Gavi, the vaccine alliance, revealed on 5 July 2023 that a groundbreaking malaria vaccine will be provided to twelve African nations over the next two years. With malaria being a leading cause of death in Africa, these vaccines are expected to play a crucial role in saving lives.

We’re excited to announce that 12 countries in Africa will be allocated a total of 18 million doses of the world’s first #malaria vaccine over the next two years with Gavi support! https://t.co/W8PS1T9uK7 @WHO @UNICEF @GSK @UNITAID @GlobalFund @MedAccessUK @PATHTweets @USAIDGH

— Gavi, the Vaccine Alliance (@gavi) July 5, 2023

Due to limited initial supply, priority will be given to areas with the highest risk of malaria-related illness and death among children. The delivery process of the vaccine is being overseen by the Framework Implementation Group, which includes representatives from the Africa Centres for Disease Control and Prevention (Africa CDC), UNICEF, WHO, and the Gavi Secretariat, alongside civil society representatives and independent advisors.

Indian Companies To Play A Crucial Role

The manufacturing of the malaria vaccine is being undertaken by Indian companies. Bharat Biotech, the firm which indigenously produced Covaxin during the Covid pandemic, will be supplying the RTS, S/AS01 vaccine in the future. GSK, a British pharmaceutical giant, transferred the manufacturing of the protein component of the vaccine to Bharat Biotech in 2021. GSK had made a commitment to provide the World Health Organization’s (WHO) pilot program with a donation of 10 million vaccine doses. Additionally, the Serum Institute of India (SII) will manufacture and supply the R21/Matrix-M malaria vaccine, which was developed by Oxford University. This vaccine is expected to receive WHO prequalification soon. The government of Ghana granted regulatory approval for the R21/Matrix-M vaccine in April 2023. SII already has the capacity to produce 200 million doses annually. The R21/Matrix-M vaccine is administered to children aged 5 to 36 months and has consistently demonstrated 75% efficacy, meeting WHO standards.

India, known for being the world’s largest manufacturer of low-cost vaccines, plays a crucial role in the production of malaria vaccines. Both Bharat Biotech and SII have been instrumental in India’s fight against COVID-19.

Malaria Vaccination Programmes In Africa

Malaria vaccination programs have already been implemented in Ghana, Kenya, and Malawi, supported by Gavi, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and the United Nations. Over 1.7 million children in these countries have received the RTS, S/AS01 vaccine since 2019, resulting in a significant reduction in severe malaria cases and related deaths among children.

In addition to Ghana, Kenya, and Malawi, nine more countries have been selected to receive the vaccine. These countries include Burundi, Benin, Burkina Faso, Cameroon, Uganda, the Democratic Republic of the Congo, Niger, Liberia, and Sierra Leone. The vaccine will be introduced into their routine immunization programs for the first time.

The first batch of vaccine doses will be allocated to Gavi through UNICEF, and they are expected to reach the selected countries between October and December 2023. The vaccine rollout is scheduled to commence in early 2024.

Thabani Maphosa, Managing Director of Country Programmes Delivery at Gavi, highlighted the potential impact of the malaria vaccine, emphasizing the need for effective utilization of the available doses. Maphosa stated that the vaccine, when deployed alongside other interventions, has the capacity to prevent tens of thousands of future deaths each year.

Malaria & Its Impact In Africa

Malaria claims the lives of millions of African children under the age of 5 annually. In 2023, Africa accounted for 95% of global malaria cases and deaths, with approximately one million children losing their lives to the disease. Ephrem T Lemango, Associate Director of Immunization at UNICEF, expressed hope that the vaccine rollout would significantly improve the chances of children, particularly in Africa, surviving malaria.

The Director of Immunization, Vaccines, and Biologicals at WHO emphasized the breakthrough nature of the malaria vaccine in improving child health and survival. With high demand and the extensive reach of childhood immunization, the allocation of doses will contribute to equitable access to malaria prevention, ultimately saving many young lives. Efforts will be intensified to increase the vaccine’s supply until all at-risk children have access to it.

(With inputs from OpIndia)

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World’s first intra-nasal vaccine for COVID developed by India has got approval from the Central Drugs Standard Control Organisation (CDSCO) for restricted use in emergency situations in the age group of 18 and above.

This was stated here today by Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh while chairing the meeting of the Societies of Autonomous Institutions of Department of Biotechnology where he also informed about the historic decision to merge the 14 societies of Biotechnology Institutes into a single society in the interest of convenient functioning, cost-effectiveness and integrated working.

The Minister lauded the role of the Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance (BIRAC) for supporting the development of world’s first Intranasal vaccine for COVID by Bharat Biotech International Limited (BBIL).

Dr Jitendra Singh informed that the Product development and Clinical trials were funded by the Department of biotechnology, Government of India and BIRAC under the Mission COVID Suraksha Program. This vaccine received approval under restricted Use in emergency situations for ages 18 and above for primary 2 dose schedule, homologous booster doses.

Dr Jitendra Singh said, India’s efforts through Mission COVID Suraksha under the dynamic leadership of Prime Minister Narendra Modi has not only strengthened AtmaNirbhar Bharat but also bolstered India’s status as a worldwide vaccine development and manufacturing center showcasing the strength of Science and Technology. It is a matter of great pride for the country, the Minister added.

Phase-III trials were conducted for safety, and immunogenicity in ~3100 subjects, in 14 trial sites across India (supported by BIRAC). Heterologous booster dose studies were conducted for safety and immunogenicity in ~875 subjects, where a booster dose (3rd dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed COVID vaccines. The clinical trials were conducted in 9 trial sites across India. National Institute of Immunology (NII), an autonomous institute of DBT in New Delhi utilized their “Human Immune Monitoring and T-cell Immunoassay Platform” to examine the vaccine-induced SARS-CoV-2-specific systemic and mucosal cellular immune responses the trial participants. Interactive Research School for Health Affairs (IRSHA), Pune (supported by BIRAC) completed the “Plaque Reduction Neutralization Assay” (PRNT) to quantify the titer of neutralizing antibody for the virus from three trial sites.

This vaccine has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern. It promises to become an important tool in mass vaccinations during pandemics and endemics.

Vaccine is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in Phases I, II and III clinical trials with successful results. It has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries. This vaccine is stable at 2-8°C for easy storage and distribution. Large manufacturing capabilities have been established by Bharat Biotech at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan India.

(Published from PIB)

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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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In a major boost and recognition for the indigenously developed Covid-19 vaccine, Covixin and its maker Bharat Biotech on November 1, the Australian Government’s Therapeutic Goods Administration (TGA) under the Department of Health recognised this made-in-India Covid-19 vaccine Covaxin to and gave a traveller’s vaccination status.

This news is also a very important foreign policy victory for the Modi government and could not have come at a better time when Prime Minister Narendra Modi is attending the G-20 summit where he met with leaders who nineteen nations plus India that control eighty five per cent of global GDP.

Australian Government recognises Bharat Biotech's Covaxin for the purpose of establishing a traveller's vaccination status: Australia’s High Commissioner to India, Barry O’Farrell AO pic.twitter.com/yMXenctRbg

— ANI (@ANI) November 1, 2021

As the World Health Organisation (WHO), keeps dragging its feet, this recognition has been approved for anyone of age 12 and above who have been vaccinated with Covaxin.

In a statement, Australia’s High Commissioner to India, Barry O’Farrell AO, said, “Australian Government recognises Bharat Biotech’s Covaxin for the purpose of establishing a traveller’s vaccination status.”

In the statement issued by TGA, the Australian government also recognized BBIBP-CorV (manufactured by Sinopharm, China) for the purpose of travel for anyone between the ages of 18 and 60. The statement read, “Today, the TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be ‘recognized’ to establish a traveller’s vaccination status. This recognition is for travellers aged 12 and over who have been vaccinated with Covaxin, and those 18 to 60 who have been vaccinated with BBIBP-CorV.”

It further said that “potentially reduce the likelihood that an incoming traveller would transmit COVID-19 infection to others while in Australia or become acutely unwell due to COVID-19.” It added that the vaccine sponsor or WHO has provided the supporting information.

With the approval of Covaxin and Covishield (manufactured by AstraZeneca, India), citizens of India and other countries who have been vaccinated with these two vaccines can travel to Australia as the summer begins and the Australian government will hope to see a surge in tourism and also this decision will benefit students as well as skilled and unskilled workers.

WHO is still deliberating to give approval for Covaxin and has set November 3 as the date of the next meeting to decide.

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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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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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