Coronavirus vaccine news highlights: Amid pandemic, vaccine's restricted use considered on safety, immunogenicity data, says ICMR chief

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. Global leaders have lauded India's leadership in scientific innovation and decisive action to combat the Covid-19 pandemic, as the country gets set to begin the world's largest vaccination drive against the novel coronavirus.

The Drug Controller General of India on Sunday approved the Oxford Covid-19 vaccine Covishield, manufactured by the Serum Institute and indigenously developed Covaxin of Bharat Biotech, for restricted emergency use in the country, paving the way for a massive inoculation drive.

. All Indian vaccines being developed against the coronavirus will have to be stored at 2-8 degrees Celsius as the logistics have been worked out while considering temperature as a factor, Department of Biotechnology Secretary Renu Swarup said on Tuesday.

. In a pandemic situation, restricted emergency use of vaccines is considered based on safety and immunogenicity data while phase three clinical trial is underway, Indian Council of Medical Research (ICMR) chief Balram Bhargava said on Tuesday.

Explaining the process followed in granting nod to Oxford Covid-19 vaccine and indigenously developed Covaxin, he said, "The existing pandemic situation, high mortality, available science and lack of definitive treatments were considered by the subject expert committee (SEC) on Covid-19 of CDSCO for granting accelerated approval to these vaccines, and that is in our legal provision."

. More Chinese cities have begun mass Covid-19 vaccinations after the New Year holidays, days after China granted conditional approval for its domestically produced vaccine as the country prepares for the Spring Festival holiday next month.

Given the goal of vaccinating 50 million people ahead of the Spring Festival, which also marks the Chinese New Year holidays, a number of cities -- including Beijing, Shanghai, Shenzhen in South China's Guangdong Province, Luliang and Linyi -- have already started mass inoculations of the vaccine, covering nine key groups of people, the state-run Global Times reported on Tuesday

. Mounting pressure on the Uddhav Thackeray-led Maha Vikas Aghadi government, the opposition BJP on Tuesday demanded free vaccination for every resident of Maharashtra.

BJP MLA and spokesperson Ram Kadam has shot off a letter to Thackeray and state’s public health and family welfare minister Rajesh Tope in this regard.

. The Union government has not banned the export of any Covid-19 vaccine that has been granted restricted emergency use approval by the drug regulator, the Health Ministry said on Tuesday, while urging the media to guard against the spread of such misinformation.

The Drugs Controller General of India (DCGI) had on Sunday approved Oxford Covid-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

Responding to a question during a press briefing on Tuesday, Union Health Secretary Rajesh Bushan said, "The Union government has not banned the export of any one of the Covid-19 vaccines and this should be absolutely clear."

. The Telangana government has put in place arrangements, including storage, for the Covid-19 vaccines and can administer the shot to about three core eligible population in the state over a period of one month, a health department official said on Tuesday.

About 10 lakh people can be vaccinated in the state per day, he said, two days after the country's drug regulator gave approval for restricted emergency use of Oxford's Covishield, manufactured by the Serum Institute, and Covaxin of Bharat Biotech here.

The state government has created the capacity to store at least three crore vaccine doses -- 1.5 crore doses at the state vaccination centre and another 1.5 crore at ten other places, he told PTI.

. Brazil's government will requisition surplus stocks from the country's syringe and needle manufacturers as it prepares to start a national vaccination campaign against Covid-19 without having secured supplies.

The Health Ministry announced the measure late on Monday and said it was still planning to hold another bidding session to buy the syringes from Brazilian producers.

"This requisitioning aims to meet the most pressing needs to start the national vaccination plan," the ministry said in a statement, adding that it awaited data on available stocks from the manufacturers.

. Indian drug regulators approved vaccines by Bharat Biotech and Serum Institute of India for restricted use on Sunday. To facilitate a smooth implementation of its ambitious inoculation campaign, the Centre has developed the digital platform CoWIN.

Here is what you need to know about the app and how to register

. This daunting challenge is not only for India but also for all the governments across the globe as they start inoculating their populations to tackle the pandemic, noted Dr Soumya Swaminathan, Chief Scientist of WHO, and Dr Hamsadvani Kuganantham, Consultant, WHO.

. India to get first shots of Covid-19 vaccine on January 13, according to multiple media reports, on Tuesday.

. "There are 4 primary vaccine stores called GMSD located in Karnal, Mumbai, Chennai and Kolkata and there are 37 vaccine stores in the country. They store vaccines in bulk and distributes further," Union Health Secretary Rajesh Bhushan .

"The facility including the number of vaccines stored and temperature trackers is monitored digitally. We have this facility for over a decade in the country," he said.

. Rajasthan Chief Minister Ashok Gehlot on Tuesday said the exchange of remarks between the Serum Institute of India and Bharat Biotech over their Covid-19 vaccines is “unfortunate”, and sought Prime Minister Narendra Modi's intervention.

Taking to Twitter, he said the "bayanbaazi" (remarks) between the Serum Institute and Bharat Biotech after the approval of their vaccines by India's drug regulator, is unfortunate.

"It is a sensitive issue in which PM must intervene," Gehlot tweeted in Hindi.

. SII chief Adar Poonawala and Bharat Biotech CMD Krishna Ella issued a joints tatement communicating their combined intent to develop manufacture and supply the Covid-19 vaccines for India and globally.

The joint statement calling truce comes after Bharat Biotech's Ella responded strongly on Poonawalla's 'safe as water' remark questioning the efficacy of Covaxin. . The absolute number of people infected with Covid-19 in India may never be known but much of the scientific community agrees the downward trajectory of the disease is real and can likely be attributed to ‘localised’ herd immunity and a younger population.

As scientists attempt to understand India's sliding Covid count, the country on Monday recorded 16,504 new Covid-19 cases, more than six times lower than the highest daily spike of 97,894 on September 16.

. The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for Covid-19, the illness caused by the virus.

Experts advise against antibody drugs in pediatric Covid-19

As of now, antibody therapies for Covid-19 should not be used to treat infections with the new coronavirus in children or adolescents, "including those ... at high risk of progression to hospitalization or severe disease," according to a panel of experts from 29 hospitals across North America who reviewed the available evidence.

Disinfecting during pandemic puts asthmatics at risk

Increased cleaning by people with asthma during the pandemic may be triggering flares of their disease, a new report suggests. Researchers who surveyed 795 U.S. adults with asthma between May and September found the proportion who disinfected surfaces with bleach at least five times a week rose by 155% after the pandemic started. Use of disinfectant wipes, sprays, and other liquids also increased, the researchers reported in Journal of Allergy & Clinical Immunology: In Practice.

News reports paint overly rosy picture of blood treatment

News reports about critically ill Covid-19 patients treated with a last-ditch procedure known as extracorporeal membrane oxygenation, or ECMO, may be painting an unrealistic picture of outcomes, a study suggests. During ECMO, blood is pumped outside of the body through a machine that removes carbon dioxide and adds oxygen before returning the blood back to the body. In a review of media reports about ECMO treatment of Covid-19, doctors found that 92% of patients in the stories survived, whereas average survival rates after ECMO in large studies have ranged from 53% in children to 63% in young and middle-aged adults.

. Indonesia will begin its nationwide Covid-19 mass vaccination programme on Jan. 13, the country's health minister said on Tuesday.

The programme will launch in Jakarta, with President Joko Widodo set to be given the first shot, Budi Gunadi Sadikin said in a statement, and vaccinations in other regions are set to start in the next two days.

. England back in lockdown

England woke up on Tuesday to a new national lockdown to contain a surge in Covid-19 cases that threatens to overwhelm parts of the health system before a vaccine programme reaches a critical mass.

Non-essential shops and hospitality remain closed, while primary and secondary schools close from Tuesday for all students except vulnerable children and those whose parents are key workers.

Most US Covid-19 vaccines sit unused

More than two-thirds of the 15 million coronavirus vaccines shipped within the United States have gone unused, US health officials said on Monday, as the governors of New York and Florida vowed to penalize hospitals that do not dispense shots quickly.

Medical authorities have confronted widespread distrust of immunization safety, even among some healthcare workers, owing in part to the record speed with which Covid-19 vaccines were developed and approved, 11 months after the virus emerged in the United States.

Indonesia vaccinating its working population first

Indonesia's mass vaccination programme is set to start next week, a senior minister said on Monday, pending authorisation from the country's food and drug agency (BPOM), as about 700,000 doses of vaccines have already been widely distributed.

Its plan to prioritise working-age adults over the elderly, aiming to reach herd immunity fast and revive the economy, will be closely watched by other countries.

. Global leaders have lauded India's leadership in scientific innovation and decisive action to combat the COVID-19 pandemic, as the country gets set to begin the world's largest vaccination drive against the novel coronavirus.

The Drug Controller General of India on Sunday approved the Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute and indigenously developed Covaxin of Bharat Biotech, for restricted emergency use in the country, paving the way for a massive inoculation drive.

Director-General of the World Health Organization Tedros Adhanom Ghebreyesus tweeted that India "continues to take decisive action & demonstrate its resolve to end #COVID19 pandemic". "As the world’s largest vaccine producer, it’s well placed to do so. If we #ACTogether, we can ensure effective & safe vaccines are used to protect the most vulnerable everywhere," Ghebreyesus said and tagged Prime Minister Narendra Modi in his tweet.

. The emergence in Britain and South Africa of two new variants of Sars-CoV-2, which are potentially far more infectious versions of the virus, has prompted widespread concern. Here is what we know -- and what we don't -- about the mutations.

All viruses mutate when they replicate in order to adapt to their environment.

Scientists have tracked multiple mutations of Sars-CoV-2, the virus that causes Covid-19, since it appeared in China in late 2019.

The vast majority of mutations did not materially alter either the virus's virulence or transmissibility.

However, one mutation -- variant B117, which likely emerged in southeastern England in September, according to Imperial College London -- has now been detected in countries across the world, including the US, France and India.

. That at least one, and potentially two, Covid-19 vaccines could be ready for a mass roll out in the next few months is indeed a good start to the new year. Yet, the fact that regulatory approvals have been granted, even if they are only emergency authorisations, to the Oxford University-AstraZeneca-Serum Institute’s Covishield and Bharat Biotech’s Covaxin even before their phase 3 trial data is available has caused concern over the seeming haste. Emergency authorisations have been given to vaccines in the US and UK, too, but not without data from the phase 3 trials in those countries.

. A pharmacist who was arrested on charges that he intentionally sabotaged more than 500 doses of the Covid-19 vaccine at a Wisconsin hospital was “an admitted conspiracy theorist” who believed the vaccine could harm people and “change their DNA,” according to the police in Grafton, Wisconsin, where the man was employed.

The police said Steven Brandenburg, 46, who worked the night shift at the Aurora Medical Center in Grafton, had twice removed a box of vials of the Moderna vaccine from the refrigerator for periods of 12 hours, rendering them “useless.”

. Twenty more persons tested Covid-19 positive with the UK strain of SARS-CoV-2 virus, taking the total number of infections of the mutant strain in India to 58, according to the Union Health Ministry.

The Centre has advised states to step up surveillance and containment measures.

. Bharat Biotech's Chairman and Managing Director Krishna Ella expressed on Monday that the company's indigenously made coronavirus vaccine, Covaxin is effective against new novel coronavirus strains and said that the company would in a week put out data to prove the "hypothesis".

. A Washington law student ended up getting more than just groceries during a recent supermarket trip, after randomly receiving a Covid-19 vaccination.

David MacMillan and his friend were at a Giant Food store in the US capital last week and were surprised when a worker in the supermarket's pharmacy section offered them each a shot.

Getting a vaccination had not been on the pair's shopping list, and currently the vaccine is being prioritised for emergency responders and other frontline workers.

MacMillan posted a recording of him getting the shot on TikTok, where it had been viewed more than 700,000 times on the short-form video sharing platform as of Monday.

He said he and his friend were offered the vaccine because health care workers had not shown up for their appointments to get the doses.

. USdrugmaker Moderna Inc said on Monday that Israel's health ministry had authorized its Covid-19 vaccine, marking the vaccine's third regulatory authorization and the first outside North America.

"Ministry of Health of Israel has secured 6 million doses and first deliveries (are) expected to begin in January," Moderna said in a statement.

Moderna has received authorization for its Covid-19 vaccine in the United States and Canada and additional authorizations are currently under review in the European Union, Singapore, Switzerland and the United Kingdom.

. Coming down heavily on critics expressing doubts about the Bharat Biotech's indigenously developed coronavirus vaccine Covaxin, the Hyderabad-based biotech major's managing director Dr Krishna Ella on Monday slammed the critics for targeting Indian clinical trials and asked why they were not questioning the UK clinical trials of another vaccine.

(ANI)

. Follow updates here .

. India 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.

. Indian drug regulators recently approved vaccines of the Serum Institute of India and Bharat Biotech against Covid-19, paving the way for one of the biggest vaccination drives in the world. The Drug Controller General of India (DCGI) gave its nod following the recommendations of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

. Scientists are not fully confident that Covid-19 vaccines will work on a new variant of the coronavirus found in South Africa, ITV's political editor said on Monday, citing an unidentified scientific adviser to the British government.

Both Britain and South Africa have discovered new, more infectious variants in the coronavirus in recent weeks that have driven a surge in cases. British Health Secretary Matt Hancock said on Monday he was now very worried about the strand found in South Africa.

. New York, the onetime center of the pandemic, faced a growing crisis on Monday over the lagging pace of coronavirus vaccinations, as deaths continue to rise in the second wave and Gov. Andrew M. Cuomo came under mounting pressure to overhaul the process.

The small number of vaccine recipients is particularly striking in New York City, where roughly 110,000 people — in a city of more than 8 million — have received the first of two doses necessary to help prevent serious cases of the disease. That is about a quarter of the total number received by the city.

The concern over vaccinations in New York echoes problems reported during a sluggish rollout across the nation, and comes as a man in his 60s became the state’s first confirmed case of a more contagious variant of the virus.

. A COVID-19 vaccine candidate from Chinese firm Stemirna Therapeutics obtains approval to conduct human testing from China's medical products regulator, the firm's partner said on Tuesday.

The potential vaccine, which Stemirna has started working on since January last year, is based on messenger RNA (mRNA) technology, Tibet Rhodiola Pharma, which is jointly developing the candidate with Stemirna, said in a filing.

The mRNA technology is also used in vaccines from Moderna Inc and Pfizer Inc. Both these vaccines are being rolled out in the United States.

. Asian markets mostly fell Tuesday following a sharp pullback on Wall Street as investors were spooked by a coronavirus surge, new lockdowns, a slow vaccine rollout and uncertainty over US Senate elections.

While analysts are broadly upbeat about the long-term outlook this year, the nascent inoculation programmes have yet to have an impact, meaning the first few months of the year will likely be bumpy.

And the task ahead was laid bare by data showing almost 280,000 Americans were infected in one day, while the country's death toll passed 300,000.

And as a new, potentially more transmissible strain rampages around the world, governments are being forced to tighten containment measures again, with England going into a six-week full lockdown after officials warned hospitals could soon face collapse.

. Mexico on Monday authorized the coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use in the country, which has one of the world's highest Covid-19 death tolls.

Deputy health minister Hugo Lopez-Gatell announced on Twitter that Mexican regulators had approved the vaccine, which has also been authorized by countries including Britain, India and Argentina.

. Prime Minister Boris Johnson imposed a strict new national lockdown Monday as Britain’s desperate race to vaccinate its population risked being overtaken by a fast-spreading variant of the coronavirus that was on track to overwhelm the nation’s beleaguered hospitals.

After several days of frighteningly high and escalating case numbers, Johnson ordered schools and colleges in England to close their doors and shift to remote learning. He appealed to Britons to stay at home for all but a few necessary purposes, including essential work and buying food and medicine.

The nationwide restrictions, officials warned, will remain in place until at least the middle of February.

The decision was a fresh setback for Johnson, coming at a time when the arrival of two vaccines appeared to provide a route out of the crisis after nine fraught months and fierce criticism of his handling of the pandemic.

. The US Food and Drug Administration said on Monday that the idea of changing the authorized dosing or schedules of Covid-19 vaccines was premature and not supported by the available data.

The FDA said it had been following discussions and news reports about reducing the number of doses, extending the length of time between doses, cutting the dosage in half, or mixing and matching vaccines in order to immunize more people.

Although these were "reasonable" questions to consider, the US regulator said, "at this time suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence."

"Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk," the agency said in a statement.

Pfizer and partner BioNTech SE as well as Moderna Inc recently won US emergency use authorization for their vaccine candidates.

The available data continues to support the use of two specified doses of each authorized vaccine at specified intervals, the FDA said.

Coronavirus vaccine news highlights: Amid pandemic, vaccine's restricted use considered on safety, immunogenicity data, says ICMR chief

Global leaders hail India's decisiveness in tackling Covid-19

All Indian vaccines being developed for storage at 2-8 degree Celsius: DBT Secretary

Amid pandemic, vaccine's restricted use considered on safety, immunogenicity data: ICMR chief

China steps up Covid-19 vaccination for key groups ahead of holiday season

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