VA-SenaJanuary 4, 2021
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5min5636

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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6min5821

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 23, 2020
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2min4276

An order to shut two evening markets in west Delhi till the end of this month for violating various coronavirus safety guidelines was withdrawn, hours after the notice was sent last night.

The Delhi government on Sunday had ordered the closure of two markets, the Punjabi Basti market and the Janta, in Nangloi area, till November 30 after it was found that wearing masks and social distancing were not being followed in these markets.

On Friday, Chief Minister Arvind Kejriwal said his government does not want to shut any market and asked representatives of market associations to provide masks to people not wearing it. Mr Kejriwal had held a virtual meeting with the representatives of market associations in the city.

As the capital struggles to contain the surge in coronavirus cases that have crossed 5.29 lakh, Mr Kejriwal had on November 17 said that his government has sought the centre’s go-ahead to allow it to shut for a few days markets that may emerge as COVID-19 hotspots.


VA-SenaNovember 19, 2020
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3min5409

Indore Covid-19: The jewellery showroom – Anand Jewels – will reopen only after fumigation is completed, officials said.

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A jewellery store in Madhya Pradesh’s Indore – one of the worst hit districts in the state by the novel coronavirus outbreak – has been temporarily closed for cleaning and disinfection after 31 employees tested positive for the highly infectious Covid-19. Health officials have started tracing the customers who visited the store in the last week.

“We have started tracing the infected staff and customers, who would have come in contact with them over the past week. We want to check if any of them has cough, cold or other symptoms of Covid so that we can have them tested,” Chief Medical Officer Dr Pravin Jadia told reporters. The jewellery showroom – Anand Jewels – is being sanitised and will reopen only after fumigation is completed, officials said.

Millions across the country celebrated Diwali and Dhanteras last week and the number of people visiting the markets rose up significantly amid festivity, compared to the last few months. Visuals from Delhi and Mumbai showed people roaming around the streets without masks and violating the government-mandated social distancing norms.

In Madhya Pradesh, over 1.86 lakh people have tested positive for coronavirus so far; over, 1,200 deaths have been reported. Indore, which reported 194 new infections yesterday, is one of the worst-affected districts.

Across India, more than 89.5 lakh people have contracted the virus since the first case was reported from Kerala on January 30. While nearly 83.83 lakh people have recovered so far, over 1.31 lakh Covid-linked deaths have been registered.

India has the second highest number of Covid cases in the world after the United States where 1.15 crore infections have been logged since the begining of the pandemic.

 


VA-SenaNovember 19, 2020
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4min5367

The vaccine’s efficacy was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.

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Pfizer Inc and BioNTech could secure emergency US and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

The vaccine’s efficacy was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.

The US Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.

“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.

The success rate of the vaccine developed by the US drugmaker and German partner BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic.

Of the 170 volunteers who contracted COVID-19 in Pfizer’s trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.

“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day.”

BioNTech’s Sahin said U.S. emergency use authorization (EUA) would be applied for on Friday.

An FDA advisory committee tentatively plans to meet on Dec. 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change. The FDA did not respond to requests for comment.

COVID-19 RUNS RAMPANT

The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine showing 94.5% effectiveness.

“We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks,” U.S. Health and Human Services Secretary Alex Azar said.

The Moderna vaccine is likely to be authorized within seven to 10 days of Pfizer receiving its EUA, U.S. officials said, with states ready to begin distribution within 24 hours.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and destroyed economies and daily life.

The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations almost daily.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over age 65, a particularly high-risk group.

“This is the evidence we needed to ensure that the most vulnerable people are protected,” said Andrew Hill, senior visiting research fellow at the University of Liverpool’s department of pharmacology.


VA-SenaNovember 18, 2020
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3min5104

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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2min4855

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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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2min4983

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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3min4672

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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4min5086

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.