Category: Covid-19

Hetero’s COVID-19 oral drug Nirmacom gets WHO prequalification

WHO made a strong recommendation for Nirmatrelvir and Ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission.

Pharmaceutical company Hetero on December 26 said it has received World Health Organization Prequalification of Medicines Programme (WHO PQ) approval for its generic version of Covid-19 oral antiviral treatment candidate nirmatrelvir.

Nirmatrelvir, which originated in Pfizer laboratories, is co-packaged with ritonavir tablets as Pfizer’s Covid-19 oral antiviral drug Paxlovid. This is the first prequalification for a generic version of Paxlovid, Hetero said.

The combi pack launched by Hetero as Nirmacom will contain nirmatrelvir 150 mg (two tablets) and ritonavir 100 mg (one tablet). A prescription only drug that the company said be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset, Nirmacom is be manufactured at Hetero’s facilities in the country.

WHO had made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate Covid-19 patients at highest risk of hospital admission, such as unvaccinated, aged or immunosuppressed patients, Hetero said in a release.

Managing Director of Hetero Group of Companies Vamsi Krishna Bandi said WHO prequalification for Nirmacom is a significant milestone and the company is committed to making the drug available faster at affordable prices across 95 low and medium income countries, including India. Hetero was among a clutch of companies that entered into a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) for manufacturing and sale of a generic version of Pfizer’s nirmatrelvir in LMICs.

“Delighted to see the first generic version of nirmatrelvir under MPP license with Pfizer receive quality assurance approval from WHO. This is an impressive achievement from Hetero as we announced the sublicence agreements just nine months ago,” MPP Executive Director Charles Gore said.

Hetero has already received emergency use authorisation (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market Nirmacom.

thehindu.com

Intranasal vaccine iNCOVACC gets restricted use nod

The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries. 

India’s first nasal Covid vaccine iNCOVACC has received approval from the Central Drugs Standard Control Organisation (CDSCO) under restricted use in an emergency for ages 18 and above, in India, for heterologous booster doses; Bharat Biotech announced on Monday.

The Hyderabad-based pharma company said that the intranasal vaccine, BBV154 or iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein. 

This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results, the company claimed. iNCOVACC has explicitly been 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.  

The intranasal vaccine was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vector construct and evaluated it in preclinical studies for efficacy.

The product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation and delivery device development, including human clinical trials, were conducted by Bharat Biotech. 

The Indian government partly funded product development and clinical trials through the Department of Biotechnology (DBT)’s Covid Suraksha Program. Dr Rajesh S. Gokhale, Secretary, DBT, and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC),  said the DCGI’s approval of Bharat Biotech’s intranasal vaccine iNCOVACC to be used as a heterologous booster dose against currently available Covid-19 vaccines is a moment of great pride for our country. 

‘Replication-deficient adenovirus vectored’
The Hyderabad-based pharma company Bharat Biotech said that the intranasal vaccine, BBV154 or iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein.

newindianexpress.com

UN chief says India taking leading role in providing reliefs

India has increased its impact of humanitarian assistance globally by providing aid to countries that need it, said UN Secretary-General Antonio Guterres. “From India’s donations of medicines, medical equipment and vaccines at the height of the COVID-19 pandemic, to humanitarian assistance and development finance to Afghanistan and Sri Lanka, India has been increasing its impact on the international stage. India is today a partner of choice of the UN,’’ said Guterres while addressing students while giving an address in Indian Institute of Technology (IIT) Mumbai.

complimented India for stepping up its efforts to supply vaccines to many countries during the peak of Covid 19. Meanwhile, Guterres complimented India as being the biggest contributor in UN Peacekeeping.

“India is also the biggest provider of military and police personnel to UN missions, including the first all-women UN police contingent to a peacekeeping mission. Over 200,000 Indian men and women have served in 49 peacekeeping missions since 1948, a remarkable contribution to peace in the world,’’ he added.

He also said that as a member of the UNSC for two years, India’s contributed significantly to promoting multilateral solutions and addressing crises. “India was a founding member of the United Nations. The drafters of the UN Charter took great inspiration from Gandhiji’s message of peace, non-violence, and tolerance,’’ he added.

Earlier, UN Chief paid tributes to the victims of the 26/11 terror attacks at the Taj Mahal Palace hotel in Mumbai. “Terror is absolute evil. There are no reasons, no pretext, no causes, and no grievances that can justify terrorism. terrorism is absolute evil. It has no room in today’s world,” Guterres added.

“I feel deeply moved to be here where barbaric terrorist acts took place where that led to the loss of 166 lives. I want to pay tribute to the victims they are heroes of all world and I want to express my deepest condolences to their families, to their friends, to the people of India, and to all those that are coming from other parts of the world that have lost their lives in Mumbai,” he said. He also said that “fighting terrorism must be a global priority for every country on earth and fighting terrorism is a central priority for the UN”.

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Bharat Biotech’s intranasal Covid vaccine gets emergency use approval

Bharat Biotech’s recombinant nasal vaccine for COVID-19 has been approved by Central Drugs Standard Control Organisation (CDSCO) for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation, Health Minister Mansukh Mandaviya tweeted on Tuesday.

“Big Boost to India’s Fight Against COVID-19! Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation,” Mr. Mandaviya tweeted.

This is the first intranasal vaccine for COVID-19 in the country.

The Minister further tweeted that this step will strengthen our collective fight against the pandemic. “India has harnessed its science, research and development, and human resources in the fight against COVID-19 under PM Narendra Modi’s leadership. With the science-driven approach and Sabka Prayas, we will defeat COVID-19.’’

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India ‘world’s pharmacy’: UNGA president

External Affairs minister S Jaishankar, after meeting Shahid, said India’s “Neighbourhood First” and the Maldives’ “India First” policies complement each other.

President of the United Nations General Assembly and Maldives foreign minister Abdulla Shahid on Monday stressed on the role played by India at the UN. External Affairs minister S Jaishankar, after meeting Shahid, said India’s “Neighbourhood First” and the Maldives’ “India First” policies complement each other.

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India supplies nearly 60% of vaccines used worldwide: Nirmala Sitharaman

India today is double dosing every citizen and produced COVID-19 vaccines even during the lockdown period, said Union Finance Minister Nirmala Sitharaman

Finance Minister Nirmala Sitharaman on Wednesday said nearly 60% of all the vaccines used in the world are produced in India and over the decades, the country has made remarkable contribution to vaccinating the world.

India today is double dosing every citizen and produced COVID-19 vaccines even during the lockdown period, she added.

Launching the book India’s Vaccine Growth Story by Sajjan Singh Yadav, Additional Secretary, Expenditure Department, Sitharaman said it is in the country’s DNA to be able to contribute to world vaccination.

“Over the decades India has made remarkable contribution. Nearly 60% of all the vaccines which are used in the world are produced in India. India has singular contribution to make to the world in terms of vaccination and that which is being produced and supplied to the entire world,” Ms. Sitharaman said.

Today, the country is double dosing every citizen, she said, adding it is not easy to produce and execute COVID vaccination at that scale.

India crossed the target of 200 crore COVID vaccinations in a time-bound manner. So far, 208.57 crore doses of COVID-19 vaccines have been administered under the nationwide inoculation drive.

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CorbeVax cleared as precaution dose vaccine, awaits WHO’s emergency use listing

This the first time that a booster dose that is different from the one used for primary vaccination has been allowed in the country

Still awaiting World Health Organisation’s emergency use listing (EUL) the Central Government on August 10 approved Biological E’s CorbeVax as a precaution dose for those above 18 years fully vaccinated with either Covishield or Covaxin.

EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in-vitro diagnostics with the ultimate aim of expediting the availability of products to people affected by a public health emergency. Also international travel in many countries requires people to get a vaccine that’s on the WHO’s approved list.

That pending, the latest approval by the Central Government makes this the first time that a booster dose that is different from the one used for primary vaccination has been allowed in the country.

This will be in addition to the existing guidelines for homologous precaution dose administration of Covaxin and Covishield vaccine. Also all necessary changes in regard to the administration of precaution dose of CorbeVax vaccine are being made on the Co-WIN portal.

The approval is based on the recommendations made recently by the Covid-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI). CorbeVax is to be considered as a precaution dose after completion of six months or 26 weeks from the date of administration of the second dose of either Covaxin or Covishield vaccines for those aged above 18 years enabling use of CorbeVax as a heterologous Covid-19 vaccine for precaution dose administration in this age group.

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Zenara Pharma gets CDSCO panel nod to manufacture Covid drug

The approval by the Central Drugs Standard Control Organisation (CDSCO) has been granted under the emergency authorisation route, Zenara Pharma said in a statement.

Zenara Pharma on Thursday said it has received the CDSCO approval to manufacture and sell combination packs of Nirmatrelvir and Ritonavir tablets, indicated as an option for patients with mild to moderate COVID-19 symptoms.

The tablets will be sold under the brand ‘Paxzen’ and are being manufactured at the company’s USFDA-approved facility in Hyderabad, it added.

The combination pack of Nirmatrelvir and Ritonavir tablets is the generic equivalent of Pfizer’s Paxlovid, which has been approved by the United States Food and Drug Administration (USFDA) for COVID-19 treatment, it added.

“We expect to launch Paxzen in the next couple of weeks and are in talks with multiple institutions and several hospitals in India to ensure that the product is readily available for patients in need,” Zenara Pharma CEO Srinivas Arutla said.

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CoWIN platform ‘know-how’ now available free of cost to any country

The National Health Authority’s offer comes after India crossed a milestone of administering 2 billion vaccine doses a week ago.

Any country interested can avail CoWIN platform, the platform will be provided free of cost, said Dr. R.S.Sharma, CEO of the National Health Authority, said on Saturday, July 23, 2022.

“Selected vendors by the country will be trained on CoWIN technology to customise it for their requirement. Usually, since the vaccination cycle is almost the same in all countries, the customisation will be limited to changes in field and master data configuration. Complete revamp of the application by any country is not expected,’’ he elaborated while speaking about (CoWIN) which provided the digital support for the COVID vaccination drive in the country.

Dr. Sharma further said that India has already signed an MoU with the Government of the Co-operative Republic of Guyana for sharing CoWIN; “We are in advanced talks with a couple of other nations to share CoWIN with them,’’ he confirmed.

India’s COVID vaccine milestone

India crossed a milestone of administering 2 billion vaccine doses a week ago and talking about its continued importance Dr. Sharma said that as CoWIN is repurposed, it could also help achieve the vision of Universal Vaccination against COVID-19 and further be repurposed for use in the healthcare sector. 

On July 5, 2021, the Central Government organised the Co-WIN Global Conclave with the endeavour to share experiences and expertise on the CoWIN platform with the global community. Over 140 countries participated in the event and nearly a dozen expressed an interest in learning from the platform and evaluating adopting it.

Stating that CoWIN has also become the world’s biggest digitally verifiable vaccination certificate generating platform, Dr. Sharma said that today Co-WIN is highly configurable and adaptable. “It has evolved based on the changing policy landscape and the requirements of the beneficiaries. The platform was developed at record speed with ample consideration to its scalability, modularity and interoperability,’’ hde said.

The CEO also spoke about the security measures that have been put in place to ensure data safety and the prevention of leaks. “CoWIN platform does not store or share any personal data. It’s for vaccination purposes and is the single source of truth to determine whether the person has been vaccinated or not,’’ said Dr. Sharma. He added the platform has deployed state-of-the-art data security systems to safeguard users’ data against any possible intrusion.

“Despite all these security features, CoWIN’s architecture still allows it to be open and interoperable. The capability to digitally authenticate these details with Aadhaar has also been provided to vaccinators. Otherwise, during vaccination a vaccinator could validate these details through a physical ID,’’ he explained, adding that besides the OTP feature the government has also limited the number of slot searches per user (restricted to 15-20) on the portal which prevents bots, browser extensions or hack attempts. Also even the API’s shared to third parties by CoWIN is through a thorough scrutiny process, ensuring proper security and audit.

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IISC scientists develop miniproteins that may prevent COVID infection

The miniproteins can not only block entry of viruses like SARS-CoV-2 into our cells but also clump virus particles together, reducing their ability to infect

Researchers at the Indian Institute of Science (IISc) Bangalore have designed a new class of artificial peptides or miniproteins that they say can render viruses like SARS-CoV-2 inactive.

According to the study, published in the journal Nature Chemical Biology, the miniproteins can not only block virus entry into our cells but also clump virus particles together, reducing their ability to infect.

The researchers noted that a protein-protein interaction is often like that of a lock and a key.

Preventing entry

The team used this approach to design miniproteins that can bind to, and block the spike protein on the surface of the SARS-CoV-2 virus, which helps it to enter and infect the human cells.

This binding was further characterised extensively by cryo-electron microscopy (cryo-EM) and other biophysical methods.

These miniproteins are helical, hairpin-shaped peptides, each capable of pairing up with another of its kind, forming what is known as a dimer. Each dimeric ‘bundle’ presents two ‘faces’ to interact with two target molecules.

The researchers hypothesised that the two faces would bind to two separate target proteins locking all four in a complex and blocking the targets’ action.

“But we needed proof of principle,” said Jayanta Chatterjee, Associate Professor in the Molecular Biophysics Unit (MBU), IISc, and the lead author of the study.

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