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Covaxin 77.8% effective after Phase 3 trials

Bharat Biotech’s Covaxin is overall 77.8 percent effective against Covid, the vaccine maker said on Saturday in a statement, citing the data from the third phase of clinical trials…reports Asian Lite News.

In a statement, the vaccine maker said, “Efficacy analysis demonstrates Covaxin to be 77.8 percent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group.”

According to the statement, the vaccine offers 65.2 percent protection against the rapidly emerging Delta variant. It was also found to be “93.4 percent effective” against severe symptomatic COVID-19 and 63.6% effective against asymptomatic COVID-19, the company said.

Covaxin is a whole virus inactivated vaccine against SARS-CoV2, developed by Bharat Biotech in partnership with ICMR and NIV Pune.

The Phase 3 clinical trial was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India.

Twelve percent of the subjects experienced commonly known side effects and less than 0.5 per cent of subjects reported serious adverse events, Bharat Biotech said, adding that the overall rate of adverse events was lower than that seen in other COVID-19 vaccines.

“The safety profile of Covaxin is now well established based on inactivated vaccines technology, and in large part due to the extensive 20-year safety track record of Bharat Biotech’s vero cell manufacturing platform. Furthermore, Bharat Biotech has so far not sought indemnity for Covaxin from the governments,” the company said.

Chairman and Managing Director, Bharat Biotech, Krishna Ella said, “The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that Innovation from India will now be available to protect the global population.”

“COVAXIN will not only benefit the Indian citizens but would also immensely contribute to protect the global community against the deadly SARS-CoV-2 virus. I am also pleased to see that COVAXIN works well against all variant strains of SARS-CoV-2. The successful development of Covaxin has consolidated the position of Indian academia and Industry in the global arena,” Prof. Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, said.

Director National Institute of Virology ICMR Prof. Priya Abraham said, “The overall efficacy of 77.8 % following the phase III clinical trial of COVAXIN® is wonderful news. ICMR-NIV and BBIL have had very fruitful interactions during this exhilarating journey. Sera from COVAXIN recipients have also been evaluated against viral variants detected in India i.e., the Alpha, Beta, Zeta, Kappa and Delta. The making of this vaccine entirely on Indian soil is a matter of great pride to every Indian”

Joint Managing Director, Bharat Biotech Suchitra Ella said, “It is a momentous day for everyone, at Bharat Biotech, as we announce the Final Phase-3 Results of COVAXIN® and its efficacy of 77.8%. We wish to thank ICMR, NIV-Pune, Virovax, DSMB and the Adjudication Committee.”

Covaxin has received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico.

The company is in discussions with WHO to obtain an emergency use listing for Covaxin. The product has been exported to several countries with additional requests for supplies being received.

Bharat Biotech is also undertaking additional clinical trials to establish safety and efficacy in children between 2-18 years of age. A clinical trial to determine the safety and immunogenicity of a booster dose is also in process. (INN)

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 Covaxin effective against both Alpha, Delta variants: US NIH

COVAXIN comprises a disabled form of SARS-CoV-2 that cannot replicate but still stimulates the immune system to make antibodies against the virus…reports Asian Lite News

The National Institute of Health (NIH) in the United States has found that Bharat Biotech’s COVAXIN vaccine generates antibodies that effectively neutralize both Alpha and Delta variants of COVID-19.

The top health research institute said that an adjuvant developed with funding from the NIH has contributed to the success of the “highly efficacious” COVAXIN COVID-19 vaccine, which roughly 25 million people have received to date in India and elsewhere.

“Results from two studies of blood serum from people who had received COVAXIN suggest that the vaccine generates antibodies that effectively neutralize the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the United Kingdom and India, respectively,” NIH said in a statement.

The adjuvant used in COVAXIN, Alhydroxiquim-II, was discovered and tested in the laboratory by the biotech company ViroVax LLC of Lawrence, Kansas with support exclusively from the NIAID Adjuvant Development Program, NIH said.

ALSO READ: ‘FDA decision on Covaxin has no bearing on us’

The adjuvant comprises a small molecule attached in a unique way to Alhydrogel, a substance frequently called alum that is the most commonly used adjuvant in vaccines for people.

“Ending a global pandemic requires a global response,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH. “I am pleased that a novel vaccine adjuvant developed in the United States with NIAID support is part of an efficacious COVID-19 vaccine available to people in India.”

COVAXIN comprises a disabled form of SARS-CoV-2 that cannot replicate but still stimulates the immune system to make antibodies against the virus. Published results from a Phase 2 trial of the vaccine indicate that it is safe and well-tolerated.

Unpublished interim results from the Phase 3 trial indicate that the vaccine has 78 per cent efficacy against symptomatic disease, 100 per cent efficacy against severe COVID-19, including hospitalization, and 70 per cent efficacy against asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19. (ANI)

ALSO READ: Covaxin trials on children set to begin

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-Top News COVID-19 EU News

Poonawalla hopes to resolve Covishield, EU travel issues soon

Europe’s vaccine passport programme, which allowed recipients to travel to and from Europe with fewer roadblocks, may not recognise recipients of the Covishield vaccine…reports Asian Lite News.

Adar Poonawalla, Chief Executive Officer (CEO) and owner of the Serum Institute of India (SII) on Monday assured Indians who have taken Covishield doses and are now facing issues while travelling to European Union countries that the matter had been escalated to the ‘highest level’.

In a tweet, Poonawala also said he hoped to resolve the matter soon, both with regulators and at a diplomatic level with countries.

“I realise that a lot of Indians who have taken COVISHIELD are facing issues with travel to the E.U., I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries,” he tweeted.

This comes after reports that travellers vaccinated with Covishield, the AstraZeneca-Oxford vaccine manufactured in India by the SII, may not be eligible for the European Union’s ‘Green Pass’.

Europe’s vaccine passport programme, which allowed recipients to travel to and from Europe with fewer roadblocks, may not recognise recipients of the Covishield vaccine.

Covishield is one of the three COVID-19 vaccines approved for use in India.

The exclusion means, travellers vaccinated with Covishield may not be eligible for the vaccine passport that will enable Europeans to move freely for work or tourism.

While the European Union had earlier said that member states should issue the certificates regardless of the type of Covid-19 vaccine, the technical specifications of the ‘Green Pass’ indicate that obligation would be limited to “vaccines that have received EU-wide marketing authorization,” the Hindustan Times reported.

According to the report, at present, four vaccines have been approved by the European Medicines Agency (EMA) that can be used in the EU member states: Comirnaty (Pfizer/BioNTech), Moderna, Vaxzervria (AstraZeneca), Janssen (Johnson & Johnson).

Covishield has not been approved by the EMA for the European market. The EU green pass will only recognise the Vaxzervria version of the AstraZeneca vaccine that is manufactured in the UK or other sites around Europe, it was reported.

Meanwhile, SII has begun manufacturing Novavax’s protein-based vaccine Covovax, CEO Adar Poonawalla has said.

The company will also begin clinical trials of Novavax for children starting July.

In the recently released Phase -3 trials, Covovax has shown overall 90 per cent efficacy against Covid-19. The US-based trials also demonstrated the two-shot vaccine 100 per cent protection against moderate and severe disease.


“The vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. Well done team,” he said.

SII’s Phase-2 and 3 clinical trials of Covovax will reportedly be conducted in 920 children — 460 each in 12-17 years and 2-11 years groups, media reports said.

In August 2020, Novavax and SII had announced an agreement under which the US biotechnology company had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries.

In March 2021, CEO Poonawalla said Covovax will be launched by September this year. (ANI)

ALSO READ-Serum begins Covovax production

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-Top News COVID-19 India News

Covaxin trials on children set to begin

Delhi AIIMS has decided to start the trial drive after the recruitment and clinical trial for single-dose Covaxin for 12-18 age group is over….reports Asian Lite News

The All India Institute of Medical Sciences (AIIMS) is learnt to have started screening of children aged 6-12 years for the clinical trials of India’s first indigenously developed Covid-19 vaccine, Bharat Biotech’s Covaxin.

Sources said that the recruitment and clinical trials of the children aged 6-12 years will start from Tuesday. The trial on children aged 6-12 has already started at AIIMS Patna.

Participants would be given the vaccine after their screening report comes. The trial would ensure if the Bharat Biotech jab is suitable for children.

Delhi AIIMS has decided to start the trial drive after the recruitment and clinical trial for single-dose Covaxin for 12-18 age group is over.

After the recruitment of 6-12 year-old children, AIIMS Delhi will be conducting trials for the age group 2-6 years of children. The trials are taking place at 525 centres.

Kolkata: Health workers give the 1st dose of vaccine to the Government workers during increasing numbers of COVID 19 cases in Kolkata 24 May, 2021. (Photo: Kuntal Chakrabarty/ IANS
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The screening of children for the trial of single-dose Covaxin among those aged between 2 and 18 years started at the AIIMS in New Delhi on June 7 after India’s drug regulator had granted permission for conducting the Phase 2 and 3 clinical trials of Covaxin in the age group 2 to 18 years on May 12.

AIIMS Patna, Mysore Medical College and Research Institute in Karnataka have also been selected to conduct clinical trials on children.

Covaxin is being used on adults in India’s ongoing Covid-19 vaccination drive since January 16 this year. The government last week cautioned that even though Covid-19 has not taken a serious shape among children till now, its impact can increase among them if there is a change in virus behaviour or epidemiology dynamics, and said preparations are being strengthened to deal with any such situation.

A national expert group has been formed to review Covid-19 infections in children and approach the pandemic in a renewed way to strengthen the nation’s preparedness, NITI Aayog Member (Health) V.K. Paul had said at a press conference.

“The group has examined signs which were not available four-five months before.”

ALSO READ: Delhi Metro resumes operations

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-Top News COVID-19 USA

Covaxin, Sputnik V jabs red-flagged in US

Campuses are proposing different measures, out of which the more complicated scenario is if students received a vaccine that has not been approved by the WHO, like Sputnik or Covaxin…reports Asian Lite News

Since March, over 400 US colleges and universities have announced students get Covid-19 vaccinations, ahead of the Autumn semester but those who have been inoculated with India’s indigenous Covaxin or the Russian-made Sputnik V are being asked to re-vaccinate as these vaccines have not yet been approved by the World Health Organisation (WHO).

Rukmini Callimachi reports in the The New York Times that Milloni Doshi, a 25-year-old student from India, who is due to start her master’s degree this fall at Columbia University’s School of International and Public Affairs, has been administered two doses of Covaxin. Now, Columbia has told her that she will need to be revaccinated with a different vaccine once she arrives on campus.

“I am just concerned about taking two different vaccines. They said the application process would be the toughest part of the cycle, but it’s really been all of this that has been uncertain and anxiety-inducing,” Doshi wrote via a messaging app.

Campuses are proposing different measures, out of which the more complicated scenario is if students received a vaccine that has not been approved by the WHO, like Sputnik or Covaxin. Many colleges are proposing that those students will need to be revaccinated, which presents both medical and logistical conundrums.

This is primarily because no data exists on whether combing vaccines from different companies is safe. “Since Covid-19 vaccines are not interchangeable, the safety and effectiveness of receiving two different Covid-19 vaccines have not been studied,” said Kristen Nordlund, spokesperson for the Centers for Disease Control and Prevention (CDC).

Nordlund also advised that people vaccinated outside the US with a vaccine not authorised by WHO should wait for a minimum of 28 days before taking the first dose of one of the Food and Drug Administration (FDA)-sanctioned vaccines.

American students have access to the Pfizer, Moderna and Johnson & Johnson vaccines, three of the eight doses authorised by the global health body. This disparity could hinder colleges that have made it a major priority to retain international students, who brought in close to USD 39 billion in tuition dollars in the year before the pandemic, according to an analysis.

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“Universities want to enroll international students because they add diversity to the campus community — and they bring money… It’s why this has been a subject of intense discussion,” said Terry W Hartle, senior vice president at the American Council on Education.

According to The New York Times, the situation is particularly challenging for students from India, which sends around 200,000 international students to American colleges every year. It is becoming increasingly hard to secure an appointment for a vaccine that will be accepted by American campuses.

“Every day, we get 10 to 15 messages and inquiries, saying ‘What does this mean? How does this impact me?'” said Sudhanshu Kaushik, who runs the North American Association of Indian Students, which is working to help fellow students.

Indiana University’s vice president for international affairs, Hannah Buxbaum, said that the administrators of the institution are working overtime to answer the roughly 200 phone calls and 300 emails that are pouring in every day from the university’s roughly 6,000 students overseas.

“Ringing off the hook doesn’t begin to describe. There is no question that there is anxiety and concern among our international students,” she said.

Many universities are only accepting the students who have been vaccinated with a WHO-approved COVID-19 vaccine. At Columbia, where one-third of the student body is from overseas, international students will be asked to present either their WHO booklet or a letter from a physician confirming they have received the requisite doses of one of the vaccines vetted by the world body, said Donna Lynne, the chief operating officer of the university’s medical centre.

Callimachi writes for The New York Times that those who will not succeed in securing a vaccine before the start of the fall semester are facing a potentially problematic process.

Many universities were vague on how they plan to deal with the logistical complexity of spacing out these unrelated vaccines, beyond saying that they planned to accommodate students undergoing this process, reports The New York Times.

At least six regional governments in India have announced emergency clinics in the past week to vaccine students going to US universities, in wake of mounting pressure from confused and anxious students, wrote Callimachi.

However, Hyderabad-based Bharat Biotech on Thursday said that biopharmaceutical company Ocugen Inc will have exclusive co-development, manufacturing, and commercialisation rights of its COVID-19 vaccine Covaxin in Canada, in addition to its existing United States rights. (ANI)

ALSO READ: Biden announces vaccine sharing plan

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COVID-19 India News

States/UTs to get 11L vax doses in 3 days

The Government of India has so far provided, both through the free of cost category and through direct state procurement category, 22,16,11,940 doses to States/UTs…reports Asian Lite News

After India crossed the 20-crore vaccination mark in 130 days, the Ministry of Health and Family Welfare said that more than 22 crore vaccine doses have been provided to States/UTs and about 1.84 crore doses were still available with the States/UTs to be administered.

The Government of India has so far provided, both through the free of cost category and through direct state procurement category, 22,16,11,940 doses to States/UTs.

Of this, the total consumption, including wastages is 20,17,59,768 doses (as per data available at 8 a.m. Thursday).

Covid Vaccine doses to the tune of 1,84,90,522 were still available with the States/UTs to be administered, the government cleared in its data amid various attacks on social media on its vaccine policy.

A total of 11,42,630 vaccine doses were in the pipeline and would be received by the States/UTs within the next three days.

As part of the nationwide vaccination drive, the central government has been supporting the States and UTs by providing them COVID Vaccines free of cost. In addition, it has also been facilitating direct procurement of vaccines by the States/UTs.

Vaccination is an integral pillar of the comprehensive strategy of Government of India for containment and management of the pandemic, along with Test, Track, Treat and COVID Appropriate Behaviour.

Implementation of the Liberalized and Accelerated Phase-3 Strategy of Covid-19 Vaccination started from May 1.

Under the Strategy, every month 50 per cent of the total Central Drugs Laboratory (CDL) cleared vaccine doses of any manufacturer is procured by Govt. of India. It continues to make these doses available to the state governments totally free of cost as was being done earlier.

ALSO READ: Bharat Biotech ready to share Covaxin formula

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-Top News COVID-19 India News

DR FAUCI: ‘Covaxin can neutralise 617 Variant of Covid-19′

A breakthrough in the fight against Covid-19. White House chief medical adviser and America’s top pandemic expert Dr Anthony Fauci said Covaxin, India’s home-grown COVID-19 vaccine, has been found to neutralise the 617 variant of the deadly virus.

“This is something where we’re still gaining data on a daily basis. But the most recent data, was looking at convalescent Sera of COVID-19 cases and people who received the vaccine used in India, the Covaxin. It was found to neutralise the 617 variants,” Dr Fauci told reporters at White House.

‘So, despite the real difficulty that we’re seeing in India, vaccination could be a very, very important antidote against this,’ Fauci added.

The New York Times said Covaxin works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface.

Developed by Bharat Biotech in partnership with National Institute of Virology and the Indian Council of Medical Research, Covaxin was approved for emergency use on January 3. Trial results later showed the vaccine has an efficacy of 78 per cent.

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