VA-SenaJanuary 4, 2021
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5min3711

India has formally approved the emergency use of two vaccines against the coronavirus disease (Covid-19) as it prepares for one of the world’s biggest drives and plans to inoculate some 300 million people on a priority list this year. Drugs Controller General of India VG Somani gave the green light for the emergency-use of two coronavirus vaccines, one developed by Astra Zeneca and Oxford University and the other by local company Bharat Biotech. Prime Minister Narendra Modi called it “a decisive turning point”.

Serum Institute of India (SII) is producing the vaccine Covi shield developed by Oxford University and pharmaceutical company AstraZeneca. It has got permission for restricted use in an emergency situation subject to certain regulatory conditions. The ongoing clinical trial within the country by the firm will continue.

Bharat Biotech has developed a whole virion inactivated Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (Pune). “The Subject Expert Committee has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue,” Somani said on Sunday.

1. ZyCoV-D: Zydus Cadila’s vaccine is being made on the DNA platform and is named ZyCoV-D. Cadila has collaborated with the Department of Biotechnology for this. DCGI has given its approval to the Ahmedabad-based drug firm to initiate Phase III clinical trials of its Covid-19 vaccine ZyCoV-D.

2. Sputnik V: This is a vaccine developed by Russia’s Gamaleya Institute. Dr Reddy’s Laboratories is conducting phases 2 and 3 clinical trials of Russian vaccine Sputnik V, while Biological E is conducting phase 1 trial of its indigenously developed vaccine candidate. Russia said on November 24 last year that its Sputnik V vaccine was 91.4% effective based on interim late-stage trial results. It started vaccinations in August and has inoculated more than 100,000 people so far. India plans to make 300 million doses of Sputnik V this year.

3. NVX-Cov 2373: NVX-COV-2373 is being developed by Serum Institute of India in collaboration with American company NovaVax. Phase 3 trial under consideration.

4. Biological E Limited vaccine: Biological E Ltd plans to start large late-stage trials of its potential Covid-19 vaccine candidate in April this year. The Hyderabad-based privately held company had said in November it had started early-stage and mid-stage human trials of its vaccine candidate, being developed in collaboration with Baylor College of Medicine in Houston and US-based Dynavax Technologies Corp, and expects results by February.

5. HGCO19: The novel mRNA vaccine candidate, HGCO19, has been developed by Pune-based Gennova Biopharmaceuticals, and supported with a seed grant under the Ind-CEPI mission of the department of biotechnology of the Union ministry of science and technology. Gennova has worked in collaboration with US’ HDT Biotech Corporation to develop the mRNA vaccine candidate. Gennova will start the phase 1 clinical trial of its indigenous vaccine candidate with the enrolment of 120 participants starting from early January, Mint reported in December last year.

6. Bharat Biotech’s second vaccine: Another vaccine is being developed by Bharat Biotech International Ltd in collaboration with Thomas Jefferson University, US, which is at the pre-clinical stages.

7. Aurobindo Pharma vaccine: Aurobindo Pharma Ltd has announced its own Covid-19 vaccine development programme through its US subsidiary Auro Vaccines. That vaccine, which uses recombinant vesicular stomatitis virus (RVSV) vector platform, is being developed by Profectus BioSciences. This vaccine is still in the pre-clinical phase. Aurobindo Pharma has said it would also make and sell US-based COVAXX’s Covid-19 vaccine candidate for supply in India and to the United Nations Children’s Fund (UNICEF) under a licensing deal.

 


VA-SenaDecember 10, 2020
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6min3888

Starting with the elderly and front line workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history

 

10Dec-aLondon: 

Britain’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy warning about the shot.

Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction since rollout began.

“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.

“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks… You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.”

Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.

The fuller guidance, clarifying that the main risk was from anaphylaxis specifically, was issued after consulting experts on allergies. The MHRA had initially advised anyone with a history of a “significant allergic reaction” not to take the shot.

Pfizer and BioNTech said they were supporting the MHRA’s investigation.

Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.

A top U.S. official said on Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until more was understood about what had happened.

Canada’s health ministry said it would look at the reported adverse reactions in Britain, but said adverse events were to be expected and would not necessarily change the risk/benefit of the shot, after the country approved the vaccine.

 

Allergic Reaction

MHRA chief Raine told lawmakers such allergic reactions had not been a feature of the Pfizer’s clinical trials

Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.

However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol, or PEG, which helps stabilise the shot and is not in other types of vaccines.

Imperial College London’s Paul Turner, an expert in allergy and immunology, who has been advising the MHRA on their revised guidance, told Reuters: “As we’ve had more information through, the initial concern that maybe it affects everyone with allergies is not true.”

“The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk,” Turner told Reuters.

The EMA said in an email that all quality, safety and efficacy data would be taken into account in assessing the vaccine, including data generated outside the EU.

In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s efficacy and safety data met its expectations for authorization.

The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.

“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” he said.

However, Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, said that the MHRA and NHS had overreacted initially.

“I would not have broadened to the degree they did,” he said.

“It’s reasonable to let the world know about this, and to be aware of it in terms of people who have had reactions like this to vaccines. I think to say medicines, foods or any other allergies is past the boundary of science.”

 


VA-SenaNovember 18, 2020
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3min3472

A decision has also been taken to increase house to house surveillance of active cases in containment zones and other vulnerable pockets for which 7,000-8,000 teams will be put on this exercise.

18Nov-CovidCentreDoubling COVID-19 testing capacity to 1 to 1.2 lakh and increasing ICU beds to over 6,000 are among the decisions taken by the government to tackle the spike in coronavirus infections in Delhi, the Centre said today.

A decision has also been taken to increase house to house surveillance of active cases in containment zones and other vulnerable pockets for which 7,000-8,000 teams will be put on this exercise, an increase from the existing 3,000 teams that are currently involved.

Union Health Secretary Rajesh Bhushan said Delhi was testing very less in June at around 5,776 tests per day and that number rose to over 50,000 in September which after it plateaud out and the recent spike of COVID cases may be because many positive cases escaped the net.

“In the last two days, decision of urgent actions taken by the government included an increase in overall beds, including ICU beds, doubling testing to 1-1.2 lakh per day, right mix of RT-PCR and antigen tests, strengthening and augmenting home care support, mobilising doctors and nurses, enforcing quarantine of contacts, containment zone SOPs and COVID appropriate behaviour,” he said.

NITI Aayog member VK Paul who heads COVID national taskforce said the ICU bed capacity will be increased from 3,523 to over 6,000 in the next few days in hospitals across Delhi.

“The capacity, which was 3,523, we will increase it to over 6,000 ICU beds in the next few days. Arrangement of over 537 new ICU beds have been made at the 1000-bed Sardar Vallabh Bhai Patel COVID facility operated by DRDO. The Delhi government is making arrangements for 2,680 ICU beds, and big hospitals under the Centre like Safdarjung and Lady Harding, in these also 45 beds will be increased. We have a plan to increase ICU bed strength by 80 per cent,” he said.

On increasing the testing capacity, Mr Paul said that arrangements would be put in place to enable ICMR and central government laboratories to do 10,000 more tests a day. Besides that, 10 mobile laboratories will be deployed in the national capital.

“We will utilise the capacity of science and technology research institutes for testing too,” he said.

 

 

 


VA-SenaNovember 18, 2020
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2min3278

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Delhi logged nearly double the number of fresh coronavirus cases over the last 24 hours as the number of tests went up. From 3,797 cases yesterday, the city recorded 6,396 cases as the number of tests went up from 30,000 to 49,031. The number of deaths remained at 99, the same as yesterday — taking the total to 7,812.

The total number of cases in Delhi is now 4,95,598, the number of active cases is 42,004. Over the last 24 hours, 4,421 people have recovered.

A day after his government said the city would not be put under another lockdown, Chief Minister Arvind Kejriwal said his government has sought the Centre’s go-ahead to allow it to temporarily shut down markets that may emerge as COVID-19 hotspots. The state also plans to scale down the number of people allowed at weddings back from 200 to 50. Mr Kejriwal’s government, which had identified the latest surge as the third wave of COVID-19, had its peak has already passed.

On Monday, Health Minister Satyendar Jain had said there was no chance of re-imposition of lockdown in the national capital since the third wave of coronavirus has peaked out in the city.

Mr Kejriwal had thanked the Central government for helping Delhi by providing 750 ICU beds. The number of beds in the city had dropped drastically, even reducing to zero in some hospitals.

The coronavirus surge in the national capital had started going up at the end of October and started reaching record heights this month. On November 11, the city saw 8,593 new cases, an all-time high.

The numbers had stayed around 3,500 over the last days, as testing figures had halved. But the number of daily Covid-related deaths increased consistently, touching 104 – the highest yet – last Thursday.


VA-SenaNovember 17, 2020
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2min3388

In India, the downward trend continues as the number of daily recoveries remained higher than the number of daily cases for the 44th consecutive day.

 

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The number of coronavirus disease (Covid-19) cases worldwide soared to 54,826,773 as the virus continues to infect thousands of people across the world. While the number of people succumbing to the disease stood at 1,323,093.

While the Covid gloom fails to be controlled, there was good news on the vaccine front. Moderna Inc said its Covid-19 vaccine was almost 95% effective in a late-stage trial, another sign of progress in the hunt for tools to fight the pandemic. This is the second vaccine in development with more than 90% effectiveness rate.

Meanwhile, in the United States infection continued to spike as more states imposed lockdown and measures restrictions to curb the spread.

President-elect Joe Biden said curbing the outbreak is key to the US recovery and called for business and government to work together.

In Europe, German Chancellor Angela Merkel fell short in a push for tougher restrictions. Sweden is introducing its tightest rules yet as cases spike, and France’s health minister said the country is regaining control of the epidemic thanks to the latest national lockdown.

While in India, the downward trend continues as the number of daily recoveries remained higher than the number of daily cases for the 44th consecutive day. Continuing the downward trend in daily infection, the number of daily infection also remained below 50,000.

 


VA-SenaNovember 17, 2020
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3min3120

17Nov2020

 

India on Tuesday recorded 29,163 new cases of the coronavirus disease (Covid-19). The countrywide tally now stands at 88,74,290, according to Union health ministry update at 8 am.

The number of active cases continue to stay below the five lakh-mark and the number of patients discharged patients has reached 82,90,370.

The country recorded 449 new fatalities due to Covid-19 which pushed the death toll to 1,30,519, according to health ministry.

The number of daily cases has been declining for six consecutive weeks, and Monday’s figure of 30,548 was a “historic low”, the health ministry said. A tweet from the ministry’s official handle presented a graph of the number of daily cases from August to November 16 which shows the cases rising till mid-September and then falling down.

The single-day peak in coronavirus cases was reported on September 17 with 97,984 fresh cases of Covid-19 and since then India has been witnessing a decline in the caseload.

Also, the trend of daily Covid-19 recoveries outpacing the daily infections continued for the 44th day on Monday when the country recorded 30,548 cases of the infection. The number of recovered patients stood at 43,851.

Meanwhile, the Centre has formed multi-disciplinary teams to visit all private hospitals in Delhi to check the status of compliance of various directions issued by Union Health Ministry for testing and treating Covid-19 patients.

The teams have been asked to start their visit immediately and submit reports within two days along with specific details, according to the Union home ministry. The Centre has devised a strategy to check the spread of the disease in the national capital, which has seen an alarming rise in the number of daily cases of Covid-19.

There is more good news on the vaccine front as US-based biotechnology firm Moderna Inc on Monday said its vaccine candidate has been found to be 94.5 per cent effective in preventing Covid-19. The announcement was based on phase 3 trials.

This comes just a week after Pfizer Inc and BioNTech SE announced that their vaccine candidate was more than 90 per cent effective in preventing the coronavirus disease.


VA-SenaOctober 6, 2020
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4min3473

The Centre-led strategies of ”test, track, trace and treat” have been followed by state governments and Union Territory administrations as part of the “whole of government” approach.

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For straight two weeks, India has maintained a steady trend of recording less than 10 lakh active COVID-19 cases while the number of people who have recuperated from the disease surged to 55,86,703, pushing the recovery rate to 84.34 per cent, the Health Ministry said on Monday.

The Centre-led strategies of ”test, track, trace and treat” have been followed by state governments and Union Territory administrations as part of the “whole of government” approach.

Early identification of cases through aggressive and accessible countrywide testing combined with other measures such as prompt and efficient tracking and tracing of contacts have borne results, the ministry said.

The Centre has issued a standard treatment protocol that has ensured a standard of treatment and cure across various public and private hospitals and health facilities.

“The active cases has been maintained below the 10-lakh mark for 14 days unabated. For two straight weeks today, the active cases are less than 1 million (10 lakhs),” the ministry said.

In total, 76,737 recoveries have been registered in a span of 24 hours in the country whereas 74,442 fresh infections were reported during the same period, health ministry data updated at 8 am showed. The new recoveries have exceeded new cases in recent days, the ministry said.

“The higher number of single-day recoveries has resulted in sustained increase in the national recovery rate, currently pegged at 84.34 per cent,” it said.

Seventy-five per cent of the new recovered cases were recorded in 10 states and union territories which are Maharashtra, Karnataka, Andhra Pradesh, Tamil Nadu, Uttar Pradesh, Kerala, Odisha, Delhi, West Bengal and Chhattisgarh.

Maharashtra alone has contributed more than 15,000 to the new recovered cases followed by Karnataka and Andhra Pradesh with more than 7,000 cases each.

A total of 74,442 new confirmed cases have been reported in a span of 24 hours in the country with 78 per cent of them being concentrated in Maharashtra, Karnataka, Kerala, Andhra Pradesh, Tamil Nadu, Uttar Pradesh, West Bengal, Odisha, Delhi and Rajasthan.

Maharashtra has reported more than 12,000 of the new cases. Karnataka contributed more than 10,000.


VA-SenaOctober 6, 2020
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6min3597

The CDC said the coronavirus can sometimes be spread through small particles that can linger in the air and infect people separated by distances previously considered safe.

 

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The novel coronavirus can spread through the air to people who are more than 6 feet away from an infectious person, the US Centers for Disease Control and Prevention said on Monday, in guidance that could raise new challenges for safely re-opening businesses and schools.

In an update to its website, the CDC said the coronavirus can sometimes be spread through small particles that can linger in the air and infect people separated by distances previously considered safe. Many social-distancing guidelines adopted by workplaces, restaurants and stores advise people to stand at least 6 feet (1.8 meters) apart to avoid transmitting the pathogen that causes Covid-19.

“Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with Covid-19 infected others who were more than 6 feet away or shortly after the Covid-19-positive person left an area,” the agency said in a news release.

The change follows months of mounting scientific evidence that Sars-CoV-2 can be transmitted through the air at greater distances than understood in earlier stages of the pandemic. There have been indications the CDC was moving toward updating its guidance. Last month, it posted and then removed a guideline on airborne transmission, later describing it as a draft posted in error.

The new guidance arrives as the pandemic appears to be shifting into a more intense phase in the US In 34 states, the seven-day average of new cases is higher than it was a month ago, and an outbreak of the virus at the White House appears to be widening. At the same time, schools are reopening, states such as Florida have lifted restrictions on restaurants and other businesses, and the approach of cooler weather and holidays is expected to push more people indoors to socialize.

Ventilation Issues A recent archived version of the CDC’s web page made no mention of airborne transmission, emphasizing that the main way the virus spreads is through close contact among people who are within six feet of each other, through respiratory droplets emitted by coughing, sneezing, and speaking. It acknowledged that the virus may spread in other ways, including on contaminated surfaces.

The CDC’s updated site includes a section acknowledging that virus particles also sometimes spread through the air, particularly in enclosed spaces with poor ventilation. Scientists believe that in these cases, airborne virus particles emitted “became concentrated enough to spread the virus to other people,” including sometimes shortly after the infectious person left.

The transmissions sometimes occurred when the infected person was breathing heavily, while singing or exercising, the agency said.

Linsey Marr, an expert on the airborne transmission of viruses at Virginia Tech, in a tweet called the update “an accurate, sorely-needed update acknowledging airborne spread and importance of masks at all times around others and of ventilation.”

Recommendations Unchanged In a Senate hearing last month, CDC Director Robert Redfield acknowledged there was evidence of airborne spread, but said the CDC document that was removed hadn’t been cleared for publication by agency staff.

“I just want to stress for the American public and for everyone here that that document that went up was a draft, had not been technically reviewed by CDC,” Redfield said on Sept. 23. He said the agency reverted to the one that had been reviewed.

The CDC Monday reiterated that it’s more common for the virus to spread through close contact with an infected person. The update doesn’t change the CDC’s recommendations for how to protect against infection by wearing masks, staying 6 feet apart, washing hands, cleaning surfaces, and staying home when sick.

“CDC’s recommendations remain the same based on existing science and after a thorough technical review of the guidance,” the agency said in news release sent to reporters Monday.

It’s unusual for the CDC to alert the media to changes in its guidelines, with updates frequently published to the agency’s website with little fanfare


VA-SenaOctober 1, 2020
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3min3142

The news deals a blow to President Donald Trump’s hopes of having an injection ready before the election to give his campaign a much-needed boost.

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Washington, United States: US biotech firm Moderna won’t seek an emergency use authorization for its coronavirus vaccine before November 25, its CEO told the Financial Times on Wednesday.

The news deals a blow to President Donald Trump’s hopes of having an injection ready before the election to give his campaign a much-needed boost.

Stephane Bancel told the newspaper: “November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA (Food and Drug Administration) – assuming that the safety data is good, i.e. a vaccine is deemed to be safe.”

Trump, whose approval has taken a hit over his handling of the Covid-19 crisis, has frequently hinted a vaccine could be ready before the November 3 vote.This has raised concern among experts that his administration may attempt to interfere with the regulatory process for political reasons.The Republican repeated his claim on Tuesday night, during a debate with his Democratic rival, former vice president Joe Biden.”It’s a possibility that we’ll have the answer before November 1,” he said.


VA-SenaSeptember 29, 2020
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1min3361

Ever since the senior BJP leader tweeted about her testing positive for the infection late on Saturday night, the AIIMS management had made arrangements, in-charge of COVID cases at the AIIMS, Madhur Uniyal, said.

Uma Bharti, COVID-19 Positive, Admitted To AIIMS

 

Rishikesh: Former Union minister and senior BJP leader Uma Bharti, who tested positive for COVID-19 recently, was on Monday admitted to the All India Institute of Medical Sciences (AIIMS) in Rishikesh.