News Analysis India

Tag: Covaxin

  • PM announces booster shots for frontline workers, 60-plus population; vaccination also to begin for 15-18 age group

    Express News Service

    NEW DELHI: Prime Minister Narendra Modi on Saturday announced precautionary additional Covid19 vaccine doses for healthcare and frontline workers across India, saying that they may be at a higher risk of contracting infection in case there is a surge of infection, in the wake of threat from the Omicron variant.

    In an address to the nation, he said 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 precaution dose denotes a third dose of the vaccine for the fully vaccinated but Modi refrained from using the term “booster dose”, as it is generally referred.

    Administration of vaccine for this group of population, estimated to be around 3-4 crore in number, will begin on January 10.  

    He also announced that beginning January 3, adolescents aged 15-18 years will be eligible for Covid19 vaccination.

    Additionally, people aged 60 and above with comorbidities will also be eligible for booster or additional shots of Covid19 vaccine, on their doctor’s advice, starting January 10.

    The mega announcements by the PM come even though the country’s top advisory panel on immunization was yet to give its final recommendation on booster doses or vaccination for kids.

    Amid Christmas and the coming new year festivities, Modi asked people to be alert and take all preventive measures but added that they should avoid panic as he reassured them about the health measures in place to deal with any exigencies.

    Administration of nasal vaccine and world’s first DNA vaccine against Covid will soon start in India as well, he said The prime minister said global experience shows that following all preventive measures at a personal level is “big weapon” to fight Covid and so is vaccination.

    This is time to be careful, while engaging in festivities, he said.

    “I would urge all of you not to panic, be careful and alert. Remember to mask up and keep washing hands,” Modi said.

    Noting that India started giving the vaccine to its citizens from January 16 this year, Modi said due to the people’s collective effort and will, India has crossed the “unprecedented” and very difficult milestone of having administered 141 crore vaccine doses.

    “Today, 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 single dose of the vaccine,” he said.

    Underlining that he was sharing key decisions with the people of the country on the occasion of Christmas, Modi said that vaccination for children between the age of 15 years to 18 years, will start in the country on January 3, 2022.

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

    “We all have experienced that the corona warriors, healthcare and frontline workers made a huge contribution in keeping the country safe in this fight. They still spend a lot of his time in the service of oronavirus patients,” he said.

    “Therefore, from the point of view of precaution, the government has decided that ‘precaution dose’ of vaccine will be administered to healthcare and frontline workers from January 10, Monday” Modi said.

    This will strengthen the confidence of healthcare and frontline workers, he said.

    Giving an overview of healthcare infrastructure in the nation, Modi said that as the virus is mutating, “our confidence to take on challenges is also multiplying”.

    “Our innovative spirit is also growing. The country today has 18 lakh isolation beds, 5 lakh oxygen supported beds, 1,40,000 ICU beds. If ICU and non-ICU beds are taken together, there are about 90,000 beds for children. Today the country has over 3,000 PSA oxygen plants functioning and four lakh oxygen cylinders have been provided across the country,” he said.

    “States are being helped to prepare a buffer dose of necessary medicines. They are also being provided with adequate testing kits,” he said.

    The decision, said the PM, had been taken by the government in the interest of people at large.

    He cautioned people not to panic but to stay vigilant, citing conflicting data from several other countries which are seeing a fresh wave of Covid19 infection.

    Modi also said that a nasal vaccine against Covid19 is on the cards in India, apart from world’s first DNA vaccine (ZyCov D by Zydus Cadila) against Covid19.

    Lauding scientists and health workers, he said the seriousness of vaccine was identified very early and along with research on it, work was also focussed on approval process, supply chain, distribution, training, IT support system and certification.

    Modi emphasised that India’s fight against the virus has from the very beginning been based on scientific principles, scientific consultation and scientific method.

    Eleven-month vaccine campaign, the prime minister said, has brought relief and normalcy in the everyday lives of the countrymen.

    Economic activities have been encouraging compared to many countries of the world, he said while noting that alertness remains of paramount importance.

    He also cautioned against efforts to spread rumours, confusion and fear by some quarters.

    Modi’s address came on a day officials said the Drugs Controller General of India (DCGI) has granted emergency use authorisation to indigenously-developed Bharat Biotech’s Covaxin for children above 12 years with certain conditions.

    It is the second vaccine to receive the regulator’s nod for use among those below 18 years after Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D.

    The significant announcement on booster doses for healthcare and frontline workers comes amid growing clamour for the third shot of Covid19 vaccines for them as there is growing evidence of high breakthrough infections due to the Omicron variant.  

    More than two months after an expert panel endorsed Covaxin for kids, the Drug Controller General of India on Saturday approved the Covid19 vaccine by Bharat Biotech for the 12-17 age group in India.

    #WATCH | Roll out of nasal vaccine and world’s first DNA COVID vaccine will start soon in our country: PM Narendra Modi pic.twitter.com/duvNp2zg2s
    — ANI (@ANI) December 25, 2021
    However, the country’s highest drug regulator has permitted the vaccine only for adolescents and not for kids under 12, as recommended by the subject expert committee on Covid19 in October.

    Earlier, the Hyderabad based vaccine maker had said that it had submitted data from clinical trials in the 2-18 years age group for Covaxin to the regulator which was thoroughly reviewed by the Central Drugs Standard Control Organization and the subject expert committee.

    “This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group,” the  company had said . “We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for Children.

    Raches Ella, clinic lead of Covid vaccines at the company had also  said in a tweet that Covaxin has been “reported to be safe and immunogenic” in a pediatric cohort and “the approval in children will help expedite the reopening of schools”.

    Now, Covaxin has become the second vaccine, after Zydus Cadila’s ZyCoV D, to be permitted for under 18 population group in India even though the country is yet to clearly spell out its policy on Covid vaccination for minors.

    Approved for adolescents aged 12-17 years of age in August by the DCGI, along with adults, ZyCoV D however is still to be rolled out for any population group in the country.

    Meanwhile, Officials in the CDSCO said that though the amount of Covaxin recommended for minors remains the same—0.5 ml—as it is for adults and will also be administered in two doses- 28 days apart- there will be slight difference in the approach.

    “It has been discussed that for adolescents, vaccines can be supplied in pre-filled syringes—instead of vaccines being taken out of vials at the time of administration,” said an official.

    This, officials said, was recommended in order to ensure that exactly the specified quantity of vaccines are administered in kids as the higher quantity may lead to adverse effects.

  • CDSCO approves shelf life of COVID-19 vaccines as 12.5 crore Indians are due for second dose

    By PTI

    NEW DELHI: The Central Drugs Standard Organisation (CDSO) has approved the shelf life of COVID-19 vaccines Covaxin to 12 months, Covishield to nine months, and ZyCoV-D to six months from the date of manufacture, the Lok Sabha was informed on Friday.

    Regarding the administration of booster doses, Union Health Minister Mansukh Mandaviya said the National Technical Advisory Group on Immunisation (NTAGI) and the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) are deliberating and considering scientific evidences related to this aspect.

    Responding to a question on the shelf life of Covid vaccines approved in the country and their active period among the vaccinated people, Mandaviya, in a written reply, said the vaccines were developed very recently, therefore, scientific evidence regarding the duration of protection is still evolving globally.

    “The National Regulator, i.e. the CDSO, has approved the shelf life of nine months for Covishield vaccine, for Covaxin vaccine it is 12 months and for ZyCoV-D vaccine it is six months from the date of manufacture,” Mandaviya said.

    On whether the government has taken stock of vaccines lying unused in government and private hospitals and proposes to procure and redistribute the unused vaccines before their dates of expiry, Mandaviya said the central government closely monitors COVID-19 vaccine stocks in states and Union Territories to ensure their optimal utilisation.

    COVID-19 vaccine stock which has not been utilised in private hospitals and nearing expiry has been taken up for redistribution by respective state governments, as advised by the Union government, for their timely utilisation, he said.

    Listing steps taken by the government to ensure adequate production and supply of Covid vaccines and booster doses along with the total expenses incurred and funds allocated and disbursed in this regard, Mandaviya said under ‘Mission Covid Suraksha’ being implemented by the Biotechnology Industry Research Assistance Council (BIRAC), a PSU of Department of Biotechnology, efforts have been made to strengthen COVID-19 vaccine manufacturing capabilities of Indian industry, to ensure optimal vaccine production.

    In this regard, augmentation of manufacturing facilities was supported at Bharat Biotech International Limited (BBIL) and Indian Immunologicals Limited (IIL), Hyderabad.

    The IIL, supported under the mission, has achieved a production capacity of around 20 lakh doses/month equivalent Drug Substance (DS) of Covaxin.

    The validation of the BBIL facility at Malur, Bengaluru is complete and production of DS started in August 2021.

    Further, support for facility augmentation at Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL), Bulandshahr; and Haffkine Biopharmaceutical Corporation Ltd (HBPCL), Mumbai; for Covaxin production is under consideration.

    An amount of Rs 260 crore has been allocated to support facility upgradation for augmented Covaxin production, out of which, an amount of Rs 27.25 crore has been disbursed so far, Mandaviya said.

    Additionally, DBT along with the PSU BIRAC, is facilitating expert advisory support for facility up-gradation at Gujarat COVID Vaccine Consortium (GCVC), for augmented production of Covaxin, he said in the written reply.

    In the current financial year i.e. 2021-22, Rs 35,000 crore has been budgeted for implementation of COVID-19 vaccination programme.

    As on November 27, an expenditure of INR 19,675.46 crore has been incurred against this allocation which has been utilised for procurement of COVID-19 vaccines for free of cost supply to states and Union Territories, he said.

    A total of 12.5 crore people are due for second dose of COVID-19 vaccine after completion of the stipulated dosage interval as on November 30, the Lok Sabha was told on Friday.

    Minister of State for Health Bharati Pravin Pawar was responding to a question on the number of people who have dropped out of taking the second dose of COVID-19 vaccine in the country.

    “As on November 30, a total of 12.5 crore people are due for the second dose of Covid vaccine after completion of stipulated dosage interval,” she noted.

    Asked if the government has prepared any plan to identify and reach out to such people who did not take the second dose, Pawar said the Centre launched ‘Har Ghar Dastak Abhiyaan’ from November 3 wherein missed beneficiaries for first dose and due beneficiaries for the second dose are identified and vaccinated through house-to-house activity.

    This campaign is undertaken across all districts, including those with first dose coverage of less than 50 per cent.

    As on November 30, a total of 29 districts have vaccination coverage less than 50 per cent for first dose of COVID-19 vaccine, she said.

    The district-wise and CVC-wise plan for COVID-19 vaccination coverage is prepared by district magistrates and district immunisation officers in all districts irrespective of their coverage.

    On whether there are any repercussions on the health of those who missed their second dose voluntarily, the minister said people who do not complete the COVID-19 vaccination schedule may not receive full protection against the infection.

    Uttar Pradesh has the highest number of beneficiaries (2,11,29,397) due for the second dose followed by Rajasthan at 1,23,32,133, Maharashtra at 1,00,31,101, Bihar at 93,60,859 and Tamil Nadu at 80,50,574 beneficiaries.

  • Efficacy of COVID vaccines satisfactory, finds ICMR study as over 115 crore inoculated in India so far

    Express News Service

    NEW DELHI: The first nationwide measurement of the real-world effectiveness of Covid-19 vaccines Covishield and Covaxin have shown 80% and 69% efficacy against severe disease, respectively. Although lower than the protection reported in clinical trials, the figures are still considered to be good.

    The findings are a result of an analysis by ICMR in 11 hospitals across 10 cities between May and July, which studied severely ill and hospitalised Covid-19 patients. In all, 1,143 cases of severe infection and 2,541 negative cases were studied.

    The study, submitted to The Lancet for publication, showed effectiveness was the highest with a gap of 6-8 weeks between two shots of Covishield and Covaxin. Importantly, efficacy estimates were similar against Delta strain and sub-lineages.

    In Phase 3 trials, Covishield had shown nearly 100% protection from severe illness and it was nearly 93% for Covaxin — India’s first indigenously developed Covid vaccine. Tarun Bhatnagar, scientist with the National Institute of Epidemiology, ICMR, and principal investigator for the study, explained that real-world effectiveness estimates will always be lower than trial-based efficacy estimates.

    “This is the largest study on real-world effectiveness (of vaccines) and findings indicate that two doses of Covaxin and Covishield have good effectiveness against the Delta strain which is the dominant circulating strain in India,” Bhatnagar said.

    He pointed out that as a majority had taken Covishield, the numbers for Covaxin are smaller in the study and hence the lower precision of the effectiveness estimates for Covaxin.

    Bhatnagar stressed that considering that effectiveness against severe infection is not close to 100%, masking and social distancing cannot be totally done away with, more so among those not vaccinated, and those who may be more vulnerable to get severe infection such as the elderly, immune-compromised and people with comorbidities

    In the pre-print of the study, scientists said these findings highlight significant real-world protection with two vaccine doses against severe Covid-19 and specifically against the Delta variant in India.

    “Substantial effectiveness of only one dose, more so for Covishield, supports the policy decision from a public health perspective to initially maximise coverage with single dose in the country,” they said. In India, most studies are limited to healthcare and frontline workers with small sample size, and none are population-representative.

    Meanwhile, the total number of COVID-19 vaccine doses administered in the country crossed 115 crore on Thursday, the Union Health Ministry said.

    According to officials, around 82 per cent of the eligible population in India has received the first dose of the vaccine while more than 41 per cent has been fully inoculated.

    In a tweet, Union Health Minister Mansukh Mandaviya said, “The country is getting protected through vaccination every day.

    As India’s vaccination coverage crosses the 115 crore mark, PM Narendra Modi ji’s words ring true — once Indians decide to do something, nothing is impossible! Har Ghar Dastak strengthening the world’s largest vaccination drive!” On Thursday, more than 65 lakh (65,45,982) vaccine doses have been administered till 7 pm.

    The daily vaccination tally is expected to increase with the compilation of the final reports for the day by late night, the ministry said.

    The ministry had on Wednesday declared that the number of individuals fully vaccinated against COVID-19 surpassed the partially vaccinated population.

    The government has recently launched a month-long ‘Har Ghar Dastak’ campaign for house-to-house COVID-19 vaccination of those who are yet to take a dose and those whose second dose is overdue.

    Mandaviya had recently said that over 12 crore beneficiaries are due for their second dose of COVID-19 vaccine and urged the state health ministers to ensure that all adult population is covered with the first dose during the ongoing ‘Har Ghar Dastak’ campaign, while those who are due for the second dose are also motivated to take the jab.

    (With PTI Inputs)

  • If citizen loses job due to vaccine administered, is state not duty bound to redress it? Kerala HC poser to Centre

    By PTI

    KOCHI: If someone loses their livelihood due to the vaccine administered by the State, is the government not duty-bound to redress his grievance? the Kerala High Court asked the Centre on Tuesday.

    The poser came during the hearing of a man’s plea for a third jab of an internationally recognised vaccine so that he can go back to Saudi Arabia, where he was working as a welder prior to the COVID-19 outbreak.

    He has moved the high court for the third jab of an internationally recognised vaccine as the two doses of COVAXIN he received is not recognised or approved in the Gulf nation and therefore, he is unable to travel there.

    Justice P V Kunhikrishnan on Tuesday said that the court was not blaming the Centre, but when a citizen stands to lose his employment or his movement is restricted due to the vaccine administered to him by the State, then “does the government not have a duty to redress his grievance”? The court directed the Assistant Solicitor General (Asst SG) Manu S, appearing for the Centre, to take instructions on why Saudi Arabia was not recognising COVAXIN when the vaccine has been approved for international emergency use by WHO.

    The Asst SG said that the vaccines were administered to save lives which was the focus during the pandemic and therefore, the Centre could not wait for international acceptance of the same.

    He also said that the government has its limitations with regard to imposing something on a foreign nation.

    The court, however, said that restriction of movement or loss of employment of a citizen due to a vaccine administered by the State was ‘infringement of his Fundamental Rights”.

    It asked the Asst SG to come with instructions on the Saudi Arabia issue by November 29, the next date of hearing.

    On November 2, the high court had observed that the Centre’s vaccination scheme has created two classes of citizens in India – those who got COVAXIN, whose movements are restricted, and those who received COVISHIELD and can go anywhere.

    The Centre had in August said that clinical trials were underway to ascertain the efficacy of administering a third dose of COVID vaccine and it will take several months to complete.

  • Inactivated virus vaccine Covaxin has cellular immune memory to Covid for at least six months: NII

    Immunological memory is the ability of the immune system to respond more rapidly and effectively to pathogens that have been encountered previously.

  • Covaxin 77.8 per cent effective against COVID, 65.2 per cent against Delta variant: Study

    By PTI

    HYDERABAD: Bharat Biotech’s vaccine Covaxin has demonstrated that it is 77.8 per cent effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group, Phase III data published in The Lancet said on Friday.

    The efficacy data which was peer reviewed also said the vaccine demonstrated 63.6 per cent protection against asymptomatic Covid-19 and 65.2 per cent safety against the Delta variant besides showing 70.8 per cent guard against all variants of SARS-CoV-2 virus.

    The efficacy analysis demonstrated that Covaxin to be 93.4 per cent effective against severe symptomatic Covid-19.

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

    “The data from our product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published COVID-19 vaccines in the world. This accomplishment reflects the undeterred commitment by my team members at Bharat Biotech, our public partners, Indian Council of Medical Research, National Institute of Virology, and the trust imposed by our trial participants who made this happen,” Bharat Biotech Chairman Krishna Ella said in a statement.

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

    Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said, following successful isolation of the SARS-CoV-2 virus at NIV, ICMR and Bharat Biotech embarked upon one of the most successful public-private partnerships to develop the virus isolate into an effective COVID-19 vaccine.

    “I am delighted to see that the phase III efficacy data has also been published in The Lancet, one of the most reputed journals worldwide. This itself speaks high about the strong position of Covaxin amongst other global front-runners COVID-19 vaccines,” Bhargava said.

    The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of “Atmanirbhar Bharat” along with the Indian academia and industry in fighting against the odds and carving a niche in the global community, he added.

    Recently, the World Health Organisation granted emergency use listing to Covaxin, enabling countries to expedite their regulatory approval to import and administer doses.

    The jab has also received emergency use authorisations in several countries with applications in process in more than 50 countries worldwide.

    Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the United States and Canada.

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

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

    Bharat Biotech is poised to achieve its goal of an annualised capacity of about 1.0 billion doses of the jab by the end of 2021.

  • Respite for Indian travellers as UK to add Covaxin to approved list from November 22

    By PTI

    LONDON: The UK government has said that India’s Covaxin will be added to its list of approved COVID-19 vaccines for international travellers from November 22, meaning that those inoculated with the Bharat Biotech-manufactured jab will not have to self-isolate after arrival in England.

    The move follows the World Health Organisation’s (WHO) Emergency Use Listing for Covaxin, which is the second most used formulation in India.

    Covishield, the India-manufactured Oxford-AstraZeneca COVID-19 vaccine, was added to the UK’s approved list last month.

    “More good news for Indian travellers to the UK. From 22 November travellers fully vaccinated with a COVID19 vaccine recognised by WHO for Emergency Use Listing, including Covaxin, will not have to self-isolate; so joining those fully vaccinated with Covishield,” Alex Ellis, British High Commissioner to India, said on Twitter on Monday.

    The changes will come into effect at 4 am on November 22.

    Besides Covaxin, China’s Sinovac and Sinopharm, both on the WHO Emergency Use Listing, will be recognised by the UK government as approved vaccines for inbound travel, benefitting fully vaccinated people from the United Arab Emirates and Malaysia.

    These fully vaccinated passengers will not be required to take a pre-departure test, day-8 test or self-isolate upon arrival.

    “As we continue to recover from the pandemic and expand our recognition of international vaccines, today’s announcements mark the next step in our restart of international travel,” said UK Transport Secretary Grant Shapps.

    “The red list and quarantine system remain vital in protecting our borders and as we’ve said, we will not hesitate to take action by adding countries to the red list if necessary,” UK Health Secretary Sajid Javid said.

    The UK government has also simplified the travel rules for all under-18s coming to England.

    They will now be treated as fully vaccinated at the border and will be exempt from self-isolation requirements on arrival, day-8 testing and pre-departure testing.

    They will only be required to take one post-arrival test and a confirmatory free PCR test if they test positive.

  • WHO panel recommends Emergency Use Listing status for Bharat Biotech’s Covaxin

    By PTI

    NEW DELHI: The Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation (WHO), has recommended Emergency Use Listing (EUL) status for Bharat Biotech COVID-19 vaccine Covaxin, sources in the know of the development said.

    The WHO is in the process of evaluating Covaxin’s clinical trial data for use of EUL. The TAG on October 26 had sought “additional clarifications” from the company for Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine.

    ALSO READ: COVID-19 vaccination drive needs to be taken door-to-door, says PM Modi

    “The Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin,” a source told PTI. The TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.

    Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials. Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

    ALSO READ: Doctors welcome expert panel’s suggestion on Covaxin for children; flag issue of global acceptance

  • Finally, WHO includes Covaxin in its emergency use list of COVID-19 vaccines

    Express News Service

    NEW DELHI: The World Health Organisation on Wednesday granted emergency use listing to Bharat Biotech’s COVID-19 vaccine Covaxin following months of detailed scrutiny of data from its clinical trials and vaccine development process.

    This brings good news to millions of vaccine recipients, international travel plans for many of whom were in limbo as non-approval by the WHO meant that most countries didn’t recognise them as having been “vaccinated” against COVID-19.

    WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply, allowing countries to expedite their own regulatory approval to import and administer vaccines.

    “WHO has granted emergency use listing (EUL) to Covaxin (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19,” the agency said in a statement.

    It added that the technical advisory group, convened by WHO and made up of regulatory experts from around the world, has determined that Covaxin meets WHO standards for protection against COVID, benefits of the vaccine far outweigh risks and it can be used across the world.

    ALSO READ: COVID-19 vaccination drive needs to be taken door-to-door, says PM Modi

    “This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

    “But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”

    Covaxin, formulated from an inactivated SARS-CoV-2 antigen and presented in single dose vials and multidose vials of 5, 10 and 20 doses, was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability.

    The vaccine was also reviewed on October 5 by WHO’s strategic advisory group of experts on immunization, which formulates vaccine-specific policies and recommendations for the use of vaccines in populations with details such as recommended age groups, intervals between doses, specific groups such as pregnant and lactating women.

    The SAGE recommended use of the vaccine in two doses, with an interval of four weeks, in all age groups of 18 and above.

    This vaccine was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements, said the UN health agency.

    It however added that the available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.

    WHO’s EUL procedure assesses the suitability of novel health products during public health emergencies. “The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

    The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. 

    As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine.

    Incidentally, the WHO recognition of Covaxin comes on a day India’s drug regulator approved its application for extending the shelf life from six months to 1 year which will largely help private hospitals clear their stock of the vaccine.

    ALSO READ: Doctors welcome expert panel’s suggestion on Covaxin for children; flag issue of global acceptance

  • Delay in submitting virus inactivation data pushes WHO nod for Covaxin

    Express News Service

    NEW DELHI:  It’s the lack of complete details of the virus inactivation process, used for making Covaxin, that is pushing its emergency use listing by the World Health Organisation (WHO), sources have told this newspaper. The WHO has sought “additional clarifications” from Covaxin maker Bharat Biotech for a final assessment on November 3.

    Sources in the Union health ministry said since Covaxin is a whole inactivated virus based vaccine, the WHO has been seeking data meticulously to ensure that the inactivation process is complete and without any loopholes.

    ALSO READ | ’11 crore missed second Covid vaccine dose’: Centre calls for meeting with state health ministers

    They also pointed out that the company has WHO approval for three out of nearly 12 vaccines it manufactures but no inactivated virus based vaccine made by the firm has got the approval till now. 

    “Therefore, WHO approval for Covaxin will be a first  for the company if it gets the nod and that’s the reason the company needs to show a meticulously documented inactivation process,” said an official.A query seeking response from Bharat Biotech on delay in WHO EUL has remained unanswered so far. A vaccine expert in Delhi pointed out that while there may not be problems with the “the inactivation process itself, it is possible that the company might not have documented the procedure carefully”. 

    ALSO READ | Bharat Biotech’s US partner Ocugen files request with FDA for Covaxin trials

    India has been pushing for WHO recognition of Covaxin as without it, the two-dose vaccine is struggling to be accepted as a valid vaccine globally and has complicated travel plans for Indians who have received it. The UN health body had on October 18 made it clear that  it “cannot cut corners” and “must evaluate it thoroughly to make sure it is safe and effective” before recommending the product for emergency use.The WHO rigour on the vaccine inactivation process comes in the backdrop of Brazil’s health regulator rejecting an application to give Covaxin a certificate of Good Manufacturing Practices following an inspection of the company’s site in Hyderabad earlier in April this year.