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bharat biotech

Covaxin trial on children results suggest same effect as on adults: Experts

by Medically Speaking Team October 12, 2021

As India’s largest COVID-19 vaccination drive begins, an AIIMS professor claims that the latest trials show that the safety and immunogenicity of India’s indigenous COVID-19 vaccine—Covaxin—are nearly the same in children as in adults over the age of 18.

Dr Sanjay K Rai, a professor at the All India Institute of Medical Sciences’ (AIIMS) Centre for Community Medicine, told ANI, “Covaxin was tested on three different age groups. The first age group examined was between the ages of 12 and 18 years, the second between the ages of 6 and 12 years, and the third between the ages of 2 and 6 years.”

Notably, Dr Rai served as the primary investigator for the COVAXIN trials on children.

“We began by completing the examination of people aged 12 to 18 years old, and then moved on to other age groups. The vaccine safety and immunogenicity of Covaxin are nearly identical. The final results of these trials, however, are still awaited. We had already conducted adult population trials. We are waiting for the results for the children “The doctor stated.

Dr. Rai stated that SARS-CoV-2 is not fatal in children around the world.

“There is only a minor infection present. It is milder than the common cold in a few children. We don’t know which of Zydus Cadila, Bharat Biotech, Pfizer, or Moderna is the mildest at the moment. These vaccines lessen the severity of the infection but not the infection itself “He stated.

Meanwhile, India’s COVID-19 vaccination coverage has surpassed 95 crores, with 46,57,679 doses administered in the last 25 hours, according to the Ministry of Health and Family Welfare on Monday.

According to the ministry’s preliminary reports issued at 7 a.m. today, India has administered 95,19,84,373 vaccines so far.

This was accomplished through 92,57,689 sessions.

In the last 24 hours, the country reported 18,132 new COVID-19 cases, the fewest in 215 days. (ANI)

October 12, 2021 0 comment

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Nasal vaccine a gamechanger, may protect from Covid infection; claims Dr Sanjay Rai

by Medically Speaking Team September 29, 2021

written by Medically Speaking Team

“We are going to start trial for nasal vaccine very soon and I believe it might be a game changer and most probably it will provide mucosal immunity. It is quite possible that it might provide protection from the infection also,” said Dr Sanjay Rai, Professor of Community Medicine from AIIMS and Principal Investigator for Covaxin.

While talking to Medically Speaking, Dr Rai stated that the investigation is heading in a positive direction.

Here are a few snippets from the exclusive interview:

Do you think there is a need for booster shot and if it is possible in a country like ours where a large number of people are yet to be vaccinated?

Dr Sanjay Rai: Everyone is discussing this right now, even WHO Chief Scientist Saumya Swaminathan stated that there is not enough evidence to support booster dose. Although few countries like Israel have already administered this to people above 60 years of age and recently USA has also adopted this policy. India started clinical trial for booster doses almost 6 months ago and yet we do not have sufficient evidence to prove that booster is beneficial. Measuring antibody level every six months is not the right criteria because it increases when the person comes in contact with antigens. As a doctor and a scientist, I believe that without proper scientific evidence, commenting on the same would not be justified.

Some doctors have advocated the need for booster doses especially for the comorbid and elderly. What would you say on that?

Dr Sanjay Rai: I can say that at least domain experts have not said this. In current scenario, social media is largely influencing people but as I mentioned earlier, it would not be appropriate to say anything without evidence. We may require booster in near future, but as per the current knowledge, best protected are the ones who recovered from Covid. Few evidences suggest that this may provide immunity for a lifetime. As per a recent serosurvey, 60% of population has been infected already with Covid and hence I can say that a majority of population is already protected.

WHO approval for Covaxin has been delayed once again. What could be the reason behind this as this can raise questions on the efficacy of the vaccine?

Dr Sanjay Rai: Few countries are just asking for RTPCR where it is still not mandatory to have a vaccine certificate. Vaccine does reduce the chance if severities but will not lessen the risk of infection. Therefore, there is no need to issue such certificates to vaccinated people. I do not know the exact reason for the delay on the part of WHO but the data is there in the public domain but we have not published it yet in the peer review journal and still we are waiting for it.

What do you have to say on the ongoing trial front of Covaxin’s nasal vaccine?

Dr Sanjay Rai: We have not really started the trial but we will begin that soon and I believe it will be a gamechanger and most probably it will provide mucosal immunity. And it is quite possible it might provide protection from the infection also. All I can say is that it is definitely going in a positive direction.

September 29, 2021 0 comment

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Covaxin likely to get WHO approval this week

by Medically Speaking Team September 14, 2021

written by Medically Speaking Team

The benefits of a WHO approval for Bharat Biotech’s Covid-19 vaccine, dubbed Covaxin, include easier international travel for Indians and vaccine export. The international health body is expected to approve the vaccine this week, according to reports.

Covaxin and Covishield – the AstraZeneca Covid-19 vaccine manufactured by the Serum Institute of India – were the two vaccines with which India began its vaccination campaign on January 16. While Covishield has received WHO approval, Covaxin has not, making international travel difficult for those who have received the homegrown vaccine.

In May, Bharat Biotech submitted an application to the World Health Organization (WHO) in Geneva for an emergency use listing (EUL). Bharat Biotech and WHO met for a pre-submission meeting on June 23. The dossier will be complete and taken up for review by the health body once Bharat Biotech submits the entire Covaxin Phase-3 clinical trials data, according to a senior official at the Hyderabad-based pharma company quoted by Times of India. The company expects to start the review process for Covaxin’s EUL application in July, after the efficacy study data is submitted, according to the official.

Business Today in a report on September 1 had said a WHO panel would convene in the week to assess Covaxin’s application for emergency use listing, which will allow persons immunised with Bharat Biotech’s vaccine to travel freely. The WHO panel will evaluate Covaxin’s immunogenicity, vaccine safety, and vaccine effectiveness, the report had said. The homegrown company had submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO).

“All documents required for emergency use listing (EUL) of Covaxin have been submitted to WHO as of July 9. The review process has now commenced with the expectation that we will receive EUL from the WHO at the earliest,” Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech had earlier said.

‘Insufficient Information’: The US Food and Drug Administration had also earlier declined to approve Covaxin. The FDA has stated that there is “insufficient information” on Covaxin to issue its emergency use authorization request for this vaccine.

September 14, 2021 0 comment

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Hospital in Chennai begins study on Covaxin booster shot efficacy

by Medically Speaking Team August 31, 2021

written by Medically Speaking Team

The booster dose is being given six months after the trial participant received the second dose of the vaccine. The efficacy of the two doses of the vaccine is likely to last at least nine months, and the booster dose is expected to increase the immune response further.

The volunteers part of the phase two trial had received both the doses of Covaxin in March, and are being given the third dose after the passage of six months. said Dr Sathyajit Mohapatra, lead researcher of Covaxin trials in SRM Medical College and Research Centre.

“The analytics are yet to be done but booster doses are expected to improve the immune response in these volunteers,” Dr Mohapatra said.

Research suggest that while antibodies sustain in many individuals who have received the vaccine doses, it might not be the same in some people as the efficacy of the vaccine might reduce and the antibodies would not sustain beyond 6-9 months. Thus, the trial is being conducted to establish the effect of third dose of Covaxin on individuals who have received both the doses of the vaccine.

“The trial is being done on a small scale to understand if the booster doses are efficient and help in improving the immune response. Another trial with a large sample size will be helpful in getting better results. The participants are being followed up, and there are no adverse effects in any of the volunteers so far,” added Dr Mohapatra.

August 31, 2021 0 comment

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WHO nod to Covaxin likely in two weeks, says NTAGI chief

by Medically Speaking Team August 30, 2021

written by Medically Speaking Team

Bharat Biotech is likely to get approval from the World Health Organization in two weeks for the emergency use listing (EUL) of its Covaxin vaccine, NK Arora, who is heading the National Technical Advisory Group on Immunization (NTAGI), told a business daily.

EUL is a WHO procedure through which it assesses the medicines, vaccines and devices used to address an outbreak classified as a ‘public health emergency of international concern’. With the approval for EUL, Bharat Biotech will be able to supply its vaccine to other countries. The Hyderabad-based company had applied to WHO for EUL in the second week of July.

With regard to the limited supply of Sputnik V vaccine in India, Arora said there is a mismatch between the manufacturing of the first and second dose of the vaccine.

“Within a week or so, a clearer picture will emerge, so that it can be taken up at high speed in the health system also, as at the moment, it is available in the private sector in limited numbers. As of now, only 8-10 lakh doses of Sputnik V vaccine doses have been provided [so far],” Arora added.

With regard to vaccines of foreign manufacturers like Moderna and Pfizer, Arora said there are administrative issues such as indemnity and liability clauses.

With respect to Johnson & Johnson, he said the vaccine will be manufactured here and then it will be made widely available. Being a single-dose vaccine, it will greatly complement existing vaccines, he added.

On India’s aim to vaccinate all of its adult population by year-end, Arora expressed optimism about achieving the goal.

He cleared the air on reports suggesting the government’s plan to reduce the interval between two doses of Covishield.

“We are studying all available evidence. Currently, we are not aware of any such proposal as to reduce the interval between the two doses of Covishield. There is also a national vaccine programme which is going to come up and be made public very soon. It will be announced in a few days,” Arora said.

According to NTAGI’s head, the results of the Covaxin clinical trial on children will be available in October, and once the regulator allows, children with comorbidities will be eligible for immunisation.

“As we have 44 crore children, we will begin vaccinating them only after the vaccination of the adult population is complete; and that too will likely begin in the first quarter of FY22. However, as soon as the ZyCov-D vaccines are available in the market, children with comorbidities will become eligible for the inoculation,” Arora said.

August 30, 2021 0 comment

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Mansukh Mandaviya releases first batch of Covaxin from Bharat Biotech’s new plant in Gujarat

by Medically Speaking Team August 29, 2021

written by Medically Speaking Team

Mansukh Mandaviya, Union Health Minister, inaugurated the first commercial batch of Covaxin on Sunday from Bharat Biotech’s new factory in Ankleshwar, Gujarat.

Mansukh Mandaviya said, “India is focused on slowing the spread of Covid-19 in the country, and the key to achieving this lies in the swift and efficient administration of vaccines. We want to ensure equitable access of the vaccine to every Indian citizen, and the expansion of Covaxin production facilities by Bharat Biotech will take us closer to this goal.”

The health minister took to Twitter to talk about the importance of vaccination drive in fighting the pandemic and said the launch “will increase the supply of vaccine in the country and will help in reaching the vaccine to every Indian.”

Mansukh Mandaviya stated during the unveiling that Covaxin manufacturing has begun at the Ankleshwar facility, adding that Bharat Biotech’s new factory would receive one crore vaccinations each month.

Bharat Biotech announced plans in May to increase vaccine manufacturing to 1 billion doses per year. With this objective in mind, the firm stated that Covaxin will henceforth be manufactured at a facility in Ankleshwar, Gujarat.

Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “We want to ensure that Bharat Biotech can ably meet the demand for Covaxin such that individuals across the country, and the globe, have access to the vaccine and can secure their health and safety. Our goal to develop a vaccine with global safety and efficacy standards has now been achieved, we are now marching towards the goal of annualized capacity of ~ 1.0 billion doses.”

The jabs manufactured at Ankleshwar facility will be available for supply starting September 2021.

Mrs. Suchitra Ella, Joint Managing Director, Bharat Biotech, added, “I am happy to share that our efforts over the last one year have fructified, and we are now several steps closer to achieving our goal of providing Covaxin to all pockets of the country and overseas. The pandemic has impacted people across the globe, and it is only through collaborative efforts that we can hope to mitigate its spread and impact.”

Talking about India’s preparedness to fight the Covid-19 pandemic, Mansukh Mandaviya said, “On block level ambulances to be already rented, on district level 1 crore medicines to be procured,” adding that, “For the beds in hospitals as well money is provided.”

The health minister also said that about 10,000 kgs of oxygen could be collected and tanks are to be procured to help the nation fight the pandemic.

August 29, 2021 0 comment

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The DCGI has approved a phase II/III trial of Bharat Biotech’s nasal Covid vaccination

by Medically Speaking August 14, 2021

written by Medically Speaking

The Union ministry of science announced on Friday that Bharat Biotech has received authorisation from India’s pharma regulator to undertake mid-to late-stage trials of their nasal Covid-19 vaccine candidate.

“This is the first Covid-19 vaccine to go through human clinical trials in India,” says the company “According to the ministry. ”

“BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.BBIL has in-licensed technology from Washington University in St Louis, USA,” it added.

Early stage trials of the vaccine candidate, BBV154, has been completed in subjects aged 18 to 60 years. The company has said that the doses of the vaccine administered to healthy volunteers were found to be well tolerated.

“Bharat Biotech’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials,” said Renu Swarup, chairperson of the Biotechnology Industry Research Assistance Council.

The company’s Covaxin Covid-19 vaccine was approved for emergency use in the country in January this year. It is being administered through an injection in the country’s inoculation drive.

Suchitra Ella, Joint Managing Director, Bharat Biotech, on Thursday, said the Hyderabad-based company has supplied 75 million doses of Covaxin so far and more will be supplied this month.

The Bharat Biotech official said that Covaxin has 65% efficacy against the B.1.617.2 delta variant of Covid-19. “Our second site is at Ankleshwar-based manufacturing plant. Sample batches are ready, it’ll go to CDL Kasauli this month for quality testing,” Ella added.

Last month, the vaccine maker said it has committed to supply over 500 million doses of Covaxin to the government under the nationwide immunisation programme.

Speaking at a virtual meet organised by the Confederation of Indian Industry, Ella said the firm facilities in four cities – Hyderabad, Bengaluru, Pune and Ankleshwar – are currently producing Covaxin.

Covaxin demonstrated 77.8% effectiveness against symptomatic coronavirus and 65.2% protection against the B.1.617.2 Delta variant, Bharat Biotech said recently, while announcing the final analysis of the jab.

August 14, 2021 0 comment

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Covaxin is efficient against Delta variant: ICMR study

by Medically Speaking Team August 3, 2021

written by Medically Speaking Team

According to a research published in the biorxiv by the Indian Council of Medical and Research (ICMR), Bharat Biotech’s Covid-19 vaccine Covaxin (BBV152) is effective against the Delta Plus (AY.1) variant of the coronavirus.

“Here, we have evaluated the IgG antibody titer and neutralizing potential of sera of Covid-19 naïve individuals full doses of BBV152 vaccine, Covid-19 recovered cases with full dose vaccines and breakthrough post-immunization BBV152 vaccines against Delta, Delta AY.1 and B.1.617.3,” the study said.

The second wave in India has been triggered by the recent appearance of the Sars-CoV-2 variation B.1.617.2 (Delta) form, which is highly transmissible.

Covaxin, a whole-virion inactivated Sars-CoV-2 vaccine used for mass immunization in the country, showed a 65.2 % protection against the Delta variant in a double-blind, randomized, multicenter, phase 3 clinical trial.

Subsequently, Delta has further, mutated to Delta AY.1, AY.2 and AY.3.

Of these, AY.1 variant was first detected in India in April 2021 and subsequently from 20 other countries as well, the study said.

The study is a pre-print and has not been peer reviewed.

Covaxin demonstrated 77.8 % effectiveness against symptomatic Covid-19 and 65.2% protection against the B.1.617.2 Delta variant, Bharat Biotech had said while concluding the final analysis of Covaxin efficacy from Phase 3 trials on July 3.

August 3, 2021 0 comment

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Initial hiccups in Bharat Biotech Bengaluru plant delayed Covaxin production: NTAGI Chief

by Medically Speaking Team August 3, 2021

written by Medically Speaking Team

India achieved the target of 47 crore COVID-19 vaccine doses till the month of July, Dr N K Arora, Chief of National Immunization Technical Advisory Group (NTAGI) said and added that some hiccups like initial difficulties in the new Bangalore plant of Bharat Biotech had delayed the production of Covaxin.

Speaking to ANI, Arora said, “The test batches of that plant weren’t satisfactory and got rejected which led to delay in ramping up production, but now the batches have been approved by the competent authority and will be available for public consumption.”

Dr NK Arora also said that Bharat Biotech will be able to ramp up almost 7-10 crore doses of its Covid vaccine in the coming weeks.

“We achieved it out of 50 crore almost 47crore doses have been administered this period, In August we think availability will increase quite significantly overall and it is expected that Bharat Biotech will be able to provide 7 – 10 crore doses per month in the coming weeks,” he said.

Further Dr Arora said, “Bharat Biotech and Serum Institute are our major vaccine suppliers and we hope that will also be our driver for completing the adult immunization in this country by the end.”

On production of Covishield and Covaxin, he said, “Serum Institute almost 8- 10 crore doses, 3-3.5 crore from Bharat Biotech and small contribution from Sputnik also. In August and coming months, there will be an exponential increase in the availability of vaccines and administration.”

August 3, 2021 0 comment

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Bharat Biotech’s Rotavirus vaccine receives ‘Prequalification’ from WHO

by Medically Speaking Team August 3, 2021

written by Medically Speaking Team

Rotavac 5D, a variation of Bharat Biotech International Limited’s Rotavac vaccine, got “Prequalification” from the World Health Organization (WHO) on Monday. Rotavac is a vaccine that prevents rotavirus, a virus that causes severe diarrhoea and vomiting in newborns and children.

“Today’s announcement is an important step to further strengthen and fulfil Bharat Biotech’s vision to address neglected diseases, and prevent infections that continue to affect millions in the developing world,” a statement from Suchitra Ella, the Hyderabad-based pharmaceutical firm’s Joint Managing Director, said.

WHO’s website describes “prequalification” as a “systematic process to determine a manufacturer’s capacity to produce a product of consistent quality in accordance with international standards and specifications laid out by WHO/United Nations Population Fund (UNFPA).” The purpose, it says, is to ensure procurement and distribution of good quality products.

Once “prequalified,” vaccines can be procured by organisations such as the United Nations Childrens’ Emergency Fund (UNICEF) and Pan-American Health Organization (PAHO).

Rotavac 5D, which was rolled out in December 2019, has a “unique” vaccine formulation that can be administered without a “buffer,” Bharat Biotech’s statement noted. With a low dosage volume of 0.5 ml, the shot is easier to be stored, and further facilitates easy cold chain management and low biomedical waste disposal after vaccination, the statement noted further.

Bharat Biotech developed Rotavac, a first-generation vaccine, in a partnership with the Government of India’s Department of Biotechnology. 16 other international partners were also involved in the project. In March 2016, India became the first country in Asia to launch an anti-rotavirus vaccine, doing so under the Universal Immunisation Program (UIP).

August 3, 2021 0 comment

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