Tag: WHO

  • 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. 

  • WHO may approve Bharat Biotech’s Covaxin ‘within 24 hours: Official

    The Hyderabad-based Bharat Biotech had applied to the WHO on April 19 for Covaxin's Emergency Use Listing (EUL).

  • India reports 13 per cent decrease in number of Covid deaths during October 11-17: WHO

    While India reported the highest numbers of new cases at 114,244, they were still an 18 per cent decrease over the previous week, said the World Health Organisation.

  • ‘Can’t cut corners’: WHO seeks more data on Covaxin before decision on emergency use listing

    By Express News Service

    NEW DELHI: The wait for emergency use listing (EUL) of COVID-19 vaccine Covaxin by the World Health Organisation is set to get longer as the UN health body on Monday said that it had sought additional inputs from the vaccine maker.

    Covaxin EUL by the WHO is particularly significant for those planning international travel as it will also pave the way for recognition by many countries.

    In a statement, the WHO said while it is aware that many people are waiting for its recommendation for Covaxin to be included in the EUL, it clarified that it “cannot cut corners’ before recommending a product for emergency use.

    “We must evaluate it thoroughly to make sure it is safe and effective,” said the agency.

    ALSO READ: Mix-and-match vaccines highly effective against COVID-19: Lancet study

    It also said that Bharat Biotech – the manufacturer of Covaxin – has been submitting data to the WHO on a rolling basis and WHO experts have reviewed the data.

    “WHO is expecting one additional piece of information from the company today. The timeframe for the WHO EUL procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries,” said the body.

    The agency said that when the information provided addresses all questions raised, the WHO and the technical advisory group will complete the assessment and come to a final recommendation on whether to grant EUL to the vaccine.

    On its part, the vaccine maker, supported by the Indian government, has been pushing for the recommendation by the WHO which was expected to come in September but was deferred to October due to the requirement for additional data.

  • Covid virus expected to continue to transmit for a very long time: WHO official Poonam Khetrapal Singh

    By PTI

    NEW DELHI: Stressing that the Covid virus may continue to transmit for a “very long time”, senior WHO official Poonam Khetrapal Singh says the level of immunity in a community, through vaccination and previous infection, will determine whether it will become endemic in the long run.

    WHO’s South-East Asia region regional director added that there is a need to get to a situation where “we are fully in control of the virus, and not the virus in control of us”.

    The endemic stage is when a population learns to live with a virus, very different from the epidemic stage when the virus overwhelms a population.

    Populations where more people were previously infected and where vaccination coverage is high are expected to be less impacted by the virus in the future than other populations, Singh told PTI in an interview.

    “The COVID-19 virus is expected to continue to transmit for a very long time. A multitude of factors will decide whether the virus will become endemic in the long run, chief among them is the level of immunity in a community, both through vaccination and previous infection,” she said.

    ALSO READ | Smoking may increase risk of COVID-19 severity, death, study finds

    On the granting of emergency use authorisation (EUA) for the indigenously developed Covaxin, she said Bharat Biotech’s dossier seeking WHO’s Emergency Use Listing (EUL) is being reviewed by technical experts and “we can expect a decision when the process is complete”.

    Discussing the role of booster doses to tackle waning immunity, Singh pointed out that cases and deaths in all countries are predominantly being driven by unvaccinated people.

    Using vaccines for booster doses constricts supply to countries where millions are still waiting for their first dose, she said.

    “Hence, WHO has called for a time-limited moratorium on COVID-19 booster doses until the end of 2021. This is to allow for at least 40 per cent of the population of each country – including those most at risk and health workers – to be vaccinated. We must remember that no one is safe till everyone is safe.”

    She said there is currently no conclusive evidence that COVID-19 vaccine efficacy against severe disease and death wanes significantly over time.

    The vaccines, the expert emphasised, have remained effective in preventing severe disease and death.

    “However, WHO has not ruled out that boosters for some population groups may be warranted in future. WHO’s recommendations on boosters will be guided by the scientific evidence, which is still evolving,” she said.

    “To make a recommendation on the use of booster doses for the general population, more data is needed on optimal timing, safety and dosage of booster doses, which may differ between vaccine products. More extensive research is needed to study the effect of booster doses in the body.”

    According to Singh, eradication is unlikely but what we can do is to prevent or minimise deaths, hospitalisations, tragedy and social, economic and health loss due to this pandemic.

    Current evidence, she said, shows that protection levels around the world remain low and most people continue to be susceptible to the virus.

    “WHO continues to recommend a strong public health response based on risk assessment, and for people to continue to protect themselves by getting vaccinated, maintaining physical distance, wearing a mask, avoiding poorly ventilated spaces, cleaning hands and following respiratory hygiene.”

    Referring to the probability of a third Covid wave, Singh said another surge and how intense it will be will depend on all of us.

    “If we together continue to adhere to public health and social measures and continue to vaccinate people as fast as possible, it will be hard for the virus to infect enough people to cause another wave,” she said.

    “From experience globally, there is enough evidence that the public health and social measures work, even against the Variants of Concern that are spreading more rapidly, and these measures are critical to limiting transmission of COVID-19 and reducing deaths. For the public health and social measures to be effective, they must be implemented well and timely and must be tailored to local settings and conditions.”

    On India’s decision to restart exporting COVID-19 vaccines, Singh said there is need for equity of vaccination administration globally to ensure that the most vulnerable such as frontline workers and the elderly are fully vaccinated.

    “At the moment, several low and lower-middle-income countries are lagging behind in vaccinating their vulnerable populations. An equitable vaccine distribution will also help check the emergence of variants by halting the spread of the virus.”

    Singh also noted that the pandemic has given “once-in-a-century opportunity” to strengthen the health system to build back better.

    “We must invest in strengthening health system resilience to ensure health security and achieve universal health coverage. It means allocation of more resources for health and its efficient governance,” she said.

    Now is also the time for countries to take lessons from the pandemic to strengthen health systems in her view.

    “Strong health systems that are primary healthcare-oriented, and which leave no one behind, create populations that are healthier, more productive and financially secure. Resilient health systems are the bedrock of emergency preparedness and response, and ensure that when acute events occur, essential health services can be maintained,” Singh said.

  • Children less severely impacted by COVID-19 pandemic: WHO chief scientist Soumya Swaminathan

    By PTI

    NEW DELHI: Children have been less severely impacted by the COVID-19 pandemic and their chances of recovery are very well, World Health Organisation (WHO) chief scientist Soumya Swaminathan said on Friday.

    She, however, said SARS-CoV2 virus may not disappear, but it is not going to cause the kind of impact and panic it caused over the last two years.

    Participating in a virtual session on ‘Priorities after Pandemic; What Young India wants?’- Indian Student Parliament, Swaminathan said the reason why people talk about children being susceptible is because vaccination programmes today in most countries are targeting people above the age of 18 and elderly as they are the most vulnerable.

    “When you do that, you are left with younger, and younger people who are unvaccinated. And, therefore, when you have the virus circulating in the community, those people are basically the susceptible population,” she said in response to a question.

    In many countries, it is seen that by vaccinating older people, the infection pattern shifts to younger people.

    “I want to assure you that children on the whole have been less severely impacted by this pandemic. Not that they don’t get infected. Yes, they do get infected as adults but they don’t get severely ill. Clearly, it is an age-related correlation with the severity,” she said.

    “Even if they get infected, the chances are that they recover very well,” the WHO chief scientist said.

    On inoculation of children against the virus in India, she said there will be vaccines for children.

    The drug regulator has given a nod to Zydus Cadila for administering to adolescents over 12 years, besides the age group of 18 years and above.

    The phase 2/3 clinical trial data of Bharat Biotech’s Covaxin in the age group two to 18 years is underway.

    The Drugs Controller General of India (DCGI) in July granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of COVID-19 vaccine Covovax on children aged two to 17 years with certain conditions.

    Swaminathan added that many countries have third, fourth and fifth waves and hoped that India will not have a third wave.

    Commenting on how the pandemic could shape, she said COVID-19 is going to become the next respiratory virus.

    Stressing that vaccines are working very well and give a good deal of protection, she said wearing a mask, avoiding crowds and mass gatherings, being in a well-ventilated place and respiratory hygiene are some of the measures that can keep the spread of the virus under control.

    “The virus may not disappear. But it is not going to cause the kind of impact, the kind of panic caused over the last two years. Some of these precautions will become part of our life,” she said.

  • Air pollution one of the biggest environmental threats to human health: WHO

    The World Health Organisation said its new air quality guidelines aim to save millions of lives from air pollution.

  • WHO chief thanks Health Minister Mansukh Mandaviya for announcing resumption of COVID vaccine export

    By PTI

    NEW DELHI: World Health Organisation (WHO) chief Tedros Adhanom Ghebreyesus on Wednesday thanked Union Health Minister Mansukh Mandaviya for announcing resumption of COVID-19 vaccine shipments to the COVAX global pool in October.

    COVAX is an initiative for equitable global access to COVID-19 vaccines. “Thank you Health Minister @mansukhmandviya for announcing #India will resume crucial #COVID19 vaccine shipments to #COVAX in October. This is an important development in support of reaching the 40% vaccination target in all countries by the end of the year. #VaccinEquity,” Ghebreyesus said in a tweet.

    Thank you Health Minister @mansukhmandviya for announcing #India will resume crucial #COVID19 vaccine shipments to #COVAX in October. This is an important development in support of reaching the 40% vaccination target in all countries by the end of the year. #VaccinEquity
    — Tedros Adhanom Ghebreyesus (@DrTedros) September 21, 2021
    Mandaviya on Monday announced that India will resume export of surplus COVID-19 vaccines in the fourth quarter of 2021 under the ‘Vaccine Maitri’ programme and to meet its commitment to the COVAX global pool, but vaccinating its own citizens remains the topmost priority of the government.

    Talking about the expected production and supply trends in the coming months, the minister said the government will receive over 30 crore doses of COVID-19 vaccines in October and over 100 crore doses in the coming quarter from October-December.

    The cumulative doses administered so far across the country has crossed 82.65 crore.

    Asserting that vaccination of its citizens remains the government’s topmost priority, Mandaviya had said, “India will be resuming export of COVID-19 vaccines under Vaccine Maitri in order to fulfil the commitment of India towards COVAX in line with our motto of ‘Vasudhaiva Kutumbakam’.”

    He said that the surplus supply of vaccines will be used to fulfil India’s commitment towards the world for the collective fight against COVID-19. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO.