Showing posts with label Covidshield. Show all posts
Showing posts with label Covidshield. Show all posts

Saturday, January 16, 2021

Fly On the Wall | Pandemic over by June!

by Harish Gupta, National Editor, Lokmat Group 

Click here to read in Hindi & Marathi

Pandemic over by June!

Strange it may sound but true. The Modi government signed the vaccine purchase agreement with the two Covid Vaccine manufacturers (Serum Institute, Pune & Bharat Biotech Ltd, Hyderabad) only at the eleventh hour. It has not signed any agreement with any of the world Pharma companies including Pfizer or Moderna or for that matter with Russia’s Sputnik V. Yet India is set to launch the world's first & largest adult immunization program. Many other nations including the WHO financed billions of dollars for vaccines. But Modi showed his true Gujrati skills and waited till the end when sellers were desperate as they had stock-piled. Modi could do this largely because the pandemic is receding in India and there is no clamour among the people to get vaccinated like in the West. The Covidshield may not have been invented in India, but it is being treated as one because Seerum is supplying to the world. But many leading scientists may have questioned the way BBL’s Covaxin was given emergency clearance by waiving efficacy data. These include immunologists like Ms (Dr) Gagandeep Kang and Dr. Vineeta Bal, Indian Institute of Science Education and Research (IISER), Pune. Even Dr Ganga Khedkar, ex-head of Immunologist department said he won’t take the Covaxin until efficacy data comes. Yet, the going for Modi has been good. Many in the PMO say that India will overcome the pandemic by May-June without vaccinating 80 crore people. He may, perhaps, get rid of his grown up beard then.

How Govt pushed for Covaxin

There is an interesting tale behind the Covaxin. As soon as the pandemic broke out in March, the PMO tossed a question towards ICMR chief Dr Balram Bhargava – Can you develop a vaccine and by when? The ICMR and its battery of scientists & immunologists have been bossing around for decades. But such a question was never posed to them by the PMO. Frankly speaking, the ICMR never invented any vaccine either of its own. Bhargava went back to his 9-member vaccine panel headed by Dr Gangandeep Kang. There was silence of the grave. The PMO was getting restive. One fine morning, Dr Bhargava dissolved the ICMR vaccine panel in early May as the PM constituted the National Task Force on Vaccine directly under him. Dr Kang quit ICMR to go back to Vellore. Modi may not be a scientist but he knew there is enough politics among the scientists too and took the command in his own hand. Within days, the ICMR-Bharat Biotech signed an agreement on vaccines.


Why was Bharat Biotech chosen?

No answers are available till date as to why ICMR chose BBL to make the vaccine. No doubt, ICMR has been working closely with Bharat Biotech and many other Pharma companies for years and has partnered with it for Rotavirus and H1N1 vaccines earlier. No one has a clue till this date of the clauses of agreement between ICMR-BBL. What is known is that the ICMR had transferred the Coronavirus strain isolated at its National Institute of Virology, Pune to BBIL for making the vaccine in May 2020 itself. What is also known is that Dr Bhavgava had created a furor by asking the BBL to produce the Covid vaccine by August 2020. He even issued a terse letter in this regard. The letter surfaced in public domain embarrassing the government as it was felt Modi wanted to make an announcement from the Ramparts of the Red Fort on August 15. The ICMR had to eat crow when BBL couldn't produce the vaccine by August 15. But the Covaxin is ICMR’s baby and all regulators had to fast-track clearances tweaking laid down procedures without Phase-III efficacy data.


Kejri’s Konkani love

Arvind Kejriwal is considered a maverick and is not the one to give up. After his failed 2017 attempts, he has set his eyes on Punjab, Goa, Uttrakhand and UP again going to polls in 2022. In order to gain a toy hold in Goa, he hit upon a novel way and set up Konkani Academy in Delhi. There was no such demand for academy and no one was clamouring for it either. But Kejriwal’s sudden love for Konkani is not missed by rivals in Goa who are poking fun at him. Obviously, the national Capital will see a lot of cultural activities to promote Konkani language and Goan culture. Will it fetch votes for AAP in Goa where Kejriwal had lost deposits in all the seats? You guess!

Sunday, January 3, 2021

Covaxin Vaccine cleared for Emergency Use today

Govt. to buy Both --Covidshield or Covaxin 
Covidshield & Covaxin
Regulators to clear both vaccins soon

by Harish Gupta, National Editor, Lokmat Group

New Delhi, Jan 2
With the Emergency approval granted to Covaxin, jointly produced by Bharat Biotech-Indian Council of Medical Research late in the evening today, India has got another shot in its arm.

Covaxin is the country's 100% indigenous vaccine while Covidshield of Seerum Institute, Pune-Astrozeneca, UK was approved yesterday by the Subject Expert Committee (SEC) yesterday. The SEC cleared the Covaxin today. 

However, the formal approval of both the vaccines by the drug regulator Central Drug Standard Control Organisation (CDSCO) is yet to be granted.

While Seerum Institute has said that it already has stock-piled 40-50 million doses which it can supply to the Government of India by March this year itself, the authorities have not reacted to the proposal so far. In fact, the government has not signed any contract with the Seerum for the supply of Covidshield so far.

Neither Dr V K Paul who is head of the Prime Minister's Task Force on Vaccine management nor the Union Health Minister Dr Harsh Vardhan said anything so far as to which vaccine will be injected/inoculated to the 3 crore frontline health workers and other related categories. 

Whether the government will buy the Covidshield or Covaxin or a combination of both the vaccines for the Emergency usage, is still being worked out. 

For three crore frontline workers, India will need 60 million doses as every person has to be given two doses. As per the estimates, these three crore priority workers can be covered during the next four-five months. There is a strong possibility that the government may now involve the private sector in the entire vaccination drive. 

If the other population is also to be vaccinated at the earliest, the government will take a decision at the highest level. 

Secondly, the CDSCO and DCGI have yet to approve Covidshield and Covaxin. Once these medical bodies clear these vaccines for usage, various government institutions including the ministries of Health and others will take up follow-up action and allocate funds accordingly.

Sources say that the government will start the process around Makar Sankranti day on January 14 or so.

Sunday, October 18, 2020

Covid Vaccine by April 2021, say experts

  • Indian Vaccine trials on right track
  • Regulators tough after Remdesivir failure
Harish Gupta, National Editor, Lokmat Group
New Delhi, Oct 17

The hype created by global drug companies notwithstanding, it is emerging that vaccines may not be possible before March-April 2021.

Highly placed sources who are handling vaccine trials in India told Lokmat on the condition of anonymity that trials on three vaccines were at various stages. The Prime Minister who chaired another meeting on Vaccine management today was told that two vaccines are undergoing phase-II trials while one is at phase-III stage.

The Bharat Biotech-ICMR joint venture drug Covaxin and ZydusCadila are at Phase-II stage and their data is yet to be shared with the regulators. The Covaxin trials are going on at 12 locations in India, the ZydusCadila vaccine trials are being done privately and its data has not been shared.

The Seerum-AstraZenca’s Covidshield is at Phase-III stage and the number of vaccine warriors has also been cut short. Yet the final product will take longer than expected. The Sputnik-V from Russia is yet to commence trails though it has been granted permission. The SinoVac Biotech of China had approached the Central Drugs Stan­dard Control Organisation (CDSCO) for trials in India. When CDSCO asked the Chinese to share data, the company never came back.

The Indian regulators are very cautious after the WHO disapproved Remdesivir which was termed as a wonder and after it was sold in 100 countries at a hefty price. Of the 26 vaccines undergoing trials at various stages, only seven are at Phase-III stage which is very crucial.

The regulators have relented on fast-tracking of procedures. But they are unwilling to compromise on the efficacy and safety of the vaccine as its effects are felt after a couple of years.

How the Vaccine is made
It is also disclosed that some of the manufacturers including producers in India are making vaccines by killing the Coronavirus itself to make the product. But they are using different methodology.