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No nod for Bharat Bio's Covaxin yet, WHO seeks 'additional clarifications'

  The technical advisory group will now meet on November 3 for a final assessment. The World Health Organisation’s technical advisory group on Tuesday sought “additional clarifications” from  Bharat Biotech  for its Covid-19 vaccine Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine. The technical advisory group will now meet on November 3 for a final assessment. Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine’s Emergency Use Listing (EUL). The technical advisory group met on Tuesday to review data on Covaxin for the emergency use listing of India’s indigenously-made vaccine. “The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” the WHO said in an email response to a question by PTI on the decision re...

Bharat Biotech likely to start manufacturing Covaxin at Pune plant soon

  Animal vaccine maker Hester Biosciences, on the other hand, is setting up a greenfield BSL-3 facility in Gujarat to make Covaxin Covaxin might soon be produced in the neighbourhood of Covishield after Hyderabad-based vaccine maker  Bharat Biotech  started engineering batches of Covaxin at Biovet’s Manjari plant near Pune. Meanwhile, Covaxin production will touch 55 mn doses a month from October.Biovet is an associate firm of Bharat Biotech. “At present engineering batches are on at the Manjari plant. Soon, commercial production will start,” said a source close to the developments. ngineering batches are run to test the functionality of the installed equipment. The Manjari plant spread over 12 hectares was acquired by Biovet. It is a ready to use vaccine plant that belonged to a Merck & Co subsidiary Intervet India. Intervet is exiting business operations in India and has thus sold the Manjari unit to Biovet. Meanwhile, Krishna Ella, chairman and managing director of...

Maharashtra puts the brake on Covid-19 vaccination for 18-44 year olds

State to divert entire Covaxin stock for 45+ Maharashtra has put the brakes on vaccination of persons in the 18-44 years age group and will use the available stock to provide second dose for those above 45 years. The decision has been taken because of non-availability of adequate stock of Covid-19 vaccines, Maharashtra health minister Rajesh Tope said on Tuesday. The state health department has announced diverting the entire stock of 275,000 Covaxin doses, which it had procured for the 18-44 age group, to vaccinate those above 45 years. Doses of Serum Institute of India’s Covishield vaccine meant for 18-44 years too could be diverted for the 45 plus group. Tope indicated challenges in procuring doses but did not disclose the quantum of Covishield which could be diverted. As of now, no instruction has been issued to districts on diverting Covishield doses. While Maharashtra has declared it would divert Covaxin doses meant for 18-44 years, seven other states had last week flagged off sho...

‘We understand India’s need,’ says US about vaccine material supply

  The Biden administration has conveyed to New Delhi that it understands India’s pharmaceutical requirements and promised to give the matter a due consideration The Biden administration has conveyed to New Delhi that it understands India’s pharmaceutical requirements and promised to give the matter a due consideration, observing that the current difficulty in the export of critical raw materials needed to manufacture COVID-19 vaccines is mainly due to an Act that forces American companies to prioritise domestic consumption. President Joe Biden and his predecessor Donald Trump had invoked the war-time Defence Production Act (DPA) that leaves US companies with no option but to give priority to the production of COVID-19 vaccines and Personal Protective Equipment (PPEs) for domestic production to combat the deadly pandemic in America, the worst-hit nation. Since the US has ramped up the production of  COVID-19 vaccines  mostly by Pfizer and Moderna so as to meet the goal of ...

India delays big exports of AstraZeneca vaccine as Covid-19 cases surge

  India is, however, not officially banning Covid-19 vaccine exports. “This is a temporary move until the supply situation stabilises in the country,” said a person close to the development India has put a temporary hold on all major exports of the AstraZeneca coronavirus vaccine made by Serum Institute of India (SII), the world’s biggest vaccine-maker, to meet domestic demand as infections rise, multiple sources confirmed. A person close to the development said that in the light of rising demand for Covid-19 vaccines, the health ministry has conveyed to SII that it should prioritise deliveries to the government of India over export commitments. The entire production of 60 million doses in April will be supplied to the government. India is, however, not officially banning  Covid-19 vaccine  exports. “This is a temporary move until the supply situation stabilises in the country,” said the person. Covid vaccine inventories have hit a low at places like Mumbai, and the gover...

All above 45 years of age to get Covid-19 vaccine from April 1: Govt

  So far, only those above 45 who had certain co-morbidities were allowed to take the vaccine after producing a letter from a registered doctor The government has decided to open up its Covid-19 vaccination drive for all above 45 years of age from April 1, and requested that all eligible people should “immediately register and get vaccinated”. The rest of the population could be considered for vaccination coverage once the current stage is over.The government has decided to open up its Covid-19 vaccination drive for all above 45 years of age from April 1, and requested that all eligible people should “immediately register and get vaccinated”. The rest of the population could be considered for vaccination coverage once the current stage is over. The government has decided to open up its  Covid-19 vaccination  drive for all above 45 years of age from April 1, and requested that all eligible people should “immediately register and get vaccinated”. The rest of the population ...

People show enthusiasm, queue up for vaccination at Tamil Nadu hospitalsV

 In Tamil Nadu, apart from online registration, the state administration also allowed people to walk in and register for coronavirus vaccinations in phase-2. Since Monday morning the vaccination center at the government hospital in Chennai was unusually busy as people walked in to get the Coronavirus vaccine shotThe situation was similar at various government hospitals in Chennai In Tamil Nadu, apart from online registration, the state administration also allowed people to walk in and register for vaccinations Seventy-year old S Jayaraman, who reached the government general hospital in Chennai at 8.30am waited patiently for his turn to register. He said he was not anxious ahead of taking the taking the vaccine and authorities had told him that he could choose the vaccine. Next to Apollo’s main hospital in Chennai, a vaccination center run by the hospital saw a good response. Fifty-eight-year old Venkatramaih, executive director of an automobile company walked into Apollo’s center t...

Australia approves Pfizer Covid vaccine; inoculations to begin next month

  The Therapeutic Goods Administration on Monday gave provisional approval for people aged 16 and over to use the vaccine developed by Pfizer and BioNTech Australia’s medical regulator has approved use of its first coronavirus vaccine, paving the way for inoculations to begin next month. The Therapeutic Goods Administration on Monday gave provisional approval for people aged 16 and over to use the vaccine developed by Pfizer and BioNTech. The regulator said priority would be given to groups that include aged-care residents and workers, frontline healthcare workers, and quarantine workers. Australian Prime Minister Scott Morrison welcomed the development. He said Australia was among the first countries to complete a comprehensive and thorough process to formally approve a vaccine rather than just grant an emergency approval. Australia is aiming to complete inoculations by October. The nation of 26 million people has reported fewer than 30,000 virus cases and a little over 900 deaths...

Mumbai prepares to vaccinate 50,000 daily and put an end to lockdowns

  The city’s Municipal Commissioner Iqbal Singh Chahal and his deputy Suresh Kakani, who’s in charge of the vaccination drive, spoke in separate interviews this week India’s business and financial hub Mumbai, once the country’s coronavirus hotspot, is building facilities to store 10 million doses of the vaccine as it aims to open fully from a strict lockdown. The city’s Municipal Commissioner Iqbal Singh Chahal and his deputy Suresh Kakani, who’s in charge of the vaccination drive, spoke in separate interviews this week before the start of a nationwide rollout on Saturday. Their responses are edited for clarity. Q. What’s the plan? Chahal:  Mumbai’s population that comes under the Municipal Corporation is about 15 million. We plan to create vaccine storage capacity of a little more than 10 million, which will be adequate as the vaccination will be done in phases. We have formed 500 teams, each having two vaccinators, two support staff and one security guard. They will initiall...

Covid-19 vaccine journey takes off; 5.6 mn doses were shipped to 13 cities

The jabs will be administered beginning January 16 Three temperature-controlled trucks filled with Covid-19 vaccine vials pulled out of Serum Institute’s production plant in Pune at 5 a.m on Tuesday, marking the start of a mega immunization drive in the country. The jabs will be administered beginning January 16. The trucks that headed to the Pune Airport were specially designed containers equipped with sensors monitoring location, temperature, light exposure and unusual jolting. The first flight to ship out the vaccine to Delhi was a SpiceJet Boeing-737 carrying 22 boxes. Each box weighing 32 kg contained around 12,000 doses of Covishield vaccines and gel packs- a portable plastic bag filled with refrigerant gel. A GoAir flight to Chennai followed shortly. In all, nine flights transported over 5.6 million doses of the vaccine to 13 cities across the country, prompting civil aviation minister Hardeep Singh Puri’s office to compare the effort to Hanuman carrying Sanjeevani from the Hima...

Centre to bear expenses for first round of Covid-19 vaccination: PM Modi

  Modi said over 300 mn citizens will get the jabs in the next few months in India against only 25 mn people who have received them in over 50 countries in around a month so far. Prime Minister Narendra Modi announced on Monday that the central government will bear the expenses of vaccinating nearly three crore healthcare and frontline workers in the first round and suggested that public representatives, a reference to politicians, should not be part of this initial exercise. Interacting with state chief ministers, Modi underscored the enormity of what he described as the world’s biggest vaccination exercise, which begins from January 16, saying over 30 crore citizens will get the jabs in the next few months in India against only 2.5 crore people who have received them in over 50 countries in around a month so far. The two already approved made-in-India COVID-19 vaccines are more cost-effective than any other in the world and have been developed as per the country’s needs, he said ...

Over 14 tonnes of AstraZeneca-Oxford vaccine to be shipped from Pune today

  Air India, GoAir, IndiGo and SpiceJet will carry the shots Over 14 tonnes of Oxford-AstraZeneca vaccines will be flown from Pune in ten flights on Tuesday. The government inked a contract with Serum Institute of India (SII) for 11 million doses and these would be flown out of Pune in the first phase. SpiceJet will carry the first batch of doses from Pune in its 8 am Delhi flight. While the first flight will carry around 700 kilograms of vaccine, the airline is also using its freights to transport the shots to Kolkata, Guwahati, Hyderabad, Bhubaneswar, and Vijayawada. Air India will be transporting vaccines on its Pune-Ahmedabad flight on Tuesday morning, the airline’s executive director (cargo) Nirbhik Narang confirmed. “Along with Pune, we will also be transporting vaccines from Mumbai. We are fully prepared,” he added. Vaccines will also be carried on IndiGo’s flights from Pune to Chandigarh and on GoAir’s flight to Chennai and Lucknow. While Pune airport will see the bulk of t...

India’s Covid-19 vaccination challenge needs a private sector helping hand

  The media and opposition figures have justifiably asked why Bharat Biotech’s candidate was approved at the same time as AstraZeneca’s, when it hasn’t even finished or published results from Stage III The Indian state faces one of the world’s most formidable challenges: rolling out a Covid-19 vaccination program for 1.3 billion people. To succeed, many things have to go right in a country that usually gets a lot wrong. The government would be wise to enlist the country’s private sector in this gargantuan effort — and soon. The vaccine rollout is already off to a shaky start. The government last week announced emergency approval for two vaccines. The first, a joint effort from AstraZeneca PLC and Oxford University, is being produced by the Serum Institute of India, the world’s largest vaccine manufacturer. The other has been developed by the Indian company Bharat Biotech International Ltd. The media and opposition figures have justifiably asked why Bharat Biotech’s candidate was ap...

Over 1 million people vaccinated against Covid-19 within 10 days in US

  Shots are rolling out from Pfizer Inc. and Moderna Inc., focused at first on hundreds of thousands of health-care workers around the country The U.S. now leads the world in Covid-19 vaccine shots administered, with more than 1.12 million doses given in the first 10 days of its campaign, according to state-by-state data compiled by Bloomberg. Three states have now vaccinated more than 1% of their populations: North Dakota, West Virginia, and Alaska. California leads in total vaccinations at 128,000 shots. The numbers fall short of a U.S. goal to administer 20 million shots in 2020, U.S. officials acknowledged Wednesday. That amount will be disbursed to states by the end of the month, but not in time to be administered. Shots are rolling out from Pfizer Inc. and Moderna Inc., focused at first on hundreds of thousands of health-care workers around the country who have been battling the virus on the front lines in hospitals. The vaccines require two shots weeks apart to deliver the h...

China’s Covid-19 vaccine over 50% effective, but Sinovac withholds data

  Chinese vaccine developers have been slow compared with their western peers in releasing efficacy data on their shots A Covid-19 vaccine developed by Chinese pharmaceutical firm Sinovac Biotech Ltd. was found to be more than 50% effective in a Brazilian clinical trial, though researchers delayed releasing more information at the request of the company. A 50% efficacy rate is a minimum standard set by U.S. regulators for emergency authorization of Covid vaccines. Messenger RNA vaccines from Moderna Inc. and Pfizer Inc. have produced far better results, reducing symptomatic Covid cases by well over 90% in giant trials. Chinese vaccine developers have been slow compared with their western peers in releasing efficacy data on their shots. As millions of healthy people count on transparency in trials before taking a shot, the lack of more specific results from Sinovac’s trial risks eroding confidence in vaccines from China. Hong Kong on Wednesday said residents will be allowed to choos...

A ‘mission of the century’ as airlines prep for gargantuan vaccine supply

  Laid low by a Covid-19 outbreak that’s decimated passenger demand, airlines will be the workhorses of the attempt to eradicate it, hauling billions of vials to every corner of the globe In cooled warehouses on the fringes of Frankfurt airport, Deutsche Lufthansa AG is preparing its depleted fleet for the gargantuan task of airlifting millions of doses of the vaccines meant to end the global pandemic. Lufthansa, one of the world’s biggest cargo carriers, began planning in April in anticipation of the shots that Pfizer Inc. to Moderna Inc. and AstraZeneca Plc are developing in record time. A 20-member task force is at work devising how to fit more of the crucial payload onto the airline’s 15 Boeing Co. 777 and MD-11 freighters, along with hold space in a vast passenger fleet now flying at just 25% of capacity. “The question is how we scale it up,” said Thorsten Braun, who leads Lufthansa’s part in the global effort. Laid low by a Covid-19 outbreak that’s decimated passenger demand,...

China’s COVID-19 vaccine trials suspended in Brazil after ‘severe incident’

  The health regulator in a statement referred to the “incident”, that occurred on October 29, without revealing further information Brazil’s health regulator Anvisa said on Monday it has suspended clinical trials of China’s Sinovac COVID-19 vaccine, following a “severe incident”.The health regulator in a statement referred to the “incident”, that occurred on October 29, without revealing further information. “National Health Surveillance Agency ANVISA has temporarily suspended human testing of the Chinese vaccine Coronavac due to ‘a serious adverse effect,'” Sputnik reported, citing Anvisa’s statement. President Jair Bolsonaro on Monday had said that their government would buy whatever coronavirus vaccine is certified by Anvisa. Brazil’s move to suspend the clinical trials of the Chinese vaccine comes amid a rising number of coronavirus cases. On Monday, the country registered 10,917 new cases, taking the country’s tally to 5,590,025, while deaths rose to 161,106. The setback for ...

Moderna vaccine appears safe, shows signs of working in older adults: Study

  Moderna COVID-19 vaccine appears safe, shows signs of working in older adults – study CHICAGO (Reuters) – Results from an early safety study of Moderna Inc’s coronavirus vaccine candidate in older adults showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults, with side effects roughly on par with high-dose flu shots, researchers said on Tuesday. The study, published in the New England Journal of Medicine, offers a more complete picture of the vaccine’s safety in older adults, a group at increased risk of severe complications from COVID-19. The findings are reassuring because immunity tends to weaken with age, Dr. Evan Anderson, one of the study’s lead researchers from Emory University in Atlanta, said in a phone interview. The study was an extension of Moderna’s Phase I safety trial, first conducted in individuals aged 18-55. It tested two doses of  Moderna’s vaccine  – 25 micrograms and 100 micrograms – in 40 adults aged...