Tag: Covaxin

Categories
-Top News India News

110 countries recognise India’s Covishield, Covaxin

Of eight WHO-approved vaccines against Covid-19 in emergency use listing, two vaccines — Covaxin and Covishield — are from India….reports Asian Lite News

As of now as many as 110 countries have recognized India’s Covid vaccines — Covishield and Covaxin — and have agreed to mutual recognition of Covid-19 vaccination certificates with India, said official sources in the Union Health Ministry.

A source with the Ministry said that at present, 110 countries have agreed to mutual recognition of vaccination certificates and those who recognise Indian vaccination certificates of travellers fully vaccinated with Covishield or World Health Organisation(WHO)-approved Covid vaccines.

As per the new travel guidelines issued by the Union Health Ministry, if a fully vaccinated traveller is coming from a country with which India has reciprocal arrangements for mutual acceptance of WHO-approved Covid-19 vaccines, they will be allowed to leave the airport and must self-monitor their health for 14 days’ post arrival.

If partially or not vaccinated travellers visit India, they will have to submit their sample for post-arrival Covid-19 test at the point of arrival after which they will be allowed to leave the airport. They will have to be undergo home quarantine for seven days and undertake re-test on the eighth day of arrival in India and if found negative, further self-monitor their health for next seven days.

“Travellers arriving from countries excluding those at risk, will be allowed to leave the airport and must self-monitor their health for 14 days’ post arrival. This is applicable to travellers from all countries, including with which reciprocal arrangements for mutual acceptance of WHO-approved Covid-19 vaccines also exist,” said the new international arrival guidelines.

Of eight WHO-approved vaccines against Covid-19 in emergency use listing, two vaccines — Covaxin and Covishield — are from India.

‘Developing Covaxin was a challenge’

Bharat Biotech Director, V. Krishna Mohan, has said developing the Covaxin in “just 10 months” was an enormous challenge.

Addressing a session on Thursday at the Bengaluru Tech Summit-2021, he said there were no vaccines when the Covid-19 hit India, and the world.

“This was a daunting challenge for the pharma sector and the prospective vaccine makers. We were given just 10 months to develop a vaccine to fight the infection but we could succeed in developing Covaxin swiftly at a level within these few months,” he said.

The Central government took the right steps at that juncture, the Bharat Biotech Director added.

“There were no such past precedents and it seems impossible to make a vaccine in such a short span of time,” he said.

The company chalked out a plan to make and develop the vaccine in India, he added.

V. Krishna Mohan further said it is difficult to quantify the hard work that went into the making of the vaccine, adding the company did not compromise on the quality or efficacy of the vaccine at any point of time.

He said Bharat Biotech was successful in releasing Covaxin in a record time and helped to save lives of crores of fellow Indians.

The Indian Council of Medical Research has positively changed its style of functioning in the last decade, he added.

Participating in the session, Deepak Sapra, CEO, API & Services, Dr Reddy’s Laboratories, said: “Covid has taught us tough lessons. With the help of our Russian partner we could develop ‘Sputnik V’ vaccines which not only helped India but also other developed countries. However, in respect of vaccine development it is a long way to go for India and Indian pharma companies.”

Divya Bizwan, Senior Vice-President of Aurobindo Pharma, said there was no dearth of talent in India.

“But, there is hardly any recognition for talent in pharma companies. It is necessary for vaccine makers to recognize this need and be more encouraging to the pool of talent that Indian pharma sector has.”

Atin Tomar, CEO of Yapan Bio, also participated in the session.

ALSO READ: Modi cautions on cryptocurrency, says nations need to work together

Categories
-Top News COVID-19

Covaxin 77.8% effective, says Lancet

Covaxin was developed under a partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, with Bharat Biotech receiving the SARS-COV-2 strains through this collaboration…reports Asian Lite News.

Covaxin, India’s first indigenous vaccine for Covid-19, has been found to be 77.8 per cent effective, according to the safety and efficacy analysis data from Phase III clinical trials peer reviewed and published in reputed medical journal The Lancet.

Hyderabad-based Bharat Biotech said the Lancet peer-review confirms the efficacy analysis which demonstrates Covaxin to be effective against Covid-19. The vaccine maker Covaxin is the only Covid-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the Delta variant at 65.2 per cent.

A”The efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group,” the company said.

The efficacy analysis also demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic Covid-19

“Safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects experiencing serious adverse events,” it said.

The efficacy data also shows 63.6 per cent protection against asymptomatic Covid-19, 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta and 70.8 per cent protection against all variants of SARS-CoV-2 virus.

Covaxin was developed under a partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, with Bharat Biotech receiving the SARS-COV-2 strains through this collaboration.

Bharat Biotech had established an ongoing collaboration with ViroVax since 2019, through the Indo-US Vaccine Action Program, to develop and evaluate IMDG (Alhydroxiquim-II), a novel TLR7/8 agonist molecule, which is formulated as part of the adjuvant in Covaxin. The Adjuvant Program of the US National Institute of Allergy and Infectious Diseases (NIAID) has supported ViroVax since 2009.

“The peer-review of Covaxin phase III clinical trial data in The Lancet, an authoritative voice in global medicine validates our commitment to data transparency and meeting the stringent peer-review standards of world leading medical journals,” said Krishna Ella, CMD of Bharat Biotech.

He said the data from their product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published Covid-19 vaccines in the world.

The phase 3 trial Efficacy and Safety Study involving 25,800 volunteers across 25 sites in India is India’s largest ever clinical trial conducted for a Covid-19 vaccine.

“I am delighted to see that the phase III efficacy data has also been published in The Lancet, one of the most reputed journals worldwide. This itself speaks high about the strong position of Covaxin amongst other global front-runners Covid-19 vaccines.A The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of Atmanirbhar Bharat along with the Indian academia and industry in fighting against the odds and carving a niche in the global community,” said Balram Bhargava, Director General of the ICMR.

Recently, the World Health Organization granted emergency use listing to Covaxin enabling countries to expedite their regulatory approval to import and administer doses. It has also received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide. Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the US and Canada.

With more than 150 million doses manufactured, supplied, and with an excellent safety and efficacy profile, Covaxin is a major contributor to the global fight against the Covid-19 pandemic.

The vaccine is currently being evaluated in controlled clinical trials in children 2-18 years of age, with results expected during Q4 2021.

Bharat Biotech said it was poised to achieve its goal of an annualized capacity of Aabout 1 billion doses of Covaxin by the end of 2021.

ALSO READ-Vaccines to be compulsory for frontline NHS staff

Categories
-Top News India News World News

WHO approves Covaxin, Health Minister hails scientists

Developed by Bharat Biotech in partnership with the ICMR and the National Institute of Virology, Covaxin is a whole virion-inactivated vaccine, reports Asian Lite News

The World Health Organisation (WHO) on Wednesday approved Covaxin, India’s first home-grown vaccine against Covid. The WHO’s Technical Advisory Group (TAG) granted the Emergency Use Listing (EUL) approval to Bharat Biotech’s Covaxin vaccine, which has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19.

The TAG has determined that the Covaxin vaccine meets WHO standards for protection against the Covid pandemic and the benefit of the vaccine far outweighs risks and the vaccine can be used, the WHO said in a tweet.

“Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above,” the global health body said.

Developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, Covaxin is a whole virion-inactivated vaccine.

With validation from the WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin. Furthermore, UNICEF, Pan-American Health Organisation (PAHO), GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide, Bharat Biotech said.

This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access, the vaccine maker said.

The EUL procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics, while adhering to stringent criteria of safety, efficacy and quality.

Commending the work of ICMR and Bharat Biotech scientists, Union Health Minister Mansukh Mandaviya said: “Today Prime Minister Narendra Modi’s dream of self-reliant India has materialised. I also thank the WHO for granting the approval.”

WHO Director General, Dr Tedros Adhanom Ghebreyesus said: “Glad to see one more vaccine, Covaxin, being granted emergency use listing. The more products we have to fight Covid-19, the better. But we must keep up the pressure to deliver Vaccine Equity and prioritise access to vulnerable groups who are still waiting for their 1st dose.”

Bharat Biotech Chairman and Managing Director, Dr Krishna Ella, said: “Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin. As an organisation, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification.”

Covaxin has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8 degrees Celsius. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.

Bharat Biotech Joint Managing Director, Suchitra Ella, said: “Covaxin is a great example of a successful public-private partnership in developing a world-class Covid-19 vaccine. We look forward to playing a larger role to help the efforts by both the developed and developing nations to control the pandemic.”

The Phase 3 trial data for Covaxin was available during June 2021. The SAGE of WHO had reviewed Covaxin data on October 5 in a meeting and granted EUL on Wednesday.

Covaxin has been evaluated through neutralising antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies and others have been extensively published in more than 12 peer-reviewed journals and available for review in the public domain.

Bharat Biotech stated that the manufacturing capacity expansion was started during first quarter 2021, as the first Phase 3 efficacy readouts were available. Within a short period of about 9 months, the capacity was scaled up to 50-55 million doses per month, as of October 2021.

It has established Covaxin manufacturing to reach an annualised capacity of 1 billion doses by the end of 2021. Technology transfer activities are also in progress to companies in India, the US, and other countries.

ALSO READ-After Australia, 5 more countries recognise India’s Covaxin

READ MORE-Guyana recognises Covaxin

Categories
-Top News Australia

After Australia, 5 more countries recognise India’s Covaxin

The TGA stated that this will have significant impact for the return of international students, and travel of skilled and unskilled workers to Australia…reports Asian Lite News.

After Australia recognised Bharat Biotech’s Covaxin for allowing entry of travellers who had received the vaccine, five more countries on Monday recognised India’s vaccine certificate. These five countries recognised both Covaxin and Covishield.

The Ministry of External Affairs (MEA) said that five more countries have recognised India’s vaccination certificate, including Estonia, Kyrgyzstan, State of Palestine, Mauritius and Mongolia.

In a tweet in the evening, MEA spokesperson Arindam Bagchi said, “Mutual recognition of Covid-19 vaccination certificates continues! Five more recognitions for India’s vaccination certificate, including from Estonia, Kyrgyzstan, State of Palestine, Mauritius and Mongolia.”

Earlier, in the day Australia recognised Bharat Biotech’s Covaxin along with Covishield for allowing entry of travellers who had received the vaccine. The Therapeutic Goods Administration (TGA), the Australian drug regulator, announced that it has recognised two more Covid-19 vaccines not registered in Australia but used widely internationally, which includes Bharat Biotech’s Covaxin and BBIBP-CorV (manufactured by Sinopharm, China).

The TGA further stated that with recognition of Covaxin, and BBIBP-CorV, along with the previously announced recognition of Coronavac (manufactured by Sinovac, China) and Covishield (manufactured by AstraZeneca), means many citizens of India and China as well as other countries in the region where these vaccines have been widely deployed will now be considered fully vaccinated on entry to Australia.

The TGA stated that this will have significant impact for the return of international students, and travel of skilled and unskilled workers to Australia.

“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,” the TGA said in a statement.

The TGA mentioned that in recent weeks it has obtained additional information demonstrating these vaccines provide protection and 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. “The supporting information has been provided to the TGA from the vaccine sponsor and or the World Health Organisation (WHO),” it said.

In addition, with input from the TGA, Australian Technical Advisory Group on Immunisation (ATAGI) (ATAGI) have determined that those who have received two doses of a TGA-approved or recognised vaccine at least 14 days apart are regarded as fully vaccinated from seven days after the second dose (with the exception of Janssen vaccine, where they are regarded as fully vaccinated seven days after the single dose). This includes homologous (two doses of the same vaccine) and heterologous (two doses of two different TGA-approved or recognised vaccines) schedules.

“From 1 November 2021, vaccinated Australians and permanent residents aged 12 and over may depart Australia without the need to seek a travel exemption,” the statement added.

ALSO READ-‘Brazil, UAE can collaborate on vaccines for future pandemics’

READ MORE-Boris, Modi talk vaccine certification, Afghan situation

Categories
-Top News Australia

Covaxin recognized by Australia

This will have significant impact for the return of international students, and travel of skilled and unskilled workers to Australia,” it said…reports Asian Lite News.

Australia on Monday recognised Bharat Biotech’s Covaxin for allowing entry of travellers who had received the vaccine.

The Therapeutic Goods Administration (TGA), the Australian drug regulator, announced that it has recognised two more Covid-19 vaccines not registered in Australia but used widely internationally, which includes Bharat Biotech’s Covaxin and BBIBP-CorV (manufactured by Sinopharm, China).

“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,” the TGA said in a statement.

The TGA further stated that with recognition of Covaxin, and BBIBP-CorV, along with the previously announced recognition of Coronavac (manufactured by Sinovac, China) and Covishield (manufactured by AstraZeneca, India), means many citizens of India and China as well as other countries in the region where these vaccines have been widely deployed will now be considered fully vaccinated on entry to Australia.

“This will have significant impact for the return of international students, and travel of skilled and unskilled workers to Australia,” it said.

The TGA mentioned that in recent weeks it has obtained additional information demonstrating these vaccines provide protection and 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.

“The supporting information has been provided to the TGA from the vaccine sponsor and or the World Health Organisation (WHO),” it said.

In addition, with input from the TGA, Australian Technical Advisory Group on Immunisation (ATAGI) (ATAGI) have determined that those who have received two doses of a TGA-approved or recognised vaccine at least 14 days apart are regarded as fully vaccinated from seven days after the second dose (with the exception of Janssen vaccine, where they are regarded as fully vaccinated seven days after the single dose). This includes homologous (two doses of the same vaccine) and heterologous (two doses of two different TGA-approved or recognised vaccines) schedules.

“From 1 November 2021, vaccinated Australians and permanent residents aged 12 and over may depart Australia without the need to seek a travel exemption,” the statement added.

ALSO READ-No approval for Covaxin yet, WHO seeks clarifications

READ MORE-India, UK, Australia to launch new group IRIS

Categories
-Top News India News

No approval for Covaxin yet, WHO seeks clarifications

The WHO said it expects to receive these clarifications from Bharat Biotech by the end of this week…reports Asian Lite News.

The World Health Organisation (WHO) on Tuesday said “additional clarifications” are needed from Bharat Biotech regarding its Covid-19 vaccine ‘Covaxin’ for a final “risk-benefit assessment” before recommending the vaccine for emergency use.

“The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure,” the WHO said.

“The TAG met today (October 26, 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 WHO said.

The WHO said it expects to receive these clarifications from Bharat Biotech by the end of this week.

“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, November 3,” the WHO said.

Last week, the WHO had said it is expecting one “additional piece” of information from Bharat Biotech regarding Covaxin. The WHO said there needs to be a thorough evaluation to ensure vaccines are safe and “cannot cut corners” before it is recommended for emergency use.

“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #Covid-19 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 WHO said in a tweet on October 18.

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).

India’s first indigenous Covid-19 vaccine, Covaxin, demonstrated 77.8 per cent efficacy in its Phase 3 clinical trial.

In June, Bharat Biotech said it concluded the final analysis of Covaxin efficacy from Phase 3 trials. The Covaxin jab has been approved in 14 countries and 70 million doses have been distributed overseas, Bharat Biotech told WHO.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.

ALSO READ-Covaxin gets emergency use approval for kids aged 2-18 years

READ MORE-WHO’s nod for Covaxin delayed again over technical queries

Categories
-Top News India News World News

Covaxin gets emergency use approval for kids aged 2-18 years

Public health experts says move can turn out to be a game changer and enable return to normalcy among the young population, reports Rachel Thomas

The Hyderabad-based pharma major Bharat Biotech’s Covaxin has got the emergency use approval for children in the age group of 2 to 18 years from the Drugs Controller General of India (DCGA).

The Subject Expert Committee on Covid-19 gave the approval for the emergency use in the children.

The expert panel said in a statement, “After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation.”

Bharat Biotech had submitted the trial data of phase 2 and 3 of Covaxin on children in the beginning of this month to the apex body — DCGI at the start of this month. The vaccine will be administered in two doses with 20 days of interval.

However, Bharat Biotech needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.

Remarkably, the global health body World Health Organisation has not granted the emergency use authorisation to Covaxin. The World Health Organisation said last week that it will carry out the risk and benefit assessment next week with experts and take a final decision on the much awaited EUL to Covid vaccine Covaxin.

The WHO said in the last meeting, “WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin”.

Meanwhile, India continues to show the declining trends in the daily trajectory of Covid caseloads. India on Tuesday reported 14,313 fresh Covid cases in the last 24 hours, lowest recorded cases in the 224 days. Total 181 deaths have also been reported in the same time span, pushing the death toll to 4,50,963, the Union Health Ministry said.

The Active Caseload is presently 2,14,900, which is the lowest in 212 days. The active Covid cases presently constitute 0.63 per cent of the country’s total positive cases.

Experts welcome move

Covid vaccinations for children and adolescents can turn out to be a game changer and enable return to normalcy among the young population, said public health experts.

“The news is very encouraging. I am very much sure that this initiative will be a game changer to protect our children and adolescents,” Dr Sujeet Ranjan, Head Nutrition, Tata Trusts said.

“In India, best efforts have been put into protecting children after the warning from the experts and the dangerous second wave. With schools reopening in many states for certain age groups, the vaccine for children 2-18 years will help them return to normal,” he added.

In a statement, Bharat Biotech said it had submitted the trial data of phase 2 and 3 of Covaxin on children to the Central Drugs Standard Control Organisation (CDSCO) at the beginning of this month.

While data on these trials has not been made public yet, tests were conducted on more than 1,000 children across the country. “The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations,” read the statement from the company.

The expert panel noted that the trial on kids showed similar efficacy rates as that on adults. However, Bharat Biotech needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.

“After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations,” the expert panel said in a statement.

Dr Rahul Nagpal, Director of Paediatric and Neonatology at Fortis Hospital, Vasant Kunj, said: “The approval to give Covid-19 vaccine to children is very good news for children as well as their parents. This approval will also open the path for children to come back to normal life completely and schools will be functional. With this approval now we can also get rid of this pandemic.”

However, some experts have also raised concerns.

“While it is reassuring to know that the vaccine has worked well in children, rollout in children must be scheduled only when we are confident that adults who are at greater risk of more severe illness have acquired immunity in large numbers,” Public Health Foundation of India President K. Srinath Reddy said.

“Children who are immunocompromised may be given early jabs. Only in 2022, we will be able to judge the need for, and benefits of, mass vaccination in children. Evidence will be available by then, from different countries,” he added.

“If the vaccine safety data is strong enough and we immunise them, it will have a big impact in reducing the transmission of Covid. This will be a major step as school, coaching centres and sport centres are gradually opening.” Dr. Akshay Budhraja, Senior Consultant, Pulmonology, Aakash Healthcare, Dwarka said.

Meanwhile, the World Health Organisation is yet to grant the emergency use authorisation to Covaxin. The global health body said last week that it will carry out the risk and benefit assessment next week with experts and take a final decision on the much awaited EUL to Covid vaccine Covaxin.

Bharat Biotech added that it is awaiting further regulatory approval from the CDSCO “prior to product launch and market availability of Covaxin for children”.

Once approved, Covaxin will become the second vaccine cleared for use on kids in India. In August Zydus Cadila’s three-dose DNA jab was the first to get approval to be used on adults and children over 12.

Serum Institute’s Novavax — for children between seven and 11 years — and Biological E’s Corbevax — cleared to conduct advanced trials on children above five — are the other potential vaccines for kids.

ALSO READ-Selective view of human rights violation dangerous, warns Modi

READ MORE-Russia accused of stealing AstraZeneca vaccine blueprint

Categories
-Top News India News

WHO’s nod for Covaxin delayed again over technical queries

Without the WHO nod, Covaxin will not be considered an accepted vaccine by most countries across the world and the delay is likely to affect students, medical tourists, business travellers and those who want to travel abroad, reports Asian Lite News

The World Health Organization (WHO) has once again delayed the emergency use authorisation (EUA) for Covaxin, the Covid-19 vaccine developed in India, and sent for more technical queries to its Hyderabad-based manufacturer Bharat Biotech.

This comes even after Bharat Biotech has said it has submitted all data required for clearance of Covaxin. Sources familiar with the matter said that this is a routine process and there is no concern in the matter. “It’s the usual process. Experts raise queries, which need to be answered by the company,” the person cited above said.

“No, it should not be delayed… Maybe a few weeks,” the WHO official told News18 when asked if the fresh set of queries will delay the approval further.

Without the WHO nod, Covaxin will not be considered an accepted vaccine by most countries across the world and the delay is likely to affect students, medical tourists, business travellers and those who want to travel abroad.

Last Friday, the Union ministry of health and family welfare hinted that the global health body was likely to give its nod anytime soon. “There is a procedure of submitting the documents for approval. WHO’s emergency use authorisation to Covaxin is expected soon,” Dr Bharati Pravin Pawar, Union minister of state in the health ministry, said, according to news agency ANI.

Before that, Dr VK Paul, chairperson of the National Expert Group on Vaccine Administration, also said that WHO’s approval for Covaxin was likely to come before the end of this month.

Bharat Biotech said it has submitted all the necessary documents required for approval on July 9. “The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest,” Dr Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement.

Covaxin and Serum Institute of India’s Covishield were the Covid-19 vaccines first used by the central government in its massive nationwide inoculation drive launched in January this year. Russia-made Sputnik was later added to the country’s vaccination drive. Covishield is the only India-made vaccine on the WHO list now.

WHO to relaunch Covid origins probe

Meanwhile, the World Health Organization (WHO) is set to relaunch investigations into the origins of the Covid-19, with a fresh probe team, the media reported.

A new team consists of about 20 scientists, and includes specialists in laboratory safety and biosecurity and geneticists and animal-disease experts versed in how viruses spill over from nature. They will hunt for new evidence in China and elsewhere, the Wall Street Journal reported.

A joint WHO-China inquiry, whose findings were released in March this year, had dismissed the possibility that the virus had emerged accidentally from a laboratory as “extremely unlikely”.

Tedros Adhanom Ghebreyesus.

Undermining its own report, Director General Tedros Adhanom Ghebreyesus in July, proposed a second phase of studies in Wuhan, which includes audits of laboratories and markets in the city of Wuhan.

As per Ghebreyesus, getting access to raw data had been a challenge for the international team that travelled to China to investigate the source of the pandemic.

According to scientists at the global health body, time is running out to determine how the pandemic began, as evidenced such as blood samples are being thrown away and antibodies in the earliest Covid-19 victims are fading to undetectable levels.

China has, however, rejected the probe accusing the WHO of “arrogance” and a “disrespect for common sense”.

Chinese scientists have also asked the WHO to extend the hunt for origins of Covid-19 to labs in other countries including the US Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Maryland.

As a result, the new team who will be chosen by the end of this week, are likely to face stiff resistance from China. The original WHO team has been disbanded, the WSJ report said.

The Chinese government has declined to clear whether it would allow a new team into the country.

The Foreign Ministry, in a statement, said that China has “cooperated fully” with the previous inquiry, the report added.

“China will continue to support and engage in global science-based origins tracing and stands firmly opposed to political maneuvering in whatever form,” Chinese President Xi Jinping told the UN General Assembly last week.

The Chinese Foreign Ministry had stated that the country will closely monitor the WHO’s selection of a new team, and that Beijing has also put forth a number of individuals to be part of it, the report said.

It is not yet clear if the new team will be able to fly experts into China or make significant progress in resolving the origins debate so long as that deadlock remains.

The new team’s “priority needs to be data and access in the country where the first reports were identified”, a WHO spokesman was quoted as saying.

ALSO READ-England hospitals can ease Covid rules to treat more patients

READ MORE-US health officials back FDA decision on Covid booster shot

Categories
-Top News COVID-19

ICMR releases new study on Covaxin doses

The antibody responses of individuals with confirmed pre-vaccination SARS-CoV-2 infection were compared with those individuals without prior evidence of infection…reports Asian Lite News.

A single-dose of Covaxin provides a similar immunity response in previously Covid-infected people as those without previous history of Covid infection with two doses of vaccine, says Indian Council of Medical Research’s latest study.

The ICMR in its recent study has found that the people already infected with Covid-19 while taking a dose of Covaxin have the same or increased antibody response as unaffected people taking two doses of Covaxin.

The pilot study was undertaken to examine SARS-CoV-2 specific antibody responses after day 0 (baseline before vaccination), day 28A2 days post-first dose (month 1) and day 56A2 days post-first dose (month 2) of BBV152 in a group of healthcare professionals as well as frontline workers.

The antibody responses of individuals with confirmed pre-vaccination SARS-CoV-2 infection were compared with those individuals without prior evidence of infection.

The blood specimens were collected from healthcare professionals and frontline workers who received BBV152 vaccine at vaccination centres in Chennai, India, during February to May 2021.

Blood samples were collected before receiving the first dose of BBV152. Prior infection with SARS-CoV-2 was determined by SARS-CoV-2 IgG positivity at baseline. The study was approved by the Ethics Committee of ICMR-NIRT.

Antibody levels were measured at three time points: on the day of vaccination (baseline), at month one following the first dose and at month two following the first dose.

https://www.youtube.com/watch?v=ngCvDWwuEgM

The results were determined via a calibration curve, which is an instrument specifically generated by two-point calibration and a master curve provided via the reagent QR code.

Almost all participants with prior Covid-19 infection except two had detectable antibodies at the time of vaccination. This study offers evidence in support of public health-oriented and immunologically sustained vaccine strategies.

Lokesh Sharma, Scientist and Media Coordinator, ICMR, says, “This is a pilot study. If such findings are confirmed in large population studies, a single dose of BBV152 vaccine may be recommended to previously confirmed Covid patients so that the naA-ve individuals could attain the larger benefit of a limited vaccine supply.”

ALSO READ-ICMR issues guidance on COVID 19 death cases

READ MORE-No compromise on Covaxin quality, says Bharat Biotech

Categories
-Top News COVID-19 India News

Decision on Covaxin emergency authorisation expected by Sept: MEA

The World Health Organisation has said the agency expects to make a decision next month on an emergency authorisation for the Indian-made COVID-19 vaccine….reports Asian Lite News

The Ministry of External Affairs (MEA) on Thursday said a decision on emergency authorisation for the Covaxin Covid-19 vaccine made by Bharat Biotech is expected to be announced by September as the World Health Organisation (WHO) takes 6-8 weeks to grant the emergency use listing.

In a media briefing, MEA spokesperson Arindam Bagchi said, “Covaxin submitted its application on July 9 so we are expecting a response by September as it takes 6-8 weeks for the WHO to grant the EUL.”

External Affairs Minister S Jaishankar had made a similar statement at the CII annual event.

The World Health Organisation has said the agency expects to make a decision next month on an emergency authorisation for the Indian-made COVID-19 vaccine.

Last week, Bharat Biotech’s Covaxin received a Good Manufacturing Practices (GMP) compliance certificate from Hungary. The certificate of GMP is now listed on the EudraGMDP database which is the collection of records of the European Community of manufacturing authorisations and certificates of good manufacturing practice, Bharat Biotech said.

Asked about the actions taken by the government on easing Covid travel restrictions, the MEA Spokesperson said, “There are many countries where Covid restrictions are there. Not just students, other people who would like to travel are facing problems. As I have said earlier, we attach high importance to ensuring ease of these restrictions whether they live abroad for education or employment. We have been actively taking up this matter at various levels including at the ministerial levels with all of the countries. I am happy to see some forward movements with some of the countries. MEA will continue to attach high priority to this issue.” (India News Network)

ALSO READ: No compromise on Covaxin quality, says Bharat Biotech

ALSO READ: Nod for proposal to study mixing of Covid-19 vaccine doses