The Evening Wrap: India fast-tracks approval for foreign-made vaccines
| | The Evening WrapTuesday | 13 April, 2021 |  |
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Govt fast-tracks approval for more foreign-produced vaccines |
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In a major shift in vaccine approval policy, the government has decided to fast track approvals for Covid-19 vaccines that have been developed outside India and have been granted the emergency use authorisation (EUA) by other drug regulatory agencies. The decision was taken based on the recommendation made by the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) at a meeting held on April 11 to "expand the basket of vaccines for domestic use and hasten the pace and coverage". The vaccines that would be eligible for the fast-track approval will include those that have been granted an EUA by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or those that have been pre-qualified by the WHO for emergency use. This would mean that Pfizer, Moderna and Johnson and Johnson vaccines would be eligible for fast-track approval. Under the fast-track approval process, the bridging studies will take place in parallel to mass vaccination. So far, clinical trials conducted in India were needed before the Indian regulator could approve the vaccine. But before mass roll-out of the vaccines that are developed and tested abroad can happen, the vaccines will be first given to 100 beneficiaries and these individuals will be assessed for seven days for safety outcomes. "The decision will facilitate quicker access to such foreign vaccines by India and would encourage imports, including import of bulk drug material, optimal utilisation of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic [use]," said a government release. Mamata stages dharna in Kolkata against EC's 24-hour ban on campaigningWest Bengal Chief Minister Mamata Banerjee on Tuesday sat on a dharna to protest against the Election Commission of India (EC) barring her from campaigning for 24 hours beginning 8 p.m. on April 12. A few minutes before noon, Banerjee arrived at the venue and sat alone on a wheelchair in front of a table with books on it. She scribbled notes on paper and also painted on canvas. Hundreds of Trinamool Congress (TMC) supporters, including women, arrived at the venue and waited in silence. Within minutes of the EC order on Monday, the Chief Minister announced her decision to protest. "To protest against the undemocratic and unconstitutional decision of the Election Commission of India, I will sit on dharna tomorrow at Gandhi Murti, Kolkata from 12 noon," Banerjee said on social media. The Trinamool chairperson was scheduled to address four rallies in the day, two in Nadia and two in North 24 Parganas, which had to be cancelled because of the ban. In a five-page order on Monday, the EC expressed dissatisfaction at Banerjee's response to the notices it had sent to her on April 7 and April 8, for violation of the provisions of Model Code of Conduct, Section 123(3) and (3A) of the Representation of the People Act, 1951, among others. The notice on April 7 was related to her remarks that urged people of the minority community not to allow any split of votes and the one on April 8 concerned remarks directed at Central forces, in which she asked people to surround (gherao) the forces. EC issues notice to West Bengal BJP president Dilip GhoshThe Election Commission (EC) on Tuesday issued a notice to West Bengal BJP president Dilip Ghosh for violating provisions of the Model Code of Conduct and the Indian Penal Code by making an "inflammatory statement" threatening the people of Bengal during a public rally in Barangar, North 24 Parganas. The EC said it had received a complaint from All-India Trinamool Congress MP Derek O'Brien about the speech that was "an open threat" to Bengal and its people. Referring to the Central forces firing on a mob on polling day on April 10 in Sitalkuchi, in which four people were killed, Ghosh said the incident would be the start. "Where did so many naughty boys come from? Those naughty boys were shot at yesterday in Sitalkuchi. These naughty boys will not be there in Bengal. This is just the beginning. Those who thought that the Central forces' rifles were meant to be just for show have well understood now the power of cartridges. And this will be carried on throughout Bengal," Ghosh was quoted as saying in the EC notice. Speaking of the fifth round of voting in the Bengal elections, Ghosh had said, "Those who will take the law in their own hands will be given a befitting answer. I hope that you all will queue up to cast your votes in the morning on 17 April. Central forces will be there in the booths. No one can show you an angry eye. Because we are here. And if someone crosses his limits then you have seen what happened in Sitalkuchi. There will be Sitalkuchi in several places. So be careful." Finding the statement to be in violation of the MCC, the IPC and Representation of the People Act, 1951, the EC said Ghosh's speech was "provocative and can seriously incite the emotions and lead to breakdown of law and order thereby adversely affecting the election process." Issuing notice, the EC asked Ghosh to explain his stand by 10 a.m. on Wednesday. In another notice to BJP West Bengal leader Rahul Sinha, the EC said his speech on Monday saying that the Central forces should have killed eight, not four people, during the Sitalkuchi incident was a violation of the MCC, and it banned him from campaigning for 48 hours. Congress debates 'outsourcing' political work after strategist's chats are leakedThe leaked contents of a virtual meeting between election strategist Prashant Kishor and senior journalists has triggered a debate within a section of the Congress party on the question of how far a political party could go in engaging with an external agency while fighting elections. The internal debate was also prompted by the party's experience in Tamil Nadu, where Kishor's organisation, the Indian Political Action Committee or I-PAC, advised the Dravida Munnetra Kazhagam (DMK), which heads an alliance in which the Congress is a junior partner. Congress insiders claim they were witness to a "sense of disquiet" among senior DMK leaders as "core political activities" were decided by the external agency. The Congress' Data Analytics chief, Praveen Chakravarty, who makes sense of the numbers for the party to help devise strategy, questioned the commitment of "external" agencies in terms of ideology. "If a political party outsources its election-fighting to a commercial external vendor, then it leads to the eventual destruction of the very idea of a political party, [which is] building a cadre based on ideology. These vendors' main objective is profits and they circulate strategic information, data, and knowledge of one party to another," said Chakravarty. "A political party outsourcing election management to an external commercial vendor is like the Finance Minister outsourcing the Budget preparation to an external consultant. It is penny wise, pound foolish," he added. The question is important as, recently, Punjab Chief Minister Captain Amarinder Singh re-engaged Kishor, who had advised Singh earlier, as his advisor, and offered him the rank of a Cabinet Minister. The debate is also important as it could decide the party's strategy with regard to Uttar Pradesh elections, scheduled next year, based on the feedback from the current round of elections. For example, in the recently concluded Assembly elections in Assam, irrespective of the outcome, the Congress has put up an impressive fight in the last two-and-half-months through a strong campaign, which included the offer of five guarantees and, among them, 1 lakh jobs. Congress' publicity in Assam was handled by DesignBoxed, which was earlier engaged by the party for the Chhattisgarh elections. Top Republican senator urges CAATSA waiver to India for the S-400 dealA top Republican Senator has urged the Biden administration to give CAATSA waiver to India, saying that any plan to impose sanctions on New Delhi for buying the Russian S-400 missile defence system would undermine its relationship with the U.S. and also affect the QUAD's ability to counter China. Countering America's Adversaries Through Sanctions Act or CAATSA is a tough U.S. law which authorises the administration to impose sanctions on countries that purchase major defence hardware from Russia. Senator Todd Young, a key member of the powerful Senate Foreign Relations Committee, wrote in the prestigious Foreign Policy magazine that if the Joe Biden administration imposes sanctions on India, it would not deter New Delhi's purchase of the S-400 missile system from Russia, but would weaken two strategic fronts at a critical time — undermine Washington's relationship with India and also affect the QUAD's ability to counter China. "Moreover, Russia could take advantage of the sanctions to reclaim its role as India's military partner of choice. Paradoxically then, sanctioning New Delhi over its Russian-made defence system would actually prove to be a geo-strategic victory for Moscow," Young wrote. Alternatively, he urged the Biden Administration to give CAATSA waiver to India. The waiver is intended at preventing U.S. sanctions on countries like India. In October 2018, India signed a $5 billion deal with Russia to buy five units of the S-400 air defence missile systems, notwithstanding warnings from the then Trump administration that going ahead with the contract may invite U.S. sanction. Japan to dump contaminated water from Fukushima nuclear plant into the seaJapan will release more than 1 million tonnes of contaminated water from the destroyed Fukushima nuclear station into the sea, the government said on Tuesday, a move opposed by neighbours, including South Korea and its own fishing industry. The first release of water will take place in about two years, giving plant operator Tokyo Electric Power time to begin filtering the water to remove harmful isotopes, build infrastructure, and acquire regulatory approval. Japan has argued that the water release is necessary to press ahead with the complex decommissioning of the plant after it was crippled by a 2011 earthquake and tsunami, pointing out that similarly filtered water is routinely released from nuclear plants around the world. Nearly 1.3 million tonnes of contaminated water, or enough to fill about 500 Olympic-sized swimming pools, is stored in huge tanks at the Fukushima Daiichi plant at an annual cost of about 100 billion yen ($912.66 million) — and space is running out. "On the premise of strict compliance with regulatory standards that have been established, we select oceanic release," the government said in a statement, adding the project would take decades to complete. Covid Watch: Numbers and DevelopmentsThe number of reported coronavirus cases from India stood at 1,37,35,586 at the time of publishing this newsletter, with the death toll at 1,72,840. In BriefPrivate weather forecast company, Skymet Weather, has said monsoon this year is likely to be 103% of the Long Period Average (LPA). The agency classified it as a "healthy normal" in a press conference on Tuesday. The LPA refers to the average all India monsoon rainfall of 88 cm, which is a 50-year mean. Evening Wrap will return tomorrow. |
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