The makers of Covaxin, Bharat biotech have started picking up stocks of its unused Covid-19 vaccines, and re-labeling them with an updated expiry date, reports India Today.

This process of re-labeling and updating of the expiry date comes after the Drugs Controller General of India (DCGI) approved the extension of the vaccine’s expiry date from nine to 12 months. 

This directive by the DCGI came after stability studies showed that the vaccine is good up to 12 months. However, earlier, the vaccine was permitted to be used only up to six months.

Every vaccine is produced has an expiry date and the shelf life is determined after various tests are conducted to assess how long a vaccine can stay stable and sterile in different environments and temperatures.

In November 2021, Bharat Biotech had received an extension of 12 months on the shelf life of its Covid vaccine Covaxin and immediately the company started to pick up the unused stock of Covaxin so it can be re-label with the new expiry date.

The recovered stock will be used for the ongoing vaccination drive and for vaccination of children in the age group 15-18, which is set to begin from Monday.

As per data ascertained from the CoWIN, over six lakh registrations have been received till Sunday evening as India gets ready to vaccinate 15 to 18-year-olds from January 3. 

In other news, India will send half a million doses of COVID-19 vaccines to Afghanistan and it will be one of the largest-ever humanitarian assistance projects received by that country after it was taken over by the Taliban. This comes after the World Health Organisation gave its much-delayed approval to this frug. 

Taliban’s “Permanent Representative Designate” to the United Nations, Suhail Shaheen told The Hindu that, “his organisation has welcomed the initiative..as our people are passing through a critical time now. We welcome and appreciate humanitarian assistance by your country. It is a positive humanitarian step,”.

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Former world number one Tennis player Jimmy Connors in a tweet has endorsed the indigenously developed Covid-19 vaccine Covaxin.

Corners in his tweet said, why major news networks like CNN and Fox News only talk about Pfizer- J&J- Moderna vaccines and not Covaxin. 

@CNN @FoxNews @US_FDA You always talk about Pfizer- J&J- Moderna vaccines — maybe a nod to #Covaxin – #ocgn – an opportunity to have an option – a choice- allow COVAXIN to get in the game— I’m no Dr.- but the others have had a chance- why not #COVAXIN !!! #Competition #lookitup

— Jimmy Connors (@JimmyConnors) December 30, 2021

He said, I’m no Dr.- but the others have had a chance- why not #COVAXIN !!! #Competition #lookitup.

Covaxin is an indigenous COVID-19 vaccine developed by Bharat Biotech in collaboration with ICMR, and the National Institute of Virology (NIV). As per Bharat Biotech, the makers of Covaxin, this vaccine has been developed using “Whole-Virion Inactivated Vero Cell-derived platform technology”.

However, this vaccine had to endure smear vaccine not only from vested foreign interests but it also had to endure doubt from some of the political parties that led to vaccine hesitancy.

As of now, 15.59 crores of Covaxin have been administered as of December 31, 2021.

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After the World Health Organisation gave the approval for the Emergency Use Listing for Covaxin, the indigenous Covid-19 vaccine developed by Bharat Biotech, the government of the United Kingdom has said that it ahs will be adding Covixin to its list of approved COVID-19 vaccines for international travellers from 22 November.

This is very important because any Indian who has been inoculated with the Bharat Biotech-manufactured vaccine will not have to self-isolate after arrival in England.

Covaxin is the second most used vaccine in India and already Covishield, the India-manufactured Oxford-AstraZeneca COVID-19 vaccine, was added to the UK’s approved list last month.

‘More good news for Indian travellers to the UK. From 22 November travellers fully vaccinated with a COVID19 vaccine recognised by WHO for Emergency Use Listing, including Covaxin, will not have to self-isolate; so joining those fully vaccinated with Covishield,’ Alex Ellis, British High Commissioner to India, said on Twitter on Monday.

The changes will come into effect at 4 am on 22 November.

“As we continue to recover from the pandemic and expand our recognition of international vaccines, today’s announcements mark the next step in our restart of international travel,” said UK Transport Secretary Grant Shapps.

“The red list and quarantine system remain vital in protecting our borders and as we’ve said, we will not hesitate to take action by adding countries to the red list if necessary,” UK Health Secretary Sajid Javid said.

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After the World Health Organisation gave approval for Covaxin for emergency use, India has initiated a diplomatic blitz to increase the list of countries that would mutually recognise vaccine certificates that would allow smoother travel for Indians.

The Indian diplomatic crops are on an overdrive to get more countries to recognise Covaxin as the number of countries accepting Indians vaccinated with the Bharat Biotech-developed vaccine could rise after WHO’s decision.

So far, Australia, Sri Lanka, Greece, Nepal, Mauritius, Estonia, Zimbabwe, and the Philippines amongst others have approved Covaxin. More importantly, Indians who have taken both doses of Covaxin will be permitted to enter the US from 8 November.

Additionally, seven countries comprising Palestine, Mauritius, Mangolia, Kyrgyzstan, Hungary, Serbia, and Estonia have opted to mutually recognise vaccine certificates with India.

As of now over 20 countries have already permitted vaccinated Indians entry without being quarantined and vice versa.

During the recently held G20 meeting in Rome, Prime Minister Narendra Modi had proposed mutual recognition of Covid vaccination certificates. Subsequently, the G20 leaders decided to work towards reopening international travel by acknowledging mutual recognition of vaccine certificates.

“Fact of the matter is that the point the PM tried to make (on vaccine certification) has been received. Most countries are quite happy with the idea of facilitating smoother international travel…and feel that we need to collectively work on it,” Indian foreign secretary Harsh Vardhan Shringla had said post the summit, as reported by the Economic Times.

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During a presser, when asked about the delay in granting Emergency Use Listing (EUL) for Bharat Biotech’s Covaxin by the World Health Organisation (WHO), Indian Foreign Secretary Harsh Vardhan Shringla said India is hopeful of getting approval soon.

According to Shringla, the regulatory body was concerned and had put some questions to Bharat Biotech and approval for the vaccine should come if the queries are responded to effectively.

“It is a technical and regulatory group. The emergency authorisation by the WHO is based on technical considerations and we are carefully following up the discussions at the WHO. We are hopeful that Covaxin will get approval soon,” Shringla said.

He also added, “India has proposed to its partner countries, primarily countries that Indian citizens normally travel to, that we should have a mutual (mechanism) that you recognise our vaccine certification and we will mutually recognise your vaccine certification,”.

“Now the advantage of this is that as we keep adding new vaccines to our stock of national vaccines, you do not need to go to every country to try and get recognition. You recognise the certification that we issue, you recognise its integrity and we will give you mutual treatment,” he said.

The foreign secretary said a number of countries have already agreed to the mutually acceptable COVID-19 vaccine certification framework proposal. He, however, did not name the countries. “So we have achieved some reciprocal arrangements with a number of countries. We are working with all of our partner countries to have similar arrangements. It will simplify international travel, it will normalise international travel,” Shringla said.

However, as Prime Minister Narendra Modi heads for the G20 summit, this mechanism could be helpful in the recovering from the economic impact of the Coronavirus pandemic. “Business travellers, tourists which contribute to the recovery of economies will be greatly benefitted from this simplified international travel regime that we are proposing and we have taken it up with the G20, we have taken it up bilaterally, we have taken it up in plurilateral forums,” he said.

“We will continue to advocate this as a means of better and easier access to citizens travelling all over the world,” Shringla added.

On India proposing waivers by the World Trade Organisation on Covid-related medical products including vaccines, he said, “We have advocated for technology transfer and diversification of supply chain and production hubs to ensure affordable and equitable access to COVID-19 disease control tools,” he said.

“I am happy to share that G20 has recognised extensive vaccination as a global public good and I think that is where discussions in the G20 will be relevant,” he added.

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The World Health Organisation’s (WHO) technical advisory group on Tuesday (October 26) again sought “additional clarifications” from Bharat Biotech for its COVID-19 vaccine Covaxin to conduct a final ‘risk-benefit assessment’ for Emergency Use Listing of the vaccine.

As per the WHO the technical advisory group will now meet on November 3 for a final assessment, however, many in India see this as a deliberate ploy to ensure that Covaxin is delayed for as long as possible so it cannot compete with other pharma companies and also Chinese influence over WHO is also now being questioned. 

“The @WHO independent Technical Advisory Group (TAG) met today & asked for additional clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data is received soon,” WHO chief scientist Dr Soumya Swaminathan said in a tweet.

Update: The @WHO independent TAG met today & asked for addnl clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data received soon

— Soumya Swaminathan (@doctorsoumya) October 26, 2021

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine’s Emergency Use Listing (EUL). In the meanwhile other vaccines developed by the likes of Pfizer, Johnson and Johnson, Moderna, and sinopharm was approved undet EUL.  

The technical advisory group met on Tuesday to review data on Covaxin for the emergency use listing and said”The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine.

“The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” it added.

But already there is enough data wherein it has been proved that Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.

However, WHO has said, “When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine,”.

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After haranguing India on the importance of not cutting any corners with regards to the issue of the emergency use listing of Bharat Biotech’s COVID-19 vaccine Covaxin, the World Health Organisation (WHO) Tedros Adhanom Ghebreyesus spoke to Union Health Minister Mansukh Mandaviya on the resumption of supplies of the Serum Institute of India-manufactured AstraZeneca vaccine to the COVAX facility.

Had a call with @mansukhmandviya, India’s Health Minister, to discuss #India’s ongoing #COVID19 vaccination programme; the need for a global pandemic agreement; digital health; & traditional medicine. We welcome India’s support to strengthen WHO, incl. via flexible, sustainable financing, Ghebreyesus tweeted on Tuesday.

The other topics that were discussed with Mandaviya was vaccine equity issues and the Covaxin Emergency Use Listing process, and technology and license sharing through C-TAP.

COVID-19 Technology Access Pool (C-TAP) was launched in May last year for facilitating timely, equitable and affordable access of COVID-19 health products by boosting their supply.

India on Thursday (October 21) also crossed a monumental milestone when it vaccinated 100 crore people (One Billion) and according to official figures, around 74.45 per cent of India’s eligible adult population has been administered at least one dose of the Covid vaccine and around 30.63 per cent have received both doses.

On Monday, WHO said it is expecting one additional piece of information from Bharat Biotech regarding its COVID-19 vaccine COVAXIN and said that it follows a thorough evaluation process to ensure vaccines are safe and cannot cut corners before recommending a vaccine for emergency use.

We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners – before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective, the global health organisation had said in a tweet.

Also, the world is waiting for India to resume the export of surplus COVID-19 vaccines in the fourth quarter of 2021 under the Vaccine Maitri’ programme and to meet its commitment to the COVAX global pool.

So far India has exported over 66 million vaccine doses to nearly 100 countries through grants, commercial shipments and the COVAX facility.

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India on Thursday (October 21) crossed a milestone administering over 1 billion COVID-19 vaccinations.

Prime Minister Narendra Modi took to social media to congratulate the health workers on achieving the feat.

India scripts history.

We are witnessing the triumph of Indian science, enterprise and collective spirit of 130 crore Indians.

Congrats India on crossing 100 crore vaccinations. Gratitude to our doctors, nurses and all those who worked to achieve this feat. #VaccineCentury

— Narendra Modi (@narendramodi) October 21, 2021

India’s COVID-19 Vaccination drive, the world’s largest vaccination drive so far, was launched by Prime Minister Narendra Modi on 16^th January 2021.

In Phase I of the vaccination drive, started 130 days ago on 16^th January, the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) prioritized Health Care Workers, and Front Line Workers (both government & private sector). Phase II of the vaccination drive started from 1^st March 202, focused on protecting the most vulnerable age groups. These prioritized age-groups included persons above 60 years of age and persons above 45 years with associated specified co-morbidities. This was further relaxed to all people above 45 years of age on 1^st April 2021. In Phase III, ‘Liberalised Pricing and Accelerated National COVID-19 Vaccination Strategy’ was adopted on 1^st May 2021. Under this strategy, everyone above 18 years of age are eligible for COVID-19 vaccination.

Recently, Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group.

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The wait for people in India who took the indigenous COVID-19 vaccine Covaxin, manufactured by Bharat Biotech just got longer as the World Health Organisation (WHO) has said it wants additional inputs from the vaccine maker.

India has now been waiting for a long time to get Emergency Use Listing (EUL) because many Indians who took Covaxin are planning international travel and without recognition, International travel will not be possible as countries won’t recognise these individuals as fully vaccinated.

In a statement, the WHO said, “while it is aware that many people are waiting for its recommendation for Covaxin to be included in the EUL, it clarified that it “cannot cut corners’ before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” said the agency.

WHO also said that Bharat Biotech – the manufacturer of Covaxin – has been submitting data to the WHO on a rolling basis and WHO experts have reviewed the data.

“WHO is expecting one additional piece of information from the company today. The timeframe for the WHO EUL procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries,” said the body.

The agency said that when it is fully satisfied with the information provided that addresses all questions raised, the WHO and the technical advisory group will then complete the assessment and come to a final recommendation on whether to grant EUL to the vaccine.

Though Covaxin has received the support of the Indian government and the latter has strongly advocated its efficacy, but it is clear that the reason why WHO deferred its decision till October on the pretext of requiring additional data must be questioned.

There are reports that a group of pharmaceutical companies and the Chinese government are lobbying to ensure Covaxin is not given EUL because for some of the pharma giants, it would mean loss of revenue, and for China, the export of Covaxin would give India more recognition on the international diplomatic stage. 

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