceutical companies in the guise of 'information' with an agenda to reap windfall gains at stock market.

    DisAgree [3] Agree [5] Reply Report Abuse

  • Langoolacharya., Belman / Washington, DC.

    Sat, Jul 04 2020

    Hat,

    To best of my knowledge ....you and this retired good for nothing fellow N.K. Ganguly, are most gullible in the world...

    Ask this fellow N.K. Ganguly , did he do any productive in his 35 years service other than taking her salaries and perks???...

    Also ask him did he write and 'Research Papers' during this period...

    Last but not least ask this good for nothing guy does he hold any patents for any new drugs...

    If answer is NO...then ask him to tuck his tail between his legs and keep quiet....and wait till August 15th or November 3rd and see if we get a Vaccine by then...

    My gut feeling...YES WE WILL...

    Till then please stop your non-sense comments here please...

    ...Tak...Takk...

    DisAgree [6] Agree [3] Reply Report Abuse

  • geoffrey, hat hill

    Sat, Jul 04 2020

    So much for your 'gut feeling' and you don't have anything else to support your argument other than of course, a few website addresses of some godforsaken pharma companies claims. I think you should focus more on you 5G trench digging job and leave vaccine development and forecasts to the virologists.

    DisAgree [2] Agree [7] Reply Report Abuse

  • SKK, Mangaluru

    Sat, Jul 04 2020

    You seem to be more expert than NK Ganguly. You start writing negative about of people when it is not suiting you and your fake leader. I have seen you making sarcastic low level comments about Congress leaders but when it comes to your favourite party and fake leader your salutations are quite respectful.

    Before making sweeping statements see if you qualified in that field to make such comments. We have two doctors in the family and they say that for trails no time limit can be set and nobody should be pressurised for such trails. Modi want to make it Independence Day event but all depends on how the trail progresses.

    DisAgree [2] Agree [9] Reply Report Abuse

  • Alwin, Mangalore

    Sat, Jul 04 2020

    Politics is more than life of common citizen. Is there possibility of extending life to a fixed date

    DisAgree Agree [3] Reply Report Abuse

  • Jossey Saldanha, Mumbai

    Sat, Jul 04 2020

    Put all these Dongi's in Jail ...

    DisAgree [1] Agree [8] Reply Report Abuse

  • j.anata, Mangaluru / Bengaluru

    Sat, Jul 04 2020

    If Vaccinne does come, I'll not give you

    DisAgree [4] Agree [1] Reply Report Abuse

  • Jossey Saldanha, Mumbai

    Sat, Jul 04 2020

    j.anata, Mangaluru / Bengaluru
    I expected some intelligent reply from you ...

    DisAgree Agree [4] Reply Report Abuse


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