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India will have to spend $1.4 billion to $1.8 billion in the first phase of a coronavirus vaccination programme, even after getting support under the COVAX global vaccine-sharing scheme, according to estimates by the GAVI vaccines alliance. India, which has the world’s second highest caseload of coronavirus behind the United States, plans to inoculate 300 million people over the next six to eight months, likely with vaccines from AstraZeneca, Russia’s Sputnik, Zydus Cadila and India’s own Bharat Biotech. Documents reviewed by Reuters underline the scale of the funding challenge India faces to immunise its vast population, with 600 million shots required in the first wave alone for critical workers and people most at risk from COVID-19. If India got 190-250 million shots of the vaccine under the COVAX facility – a best case scenario – then the government would need to line up about $1.4 billion to make up for the shortfall, according to an unpublished report prepared for GAVI’s three-da

Covaxin – one of three coronavirus vaccine candidates being considered for emergency use authorisation in India – induced an immune response and registered no serious adverse events, interim findings of Phase I trials have revealed. The vaccine induced a neutralising antibody (an immune response) and was well-tolerated in all dose groups with no vaccine-related serious adverse events, pre-publication data showed. After the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication. The most common adverse event was pain at the injection site, which resolved spontaneously. A patient vaccinated July 30 had a fever and headache five days later. Although this was originally classified as a “serious adverse event”, he later tested positive for COVID-19. Emergency use approval of a drug – which is what Bharat Biotech (and two other firms) have applied for) can be granted if there is sufficient e

Cipla shares gained nearly 5 per cent to top the gainers list on the BSE after the pharma major announced settlement of its patent litigation with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, in the United States. The shares of Cipla touched an intra-day high of ₹ 792.80, up 4.8 per cent in early trading on the back of the news development. At 9:55 am, the shares of Cipla were trading at ₹ 784.75, up 3.89 per cent. on the BSE. As part of the settlement, the parties will file consent judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, Cipla said in a regulatory filing to the stock exchanges.

The US Food and Drug Adminstration on Friday granted the Pfizer-BioNTech Covid-19 vaccine an emergency use authorization, paving the way for its imminent rollout across the country. “I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19,” Denise Hinton, the agency’s chief scientist wrote in a letter to a Pfizer executive. President Donald Trump said the first US vaccine will be administered “in less than 24 hours”. 

Britain’s AstraZeneca said on Friday it would investigate combining its experimental COVID-19 vaccine with Russia’s Sputnik V vaccine candidate, a move Russian scientists have suggested could sharply boost efficacy. The developers of Sputnik V suggested on Twitter last month that AstraZeneca try the combination. “Sputnik V is happy to share one of its two human adenoviral vectors with AstraZeneca to increase the efficacy of (the) AstraZeneca vaccine. Using two different vectors for two vaccine shots will result in higher efficacy than using the same vector for two shots,” they said on Nov. 23. In its statement on Friday, AstraZeneca said it was considering how it could assess combinations of different vaccines, and would soon begin exploring with Russia’s Gamaleya Institute, which developed Sputnik V, whether two common cold virus-based vaccines could be successfully combined. Data published in a journal this week showed that AstraZeneca’s vaccine, being developed along with The Univer

An expert committee convened by the US Food and Drug Administration voted heavily in favor of recommending the Pfizer-BioNTech Covid-19 vaccine for emergency use approval on Thursday. The final voting tally was 17 in favor, four against and one abstention. The committee was tasked with answering whether, “based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risk for use in individuals 16 years of age and older?” The vote by the independent experts and researchers, including infectious disease specialists, biostatisticians and other scientists, isn’t binding but the FDA is expected to follow the recommendation within the coming days. Britain, Canada, Bahrain and Saudi Arabia have already approved the vaccine, the first in the world to complete a large-scale, phase 3 clinical trial. Russian and Chinese vaccines are already being administered on a large scale, but without having completed comparable clinical trials. T

India, the world’s biggest vaccine maker, is getting set for the massive global blitz to contain the coronavirus pandemic with its pharmaceutical industry and partners freeing up capacity and accelerating investments even without firm purchase orders. India manufactures more than 60% of all vaccines sold across the globe, and while its $40 billion pharmaceutical sector is not yet involved in the production of the expensive Pfizer Inc and Moderna shots, the nation will play a pivotal role in immunizing much of the world. Indian companies are set to produce eight, more affordable vaccines designed to fight COVID-19, including AstraZeneca’s Covishield, called the “vaccine for the world” by its developers. “There are many vaccines being produced in countries around the world but there’s only one nation that has the manufacturing capacity to produce sufficient quantities to satisfy the demands of citizens in every country, and that’s India,” said Australia’s ambassador to India, Barry O’Far

Serum institute and Bharat Biotech’s proposals for emergency vaccine use were not cleared today over inadequate safety and efficacy data, sources said on Wednesday. The two have been asked by a panel of experts to provide more data. “Both proposals are not approved due to inadequate safety and efficacy data available currently. Both have been asked for more data,” the sources The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) met today to review the applications of Pfizer, Serum Institute of India and Bharat Biotech. Approvals are a long process and this is only the start, sources said. The committee can only recommend, but the decision to approve vaccines is with the Drugs Controller General of India (DCGI), the health ministry said. “It is standard practice for the government to hold several meetings. The process is expected to go on for one or two weeks,” sources in Serum Institute said on the development.

The Indian equity benchmarks rose to new highs on Wednesday as sustained buying of Indian equities by foreign institutional investors (FIIs) and news of progress in Covid-19 vaccine development cheered investors’ sentiment. The Sensex rose as much as 555 points to hit a record high of 46,164.10 and Nifty 50 index climbed above 13,500 for the first time. HDFC Bank, Reliance Industries, Infosys, Kotak Mahindra Bank and Asian Paints were the top movers in today’s session. The Sensex closed 495 points higher at an all-time high of 46,103 and Nifty 50 index advanced 136 points to settle at record high of 13,529. The markets have been hitting record highs on news of progress in Covid-19 vaccine development amid sustained buying of Indian shares by Foreign Institutional Investors (FIIs), analysts said. FIIs bought shares worth ₹ 2,909.60 crore on Tuesday. Eight of 11 sector gauges compiled by the National Stock Exchange ended higher led by the Nifty Media index’s nearly 4 per cent gain. Banki

American pharmaceutical giant Pfizer, which sought approval from India’s drug regulator Drugs Controller General of India ((DGCI) for emergency use authorisation of its coronavirus vaccine, clarified storage concerns about its vaccine. Pfizer requires a temperature of minus 70 degrees Celsius and experts have raised questions that India’s existing cold storage facilities do not match these conditions. Pfizer told NDTV in a statement that it has “developed detailed logistical plans and tools to support effective vaccine transport, storage and temperature monitoring” and will be using different options for storage, ranging from temperature-controlled thermal shippers to refrigeration units that are commonly available in hospitals. It also said that the pricing of the vaccine will depend on the doses ordered and the advance commitments with the government.

A total of 17 volunteers have been administered Russia’s Sputnik V coronavirus vaccine at a Pune hospital as part of the human clinical trials, doctors said today. Sputnik V vaccine has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and Russian Direct Investment Fund (RDIF). According to reports, India has purchased 100 million doses of the candidate from Russia. “Seventeen healthy volunteers were administered Sputnik V vaccine in the last three days as part of human trials,” Dr SK Raut, Head of Clinical Research Department of Noble Hospital, said.

American pharma giant Pfizer has sought approval from the country’s drug regulator – the DCGI (Drugs Controller General of India) – for emergency use authorisation of its coronavirus vaccine, say sources. The vaccine is ready to be rolled out in the United Kingdom and Bahrain. This is the first such request received by the DCGI amid the race to find a vaccine for the deadly virus, which has affected over 96 lakh people in India. The drug regulator may give emergency approval if it is satisfied by the results of the trials conducted outside India, sources have added. On Wednesday, the United Kingdom became the first western country to clear the Covid-19 shot developed jointly by Pfizer and German biotechnology partner BioNTech, which has reported an efficiency of 95 per cent in the third stage of trials. In its application submitted on Friday, Pfizer India sought permission to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian popul

The Delhi government has directed all public and private medical facilities to finish enrolling their healthcare workers by December 5 midnight for a COVID-19 vaccine, which should be available in a few weeks.  According to sources, many registered and non-registered facilities have already submitted this data as the process had started in October.   The government-run facilities that have not completed the task been told to upload the data on Delhi State Health Mission website — https://dshm.delhi.gov.in. Private health facilities will have to seek login access to submit the names. Healthcare workers include all medical, para-medical, supporting, security, sanitation and administration staff at centre of allopathy, dentistry, Ayush, physiotherapy, diagnostic and radiology labs. The directive comes amid similar exercises being held across states, which recently attended a meeting with Prime Minister Narendra Modi on evaluating their preparedness for a vaccine rollout, including cold st

Britain approved Pfizer’s COVID-19 vaccine on Wednesday, jumping ahead of the United States and Europe to become the West’s first country to formally endorse a jab it said should reach the most vulnerable people early next week. Prime Minister Boris Johnson touted the medicine authority’s approval as a global win and a ray of hope amid the gloom of the novel coronavirus which has killed nearly 1.5 million people globally, hammered the world economy and upended normal life. Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, in record time – just 23 days since Pfizer published the first data from its final stage clinical trial. “It’s fantastic,” Johnson said. “The vaccine will begin to be made available across the UK from next week. It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.” The w

The government today said it had found no reason to stop the Oxford vaccine trials in India after reviewing a Chennai volunteer’s allegation of serious adverse effects, including memory loss and change in behavior. The Adar Poonawalla-led Serum Institute of India (SII) also said the vaccine was “safe and immunogenic” and the Data and Safety Monitoring Board and the Ethics Committee had “independently cleared” the trials after examining the complaint. ”After initial causality assessment, findings did not necessitate stoppage of the Serum trials. SII vaccine trials have entered Phase 3. After reviewing all documents, SII has been given permission to conduct Phase 3 trials. Bharat Biotech also has been allowed to conduct Phase 3 trials,” said Rajesh Bhushan, Health Secretary. The 40-year-old marketing professional was a volunteer for the third phase of the Covid vaccine trial and was administered a dose on October 1. The wife of the volunteer said since he received a trial dose, he had lo

The Serum Institute of India has responded to “malicious and misconceived” allegations by preparing a ₹ 100 crore defamation suit against a Covishield coronavirus vaccine trial participant who claimed to suffer a “virtual neurological breakdown” after being administered a dose. the Serum Institute said that while it sympathised with the volunteer’s medical condition there was “absolutely no correlation with the vaccine trial and the medical condition of the volunteer”. “The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medial problems on the COVID vaccine trial,” the statement said “The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vacci

The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), and Hetero, one of India’s leading generic pharma companies (through its biologics arm “Hetero Biopharma”), have agreed to produce in India over 100 million doses per year of the world’s first registered vaccine against the novel coronavirus infection — Sputnik V. The parties plan to start the production of Sputnik V in the beginning of 2021. The Gamaleya Center and RDIF announced on November 24 positive results obtained during the second interim data analysis of the largest double-blind, randomised, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers. Interim trial results have once again confirmed the high efficacy of the Sputnik V vaccine, the world’s first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors.

Malaysia has agreed to buy 12.8 million doses of Pfizer’s COVID-19 vaccine, becoming the first country in Southeast Asia to announce a deal with the US drugmaker after some expressed reservations over the need for ultra-cold storage. While final trial data showed that Pfizer’s vaccine is 95 per cent effective, many Asian countries are not betting on it partly due to tropical heat, remote island communities and a lack of ultra-cold freezers. Pfizer’s vaccine, jointly developed with German partner BioNTech, must be stored and transported at minus 70 degrees Celsius (-94F), although it can be kept in a fridge for up to five days, or up to 15 days in a thermal shipping box. Prime Minister Muhyiddin Yassin said on Friday that Malaysia would prioritise “high-risk groups… including frontliners, senior citizens, and those with non-communicable diseases, such as heart diseases and diabetes”. Pfizer will deliver the first one million doses in the first quarter of 2021, with 1.7 million, 5.8 mill

AstraZeneca Plc and the University of Oxford, among the front-runners in the quest to deliver a Covid-19 vaccine, face mounting questions about their trial results after acknowledging a manufacturing error. While an announcement Monday by Astra and Oxford showed their shot was 70% effective on average in a late-stage study, the scant details released by the UK partners have sparked worries about whether regulators would clear it. In a later statement, Oxford said a difference in manufacturing processes led to some participants being given a half dose instead of a full one. Astra and Oxford said their vaccine was 90% effective when a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62%. But the head of the US vaccine program known as Operation Warp Speed said the next day that the dose showing the higher level of effectiveness was tested in a younger population, and that the half-dose was given to some people because of an error in the quanti

The news reached Sarah Gilbert Saturday evening that the Covid-19 vaccine she’s developed with AstraZeneca Plc appeared to work. But the University of Oxford professor had expected a key number: Was it more than 90% effective, as others have been — or less? Instead, when her colleague Andrew Pollard called with the results, he wanted to show her slides instead of simple figures. “I didn’t really understand why we would have to go through slides,” she recalled. “But then it became clear — because it’s rather more complicated in our trial.” That complexity has led uncertainty to swirl around one of the front-runners along with Pfizer Inc. and Moderna Inc. in the race for a shot to end the pandemic. Questions about the most effective dose of the vaccine, its safety record and the partners’ approach to testing it have cast doubt on whether the U.S. Food and Drug Administration will clear it. Early Monday, AstraZeneca and Oxford reported results after 131 trial participants in the U.K. and