After Sputnik V, Johnson & Johnson poised for India entry as govt eases rules for vaccines

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India on Tuesday decided to fast-track approvals for foreign-produced COVID-19 vaccines that have been granted emergency authorisation in other countries, paving the way first for Johnson & Johnson and then Novavax , both US vaccines, to be produced in the country soon.</p>
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The government’s decision comes amid an acute shortage of vaccines and surging coronavirus infections worldwide.</p>
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“The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country,” the health ministry said in a statement.</p>
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Earlier such emergency approvals for production and distribution of Covid-19 vaccines was given only after “bridge trials” were carried out in India which extended across three phases that took several months.</p>
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The decision comes a day after India gave the go-ahead for the production and distribution of Russia’s Sputnik V vaccine in the country. "Once local production starts India and Russia will not only be looking after  their own needs but also saving lives in third countries," Roman Babushkin, Deputy Chief of Mission in the Russian embassy in New Delhi told India Narrative.</p>
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Leading health experts in the country were also of the view that the long-drawn bridge trials required to prove that foreign vaccines were effective and safe for Indians were delaying the roll out of new shots at a time when there was a dire need to augment capacity which was far short of demand. </p>
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J&J has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine while US pharma giant Novavax has an agreement with Serum Institute of India.</p>
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Since the J&J vaccine has been approved for use in the United States, the European Union and other nations including Thailand and South Africa it can be rolled out  under the new liberalised rules in India. </p>
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Novavax Inc’s COVID-19 vaccine could be cleared for use in the United States as soon as May if U.S. regulators authorize it based on data from the company’s British trial, which could be completed “in the coming weeks,” its chief executive Stanley Erck had said earlier this month.</p>
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Novavax’s vaccine production plants should all be fully functional by April, the company has said.</p>
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Both Johnson & Johnson and Novavax have the support of the Indo-Pacific Quad agreement between the US, India, Japan and Australia to expedite vaccine production as most countries do not have enough doses to fight the deadly Covid-19. Quad agreement signed after Joe Biden took over as US President provides for US and Japanese finance coming together with Indian manufacturing capacity to roll out more vaccines for the war against the pandemic. </p>
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Johnson & Johnson has held talks with the Indian government to start clinical trials of its single-dose COVID-19 vaccine in the country, the company had said on Friday.</p>
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Pfizer which had earlier refused to undertake bridge trials for its vaccine in India is also eligible to import its vaccines in accordance with the new rules. However, it is not considered a mass vaccine as it needs to be stored at -70 degrees Celsius and most countries do not have this deep freeze infrastructure.</p>
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Apart from the foreign vaccines, India will also be approving two more indigenous vaccines for production soon, one being developed by Zydus Cadila and the other, a nasal vaccine, from Bharat Biotech.</p>
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India has emerged as the “pharmacy of the world” during the Covid-19 pandemic supplying vaccines to over 80 countries amid an acute shortage of doses worldwide even as some foreign media reports have been claiming that New Delhi has banned exports.</p>
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However, WHO chief Tedros Adhanom Ghebreyesus has clearly stated that India has not banned exports of vaccines but was understandably prioritising its own needs to tackle a second wave of coronavirus cases.  The WHO is sourcing vaccine supplies from India for the poor countries and clearly has no reason for complaint.</p>
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At the same time India is working on a war footing to produce more vaccines which will be rolled out in the coming months this will help to ameliorate the shortage and the new liberalised rules will help to achieve this goal </p>
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Meanwhile, India has stepped up its inoculation campaign with the vaccination of a record 40.05 lakh people on Monday. However,</p>
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The number of vaccine doses administered in the country have now gone up to an impressive 10.85 million. India has already become the fastest country in the world to administer 100 million doses of Covid-19 vaccine on Saturday, achieving the feat in 85 days to surpass the 89-day record of the USA. China had taken 102 days to reach the 100 million vaccinations mark.</p>