The Evening Wrap: Pfizer agrees to let other companies make its COVID-19 pill

Drugmaker Pfizer Inc. has signed a deal with a U.N.-backed group to allow other manufacturers to make its experimental COVID-19 pill, a move that could make the treatment available to more than half of the world’s population. In a statement issued Tuesday, Pfizer said it would grant a license for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population. The deal excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a Brazilian drug company could get a license to make the pill for export to other countries, the medicine could not be made generically for use in Brazil. Still, health officials said the fact that the deal was struck even before Pfizer’s pill has been authorised anywhere, could help to end the pandemic quicker. “It’s quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than 4 billion people,” Esteban Burrone, head of policy at the Medicines Patent Pool, said. He estimated that other drugmakers would be able to start producing the pill within months, but acknowledged the agreement wouldn’t please everyone. “We try to strike a very delicate balance between the interests of the (company), the sustainability required by generic producers and most importantly, the public health needs in lower and middle-income countries,” Burrone said. Under the terms of the agreement, Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 remains a public health emergency. Earlier this month, Pfizer said its pill cut the risk of hospitalisation and death by nearly 90% in people with mild to moderate coronavirus infections. Independent experts recommended halting the company’s study based on its promising results. Pfizer said it would ask the U.S. Food and Drug Administration and other regulators to authorise the pill as soon as possible. Since the pandemic erupted last year, researchers worldwide have raced to develop a pill to treat COVID-19 that can be taken at home easily to ease symptoms, speed recovery and keep people out of the hospital. At the moment, most COVID-19 treatments must be delivered intravenously or by injection. Britain authorised Merck’s COVID-19 pill earlier this month, and it is pending approval elsewhere. In a similar deal with the Medicines Patent Pool announced in October, Merck agreed to let other drugmakers make its COVID-19 pill, molnupiravir, available in 105 poorer countries. Doctors Without Borders said it was “disheartened” that the Pfizer deal does not make the drug available to the entire world, noting that the agreement announced Tuesday also excludes countries including China, Argentina and Thailand. “The world knows by now that access to COVID-19 medical tools needs to be guaranteed for everyone, everywhere, if we really want to control this pandemic,” said Yuanqiong Hu, a senior legal policy adviser at Doctors Without Borders. The decisions by Pfizer and Merck to share their COVID-19 drug patents stands in stark contrast to the refusal of Pfizer and other vaccine-makers to release their vaccine recipes for wider production. A hub set up by the World Health Organisation in South Africa intended to share messenger RNA vaccine recipes and technologies has not enticed a single pharmaceutical to join. Fewer than 1% of Pfizer’s COVID-19 shots have gone to poorer countries. Kartarpur corridor will be reopened on Wednesday: Amit Shah The Kartarpur Sahib Gurdwara Corridor would be reopened on Wednesday, Union Home Minister Amit Shah said on Tuesday. The announcement comes ahead of the birth anniversary of Sikhism founder Guru Nanak on Friday. The corridor, inaugurated in 2019, links two important shrines — Dera Baba Nanak in Gurdaspur district of Punjab and Gurdwara Darbar Sahib in Kartarpur, Pakistan, and allows pilgrims to travel visa-free. A Ministry of Home Affairs’ statement said the decision was taken “keeping in view the improved COVID-19 situation.” The operations at the corridor had been suspended since March 16, 2020 on account of the pandemic. “In a major decision that will benefit large numbers of Sikh pilgrims, PM @Narendramodi govt has decided to re-open the Kartarpur Sahib Corridor from tomorrow, Nov 17. This decision reflects the immense reverence of Modi govt towards Shri Guru Nanak Dev Ji and our Sikh community,” Shah tweeted. He added, “The nation is all set to celebrate the Prakash Utsav of Shri Guru Nanak Dev ji on 19th of November and I am sure that PM @NarendraModi govt’s decision to reopen the Kartarpur Sahib corridor will further boost the joy and happiness across the country.” Shah had held review meetings with officials to expedite the resumption of the operation of the corridor at an opportune time. Pilgrimage would be facilitated as per the existing procedures and adherence to COVID-19 protocols, the Ministry added. India had signed an agreement with Pakistan on October 24, 2019 on the modalities for operationalisation of the corridor at Zero Point, International Boundary, Dera Baba Nanak. Punjab BJP leader Harjit Singh observed that a group of 250 pilgrims would go to the Kartarpur gurdwara. As reported by The Hindu, the Pakistan government had issued around 3,000 visas to pilgrims to visit gurdwaras in Pakistan, including to Nankana Sahib, Guru Nanak’s birth place. The Kartarpur gurdwara is where he died. How a coconut should be broken or a pooja should be done is not for constitutional court to look into: CJI Ramana The Supreme Court on Tuesday said constitutional courts could not interfere with day-to-day rituals and sevas performed in temples on the basis of “public interest” petitions. Religious scholars and priests were best equipped to go into the question whether rituals in a temple were being conducted in accordance with customs and traditions. The writ jurisdiction of a constitutional court under Articles 226 and 32 was limited. Whether a particular ritual was being performed in the right way or not was a “disputed question of fact”, the court explained. At most, it could be a subject for filing a civil suit in a subordinate court. “How a coconut should be broken or a pooja should be done in a temple is not for a constitutional court to look into,” Chief Justice of India N.V. Ramana said. The Bench, also comprising Justices A.S. Bopanna and Hima Kohli, was hearing a writ petition filed by Srivari Daadaa alleging that rituals were not being performed as per traditions at the famous Tirumala Tirupati temple. He also complained about the procedure for darshan. Justices Bopanna and Kohli agreed the Supreme Court could not interfere with the daily conduct of rituals in a temple on the basis of a writ petition. The court said, at the most, it could ask the temple administration to clarify in case devotees complain about discrimination or of not allowing darshan while taking into consideration the current public health crisis. Disposing of the case, the court, in its order, directed the Tirupati administration to respond to Daadaa’s grievances regarding darshan procedures and other administrative issues within eight weeks. The court said Daadaa could file a civil suit in a lower court to dispute factual issues regarding the performance of rituals. Sheena Bora murder case: HC rejects Indrani Mukerjea’s bail plea The Bombay High Court on Tuesday rejected the bail plea filed by Indrani Mukerjea, accused of killing her daughter Sheena Bora in 2012. A single bench of Justice Nitin Sambre was hearing the bail plea filed by Mukerjea in October 2020 on merits. She was arrested in August 2015 and has been lodged at the Byculla jail from October that year. Sheena’s partially-burnt body was found in the forests of Maharashtra’s Raigad District on April 24, 2012. On August 6, 2020, a special Central Bureau of Investigation (CBI) court rejected Mukerjea’s bail on merits and said, “There is no doubt that the accused (Ms Mukerjea) is an influential and wealthy person. Therefore, the possibility of influencing prosecution witnesses cannot be ruled out,” the judge said. In November 2018, a special CBI court had rejected her third medical bail plea. Mukerjea was charged under a very serious offence. Although the majority of the trial is completed, the key witness, Rahul Mukerjea, is yet to depose. If she is granted bail, she can tamper with the evidence and witnesses. All her medical needs are taken care of and in case of any serious complications, authorities are competent enough to handle it. There is no medical treatment that JJ or any other hospital cannot offer, the court said. In September 2017, the special court had rejected her second bail plea on grounds of “threat to life inside jail” and said, “the threats are exaggerated” and that she would be much safer inside prison. The court had taken into account the prosecution’s argument that Mukerjea has been kept in a secure jail. The prison premises are guarded round the clock and have CCTV cameras, it had said. In 2016, Mukerjea’s first medical bail plea was rejected by the special court. The case was detected by Mumbai police in 2015 and then transferred to CBI which filed its first chargesheet on November 19, 2015. The supplementary chargesheet was filed on February 14, 2016. The trial which commenced on February 24, 2017, however, is currently stalled. Biden, Xi agree on need to avoid conflict amid growing differences United States President Joe Biden and China’s President Xi Jinping on Tuesday agreed on the need to “responsibly” manage a competitive relationship but did not arrive at any significant breakthrough on any of the thorny issues that have led to increasingly confrontational ties. The two leaders on Tuesday morning (Monday evening in Washington) spoke for over three hours in their first virtual summit, convened from the Roosevelt Room in the White House and the Great Hall of the People in Beijing. Xi greeted Mr. Biden as an “old friend” while the U.S. President noted that the two, from their time as Vice Presidents, had “spent an awful lot of time talking to one another” and had “never been that formal with one another”. The change in tone was obvious from a March meeting in Alaska between senior officials that saw accusations traded in front of the cameras and marked a turbulent start to the Biden administration’s engagement with China. But pleasantries aside, both sides essentially reinforced their positions on many of the core issues that have strained the relationship. Any headway on these issues would have been a surprise, with expectations ahead of the summit focused firmly on what a senior U.S. administration official had described as discussing “guardrails” rather than on any specific deliverables. The main takeaway was a mutual recognition of the need to manage competition amid differences. Biden called for “common sense guardrails to ensure that competition does not veer into conflict,” the White House said, although its readout did not detail the nature of these measures beyond saying the two leaders talked about how the two sides could continue to engage on a number of areas. The U.S. President also underlined the “importance of managing competition responsibly.” Xi, for his part, said “mutual respect, peaceful coexistence and win-win cooperation” should be the “three principles” guiding ties, the Chinese Foreign Ministry said in its readout. He said the two countries “need to treat each other as equals” and that “no conflict and no confrontation is a line that both sides must hold.” “Drawing ideological lines or dividing the world into different camps or rival groups,” he said, “will only make the world suffer”, calling on the U.S. “to meet its word of not seeking a ‘new Cold War’, with concrete actions.” The unanswered question was how both sides would “responsibly manage” differences when neither appeared to give ground on any of them. The Chinese President said on the one hand that “the key is to manage [differences] constructively so that they don’t magnify or exacerbate” but added that “China will certainly defend its sovereignty, security and development interests.” He added that it was “important that the U.S. properly handle the relevant issues with prudence.” Top of those issues is Taiwan. Biden said the U.S. “strongly opposes unilateral efforts to change the status quo or undermine peace and stability across the Taiwan Strait”. He also “discussed the importance of a free and open Indo-Pacific, and communicated the continued determination of the United States to uphold our commitments in the region,” the White House said, highlighting the “importance of freedom of navigation and safe overflight to the region’s prosperity.” Biden, in effect, said that the U.S. was committed to the status quo from its side on Taiwan, by underlining the country’s commitment to the “one China” policy, the Taiwan Relations Act, the three Joint Communiques and the Six Assurances. Under its one China policy, Washington recognises Beijing alone as the formal government of China, but under the Taiwan Relations Act, the U.S. will support Taiwan if it is attacked by Beijing. Xi, in contrast, referred to what he called “the true status quo of the Taiwan question” which was that “there is but one China in the world and Taiwan is part of China.” “We have patience and will strive for the prospect of peaceful reunification with utmost sincerity and efforts,” he said. “That said, should the separatist forces for Taiwan independence provoke us, force our hands or even cross the red line, we will be compelled to take resolute measures.” Biden also raised “concerns” on China’s actions in Xinjiang, Tibet and Hong Kong and human rights issues more broadly, which brought a response from Xi saying that “democracy is not mass produced with a uniform model” and “dismissing forms of democracy that are different from one’s own is in itself undemocratic.” “China is ready to have dialogues on human rights on the basis of mutual respect,” he said, “but we oppose using human rights to meddle in other countries’ internal affairs.” Covid Watch: Numbers and Developments The number of reported coronavirus cases from India stood at 3,44,56,108 at the time of publishing this newsletter, with the death toll at 4,63,827. Evening Wrap will return tomorrow. [logo] The Evening Wrap 16 NOVEMBER 2021 [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]( Pfizer agrees to let other companies make its COVID-19 pill Drugmaker [Pfizer Inc. has signed a deal with a U.N.-backed group]( to allow other manufacturers to make its experimental COVID-19 pill, a move that could make the treatment available to more than half of the world’s population. In a statement issued Tuesday, Pfizer said it would grant a license for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population. [Pfizer said it would ask the U.S. Food and Drug Administration and other regulators to authorise the pill as soon as possible. File]  The deal excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a Brazilian drug company could get a license to make the pill for export to other countries, the medicine could not be made generically for use in Brazil. Still, health officials said the fact that the deal was struck even before Pfizer’s pill has been authorised anywhere, could help to end the pandemic quicker. “It’s quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than 4 billion people,” Esteban Burrone, head of policy at the Medicines Patent Pool, said. He estimated that other drugmakers would be able to start producing the pill within months, but acknowledged the agreement wouldn’t please everyone. “We try to strike a very delicate balance between the interests of the (company), the sustainability required by generic producers and most importantly, the public health needs in lower and middle-income countries,” Burrone said. Under the terms of the agreement, Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 remains a public health emergency. Earlier this month, Pfizer said its pill cut the risk of hospitalisation and death by nearly 90% in people with mild to moderate coronavirus infections. Independent experts recommended halting the company’s study based on its promising results. Pfizer said it would ask the U.S. Food and Drug Administration and other regulators to authorise the pill as soon as possible. Since the pandemic erupted last year, researchers worldwide have raced to develop a pill to treat COVID-19 that can be taken at home easily to ease symptoms, speed recovery and keep people out of the hospital. At the moment, most COVID-19 treatments must be delivered intravenously or by injection. Britain authorised Merck’s COVID-19 pill earlier this month, and it is pending approval elsewhere. In a similar deal with the Medicines Patent Pool announced in October, Merck agreed to let other drugmakers make its COVID-19 pill, molnupiravir, available in 105 poorer countries. Doctors Without Borders said it was “disheartened” that the Pfizer deal does not make the drug available to the entire world, noting that the agreement announced Tuesday also excludes countries including China, Argentina and Thailand. “The world knows by now that access to COVID-19 medical tools needs to be guaranteed for everyone, everywhere, if we really want to control this pandemic,” said Yuanqiong Hu, a senior legal policy adviser at Doctors Without Borders. The decisions by Pfizer and Merck to share their COVID-19 drug patents stands in stark contrast to the refusal of Pfizer and other vaccine-makers to release their vaccine recipes for wider production. A hub set up by the World Health Organisation in South Africa intended to share messenger RNA vaccine recipes and technologies has not enticed a single pharmaceutical to join. Fewer than 1% of Pfizer’s COVID-19 shots have gone to poorer countries. [underlineimg] Kartarpur corridor will be reopened on Wednesday: Amit Shah The [Kartarpur Sahib Gurdwara Corridor would be reopened on Wednesday]( Union Home Minister Amit Shah said on Tuesday. The announcement comes ahead of the birth anniversary of Sikhism founder Guru Nanak on Friday. The corridor, inaugurated in 2019, links two important shrines — Dera Baba Nanak in Gurdaspur district of Punjab and Gurdwara Darbar Sahib in Kartarpur, Pakistan, and allows pilgrims to travel visa-free. A Ministry of Home Affairs’ statement said the decision was taken “keeping in view the improved COVID-19 situation.” The operations at the corridor had been suspended since March 16, 2020 on account of the pandemic. “In a major decision that will benefit large numbers of Sikh pilgrims, PM @Narendramodi govt has decided to re-open the Kartarpur Sahib Corridor from tomorrow, Nov 17. This decision reflects the immense reverence of Modi govt towards Shri Guru Nanak Dev Ji and our Sikh community,” Shah tweeted. [Kartarpur Sahib is one of the holiest sites in Sikhism.]  He added, “The nation is all set to celebrate the Prakash Utsav of Shri Guru Nanak Dev ji on 19th of November and I am sure that PM @NarendraModi govt’s decision to reopen the Kartarpur Sahib corridor will further boost the joy and happiness across the country.” Shah had held review meetings with officials to expedite the resumption of the operation of the corridor at an opportune time. Pilgrimage would be facilitated as per the existing procedures and adherence to COVID-19 protocols, the Ministry added. India had signed an agreement with Pakistan on October 24, 2019 on the modalities for operationalisation of the corridor at Zero Point, International Boundary, Dera Baba Nanak. Punjab BJP leader Harjit Singh observed that a group of 250 pilgrims would go to the Kartarpur gurdwara. As reported by The Hindu, the Pakistan government had issued around 3,000 visas to pilgrims to visit gurdwaras in Pakistan, including to Nankana Sahib, Guru Nanak’s birth place. The Kartarpur gurdwara is where he died. [underlineimg] How a coconut should be broken or a pooja should be done is not for constitutional court to look into: CJI Ramana The [Supreme Court on Tuesday said constitutional courts could not interfere with day-to-day rituals]( and sevas performed in temples on the basis of “public interest” petitions. Religious scholars and priests were best equipped to go into the question whether rituals in a temple were being conducted in accordance with customs and traditions. The writ jurisdiction of a constitutional court under Articles 226 and 32 was limited. Whether a particular ritual was being performed in the right way or not was a “disputed question of fact”, the court explained. At most, it could be a subject for filing a civil suit in a subordinate court. “How a coconut should be broken or a pooja should be done in a temple is not for a constitutional court to look into,” Chief Justice of India N.V. Ramana said. The Bench, also comprising Justices A.S. Bopanna and Hima Kohli, was hearing a writ petition filed by Srivari Daadaa alleging that rituals were not being performed as per traditions at the famous Tirumala Tirupati temple. He also complained about the procedure for darshan. Justices Bopanna and Kohli agreed the Supreme Court could not interfere with the daily conduct of rituals in a temple on the basis of a writ petition. The court said, at the most, it could ask the temple administration to clarify in case devotees complain about discrimination or of not allowing darshan while taking into consideration the current public health crisis. Disposing of the case, the court, in its order, directed the Tirupati administration to respond to Daadaa’s grievances regarding darshan procedures and other administrative issues within eight weeks. The court said Daadaa could file a civil suit in a lower court to dispute factual issues regarding the performance of rituals. [underlineimg] Sheena Bora murder case: HC rejects Indrani Mukerjea’s bail plea The [Bombay High Court on Tuesday rejected the bail plea filed by Indrani Mukerjea]( accused of killing her daughter Sheena Bora in 2012. A single bench of Justice Nitin Sambre was hearing the bail plea filed by Mukerjea in October 2020 on merits. She was arrested in August 2015 and has been lodged at the Byculla jail from October that year. Sheena’s partially-burnt body was found in the forests of Maharashtra’s Raigad District on April 24, 2012. On August 6, 2020, a special Central Bureau of Investigation (CBI) court rejected Mukerjea’s bail on merits and said, “There is no doubt that the accused (Ms Mukerjea) is an influential and wealthy person. Therefore, the possibility of influencing prosecution witnesses cannot be ruled out,” the judge said. In November 2018, a special CBI court had rejected her third medical bail plea. Mukerjea was charged under a very serious offence. Although the majority of the trial is completed, the key witness, Rahul Mukerjea, is yet to depose. If she is granted bail, she can tamper with the evidence and witnesses. All her medical needs are taken care of and in case of any serious complications, authorities are competent enough to handle it. There is no medical treatment that JJ or any other hospital cannot offer, the court said. In September 2017, the special court had rejected her second bail plea on grounds of “threat to life inside jail” and said, “the threats are exaggerated” and that she would be much safer inside prison. The court had taken into account the prosecution’s argument that Mukerjea has been kept in a secure jail. The prison premises are guarded round the clock and have CCTV cameras, it had said. In 2016, Mukerjea’s first medical bail plea was rejected by the special court. The case was detected by Mumbai police in 2015 and then transferred to CBI which filed its first chargesheet on November 19, 2015. The supplementary chargesheet was filed on February 14, 2016. The trial which commenced on February 24, 2017, however, is currently stalled. [underlineimg] Biden, Xi agree on need to avoid conflict amid growing differences United States President [Joe Biden and China’s President Xi Jinping on Tuesday agreed on the need to “responsibly”]( manage a competitive relationship but did not arrive at any significant breakthrough on any of the thorny issues that have led to increasingly confrontational ties. The two leaders on Tuesday morning (Monday evening in Washington) spoke for over three hours in their first virtual summit, convened from the Roosevelt Room in the White House and the Great Hall of the People in Beijing. Xi greeted Mr. Biden as an “old friend” while the U.S. President noted that the two, from their time as Vice Presidents, had “spent an awful lot of time talking to one another” and had “never been that formal with one another”. The change in tone was obvious from a March meeting in Alaska between senior officials that saw accusations traded in front of the cameras and marked a turbulent start to the Biden administration’s engagement with China. But pleasantries aside, both sides essentially reinforced their positions on many of the core issues that have strained the relationship. Any headway on these issues would have been a surprise, with expectations ahead of the summit focused firmly on what a senior U.S. administration official had described as discussing “guardrails” rather than on any specific deliverables. The main takeaway was a mutual recognition of the need to manage competition amid differences. Biden called for “common sense guardrails to ensure that competition does not veer into conflict,” the White House said, although its readout did not detail the nature of these measures beyond saying the two leaders talked about how the two sides could continue to engage on a number of areas. The U.S. President also underlined the “importance of managing competition responsibly.” Xi, for his part, said “mutual respect, peaceful coexistence and win-win cooperation” should be the “three principles” guiding ties, the Chinese Foreign Ministry said in its readout. He said the two countries “need to treat each other as equals” and that “no conflict and no confrontation is a line that both sides must hold.” “Drawing ideological lines or dividing the world into different camps or rival groups,” he said, “will only make the world suffer”, calling on the U.S. “to meet its word of not seeking a ‘new Cold War’, with concrete actions.” The unanswered question was how both sides would “responsibly manage” differences when neither appeared to give ground on any of them. The Chinese President said on the one hand that “the key is to manage [differences] constructively so that they don’t magnify or exacerbate” but added that “China will certainly defend its sovereignty, security and development interests.” He added that it was “important that the U.S. properly handle the relevant issues with prudence.” Top of those issues is Taiwan. Biden said the U.S. “strongly opposes unilateral efforts to change the status quo or undermine peace and stability across the Taiwan Strait”. He also “discussed the importance of a free and open Indo-Pacific, and communicated the continued determination of the United States to uphold our commitments in the region,” the White House said, highlighting the “importance of freedom of navigation and safe overflight to the region’s prosperity.” Biden, in effect, said that the U.S. was committed to the status quo from its side on Taiwan, by underlining the country’s commitment to the “one China” policy, the Taiwan Relations Act, the three Joint Communiques and the Six Assurances. Under its one China policy, Washington recognises Beijing alone as the formal government of China, but under the Taiwan Relations Act, the U.S. will support Taiwan if it is attacked by Beijing. Xi, in contrast, referred to what he called “the true status quo of the Taiwan question” which was that “there is but one China in the world and Taiwan is part of China.” “We have patience and will strive for the prospect of peaceful reunification with utmost sincerity and efforts,” he said. “That said, should the separatist forces for Taiwan independence provoke us, force our hands or even cross the red line, we will be compelled to take resolute measures.” Biden also raised “concerns” on China’s actions in Xinjiang, Tibet and Hong Kong and human rights issues more broadly, which brought a response from Xi saying that “democracy is not mass produced with a uniform model” and “dismissing forms of democracy that are different from one’s own is in itself undemocratic.” “China is ready to have dialogues on human rights on the basis of mutual respect,” he said, “but we oppose using human rights to meddle in other countries’ internal affairs.” [underlineimg] Covid Watch: Numbers and Developments The number of reported coronavirus cases from India stood at 3,44,56,108 at the time of publishing this newsletter, with the death toll at 4,63,827. 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