Tag: Covaxin

  • Serum Institute, Bharat Biotech cut COVID vaccine prices for private hospitals to Rs 225

    By PTI

    NEW DELHI: Vaccine majors Serum Institute of India (SII) and Bharat Biotech on Saturday said they have decided to cut prices of the precaution dose of their respective COVID-19 vaccines to Rs 225 per shot for private hospitals after discussions with the government.

    “We are pleased to announce that after discussion with the central government, SII has decided to revise the price of COVISHIELD vaccine for private hospitals from Rs 600 to Rs 225 per dose,” SII CEO Adar Poonawalla said in a tweet.

    On Friday, the company had said that the precaution dose of its Covishield vaccine against COVID-19 will be priced at Rs 600 per shot for eligible individuals.

    Bharat Biotech Co-Founder Joint Managing Director Suchitra Ella in a tweet said: “We welcome the decision to make available precautionary dose for all adults. In consultation with the Central Government, we have decided to revise the price of #COVAXIN from Rs 1,200 to Rs 225 per dose, for #privatehospitals.”

    SII and Bharat Biotech have been major suppliers of COVID-19 vaccines to the government so far.

    The Union Health Ministry on Friday announced that those above the age of 18 years who have completed nine months after the administration of the second dose will be eligible for the precaution dose.

    According to the health ministry, so far, about 96 per cent of all those above the age of 15 years in India have received at least one vaccine dose, while about 83 per cent have received both doses.

    More than 2.4 crore precaution doses have also been administered to healthcare workers, frontline workers and those aged above 60 years.

    Besides, 45 per cent of beneficiaries in the 12-14 years age group have received the first dose, the ministry said.

    The ongoing free COVID-19 inoculation programme through government vaccination centres for the first and the second dose to the eligible population as well as the precaution dose to healthcare workers, frontline workers and those above 60 years will be accelerated, the ministry stated.

  • WHO’s supply suspension of Covaxin not to impact travel of people: MEA

    Arindam Bagchi said the issue was something to do with certain processes and manufacturer of Covaxin and the WHO are looking into the matter.

  • Government expert panel recommends regular market approval for Covishield, Covaxin

    By PTI

    NEW DELHI: An expert panel of India’s central drug authority on Wednesday recommended granting regular market approval to Covid vaccines Covishield and Covaxin, which are currently only authorised for emergency use in the country, subject to certain conditions, official sources said.

    Pharma companies Serum Institute of India (SII) and Bharat Biotech had submitted applications to the Drugs Controller General of India (DCGI) seeking regular market authorisation for their respective COVID-19 vaccines Covishield and Covaxin.

    Prakash Kumar Singh, director (government and regulatory affairs) at SII, had submitted an application to the DCGI on October 25 on this matter.

    On that DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.

    In addition to the successful completion of phase 2/3 clinical study in India, till now, more than 100 crore doses of Covishield vaccine have been administered to the people in this country and worldwide, Singh is learnt to have stated in the response.

    “Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine,” he had said.

    In an application sent to the DCGI a couple of weeks ago, V Krishna Mohan, whole-time director at the Hyderabad-based company, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.

    Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had said in the application.

    Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.

    “The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech’s application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions,” an official source said.

    During last week’s meeting the SEC had sought more data and information from the two companies.

    Meanwhile, the cumulative COVID-19 vaccine doses administered in the country crossed 159.54 crore on Wednesday, the Ministry of Health and Family Welfare stated.

    More than 62 lakh (62,39,005) vaccine doses were administered in the day till 7 pm.

    Over 61 lakh precaution doses have been administered to frontline workers, healthcare workers, and citizens aged 60 and above, the ministry stated.

    A total of 3,82,93,986 doses have been given to adolescents in the age group of 15 to 18 years, according to the health ministry’s interim data.

    The government rolled out the countrywide vaccination drive on January 16 last year with healthcare workers getting jabbed in the first phase.

    From February 2, this was extended to frontline workers.

    The next phase of COVID-19 vaccination commenced from March 1, 2021, for people above 60 years, and those aged 45 and above but with specified co-morbid conditions.

    All citizens aged 45 and above were eligible for the jab from April 1.

    The government then decided to expand its vaccination drive by allowing all citizens above 18 years to get vaccinated from May 1.

    The next phase of COVID-19 vaccination commenced from January 3 this year for adolescents in the age group of 15-18 years.

    India began administering the precaution dose to healthcare workers, frontline workers, including personnel deployed for election duty, and those aged 60 years and above with co-morbidities from January 10 even as the country began witnessing a spike in infections fuelled by the Omicron variant of the virus.

  • Maharashtra: Centre denies Rajesh Tope’s vaccine shortage claim

    By Online Desk

    CHENNAI: The Centre on Friday described as “ill-informed and “incorrect” some media reports alleging vaccine shortage in Maharashtra, further stating that due to lack of vaccine the State Government is unable to increase the pace of vaccination in the state. 

    State health minister Rajesh Tope on Thursday said that Maharashtra is facing shortage of both Covaxin and Covishield vaccines.

    He told reporters that since vaccination drive for teenagers and precaution doses are being given to senior citizens, frontline and health workers, there is a shortage of vaccine. Tope said that the state has demanded an additional 50 lakh Covishield and 40 lakh Covaxin doses from the Centre.

    Meanwhile, a press statement issued by the Ministry of Health and Family Welfare chose to clarify that, as per the reports available today (January 14, 2022), Maharashtra has over 24 lakh unutilized doses of Covaxin available with it. An additional 6.35 lakh doses have been received today. As per their weekly consumption data available on Co-WIN, the average consumption by Maharashtra for Covaxin to cover the eligible beneficiaries for 15-17 years and for precaution dose is almost 2.94 lakh doses per day. Therefore, the State has adequate vaccine doses for about 10 days to cover the eligible beneficiaries with Covaxin.

    Furthermore, for Covishield, the state has 1.24 crore unutilized and balance doses available as on date. With an average consumption of 3.57 lakhs per day, this will sustain for more than 30 days for the beneficiaries to be vaccinated using the vaccine.

    “Hence, the media reports are not factually correct and do not reflect the correct picture of the available stock of balance and unutilized COVID vaccine doses with Maharashtra,” the Centre claimed.

  • Third dose of Covaxin beneficial for highest protection, says Bharat Biotech citing study

    Express News Service

    NEW DELHI: A third booster dose of Covaxin, the Covid19 vaccine by Bharat Biotech, is safe and immunogenic and may be beneficial to ensure persistent immunity to prevent breakthrough infections, a phase 2 randomised, double blind study has shown.

    The study led by the company but in which 11 institutions included ICMR, AIIMS New Delhi and some international collaborators also participated, has shown that neutralisation titers against wild – type and Delta variants were 5 times higher in those with the third dose than in people after a two-dose schedule.

    Based on the findings, Bharat Biotech underlined that while protection against the severe disease remains high across the full six months—following full vaccination with Covaxin—a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected.

    “Based on emerging data, Bharat Biotech believes that a third dose may be beneficial to maintain the highest levels of protection,” it said.

    ALSO READ: Paracetamol not recommended after being vaccinated with Covaxin: Bharat Biotech

    The study results come at a time when the government is about to allow the most vulnerable population groups to avail a third Covid19 jab but with a caveat of having completed nine months since the administration of their second doses.

    The research has meanwhile shown similar increases in neutralizing antibodies against Alpha, Beta, Delta plus were observed after analysing comparison between 184 previously vaccinated individuals who either received a third dose of Covaxin or placebo.

    The findings are now part of a pre-print titled “Persistence of immunity and impact of a third (booster) dose of an inactivated SARS-CoV2 vaccine, BBV152; a phase 2, double-blind, randomised controlled trial” that has been released on the preprint repository of medical science, MedRXiv.

    It also depicted that the booster dose led to a pronounced increase in CD4+ T- and CD8+ Tcell response (types of T cells, an important arm of immunity) which may allow Covaxin to confer long-term protective efficacy against severe SARS-CoV-2.

    Importantly, the frequency of adverse events was lower than vaccines from other manufacturing platforms, said the study adding that durable neutralising, T and B cell responses were detected six months after vaccinations which suggests good immune memory responses and long-term protection from severe disease.

    Also, 90% of recipients had a detectable neutralizing antibody response against the wild – type strain six months after the second dose.

    The company also said in the statement that neutralizing antibodies against homologous and heterologous SARS-CoV-2 variants increased from 19- to 265- fold after a third vaccination.

    “These trial results provide a strong foundation towards our goal to provide Covaxin as a booster dose,” said Krishna Ella, Chairman and Managing Director of Bharat Biotech.

  • Assam aims to administer first Covaxin dose to all teenagers within January 9

    By PTI

    GUWAHATI: The Assam government is targeting to administer the first dose of Covaxin to all teenagers in the 15-18 years age group within seven days from the beginning of the national inoculation drive for this category from January 3, Health Minister Keshab Mahanta said on Friday.

    The administration aims to fully vaccinate the students by mid-February before their annual and board examinations begin by the end of that month.

    “As the people in the 15-18 years age group are mostly students, we have decided to carry out the drive at schools and colleges. Detailed discussions have been held with deputy commissioners and other officials, and they are ready to set up the vaccination centres at the educational institutions in a phased manner,” the minister told reporters.

    “We aim to administer the first dose to all the beneficiaries within seven days from January 3, when the national drive begins. We will give Covaxin to the youngsters so that they are able to take the next dose by mid-February. Our target is to ensure that students are fully vaccinated well before their annual and board examinations, which will begin in February-end,” he said.

    Mahanta urged the guardians to ensure that their wards are vaccinated as no online examinations are likely to be held in this term and the students can safely sit for their offline exams.

    Besides the special camps at the educational institutions, all regular vaccination sites will have a special counter for the 15 to 18 years category, he said.

    The minister said that a detailed plan for giving booster dose to people above 60 years of age and frontline workers from January 10 is also being worked on.

    On the threat posed globally by the new Omicron variant of COVID-19, Mahanta said though no case of this strain has been detected in the state so far, his department is fully prepared to tackle any eventuality.

    “We have readied 9,000 beds for Omicron patients, and we will increase this number to 25,000 within a week. Moreover, we have 1,000 ICU beds and 2,600 beds with oxygen supply ready for Omicron patients,” he said.

    He said that the laboratory at North East Institute of Science and Technology, Jorhat is equipped to conduct genome sequencing to detect Omicron cases, while another such facility will be established at Gauhati Medical College and Hospital.

    The minister said that eight medical colleges and hospitals are functioning in the state, and another will start operating in Dhubri next year.

    Work on six more is underway, while five more will also be constructed, he said.

    Eight dedicated cancer hospitals are likely to be completed by April, while all the 4,600 health sub-centres in the state are being converted into health and wellness centres to ensure the availability of primary treatment at the local level, he said.

    As many as 3,361 new appointments in various categories, including doctors, have been made since May when the Himanta Biswa Sarma government assumed office, Mahanta said.

    The state’s COVID-19 tally is now at 6,20,573, of which 6,164 patients have succumbed to the infection and 6,12,282 have recovered so far.

    The administration has administered 2,17,27,725 first doses and 1,57,89,763 second doses.

  • Covaxin triggers higher antibody response in kids than adults: Bharat Biotech cites trial data

    Express News Service

    NEW DELHI: Days after the government announced that 15 to 17-year-olds in India will be eligible for the Covid vaccine — only Covaxin for now — from January 3, its maker Bharat Biotech on Thursday claimed that the vaccine is safe, well-tolerated and immunogenic for the 2-18 age group.

    Citing data from the phase 2, 3 clinical trials, the company, in a statement, said that neutralizing antibodies in children, on average, were found to be 1.7 times higher than in adults.

    These trials involved 525 participants, categorised into three groups, those aged 12-18 years, kids aged 6-12 years and those aged 2-6 years, comprising 175 subjects each.

    “The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity,” said the vaccine maker adding that the data was submitted to the Central Drugs Standard Control Organisation in October based on which it was approved for 12-18 year age group recently.  

    ALSO READ | Only Covaxin for 15-18-year-olds for now; precaution doses after 39 weeks of second Covid jab

    The statement said that during the study, no serious adverse event was reported and 374 subjects reported either mild or moderate severity symptoms with 78.6% getting resolved within 1 day.

    Pain at the injection site, like is the case with most adults receiving the vaccine, was the most commonly reported adverse event.

    Seroconversion was documented at 95-98%, in all three groups four weeks after the second dose, indicating superior antibody responses in children when compared to adults, as per the statement.

    In earlier Covaxin studies in adults, cross-reactive memory T cells against all variants of concern was reported. Studies are underway to evaluate T cell responses against the Omicron variant and since Covaxin is an inactivated vaccine corroborative results are expected, said Bharat Biotech.

    “Safety of the vaccine is critical for children and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children,” said company chairman and managing director Krishna Ella.

    “We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically.”

  • Over-60s won’t need co-morbidity certificate for precautionary Covid jab, says Centre in U-turn

    Express News Service

    NEW DELHI: After first announcing that 60-plus people who wish to avail precautionary Covid-19 jabs from January 10 will need a certificate to prove the existence of a co-morbidity, the Centre has now dropped the clause.

    In a letter to the states on Tuesday, Union health secretary Rajesh Bhushan said that anyone over 60, on their doctor’s advice, can now take the shot and will not be required to show the co-morbidity certificate at the Covid-19 vaccination centre.

    This, in practical terms, will make the entire 60 plus population in India, who have completed 39 weeks since their second Covid vaccination, eligible for the precaution dose against coronavirus that is being permitted also for healthcare and frontline workers.

    ALSO READ | Boost for India’s COVID fight as country approves vaccines Corbevax, Covovax and Molnupiravir pill

    “All persons aged 60 years and above with co-morbidities will not be required to produce or submit any certificate from a doctor, at the time of administration of precaution dose,” wrote Bhushan to state chief secretaries adding that such people are expected to obtain the advice of their doctor before deciding to avail of the precautionary dose.

    The development comes after a section of people, including several doctors, had protested the requirement of doctors’ certificate to avail precautionary Covid-19 jabs, first announced by Prime Minister Narendra Modi on December 25.

    “There is no provision of such a certificate in India’s healthcare system to avail any service. Then, why create this unnecessary hurdle to get the Covid-19 booster jab administered?” said a senior medical professional attached with AIIMS, Delhi who is also a member of ICMR advisory group on Covid-19 clinical management.

    ALSO READ | BCCI President Sourav Ganguly admitted to hospital after testing positive for COVID-19

    Meanwhile, as Covid-19 vaccination for the 15-17 year age group opens from January 3, the Centre urged district officials to identify dedicated session sites or earmarked Covid-19 vaccination centers for their immunisation as only Covaxin is to be administered to them.

    “lt must be ensured that no mixing of vaccines is done. Hence, preferably separate session sites (Covid-19 vaccination centres) should be identified. Separate queue with proper and prominent signage and separate vaccination team must be used, if the identified session site is the same where adult vaccination is also ongoing,” said the letter.

  • Only Covaxin for 15-18 year olds for now; precaution doses after 39 weeks of second Covid jab

    Express News Service

    NEW DELHI: The Centre on Monday announced that healthcare, frontline workers and those above 60 years with underlying illnesses will be eligible for the third shots against Covid-19 from January 10 only if they have completed 39 weeks since their full vaccination.

    It also said that for the 15-18 year olds, for whom Covid vaccination opens from January 3, only Covaxin will be available since this is the Covid-19 vaccine granted emergency use authorisation for the age group.

    In a document titled “Guidelines for Covid-19 vaccination of children between 15-18 years and precaution dose to healthcare workers, frontline workers and 60+ population with comorbidities” released on Monday, the Union health ministry said that the adolescents with birth year 2007 or before can register on Co-WIN.

    They can, however, also avail walk-in vaccination service.

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    As a matter of abundant precaution, for those healthcare workers and frontline workers who have received two doses, another dose of Covid-19 vaccine would be provided from January 10, said the document, adding that the prioritization and sequencing of this precaution dose would be based on the completion of 9 months or 39 weeks from the date of administration of second dose.

    All persons aged 60 years and above with comorbidities who have received two doses of COVID-19 vaccine, will on doctor’s advice be provided with a precaution dose, provided they complete 39 weeks since the administration of the second Covid jab.

    “Co-WIN system will send SMS to such beneficiaries for availing the precaution dose when the dose becomes due. Registration and appointment services can be accessed through both, the online and the onsite modes,” the ministry clarified. 

    Though the document did not clarify on the type of vaccine to be available as the third dose for the beneficiaries, officials said that it will be the same vaccine as that administered during the two previous doses.

    The government is now looking at an additional 8 crore beneficiaries in the 15-18 year age group, 3 crore healthcare and frontline workers and nearly 10-15 crore people above 60 years with comorbidities.

    ALSO READ | COVID: Raise vigil against Omicron variant, say Chennai doctors

    “All citizens irrespective of their income status are entitled to free Covid19 vaccination at government vaccination centres,” said the government, adding that those who have the ability to pay are encouraged to use private vaccination centers.

    Officials said that senior citizens with pre-conditions will simply need to choose a slot and centre for the additional Covid shot, provided they have completed nine months since full vaccination. They will need to show a co-morbidity certificate from a qualified doctor at the vaccination centre.

    Officials meanwhile said that a meeting of experts from the National Technical Advisory Group on Immunization is being called on Monday evening to further discuss the nitty-gritty of rolling out the “precaution doses”. 

  • For now, Covaxin likely to be only vaccine available for children of 15-18 years

    By PTI

    NEW DELHI: Bharat Biotech’s Covaxin is likely to be the only COVID-19 vaccine available, for now, for children in the age group of 15-18 years, who will be inoculated from January 3, official sources said.

    Also, healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.

    Prime Minister Narendra Modi, in a televised address to the nation on Saturday night, announced that vaccination against COVID-19 for children between 15-18 years will start from January 3, while “precaution dose” for healthcare and frontline workers would be administered from January 10.

    The decisions came amid rising Covid cases linked to the Omicron variant of the virus.

    The precaution dose will also be available for citizens above 60 years of age and with comorbidities on the advice of their doctor from January 10 next year as well, the prime minister had said.

    “Bharat Biotech’s Covaxin is the only COVID-19 vaccine which will be administered, for now, to children in the age group of 15-18 years who will be inoculated from January 3. The estimated population to be covered in this category is seven to eight crores,” an official source said.

    The source said that Zydus Cadila’s vaccine ZyCoV-D has not yet been introduced in the country’s inoculation programme, even for adults, though it had received emergency use authorisation from the drug regulator on August 20, making it the first vaccine that could be administered in the age group of 12-18 years in the country.

    The indigenously developed ZyCoV-D is the world’s first DNA-based needle-free COVID-19 vaccine.

    The gap between the second and third dose of COVID-19 vaccine, which is being termed as “precaution dose”, is likely to be nine to 12 months.

    Necessary modifications are being done on the CoWIN portal to register the new category of vaccination.

    The Drugs Controller General of India (DCGI) granted emergency use authorisation to indigenously-developed Covaxin for children above 12 years with certain conditions on Friday.

    More than 61 per cent of India’s adult population has received both doses of the vaccine.

    Similarly, about 90 per cent of the adult population has received the first dose of Covid vaccine.

    The cumulative COVID-19 vaccine doses administered in the country has exceeded 141 crore, according to the health ministry.

    A stock of four to five crore vaccine doses of Covaxin are available with states and union territories.

    A senior epidemiologist at AIIMS who is the principal investigator of Covaxin trials for adults and children at the institute on Sunday termed the Centre’s decision to vaccinate children against Covid “unscientific” and said it will not yield any additional benefit.

    Dr Sanjay K Rai, who is also the president of the Indian Public Health Association, said before implementing the decision, data from countries that have already started vaccinating children should be analysed.

    In an address to the nation on Saturday night, Prime Minister Narendra Modi announced that vaccination against COVID-19 for children in the 15 to 18 age group will start from January 3.

    This will reduce the worries of children going to schools and colleges and their parents, and boost the fight against the pandemic, he said, adding that the move is also likely to aid in normalisation of teaching in schools.

    “I am a great fan of PM Modi for his selfless service to nation and taking right decisions at right time. But I am completely disappointed with his unscientific decision on children vaccination,” Rai said in a tweet tagging the Prime Minister’s Office.

    Elaborating his viewpoint, Rai said there should be a clear-cut objective of any intervention.

    The objective is to either prevent coronavirus infection or severity or death.

    “But according to whatever knowledge we have about vaccines, they are unable to make a significant dent in the infection. In some countries, people are getting infected even after taking booster shots.”

    “Also, 50,000 breakthrough infections are being reported per day in the UK. So this proves that vaccination is not preventing coronavirus infection but vaccines are effective in preventing severity and death,” Rai told PTI.

    He said mortality due to COVID-19 in susceptible populations is around 1.5 per cent, which means 15,000 deaths per million population.

    “Through vaccination, we can prevent 80-90 per cent of these deaths, which means that 13,000 to 14,000 deaths per million (population) can be prevented,” he added.

    Serious adverse events following immunisation are between 10 to 15 per million population, Rai said.

    “So, if you do the risk and benefit analysis in adults, it is a huge benefit,” he said.

    In the case of children, he said, the severity of infection is very low and according to data available in the public domain, only two deaths per million population have been reported.

    “In this section (children), 15,000 (people) are not dying and keeping in mind the adverse effects also, if you do the risk and benefit analysis, then the risk is more than the benefits based on the available data,” Rai explained.

    “Both the objectives are not being fulfilled by initiating vaccination among children,” he said.

    Few countries, including the US, started vaccinating children four-five months ago.

    The data of these countries should be analysed before initiating Covid vaccination for children, he said.