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Vaccine manufacturers frame plans to boost production

Vaccine makers have started drawing up plans to expand production as they await further clarity on pricing from the central government and orders from the state governments. But supply is expected to increase only from June.

At the meeting with Prime Minister Narendra Modi on Tuesday evening, vaccine companies were asked to scale up capacities and it is expected that Serum Institute of India’s (SII) capacities will go up by May. It is estimated that production by SII and Bharat Biotech along with Sputnik imports will result in a supply of 200 million vaccines in June, compared to 70 million currently. Vaccine makers were also asked to negotiate prices with hospitals for private market.

The companies, on their part, have requested the government to price jabs at globally competitive rates. Low prices in India could set a benchmark for unremunerative export prices, they said. Companies manufacturing vaccines are looking at a price of Rs 500 to Rs 1,000 per dose for the Indian private market, industry insiders told ET.

Bharat Biotech on Tuesday announced that it will manufacture 700 million doses of the Covaxin vaccine annually. It plans to export the vaccine to over 60 countries and it has fixed a price of $15 to $20 per dose for the international markets. In India, the company could offer the vaccine around $10 per dose, ET has learnt.

‘Tieups with Multiple Channels Likely’

Dr Reddy’s Laboratories plans to import 50 million doses of the Sputnik V vaccine by May end or June, said company officials. The vaccine will be sold at $9 per dose in India. “We will reach out to multiple channels and collaborate with them — central government, state governments, private sector, healthcare service providers,” Dr Reddy’s spokesperson told ET.

Supply of the Russian vaccine is expected to increase after June when the bridging trials conducted by its local contract manufacturers are approved and the drugs regulator inspects their facilities.

The drugs regulator has started inspection of companies such as Hetero Healthcare which has signed up with RDIF (Russian Direct Investment Fund), the country’s sovereign fund that is backing the Sputnik vaccine.

Johnson and Johnson, the US drug major, has submitted an application on Monday to the Drugs Controller General of India (DCGI) requesting approval to conduct a bridging clinical study of its single-dose Janssen Covid-19 vaccine candidate in India. This is likely to be approved by July.

In an interview to ET earlier this month, Ahmedabad-based

Cadila

had said that it was going to submit data for its DNA vaccine — which will have three doses — for approval in June. The company has a capacity of manufacturing 10 million doses per month with a provision to expand the facility if needed, and is planning to price the vaccine at Rs 250 per dose.

Meanwhile, state officials in Maharashtra said that they were ready to procure the vaccines from companies.

“We were at the mercy of the central government for vaccines. If we get the option to procure on our own, we will go the extra mile to vaccinate citizens of Mumbai,” said a senior BMC official. “We have enough budget to vaccinate 8 million Mumbai citizens,” the official added.

Johnson and Johnson yet to give info for bridge trial: Sources

Two months after US-based pharma major Johnson and Johnson (J&J) said it will conduct a bridging trial of its single-dose vaccine in India, it has failed to make much headway, people in the know told ET.

“The company is yet to provide information that was sought before giving it a go-ahead to conduct a bridging trial,” the same people said. The company was asked to submit information such as complete details of the product, clinical evidence as well as documents related to the efficacy and safety of the product.

The company did not respond to an email sent by ET. On May 20, the company had told ET that it was “closely working with the government to resolve the issue”.

J&J had approached India’s drug regulator for conducting a bridging trial after India relaxed regulatory requirement for imported vaccines.

J&J’s application was returned to the company (immediately after it applied in April) after the regulatory body found certain discrepancies in it and the company has not got back since April, said a person.

The company wants to conduct a bridging trial and had not asked for a waiver as it is entitled to under a relaxed regulatory regime that was put in place in April. “As part of the ongoing process, we have also submitted additional information requested by the DCGI office. We are working closely with the regulatory agency to facilitate the review,” J&J had said in a statement on May 20.

Earlier in a statement to ET on May 14, J&J said it was awaiting approval from the Drugs Controller General of India (DCGI) for bridging trials of its one-dose Covid-19 vaccine.

In April, India had said it will allow easy access and regulatory clearances to US FDA or EU approved vaccines. The study by J&J is aimed to comply with local regulations. The company had earlier said that the application was in line with its commitment to provide safety and efficacy data necessary to support worldwide emergency use of the Janssen vaccine candidate.

Must extend side-effects monitoring to 28 days after vaccination: Top official

(This story originally appeared in on May 16, 2021)

All states should monitor vaccine recipients for Adverse Events Following Immunisation (AEFI) for 28 days, a top public health official has said. Currently, recipients are monitored for AEFI for the first 72 hours after receiving a jab.

Dr NK Arora, member of the national AEFI Adverse Events Following Immunization (AEFI) committee, said with more vaccines set to enter the market, monitoring for side-effects should be enhanced.

He added that all AEFI data will soon be up on a public portal, a move many health experts have been calling for.

Dr Arora said out of seven crore vaccine recipients assessed so far, less than 0.5% cases have involved severe AEFIs.

“We have submitted detailed analyses to the government. The data should be out soon,” he said.

He said that longer monitoring durations was essential and was the norm in many countries.

“All states should direct local authorities to develop a mechanism which will allow recipients to report side effects for 28 days. This system should record such events and update them on the CoWIN website,” he said.

Many health experts have called for the release of AEFI data. They said that publicly available information on side effects can help reduce vaccine hesitancy.

All the Covid-19 vaccines are new and experts said extensive follow-ups are needed with recipients to look for unusual adverse events.

There are five types of AEFIs: vaccine product-related reaction, vaccine quality defect-related reaction, immunisation error, immunisation anxiety-related reaction and coincidental event.

It’s the job of the national AEFI committee to determine the type of event a recipient has suffered from.

Earlier this week, the Centre said the country can expect to have 25-30 crore doses available per month with international vaccines arriving too.

“The companies will be carrying out bridging trials with 1,500-1,600 volunteers at different sites for Johnson and Johnson and Novovax. These trials will be carried out even as the vaccines are being utilised,” Dr Arora said.

Brexit to take full effect as UK leaves EU single market

London: Brexit becomes a reality on Thursday as Britain leaves Europe’s customs union and single market, ending nearly half a century of often turbulent ties with its closest neighbours.

The UK‘s tortuous departure from the European Union takes full effect when Big Ben strikes 11:00 pm (2300 GMT) in central London, just as most of the European mainland ushers in 2021 at midnight.

Brexit has dominated British politics since the country’s narrow vote to leave the bloc in June 2016, opening deep political and social wounds which remain raw.

But both sides are now keen to move on to a new future.

Prime Minister Boris Johnson called Brexit “a new beginning in our country’s history and a new relationship with the EU as their biggest ally”.

“This moment is finally upon us and now is the time to seize it,” he added. The British pound surged to a 2.5-year peak against the US dollar before the long-awaited departure from the single market.

Legally, Britain left the EU on January 31 but has been in a standstill transition period during fractious talks to secure a free-trade agreement with Brussels, which was finally clinched on Christmas Eve.

Once the transition ends, EU rules will no longer apply, with the immediate consequence being an end to the free movement of more than 500 million people between Britain and the 27 EU states.

Customs border checks will be back for the first time in decades, and despite the free-trade deal, queues and disruption from additional paperwork are expected.

Symbolic departure – Britain
A financial and diplomatic big-hitter plus a major NATO power — is the first member state to leave the EU, which was set up to forge unity after the horrors of World War II.

The EU has lost 66 million people and an economy worth $2.85 trillion, but Brexit, with its appeal to nationalist populism, also triggered fears other disgruntled members could follow suit.

“It’s been a long road. It’s time now to put Brexit behind us. Our future is made in Europe,” Commission president Ursula von der Leyen said on Wednesday, as she signed the trade pact.

British pro-Brexit newspapers hailed the new post-EU era. “A new dawn for Britain,” said the Daily Mail. The Sun said: “The New Year marks a glorious new chapter.”

The Daily Express evoked wartime prime minister Winston Churchill and called 11:00 pm the country’s “finest hour”.

But the Daily Telegraph, where Johnson made his name as a Brussels-bashing Europe correspondent, sounded a note of caution, with the EU having long been blamed for the country’s ills.

“Politicians will have to get used to bearing much greater responsibilities than they have been used to while the UK has been in the EU,” it said.

New beginning
In January, flag-waving Brexiteers led by populist anti-EU former lawmaker Nigel Farage cheered and pro-EU “remainers” mourned.

But no formal events are planned for the end of the transition.

Public gatherings are banned due to the coronavirus outbreak, which has claimed more than 72,000 lives and infected more than 2.4 million in Britain, including Johnson himself.

Johnson is looking not only to a future free of Covid but also of rules set in Brussels, as Britain forges its own path for the first time since it joined the then European Economic Community in 1973.

On Wednesday, he hailed regulatory approval of Oxford University and

AstraZeneca

‘s Covid vaccine, and a “new beginning” for a prosperous, more globally focused Britain.

As well as ensuring tariff- and quota-free access to the EU’s 450 million consumers, Britain has recently signed trade deals with countries including Japan, Canada, Singapore and Turkey.

It is also eyeing another with India, where Johnson plans to make his first major trip as prime minister next month, and with incoming US president Joe Biden’s administration.

Practical application
In the short term, all eyes will be closer to home and focused on how life outside the EU plays out in practical terms, from changes in pet passports to driving licence rules.

That includes disruption at the ports, stoking fears of food and medicine shortages, as well as delays to holidaymakers and business travellers used to seamless travel in the EU.

British fishermen are disgruntled at a compromise to allow continued access for EU boats in British waters.

The key financial services sector also faces an anxious wait to learn on what basis it can keep dealing with Europe, after being largely omitted from the trade deal.

Northern Ireland’s border with EU member state Ireland will be closely watched to ensure movement is unrestricted — a key plank of a 1998 peace deal that ended 30 years of violence over British rule.

And in Scotland, where most opposed Brexit, Johnson faces a potential constitutional headache from a resurgent independence movement.

Joe Biden to urge G-7 leaders to call out, compete with China

The United States plans to push democratic allies on Saturday to publicly call out China for forced labour practices as the Group of Seven leaders gather at a summit where they will also unveil an infrastructure plan meant to compete with Beijing’s efforts in the developing world.

The provocative proposal is part of President Joe Biden’s escalating campaign to get fellow democratic leaders to present a more unified front to compete economically with China in the century ahead, according to two senior administration officials who briefed reporters on the condition of anonymity because they were not authorized to discuss the plans for the seaside summit publicly.

The officials said Biden wanted G-7 leaders to speak out in a single voice against forced labour practices targeting Uyghur Muslims and other ethnic minorities.

Biden hopes the denunciation will be part of the joint communique released at the summit’s end, but some European allies have been reluctant to so forcefully split with Beijing. It may not be clear until the three-day summit ends on Sunday whether the leaders will take that step.

The wealthy nations’ leaders were all smiles and unity as they were welcomed to the summit on Friday by British Prime Minister Boris Johnson on the freshly raked sand of Carbis Bay for their first gathering since 2019.

Last year’s gathering was canceled because of COVID-19, and recovery from the pandemic is dominating this year’s discussions, with members of the wealthy democracies’ club expected to commit to sharing at least 1 billion vaccine shots with struggling countries.

China also loomed large over the meeting on the craggy coast of Cornwall. Biden’s proposed critique of China’s labour practices was to be raised as the allies unveil an infrastructure proposal dubbed “Build Back Better for the World,” a name that echoes the slogan of the American president’s election campaign.

The plan calls for spending hundreds of millions of dollars in collaboration with the private sector. It’s designed to compete with China’s trillion-dollar “Belt and Road Initiative,” which has launched a network of projects and maritime lanes that already snake around large portions of the world, primarily Asia and Africa.

Critics say the projects often create massive debt and expose nations to undue influence by Beijing.

Not every European power has viewed China in as harsh a light as Biden, who has painted the rivalry with the techno-security state as the defining competition for the 21st century. But there are signs that Europe is willing to put greater scrutiny on Beijing.

Weeks before Biden took office last year, the European Commission announced it had come to terms with Beijing on the Comprehensive Agreement on Investment, a deal meant to provide Europe and China greater access to each other’s markets. The Biden administration had hoped to have consultations on the pact.

But the deal has been put on hold, and the European Union in March announced sanctions targeting four Chinese officials involved with human rights abuses in Xinjiang. Beijing, in turn, responded by imposing sanctions on several members of the European Parliament and other Europeans critical of the Chinese Communist Party.

Biden administration officials see the moment as an opportunity to take concrete action to speak out against China’s reliance on forced labor as an “affront to human dignity.”

While calling out China in the communique wouldn’t create any immediate penalties for Beijing, one senior administration official said the action was meant to send a message that the G-7 was serious about defending human rights and working together to eradicate the use of forced labor.

An estimated 1 million people or more – most of them Uyghurs – have been confined in reeducation camps in China’s western Xinjiang region in recent years, according to researchers. Chinese authorities have been accused of imposing forced labor, systematic forced birth control, torture and separating children from incarcerated parents.

Beijing rejects allegations that it is committing crimes.

Opening three days of talks in southwest England, Johnson on Friday warned that world leaders must not repeat errors made over the past 18 months – or those made during the recovery from the 2008 global financial crisis.

“It is vital that we don’t repeat the mistake of the last great crisis, the last great economic recession in 2008, when the recovery was not uniform across all parts of society,” he said after leaders posed for a “family photo” by the sea.

“And I think what’s gone wrong with this pandemic, and what risks being a lasting scar, is that I think the inequalities may be entrenched,” Johnson added.

The leaders of the G-7 – which also includes Canada, France, Germany, Italy and Japan – hope the meeting at the seaside resort will energize the global economy.

As Johnson led the politicians off the beach, French President Emmanuel Macron threw his arm around the shoulders of Biden, whom he was meeting for the first time. The two men will have more formal talks on Saturday, a meeting between allies who recalibrated their relationship during the four years of President Donald Trump‘s “America first” foreign policy.

Macron’s preference for multilateralism was out of step with Trump’s isolationist tendencies. But the Trump era was often framed by Macron as a clarifying moment – one in which Europe had to step forward as America drifted away from alliances and toward Trumpism.

In Video: Coronavirus set to dominate discussions as G-7 summit begins