The Evening Wrap: Covaxin does not have WHO’s emergency use listing for use in children

On December 25, 2021, Prime Minister Narendra Modi announced that adolescents aged 15-17 years will be eligible for a COVID-19 vaccine beginning January 3. Two days after the announcement, the Health Ministry issued guidelines for the vaccination programme for teenagers. While clearly stating that teenagers aged 15 or older (all those whose birth year is 2007 or before) will be able to register on Co-WIN, the Ministry emphasised that only Covaxin will be administered to this age group. Covaxin was granted an emergency use approval for use in children 12 years and above on the same day the Prime Minister made the announcement. However, the Ministry guidelines wrongly state that Covaxin is the “only vaccine with WHO’s emergency use listing (EUL) for the age-group 15-18”. On November 3, 2021, the WHO issued an emergency use listing (EUL) for Covaxin for use in adults. The press release of November 3 says that WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations, had on October 5 reviewed Covaxin and “recommended” the vaccine in “all age groups 18 and above”. On November 3, WHO also took to Twitter to broadcast its decision to include Covaxin in the emergency use listing of COVID-19 vaccines. In a series of tweets, the WHO reiterated that the SAGE had reviewed and recommended the “use of Covaxin in two doses, with a dose interval of four weeks, in all age groups 18 and above”. A statement issued on November 24 last year once again stresses that Covaxin has not received emergency use listing for use in children. It states that though Covaxin developed by Bharat Biotech has been approved in India for children 12-17 years, it has “not yet received WHO EUL for this age indication”. For Covaxin to be approved for children above 12 years to be granted an emergency use listing, Bharat Biotech has to submit manufacturing quality data, clinical and non-clinical data of the vaccine in children above 12 years and labelling details. It is not clear how the Health Ministry had incorrectly said Covaxin has an EUL for the 15-18 years age group. PM Modi's security lapse: Punjab CM Channi says ‘poor response’ made Modi go back A day after Prime Minister Narendra Modi’s security lapse in Punjab, Chief Minister Charanjit Singh Channi on Thursday said it was wrong to blame his government for the Prime Minister going back without addressing an event. The actual reason for the decision was the “poor response” to PM Modi’s proposed gathering in Ferozepur, he stated. The Punjab government, meanwhile, constituted a high-level committee to investigate the security lapse. At a rally in Machhiwara, Channi said, “Punjabis have never ever shied away from making sacrifices for the nation and none can question the nationalistic credentials of Punjab. The fact of the matter surrounding the Prime Minister going back without addressing the gathering was that barely 700 people turned up at rally site. This forced him to retrace his steps and later the blame was pinned on our government citing security threat to Modi. The truth is that five days before the scheduled rally of the Prime Minister, the Special Protection Group took over the landing spot, rally site and each security detail but later on the Prime Minister’s cavalcade suddenly took land route.” The route was cleared by the SPG, he noted. If there was any danger to the Prime Minister, then every Punjabi was nationalist enough to shed his blood and face the bullets as they have done before in the service of the nation, he stated. He asked forces inimical to Punjab to stop defaming the State. “The anti-Punjab forces should shun vendetta politics and ponder over why the people especially farmers don’t like them,” he stressed. An official statement said, “In order to carry out a thorough probe into the lapses that occurred during Prime Minister’s visit to Ferozepur yesterday, the Punjab government has constituted a high-level committee”. The committee, comprising justice Mehtab Singh Gill (retd.) and Principal Secretary, Home Affairs and Justice, Anurag Verma, would submit its report within three days, it stated. The Prime Minister’s event at Ferozepur was cancelled after his convoy was stuck on a flyover for 15-20 minutes as the road was blocked by protesters near the National Martyrs Memorial in Hussainiwala. The Ministry of Home Affairs termed it “a major lapse in the security of PM”. It sought a detailed report from the State government and asked it to fix responsibility for the lapse and take strict action. SC may hear on Jan. 7 plea alleging Punjab police ‘connivance’ in PM’s security lapse The Supreme Court on Thursday indicated it may urgently hear on January 7 a petition alleging that the security breach which left Prime Minister Narendra Modi’s motorcade stranded on a flyover in Punjab for 15 to 20 minutes was done with the “connivance” of the State Police and posed the “single biggest lapse in security of any Indian Prime Minister in recent years”. “While the Chief Secretary, State of Punjab and Director General of Police gave assurances to the Special Protection Group [which protects the PM] that the route is clear, it was found that the same was not true resulting in a precarious situation. The lapse in the security of the Prime Minister was occasioned clearly in connivance with the Punjab police. It was only the Punjab government that knew the precise route of the Prime Minister, which is never shared due to high security reasons,” the petition filed by an NGO, Lawyer’s Voice, said. A Bench led by Chief Justice of India N.V. Ramana asked senior advocate Maninder Singh, who mentioned the NGO’s case for urgent hearing, to serve a copy of the petition to the Punjab government. The petition sought disciplinary action against Punjab Chief Secretary Anirudh Tewari and Director General of Police Sidharth Chattopadhyaya, both of whom have been made parties in the case. Hashtags, yagyas, protests — BJP goes all out on PM 'security breach' issue From strong statements and attacks on the Congress to holding ceremonies of the ‘Mahamrityunjaya Yagya’ (a consecration aimed at removing any threat to life against a particular individual), the BJP and Ministers of the Union government ratcheted up the issue of the breach of security during Prime Minister Narendra Modi’s trip to Punjab on Wednesday. Minister for information and broadcasting Anurag Thakur termed the security breach “not just a lapse, but a major lapse in the Prime Minister’s security in Punjab”. Whatever steps needed to be taken for justice would be taken, he stated. “After gathering necessary information, whatever steps, as big and stringent as they may be, will be taken… I believe the country’s judicial system gives justice to all and in the case of this whatever steps need to be taken will be taken,” he said while briefing the media about Cabinet decisions. The BJP and some of his Cabinet colleagues squarely blamed the Congress, which is in power in Punjab, over the issue. “Prime Minister Modi was in Punjab where the Congress is in power and his security was compromised. It is utterly shameful that Congress people are saying bad words about him,” Defence Minister Rajnath Singh said at a public meeting in Uttarkashi. Sources in the party said the issue was in a manner of the “main bhi chowkidar hoon [I am also a chowkidar]” campaign that Modi ran during the 2019 polls. Party social media followers have been changing their handles to “I am Modi” to identify with him. How you came up with ₹8 lakh limit within 3 days of introducing EWS quota, SC asks Government The Supreme Court on Thursday wondered how the Union government came up with the ₹8 lakh annual income limit within just three days of introducing 10% reservation for the economically weaker sections (EWS) of society. The Constitution (One Hundred and Third) Amendment Act introducing EWS quota came into force on January 14, 2019. On January 17 the same year, the government released an official memorandum (OM) informing that families earning a gross annual income below ₹8 lakh would be identified as EWS for benefit of reservation. “The Amendment came on January 14. On January 17, the OM comes... So the whole process of consultation, discussion, etc, with Social Justice Ministry was completed and everything was done by January 17?” Justice D.Y. Chandrachud asked Solicitor General Tushar Mehta. Mehta said the ₹8 lakh limit was derived after study. “It was not an unstudied position,” the top law officer maintained. The Bench, also comprising Justice A.S. Bopanna, then pointed to an affidavit filed by the government in October last, which revealed that the ₹8 lakh threshold was “largely based” on the criterion to identify the creamy lawyer in OBC quota. The court said this earlier position in October was quite contrary to the later conclusions of the government's own expert committee headed by former Finance Secretary Ajay Bhushan Pandey in December. The committee, formed by the government to review the ₹8 lakh limit, in its report on December 31, maintained that the ₹8 lakh threshold fixed to identify EWS was not a “mechanical adoption” of the OBC creamy layer cut-off. Justice Chandrachud remarked, “The review committee seems to be just trying to justify the ₹8 lakh limit post facto... They have done their best to justify the ₹8 lakh limit”. Justice Chandrachud, however, moments before rising for the day, said it was in national interest that NEET counselling should continue. “In national interest, counselling has to begin,” he stated. The court shared the concern raised by lawyers that the country needed specialist doctors to combat the prolonged public health crisis posed by the pandemic. It reserved the case for orders and allowed lawyers to file their written arguments by January 7. In his arguments for the Centre, Mehta asked whether anybody with “common sense” would think ₹8 lakh was an “irrational” income limit for determining EWS. He said EWS had “stricter criterion” and considered the gross annual income of the family and not just that of the individual seeking reservation benefits. He referred to the Pandey committee report, which said the ₹8 lakh criterion struck a “fine balance” between over-inclusion and inclusion errors. The government rejected the accusation by petitioners, represented by advocate Charu Mathur, that it “changed the rules of the game midway” through the NEET admission process by issuing a notification on July 29 last year announcing 27% quota to OBCs and 10% reservation to EWS in the All India Quota. Mehta said the notification came much prior to the date on which NEET was conducted and the commencement of the counselling process. However, senior advocate Shyam Divan argued that the candidates had registered for the exam in February last year with the particular seat matrix available at that time. The July 29 notification had indeed changed the seat matrix by including further reservation, thus changing the rules of the game unfairly. Election Commission reviews law and order, COVID-19 situation in poll-bound States With COVID-19 infections rising every day, the Election Commission on Thursday reviewed the situation with health officials in the five States where Assembly polls are scheduled. An EC official said the Commission met Union Health Secretary Rajesh Bhushan, All-India Institute of Medical Sciences Director Randeep Guleria and Indian Council of Medical Research Director General Balram Bhargava for a “complete review on the current COVID infection status”. The Commission took inputs from the medical experts about the safety measures to be implemented, the official said. It reiterated to the Health Secretary that all those eligible should be given the first and second dose of the vaccine. It also had a discussion about the law and order in the States — Goa, Manipur, Punjab, Uttar Pradesh and Uttarakhand — with Home Secretary Ajay Kumar Bhalla, the official said. The Health Secretary had earlier briefed the Commission about the COVID-19 situation in the States on December 27, 2021. Covid Watch: Numbers and Developments The number of reported coronavirus cases from India stood at 3,51,39,568 at the time of publishing this newsletter, with the death toll at 4,82,959. Evening Wrap will return tomorrow. [logo] The Evening Wrap 06 JANUARY 2022 [The Hindu logo] Welcome to the Evening Wrap newsletter, your guide to the day’s biggest stories with concise analysis from The Hindu. [[Arrow]Open in browser]( [[Mail icon]More newsletters]( Covaxin does not have WHO’s emergency use listing for use in children On December 25, 2021, Prime Minister Narendra Modi announced that adolescents aged 15-17 years will be eligible for a COVID-19 vaccine beginning January 3. Two days after the announcement, the Health Ministry issued guidelines for the vaccination programme for teenagers. While clearly stating that teenagers aged 15 or older (all those whose birth year is 2007 or before) will be able to register on Co-WIN, the Ministry emphasised that only Covaxin will be administered to this age group. Covaxin was granted an emergency use approval for use in children 12 years and above on the same day the Prime Minister made the announcement. However, the [Ministry guidelines wrongly state that Covaxin is the “only vaccine with WHO’s emergency use listing (EUL) for the age-group 15-18”](. [A teenager getting her vaccine dose of covaxin during the vaccination drive for teenagers between 15 to 17 years age group in New Delhi, on January 6, 2022.]  On November 3, 2021, the WHO issued an emergency use listing (EUL) for Covaxin for use in adults. The press release of November 3 says that WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations, had on October 5 reviewed Covaxin and “recommended” the vaccine in “all age groups 18 and above”. On November 3, WHO also took to Twitter to broadcast its decision to include Covaxin in the emergency use listing of COVID-19 vaccines. In a series of tweets, the WHO reiterated that the SAGE had reviewed and recommended the “use of Covaxin in two doses, with a dose interval of four weeks, in all age groups 18 and above”. A statement issued on November 24 last year once again stresses that Covaxin has not received emergency use listing for use in children. It states that though Covaxin developed by Bharat Biotech has been approved in India for children 12-17 years, it has “not yet received WHO EUL for this age indication”. For Covaxin to be approved for children above 12 years to be granted an emergency use listing, Bharat Biotech has to submit manufacturing quality data, clinical and non-clinical data of the vaccine in children above 12 years and labelling details. It is not clear how the Health Ministry had incorrectly said Covaxin has an EUL for the 15-18 years age group. [underlineimg] PM Modi's security lapse: Punjab CM Channi says ‘poor response’ made Modi go back A day after Prime Minister Narendra Modi’s security lapse in Punjab, Chief Minister Charanjit Singh Channi on Thursday said it was wrong to blame his government for the Prime Minister going back without addressing an event. The [actual reason for the decision was the “poor response” to PM Modi’s proposed gathering in Ferozepur]( he stated. The Punjab government, meanwhile, constituted a high-level committee to investigate the security lapse. At a rally in Machhiwara, Channi said, “Punjabis have never ever shied away from making sacrifices for the nation and none can question the nationalistic credentials of Punjab. The fact of the matter surrounding the Prime Minister going back without addressing the gathering was that barely 700 people turned up at rally site. This forced him to retrace his steps and later the blame was pinned on our government citing security threat to Modi. The truth is that five days before the scheduled rally of the Prime Minister, the Special Protection Group took over the landing spot, rally site and each security detail but later on the Prime Minister’s cavalcade suddenly took land route.” The route was cleared by the SPG, he noted. If there was any danger to the Prime Minister, then every Punjabi was nationalist enough to shed his blood and face the bullets as they have done before in the service of the nation, he stated. He asked forces inimical to Punjab to stop defaming the State. “The anti-Punjab forces should shun vendetta politics and ponder over why the people especially farmers don’t like them,” he stressed. An official statement said, “In order to carry out a thorough probe into the lapses that occurred during Prime Minister’s visit to Ferozepur yesterday, the Punjab government has constituted a high-level committee”. The committee, comprising justice Mehtab Singh Gill (retd.) and Principal Secretary, Home Affairs and Justice, Anurag Verma, would submit its report within three days, it stated. The Prime Minister’s event at Ferozepur was cancelled after his convoy was stuck on a flyover for 15-20 minutes as the road was blocked by protesters near the National Martyrs Memorial in Hussainiwala.  The Ministry of Home Affairs termed it “a major lapse in the security of PM”. It sought a detailed report from the State government and asked it to fix responsibility for the lapse and take strict action. [underlineimg] SC may hear on Jan. 7 plea alleging Punjab police ‘connivance’ in PM’s security lapse The Supreme Court on Thursday indicated [it may urgently hear on January 7 a petition]( alleging that the security breach which left Prime Minister Narendra Modi’s motorcade stranded on a flyover in Punjab for 15 to 20 minutes was done with the “connivance” of the State Police and posed the “single biggest lapse in security of any Indian Prime Minister in recent years”. “While the Chief Secretary, State of Punjab and Director General of Police gave assurances to the Special Protection Group [which protects the PM] that the route is clear, it was found that the same was not true resulting in a precarious situation. The lapse in the security of the Prime Minister was occasioned clearly in connivance with the Punjab police. It was only the Punjab government that knew the precise route of the Prime Minister, which is never shared due to high security reasons,” the petition filed by an NGO, Lawyer’s Voice, said. A Bench led by Chief Justice of India N.V. Ramana asked senior advocate Maninder Singh, who mentioned the NGO’s case for urgent hearing, to serve a copy of the petition to the Punjab government. The petition sought disciplinary action against Punjab Chief Secretary Anirudh Tewari and Director General of Police Sidharth Chattopadhyaya, both of whom have been made parties in the case. [underlineimg] Hashtags, yagyas, protests — BJP goes all out on PM 'security breach' issue From strong statements and attacks on the Congress to holding ceremonies of the ‘Mahamrityunjaya Yagya’ (a consecration aimed at removing any threat to life against a particular individual), [the BJP and Ministers of the Union government ratcheted up the issue of the breach of security during Prime Minister Narendra Modi’s trip to Punjab]( on Wednesday. Minister for information and broadcasting Anurag Thakur termed the security breach “not just a lapse, but a major lapse in the Prime Minister’s security in Punjab”. Whatever steps needed to be taken for justice would be taken, he stated. “After gathering necessary information, whatever steps, as big and stringent as they may be, will be taken… I believe the country’s judicial system gives justice to all and in the case of this whatever steps need to be taken will be taken,” he said while briefing the media about Cabinet decisions. [Assam Chief Minister Himanta Biswa Sarma with Assam BJP President Bhabesh Kalita during a ceremony for well being of PM Narendra Modi, in Guwahati, on January 06, 2022.]  The BJP and some of his Cabinet colleagues squarely blamed the Congress, which is in power in Punjab, over the issue. “Prime Minister Modi was in Punjab where the Congress is in power and his security was compromised. It is utterly shameful that Congress people are saying bad words about him,” Defence Minister Rajnath Singh said at a public meeting in Uttarkashi. Sources in the party said the issue was in a manner of the “main bhi chowkidar hoon [I am also a chowkidar]” campaign that Modi ran during the 2019 polls. Party social media followers have been changing their handles to “I am Modi” to identify with him. [underlineimg] How you came up with ₹8 lakh limit within 3 days of introducing EWS quota, SC asks Government The Supreme Court on Thursday wondered how the Union government came up with the ₹8 lakh annual income limit within just three days of introducing 10% reservation for the economically weaker sections (EWS) of society. The Constitution (One Hundred and Third) Amendment Act introducing EWS quota came into force on January 14, 2019. On January 17 the same year, the government released an official memorandum (OM) informing that families earning a gross annual income below ₹8 lakh would be identified as EWS for benefit of reservation. “The Amendment came on January 14. On January 17, the OM comes... So the whole process of consultation, discussion, etc, with Social Justice Ministry was completed and everything was done by January 17?” Justice D.Y. Chandrachud asked Solicitor General Tushar Mehta. [Mehta said the ₹8 lakh limit was derived after study](. “It was not an unstudied position,” the top law officer maintained. The Bench, also comprising Justice A.S. Bopanna, then pointed to an affidavit filed by the government in October last, which revealed that the ₹8 lakh threshold was “largely based” on the criterion to identify the creamy lawyer in OBC quota. The court said this earlier position in October was quite contrary to the later conclusions of the government's own expert committee headed by former Finance Secretary Ajay Bhushan Pandey in December. The committee, formed by the government to review the ₹8 lakh limit, in its report on December 31, maintained that the ₹8 lakh threshold fixed to identify EWS was not a “mechanical adoption” of the OBC creamy layer cut-off. Justice Chandrachud remarked, “The review committee seems to be just trying to justify the ₹8 lakh limit post facto... They have done their best to justify the ₹8 lakh limit”. Justice Chandrachud, however, moments before rising for the day, said it was in national interest that NEET counselling should continue. “In national interest, counselling has to begin,” he stated. The court shared the concern raised by lawyers that the country needed specialist doctors to combat the prolonged public health crisis posed by the pandemic. It reserved the case for orders and allowed lawyers to file their written arguments by January 7. In his arguments for the Centre, Mehta asked whether anybody with “common sense” would think ₹8 lakh was an “irrational” income limit for determining EWS. He said EWS had “stricter criterion” and considered the gross annual income of the family and not just that of the individual seeking reservation benefits. He referred to the Pandey committee report, which said the ₹8 lakh criterion struck a “fine balance” between over-inclusion and inclusion errors. The government rejected the accusation by petitioners, represented by advocate Charu Mathur, that it “changed the rules of the game midway” through the NEET admission process by issuing a notification on July 29 last year announcing 27% quota to OBCs and 10% reservation to EWS in the All India Quota. Mehta said the notification came much prior to the date on which NEET was conducted and the commencement of the counselling process. However, senior advocate Shyam Divan argued that the candidates had registered for the exam in February last year with the particular seat matrix available at that time. The July 29 notification had indeed changed the seat matrix by including further reservation, thus changing the rules of the game unfairly. [underlineimg] Election Commission reviews law and order, COVID-19 situation in poll-bound States With COVID-19 infections rising every day, [the Election Commission on Thursday reviewed]( the situation with health officials in the five States where Assembly polls are scheduled. An EC official said the Commission met Union Health Secretary Rajesh Bhushan, All-India Institute of Medical Sciences Director Randeep Guleria and Indian Council of Medical Research Director General Balram Bhargava for a “complete review on the current COVID infection status”. The Commission took inputs from the medical experts about the safety measures to be implemented, the official said. It reiterated to the Health Secretary that all those eligible should be given the first and second dose of the vaccine. It also had a discussion about the law and order in the States — Goa, Manipur, Punjab, Uttar Pradesh and Uttarakhand — with Home Secretary Ajay Kumar Bhalla, the official said. The Health Secretary had earlier briefed the Commission about the COVID-19 situation in the States on December 27, 2021. [underlineimg] Covid Watch: Numbers and Developments The [number of reported coronavirus cases from India]( stood at 3,51,39,568 at the time of publishing this newsletter, with the death toll at 4,82,959. [underlineimg] Evening Wrap will return tomorrow. Today's Top Picks [[‘Bulli Bai’ app creator arrested] ‘Bulli Bai’ app creator arrested]( [[Science quiz: On origin and anthropology] Science quiz: On origin and anthropology]( [[Ajith’s ‘Valimai’ release postponed due to surge in COVID-19 cases] Ajith’s ‘Valimai’ release postponed due to surge in COVID-19 cases]( [[50 Cheetahs to be introduced in India in next 5 years: Environment Minister] 50 Cheetahs to be introduced in India in next 5 years: Environment Minister]( Copyright @ 2021, THG PUBLISHING PVT LTD. 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