BHU’s Covaxin safety study riddled with major limitations
6 months, 4 weeks ago

BHU’s Covaxin safety study riddled with major limitations

The Hindu  

An observational study carried out by researchers from the Banaras Hindu University, Varanasi to assess the safety of Covaxin, particularly the long-term adverse events of special interest one year after vaccination, in adolescents and adults has been criticised by ICMR for the poor study design. Given the limitations of the study one can “certainly say that the study can’t be used to draw the conclusions it does,” Dr. Menon says in an email. Thus their conclusion that “nearly one-thirds of participants receiving the BBV152 vaccine reported adverse effects of special interest” is misleading, and most likely erroneous,” says Dr. Rajeev Jayadevan, co-chairman of the National IMA COVID task Force. Dismissing Dr. Patwardhan’s argument that a control group may not be necessary in a longitudinal observational study, Dr. Menon says: “If the question, as here, is the possibility of adverse effects following vaccination, it is a question about causality. If, in a normal non-COVID year, an equally substantial fraction of people were afflicted by upper respiratory tract infections, that would certainly be relevant to asking if the vaccine was responsible for the AESIs picked up by this survey.” Objecting to Dr. Patwardhan’s claim made in a tweet that the “goal is often to observe natural progressions and associations rather than to establish direct causal relationships with the use of a control group”, Dr. Menon points out that the paper clearly states that “serious adverse events may occur in 1% of BBV152 recipients”, which is a statement of specific causality.

Safety Vaccination Events Control Covid Group Study Participants Menon Bhu Adverse Covaxin Vashishtha Aesis Special Interest Patwardhan  study  menon  events  group  riddled  dr  participants  limitations  control  aesis  vaccination  covaxin  bhus  major  safety  adverse

History of this topic

The right way to counter a poor Covaxin safety study
4 months, 3 weeks ago

The right way to counter a poor Covaxin safety study

The Hindu  

It took all of five days for the Indian Council of Medical Research to strongly criticise the poor design of the long-term safety study of Covaxin by researchers from the Banaras Hindu University, Varanasi. A publication failure that is glaring Three years after the interim data were posted as a preprint, Bharat Biotech and ICMR are yet to publish any …

Why COVID vaccine safety needs scrutiny | Explained
6 months, 4 weeks ago

Why COVID vaccine safety needs scrutiny | Explained

The Hindu  

The story so far: The Indian Council for Medical Research issued a letter to the researchers of Banaras Hindu University last week, countering their study on the side effects of India’s indigenous vaccine for COVID — Covaxin. The one-year observational, follow-up study titled ‘Long-term safety analysis of the BBV152 coronavirus vaccine in adolescents and adults: Findings from a one-year prospective …

BHU study on Covaxin side effects poorly designed, erroneously acknowledges ICMR: Dr Bahl
7 months ago

BHU study on Covaxin side effects poorly designed, erroneously acknowledges ICMR: Dr Bahl

Deccan Chronicle  

New Delhi: The Indian Council of Medical Research Director General Dr Rajiv Bahl on Monday criticised a recently published study on the long-term safety analysis of the Covaxin in adults and adolescents for its poor methodology and design, and clarified the article misleadingly and erroneously "acknowledges" ICMR. A research paper, titled 'Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in …

ICMR distances itself from safety study on Covaxin
7 months ago

ICMR distances itself from safety study on Covaxin

Hindustan Times  

The country’s apex biomedical research regulator, the Indian Council of Medical Research, has distanced itself from a Banaras Hindu University study that raised concerns on safety of Bharat Biotech’s Covid vaccine, Covaxin, and threatened legal action against the study’s authors for acknowledging ICMR’s support for a poorly designed study without its consent. ICMR chief Rajiv Bahl has formally written to …

Covaxin side effects: Amid concerns of adverse events, should Covaxin takers be worried?
7 months ago

Covaxin side effects: Amid concerns of adverse events, should Covaxin takers be worried?

Hindustan Times  

A team of researchers at BHU in a one-year follow-up study found out that nearly one-third of 926 individuals who received Bharat Biotech's anti-Covid vaccine Covaxin reported 'adverse events of special interest,' or AESI. Serious AESI, including stroke and Guillain-Barre syndrome, were reported in around one per cent of individuals as per the study. Serious AESI, including stroke and Guillain-Barre …

1 in 3 Covaxin takers reported adverse events, BHU study claims
7 months, 1 week ago

1 in 3 Covaxin takers reported adverse events, BHU study claims

Hindustan Times  

A one-year follow-up study conducted by researchers at Banaras Hindu University has found that nearly one-third of individuals who received Bharat Biotech's Covaxin reported 'adverse events of special interest'. Read: AstraZeneca Covid vaccine related to another rare but deadly blood clotting disorder Adverse Events of Special Interest: Around 33% of participants reported AESI, with new-onset skin and subcutaneous disorders, general …

BHU study: Over 30 per cent of Covaxin recipients report adverse events
7 months, 1 week ago

BHU study: Over 30 per cent of Covaxin recipients report adverse events

India TV News  

A recent study conducted by researchers at Banaras Hindu University revealed that over 30% of individuals who received Bharat Biotech's Covaxin reported adverse events. The one-year follow-up study, encompassing 926 participants, shed light on the long-term safety of the BBV152 vaccine, with serious adverse events of special interest such as stroke and Guillain-Barre syndrome reported in one per cent of …

Over 30% Covaxin takers suffered from health issues after one year, claims BHU study
7 months, 1 week ago

Over 30% Covaxin takers suffered from health issues after one year, claims BHU study

New Indian Express  

NEW DELHI: Nearly one-third of the individuals who received Bharat Biotech's anti-Covid vaccine Covaxin reported 'adverse events of special interest,' or AESI, according to a one-year follow up study conducted by a team of researchers at Banaras Hindu University. Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at …

‘Safety is primary focus’: Covaxin-developer amid reports on AstraZeneca vaccine
7 months, 3 weeks ago

‘Safety is primary focus’: Covaxin-developer amid reports on AstraZeneca vaccine

Hindustan Times  

Amid reports over potential rare side effects of the AstraZeneca-Oxford COVID-19 vaccine, Bharat Biotech, which developed the Covaxin, said in a statement that the vaccine was developed with a "single-minded focus on safety first." It stated that Covaxin was the "only Covid vaccine" in government of India's COVID-19 immunisation program to have conducted efficacy trials in India. "@bharatbiotech announcement - …

Bharat Biotech misstated Covaxin trial data
2 years ago

Bharat Biotech misstated Covaxin trial data

Deccan Chronicle  

HYDERABAD: Extremely serious procedural leniencies and incorrect reporting of the results of trials of Covaxin, Bharat Biotech’s anti-Covid vaccine, have come to light, raising some very uncomfortable questions on the vaccine’s rollout for general use in India. Inquiries and investigation into the three phases of human trials of Covaxin have found grave reporting errors – some that appear to be …

Govt, Bharat Biotech Deny ‘Shortcut’ in Covaxin Trials: What's the Controversy?
2 years, 1 month ago

Govt, Bharat Biotech Deny ‘Shortcut’ in Covaxin Trials: What's the Controversy?

The Quint  

The allegations: Here's a quick run through of the STAT report. It said that Bharat Biotech: Omitted data of some participants in the phase 1 trial when the study was published in a medical journal. The report says they had access to internal documents from the company, and they also quote people in the company, including Krishna Mohan, one of …

Covaxin demonstrates robust safety and immunogenicity in children 2-18 years: Bharat Biotech
2 years, 6 months ago

Covaxin demonstrates robust safety and immunogenicity in children 2-18 years: Bharat Biotech

The Hindu  

Bharat Biotech International Limited, on Friday, announced that COVID-vaccine Covaxin has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects in phase II/III study. The company in its press release said that Bharat Biotech had conducted phase II/III, open-label, and multi-centre study to evaluate the safety, reactogenicity, and immunogenicity Covaxin in healthy children and adolescents in 2-18 years …

Covaxin safe, well-tolerated in 2-18 years age-group, announces Bharat Biotech
2 years, 6 months ago

Covaxin safe, well-tolerated in 2-18 years age-group, announces Bharat Biotech

Firstpost  

The clinical trial conducted in the paediatric population between June 2021 to September 2021 has shown safety, less reactogenic, and robust immunogenicity Hyderabad: Bharat Biotech International Limited on Friday announced that its COVID-19 vaccine Covaxin has proven to be safe, well-tolerated and highly immunogenic in paediatric subjects in phase II/III study. Bharat Biotech had conducted phase II/III, open-label, and multi-centre …

No Haste In Granting Emergency Use Authorization To Covaxin & Covishield: Supreme Court
2 years, 7 months ago

No Haste In Granting Emergency Use Authorization To Covaxin & Covishield: Supreme Court

Live Law  

In its judgment holding that the policy of the Union Government on COVID-19 vaccination policy is reasonable, the Supreme Court rejected the contention that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data.The court observed that the challenge to the procedures adopted by the expertbodies while granting. "However, it …

WHO pauses Covaxin supply via UN bodies
2 years, 8 months ago

WHO pauses Covaxin supply via UN bodies

The Hindu  

Bharat Biotech to upgrade facility The World Health Organisation on Saturday suspended supply of Bharat Biotech’s COVID vaccine, Covaxin, to allow the manufacturer to upgrade facilities and address deficiencies found during an inspection last month. ‘Will meet standards’ In a statement issued on April 1, Bharat Biotech said it was fully committed to implementing facility improvements and upgrades to ensure …

Covaxin booster shot may provide long-term immunity against severe Covid, says Bharat Biotech
2 years, 11 months ago

Covaxin booster shot may provide long-term immunity against severe Covid, says Bharat Biotech

India Today  

A booster dose of Bharat Biotech's Covid-19 vaccine Covaxin, administered six months after the second dose, could provide long-term immunity from severe SARS-CoV-2 infection, a study by Bharat Biotech and the Indian Council of Medical Research - National Institute of Virology, Pune, has indicated. The study, published on medRxiv and not yet peer-reviewed, said that the Covaxin booster shot is …

Covaxin shows 50% effectiveness against symptomatic Covid-19, says Lancet study
3 years, 1 month ago

Covaxin shows 50% effectiveness against symptomatic Covid-19, says Lancet study

India Today  

Two doses of Covaxin are 50 per cent effective against the symptomatic disease, according to the first real-world assessment of India's indigenous Covid-19 vaccine published in The Lancet Infectious Diseases journal. Results of an interim study recently published in The Lancet showed that two doses of Covaxin, also known as BBV152, had 77.8 per cent efficacy against symptomatic disease and …

How Macaulay Putras Ridiculed Covaxin and Data Proved Them Wrong
3 years, 1 month ago

How Macaulay Putras Ridiculed Covaxin and Data Proved Them Wrong

News 18  

The Phase III human clinical trials of Covaxin began in mid-November 2020, involving 26,000 volunteers, between 18 and 98 years of age, across 21 sites. It was India’s first and only Phase III study for a COVID-19 vaccine, and the largest Phase III efficacy trial ever conducted here for any vaccine. He said that if the East India Company had …

Covaxin data looks good, WHO nod expected by September-end: Dr VK Paul | Exclusive
3 years, 3 months ago

Covaxin data looks good, WHO nod expected by September-end: Dr VK Paul | Exclusive

India Today  

As India crossed the landmark of administering 75 crore Covid-19 vaccine doses, Dr VK Paul, member of Niti Aayog and head of the Covid-19 task force, said India was well on its path in achieving complete vaccination of the entire adult population by the end of the year. ON BOOSTER DOSES Dr VK Paul also said that just yet there …

Covaxin effective against new Delta Plus variant, says study
3 years, 4 months ago

Covaxin effective against new Delta Plus variant, says study

Hindustan Times  

Covaxin can effectively neutralise the Delta Plus, the vaccine’s manufacturer Bharat Biotech said citing laboratory studies it carried out along with the Indian Council of Medical Research. Bharat Biotech in June said the final efficacy estimates, based on its phase 3 trials, showed Covaxin had an efficacy rate of 77.8% against the Sars-Cov-2 virus that most closely resembles the origin …

WHO assessing Covaxin data for EUL, decision on date 'to be confirmed'
3 years, 5 months ago

WHO assessing Covaxin data for EUL, decision on date 'to be confirmed'

Firstpost  

WHO on Covaxin: The Bharat Biotech vaccine has demonstrated 77.8% effectiveness against symptomatic COVID-19 and 65.2% protection against the B.1.617.2 Delta variant Hyderabad: The World Health Organisation, which is currently reviewing Bharat Biotech’s application for an Emergency Use Listing of its COVID-19 vaccine Covaxin, has said it is assessing the data of the jab. Suchitra Ella, joint managing director of …

WHO to take decision on emergency use listing of Bharat Biotech's Covaxin in 4-6 weeks
3 years, 5 months ago

WHO to take decision on emergency use listing of Bharat Biotech's Covaxin in 4-6 weeks

India Today  

World Health Organisation chief scientist Soumya Swaminathan has said that the WHO is likely to take a decision on Emergency Use Listing of Bharat Biotech’s Covid-19 vaccine Covaxin within four to six weeks. Bharat Biotech has now started uploading their data on our portal and that is the next vaccine that will be reviewed by our experts committee,” the chief …

Covaxin approval soon? WHO chief scientist says Phase-3 trial data looks good
3 years, 5 months ago

Covaxin approval soon? WHO chief scientist says Phase-3 trial data looks good

India Today  

As Hyderabad-based pharma firm Bharat Biotech awaits the World Health Organisation's approval for the emergency use listing for Covaxin, WHO Chief Scientist Soumya Swaminathan has said Covaxin's Phase-3 data looks promising and the vaccine can hopefully be approved by the WHO by mid to late August. In a recent interview, Swaminathan said the Phase-3 trial data of Covaxin looks encouraging …

Final analysis of Covaxin efficacy out; 65.2 per cent effective against Delta
3 years, 5 months ago

Final analysis of Covaxin efficacy out; 65.2 per cent effective against Delta

Deccan Chronicle  

Hyderabad: Bharat Biotech's Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant. The efficacy analysis demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic COVID-19 cases while safety analysis shows adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side …

Covaxin is 65.2% effective against Delta variant, says Bharat Biotech
3 years, 5 months ago

Covaxin is 65.2% effective against Delta variant, says Bharat Biotech

Op India  

On Saturday, Bharat Biotech announced the safety and efficacy analysis data from Phase-3 clinical trials of Covaxin – an indigenous vaccine developed to fight the deadly pandemic Covid-19. Citing pre-print data from the country’s largest efficacy trial, Bharat Biotech revealed that the Indian-made Covaxin achieved an overall efficacy of 77.8% against symptomatic Covid-19 patients. Here are the overall efficacy rates …

Bharat Biotech's COVAXIN has 77.8% efficacy in Phase 3 trials, says report: All you need to know
3 years, 6 months ago

Bharat Biotech's COVAXIN has 77.8% efficacy in Phase 3 trials, says report: All you need to know

Firstpost  

The data will be reviewed by the WHO on 23 June in a ‘pre-submission meeting’, and COVAXIN will be allowed for export to other countries only after an approval from the global health body The indigenously developed COVID-19 vaccine COVAXIN has an efficacy of 77.8 percent as per phase three clinical trials data submitted to the Drugs Controller of India, …

Covaxin shows 77.8% efficacy in phase 3 trial, likely to get clearance today
3 years, 6 months ago

Covaxin shows 77.8% efficacy in phase 3 trial, likely to get clearance today

India TV News  

The phase three trial of Bharat Biotech's Covaxin has shown an efficacy of 77.8 per cent in protection against COVID-19, sources said on Tuesday. Meanwhile, in a major boost for Bharat Biotech, the World Health Organisation has accepted its Expression of Interest for Covid-19 vaccine Covaxin and scheduled a pre-submission meeting on June 23, a step that will take the …

Covaxin shows 77% efficacy in Phase 3 trials, Bharat Biotech informs govt panel, data under review
3 years, 6 months ago

Covaxin shows 77% efficacy in Phase 3 trials, Bharat Biotech informs govt panel, data under review

India Today  

The results of Phase 3 clinical trials of Bharat Biotech’s Covaxin vaccine have come. Bharat Biotech on Tuesday made a presentation in which the data was presented to the panel, showing 77.8% efficacy of Covaxin. Meanwhile, the World Health Organisation has also accepted Bharat Biotech’s Expression of Interest for Covaxin and has scheduled a pre-submission meeting tomorrow. Bharat Biotech had …

Covaxin's phase 3 results soons, says Bharat Biotech
3 years, 6 months ago

Covaxin's phase 3 results soons, says Bharat Biotech

India TV News  

Bharat Biotech on Saturday said scientific standards and commitment of the indigenously-developed COVID-19 vaccine Covaxin are transparent, and the company has so far published nine research studies on its safety and efficacy. The complete data for Phase I and II, and partial data for Phase III trials of Covaxin have been thoroughly scrutinised by the regulators in India, Bharat Biotech …

SEC recommends Bharat Biotech’s Covaxin phase 2, 3 clinical trials on 2- to 18-year-olds
3 years, 7 months ago

SEC recommends Bharat Biotech’s Covaxin phase 2, 3 clinical trials on 2- to 18-year-olds

Firstpost  

The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur. Bharat Biotech’s COVID-19 vaccine Covaxin was on Tuesday recommended by an expert panel for phase II/III clinical trial on those aged between two to 18 years, official sources said. The Subject Expert Committee on COVID-19 of the …

Expert panel approves Bharat Biotech's Covaxin for phase 2/3 trials on 2-18 year-olds
3 years, 7 months ago

Expert panel approves Bharat Biotech's Covaxin for phase 2/3 trials on 2-18 year-olds

India TV News  

Bharat Biotech's COVID-19 vaccine Covaxin was on Tuesday recommended by an expert panel for phase II/III clinical trial on those aged between two to 18 years, official sources said. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate …

Bharat Biotech's Covaxin Gets Approval for Phase 2/3 Trials on 2-18 Year-olds
3 years, 7 months ago

Bharat Biotech's Covaxin Gets Approval for Phase 2/3 Trials on 2-18 Year-olds

News 18  

Bharat Biotech’s COVID-19 vaccine Covaxin was on Tuesday recommended by an expert panel for phase II/III clinical trial on those aged between two to 18 years, official sources said. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization on Tuesday deliberated upon Hyderabad-based Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials to evaluate …

Covaxin offers protection against double mutant variant found in India: study
3 years, 7 months ago

Covaxin offers protection against double mutant variant found in India: study

The Hindu  

A study has found that people who have been vaccinated with Covaxin have protection against the double mutant variant first found in India. “The study found that the neutralising capacity against the double mutant variant was found to be good in both groups — people who have received the vaccine and those who have recovered from COVID-19,” says Dr. Samiran …

Coronavirus | Updated data from Covaxin phase 3 trial shows 78% efficacy
3 years, 8 months ago

Coronavirus | Updated data from Covaxin phase 3 trial shows 78% efficacy

The Hindu  

The efficacy of Covaxin has dropped a tad lower - 78% - than the 81% reported in March. “Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of COVAXIN,” Bharat Biotech said in a statement. The efficacy data against severe COVID-19 and asymptomatic infections is highly significant, as this helps reduce …

Bharat Biotech's Covaxin shows 78 per cent efficacy in phase-3 interim analysis
3 years, 8 months ago

Bharat Biotech's Covaxin shows 78 per cent efficacy in phase-3 interim analysis

India Today  

Bharat Biotech's vaccine Covaxin has shown the efficacy of 78 per cent against mild, moderate and severe cases of Covid-19, as per Phase III interim analysis results, the vaccine maker said on Wednesday. It further noted that the second interim data of the Phase III study also showed that chances of hospitalisation due to the infectious disease were reduced by …

Covaxin shows 78% efficacy in mild to severe Covid-19 cases: Bharat Biotech
3 years, 8 months ago

Covaxin shows 78% efficacy in mild to severe Covid-19 cases: Bharat Biotech

India Today  

Bharat Biotech on Wednesday announced results of its second interim analysis for Covaxin and said the vaccine has demonstrated an overall interim clinical efficacy of 78 per cent against mild, moderate and severe Covid-19. Apart from this, the result showed that Covaxin's efficacy against asymptomatic Covid-19 cases was 70 per cent, suggesting decreased transmission of the virus in recipients of …

Covaxin Out of Clinical Trial Mode, Granted Restricted Emergency Use Authorisation
3 years, 9 months ago

Covaxin Out of Clinical Trial Mode, Granted Restricted Emergency Use Authorisation

News 18  

The Centre on Thursday said Bharat Biotech's indigenously developed Covaxin is out of the "clinical trial mode" and that it has now been granted the regular restricted emergency use authorisation just like Covishield manufactured by Serum Institute. India's drug regulator on January 3 had granted permission for the restricted use of Covaxin in emergency situations in the public interest as …

Covaxin may see higher uptake post authorization
3 years, 9 months ago

Covaxin may see higher uptake post authorization

Live Mint  

Uptake of the domestically developed covid-19 vaccine Covaxin may significantly increase as states that have been cautious about administering it become more confident after a full regulatory emergency licensure is given to it. Bharat Biotech International Ltd, the manufacturer of Covaxin, has submitted its interim data on the vaccine, which showed 81% efficacy, to the Drugs Controller General of India …

Expert panel approves Covaxin for emergency use, waives off clinical trial condition
3 years, 9 months ago

Expert panel approves Covaxin for emergency use, waives off clinical trial condition

India Today  

The subject expert committee of the Central Drugs Standard Control Organisation has approved Bharat Biotech's Covaxin for emergency use authorisation in India. On March 3, Bharat Biotech announced results of Phase 3 clinical trials of Covaxin, saying the vaccine demonstrates interim clinical efficacy of 81 per cent. The Phase 3 clinical trials involved 25,800 volunteers, making it the "largest trials …

Covaxin phase 2 data shows vaccine safe, induces immune response, says Lancet study
3 years, 9 months ago

Covaxin phase 2 data shows vaccine safe, induces immune response, says Lancet study

Firstpost  

New Delhi: India’s first indigenous vaccine against COVID-19, Covaxin, is safe and generates immune response without any serious side effects, according to the interim results of the phase 2 trials published in The Lancet Infectious Diseases journal. The phase 2 trial to evaluate the immunogenicity and safety of the BBV152 vaccine was conducted in healthy adults and adolescents aged 12-65 …

Covaxin 81 per cent effective against Covid-19: Survey
3 years, 9 months ago

Covaxin 81 per cent effective against Covid-19: Survey

Deccan Chronicle  

Hyderabad: Covaxin developed by Bharat Biotech and the Indian Council for Medical Research has shown 81 per cent efficacy against Covid-19, based on a survey done on 25,800 participants, says an interim analysis of clinical trial results provided by the company. Dr Krishna Ella, chairman and managing director of Bharat Biotech, said, "Covaxin demonstrates high clinical efficacy against Covid-19 and …

Bharat Biotech releases Phase 3 results of Covaxin, says it shows 81% interim clinical efficacy
3 years, 9 months ago

Bharat Biotech releases Phase 3 results of Covaxin, says it shows 81% interim clinical efficacy

India Today  

Indian vaccine manufacturer Bharat Biotech on Wednesday announced results of Phase 3 clinical trials of its Covid-19 vaccine candidate, Covaxin, saying the vaccine demonstrates interim clinical efficacy of 81 per cent. Bharat Biotech said the Phase 3 clinical trials for Covaxin involved 25,800 volunteers, making it the "largest trials ever conducted in India" in collaboration with the Indian Council of …

Chhattisgarh minister wants Covaxin stopped, Harsh Vardhan asks why serve vested interests
3 years, 10 months ago

Chhattisgarh minister wants Covaxin stopped, Harsh Vardhan asks why serve vested interests

India Today  

As Chhattisgarh Health Minister TS Singh Deo expressed doubts over the safety of Covaxin over the Bharat Biotech vaccine not completing Phase 3 trials yet, Union Health Minister Harsh Vardhan slammed the Congress leader saying it is not befitting of a state minister to cast doubts and serve vested interests. The primary concerns of the state are : The inhibitions …

Lancet Publishes Data from Bharat Biotech's Phase 1 Trial, Developers Hail Move
3 years, 11 months ago

Lancet Publishes Data from Bharat Biotech's Phase 1 Trial, Developers Hail Move

News 18  

Putting to rest concerns raised after its emergency approval earlier this month, the Lancet Infectious Disease journal published a study that said Covaxin – India’s first indigenous vaccine against Covid-19 – showed enhanced immune response without any serious side effects in the participants enrolled for the phase 1 trials. This is the first clinical trial data publication of a vaccine …

Bharat Biotech, ICMR publish Covaxin Phase 1 data showing safe, enhanced immunity to Covid-19 disease
3 years, 11 months ago

Bharat Biotech, ICMR publish Covaxin Phase 1 data showing safe, enhanced immunity to Covid-19 disease

Firstpost  

Almost three weeks after the COVID-19 vaccine candidate from Bharat Biotech and ICMR, Covaxin, was given emergency use approval by Indian authorities, the duo has published an interim report in leading medical peer-reviewed journal Lancet today. The study reports findings from the vaccine’s adaptive Phase 1 trials in 375 healthy volunteers at 11 different trial sites across India. However, the …

Who should not get Covaxin? Bharat Biotech issues fact sheet, warns of possible side effects
3 years, 11 months ago

Who should not get Covaxin? Bharat Biotech issues fact sheet, warns of possible side effects

India TV News  

Bharat Biotech, the manufacturer of Covaxin, has issued a fact sheet on who should avoid taking the drug to avoid possible side effects. "You should not get Bharat Biotech's COVID-19 vaccine Covaxin if you have any history of allergies. The vaccine maker in the fact sheet on Covaxin, posted in its website, said the clinical efficacy of the vaccine is …

Amid Reports of Side Effects, Bharat Biotech Issues Fact Sheet for Who Should Avoid Getting Covaxin
3 years, 11 months ago

Amid Reports of Side Effects, Bharat Biotech Issues Fact Sheet for Who Should Avoid Getting Covaxin

News 18  

Bharat Biotech on Tuesday issued a set of cautionary guidelines for people with certain conditions who, it said, should consult with their vaccine provider and preferably avoid getting the Covaxin shot. A fact sheet shared on the company’s website said those suffering from allergies, fever, or a bleeding disorder, among other conditions, should take advice from their doctor/vaccine provider, and …

Bharat Biotech releases risks, benefits of Covaxin, asks pregnant women to avoid dose
3 years, 11 months ago

Bharat Biotech releases risks, benefits of Covaxin, asks pregnant women to avoid dose

India Today  

Bharat Biotech has released a fact sheet on the risks and benefits of the coronavirus vaccine 'Covaxin' a few days after the nationwide vaccination drive was launched. Bharat Biotech's fact sheet has advised pregnant or breastfeeding women, besides people with high fever or bleeding disorders, not to take the vaccine. In its fact sheet, Bharat Biotech says in the ongoing …

Covaxin not to be used in cases of allergy, fever, poor immunity
3 years, 11 months ago

Covaxin not to be used in cases of allergy, fever, poor immunity

The Hindu  

Those with any history of allergies, fever and bleeding disorder, on blood thinners and who are immunity compromised or on medication have been told by COVAXIN manufacturer Bharat Biotech not to take the vaccine. A statement uploaded on the company website on Monday said the vaccine was also contraindicated for pregnant/lactating women, those using other COVID-19 vaccines and people with …

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