VA-SenaJanuary 4, 2021
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5min5634

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-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-SenaOctober 6, 2020
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6min5258

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-SenaSeptember 18, 2020
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4min4698

 

Geneva, Switzerland

Geneva, Switzerland: Too many doctors and nurses are paying the ultimate price while battling Covid-19, the World Health Organization said Thursday as it launched a charter aiming to boost safety for health workers.

The UN health agency said that the pandemic had exposed health workers and their families to “unprecedented levels of risk”.

While the coronavirus crisis has taken a heavy toll overall, data from many countries and regions show that healthcare workers have been infected at a far higher rate than the general population.

Health workers represent less than three percent of the population in most countries and less than two percent in low- and middle income countries, but account for around 14 percent of all Covid-19 cases reported to the WHO.

In some countries, the proportion has been as high as 35 percent, the body said.

On Wednesday, the International Council of Nurses said thousands of nurses had likely died in the pandemic, pointing to numbers from just 44 countries showing 1,097 deaths by mid-August.

“The Covid-19 pandemic has reminded all of us of the vital role health workers play to relieve suffering and save lives,” WHO chief Tedros Adhanom Ghebreyesus told a virtual briefing.

“We all owe health workers an enormous debt, not just because they have cared for the sick, but because they risk their own lives in the line of duty.”

The risks are not only physical. The WHO pointed to “extraordinary levels of psychological stress” on health workers, who have been asked to work long, draining hours battling Covid-19, living in constant fear of being infected.

Many are also living separated from their families, and facing social stigma amid fear they are carrying the virus. – Depression, anxiety –

These strains are increasing the likelihood of depression among medical professionals, who were already more at risk of suicide than the general public in a number of countries prior to the pandemic.

One in four health care workers surveyed for a recent study said they were struggling with depression and anxiety amid the pandemic, while one in three said they had suffered insomnia, the WHO said.

In its charter presented Thursday, the WHO emphasised the legal and moral obligations governments have to ensure the health, safety and wellbeing of health workers.

The charter among other things calls on countries to develop programmes that better protect the health and safety of medical workers, and to combine them with patient safety policies.

It also calls for better policies for protecting health workers from violence in the workplace, and for improving access to mental health support.

And it demands that minimum standards for patient safety, infection prevention and control, as well as for occupational safety are implemented across all care facilities.

Access to personal protective equipment (PPE), as well as sufficient training in how to use such equipment safely should also be guaranteed, it said.


VA-SenaSeptember 9, 2020
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1min4517

 

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With 89,706 infections being reported in a day, India’s COVID-19 tally went past 43 lakh, while 33,98,844 people have recuperated from the disease so far pushing the national recovery rate to 77.77 per cent on Wednesday, according to data shared by the Union Health Ministry.

The total coronavirus cases mounted to 43,70,128, while the death toll rose to 73,890 with 1,115 people succumbing to the disease in a span of 24 hours in the country, the data updated at 8 am showed.

The COVID-19 case fatality rate has further dropped to 1.69 per cent.

There are 8,97,394 active cases of COVID-19, which is 20.53 per cent of the total caseload in the country, the data stated.

India’s COVID-19 tally had crossed the 20-lakh mark on August 7, reached 30 lakh on August 23 and went past 40 lakh on September 5.

According to the Indian Council of Medical Research (ICMR), a cumulative total of 5,18,04,677 samples have been tested up to September 8 with 11,54,549 samples being tested on Tuesday.


VA-SenaAugust 25, 2020
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3min42470

The observer-blind, randomised controlled study to determine the safety and immunogenicity of “Covishield” on healthy Indian adults will begin at Bharati Vidyapeeth Medical College and Hospital in Pune.

 

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The phase 2 human clinical trial of the Oxford COVID-19 vaccine candidate in the country by Pune-based Serum Institute of India (SII) is set to begin today.

The observer-blind, randomised controlled study to determine the safety and immunogenicity of “Covishield” on healthy Indian adults will begin at Bharati Vidyapeeth Medical College and Hospital in Pune.

Serum Institute of India has partnered with British-Swedish pharma company AstraZeneca for manufacturing the COVID-19 vaccine candidate, developed by the University of Oxford.

“We have got all approvals from the Central Drugs Standard Control Organisation (CDSCO). We are going to start the human clinical trial process at the Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital from August 25.

“We are sure that in line with the philosophy of our group, we are going to make available a world class COVID-19 vaccine for people of our country and make our country ‘AatmaNirbhar’,” Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs, Serum Institute of India (SII) said.

As a rapid regulatory response, the Drugs Controller General of India (DCGI) on August 3 had given nod to the Pune Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford COVID-19 vaccine candidate in the country.

The trials are to be conducted across 17 selected sites, including AIIMS Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore, SII sources had said.

Around 1,600 people aged above 18 years are likely to participate in the trials.

To introduce the vaccine, SII, the world’s largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca


VA-SenaJuly 14, 2020
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5min44220

Glenmark Pharmaceuticals on Monday announced a price reduction of its generic version of favipiravir, FabiFlu, by 27 per cent in India.

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Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, on Monday announced a price reduction of its generic version of favipiravir, FabiFlu, by 27 per cent in India. This means the new MRP would be INR 75 per tablet from the earlier INR 103 per tablet. The pharmaceutical firm also announced that it has commenced post-marketing surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1000 patients that are prescribed with the oral antiviral, as part of an open-label, multicenter, single-arm study.

The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country, the company said in a release on Monday. Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house R&D team within the country, ensuring self-reliance with regard to long-term production and manufacturing. The API is manufactured at the Gujarat production facility which is USFDA & MHRA-UK approved. The formulation product is manufactured at the facility in Himachal Pradesh, which is also USFDA and MHRA-UK approved.

“We expect this post-marketing surveillance study to shed more light on the drug’s clinical effectiveness and safety in a large cohort of patients prescribed FabiFlu. Our priority from the start of this pandemic has been to offer patients in India an effective treatment for COVID-19, while also ensuring accessibility to the masses. Our internal research shows us that we launched FabiFlu in India at the lowest market cost as compared to the cost of Favipiravir in other countries where it is approved. And now we hope that this further price reduction will make it even more accessible for patients across the country,” said Mr Alok Malik, Senior Vice President & Head – India business, Glenmark Pharmaceuticals Ltd., commenting on these developments.

Despite investing significantly in R&D, clinical trials and the manufacturing of FabiFlu (API and formulations), Glenmark has managed to keep the pricing of FabiFlu® lower as compared to its price in other countries. FabiFlu in India was originally launched at INR 103/tab, while, its price as INR is higher in the remaining countries. (INR 600/tab in Russia, INR 378/tab in Japan, INR 350/tab in Bangladesh and INR 215/tab in China). Based on trade data available for 200mg/tab from the respective countries and currency rates in respective countries equivalent to INR recorded.

On June 20th, Glenmark announced that it received manufacturing and marketing approval from India’s drug regulator for FabiFlu, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19. The manufacturing and marketing approval was granted as part of the accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India. The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.

Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu use. The company has also completed the phase 3 clinical trial with Favipiravir (FabiFlu) in mild to moderate COVID-19 patients in India. The trial results will be available shortly.

Glenmark is also conducting another Phase 3 clinical trial to evaluate the efficacy of two antivirals drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India. The combination study which is called the FAITH trial is looking to enroll 158 hospitalised patients of moderate COVID-19 in India. Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening the duration of virus shedding, facilitating early clinical cure and discharge of patients.


VA-SenaJuly 14, 2020
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4min47980

 

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Russian scientists claimed on Monday that they hope to launch the world’s first coronavirus as soon as next month, as per report. On Sunday, Russia’s Sechenov University said that it had successfully completed clinical trials of a COVID-19 vaccine developed by the state-run Gamalei Institute of Epidemiology and Microbiology.

The head and chief researcher at Sechenov University Center for Clinical Research on Medications Elena Smolyarchuk told Russian news agency TASS that clinical trials of the vaccine on volunteers have been completed and study data showed the candidate’s effectiveness.

“The research has been completed and it proved that the vaccine is safe,” Smolyarchuk was quoted as saying by TASS of its trial.

The Gamalei center’s director Alexander Gintsburg told TASS that he hopes the vaccine will ‘enter civil circulation’ on August 12-14, adding that private companies may begin mass production by September, The Moscow Times reported.

Meanwhile, the World Health Organization’s protocols said that a vaccine has to go through three phases of studies before being approved for large-scale production. Also, WHO’s draft landscape of coronavirus vaccines lists the Russian candidate vaccine study as a phase 1 trial. Perhaps, till date, no vaccine has been approved for large-scale use without undergoing the third phase of testing, which is the largest in terms of the number of participants. A candidate vaccine usually undergoes industrial production if the last phase shows clear and definitive evidence of its safety and efficacy.

According to The Moscow Times report, Smolyarchuk had said earlier in July that some participants developed typical responses to injections like headaches, elevated body temperatures. However, these symptoms were resolved within 24 hours.

In a July 3 press release, the university stated that the Russian Health Ministry will take a decision on the effectiveness of the substance based on the results of biochemical tests.

The Sechenov First Moscow State Medical University will discharge the two groups of volunteers on July 15 and July 20 after spending 28 days in isolation to protect them from exposure to other infections. The trial participants, aged 18-65, will be monitored for six months after their release, added Smolyarchuk.

It may be noted that the first stage of the vaccine trial at the university was launched on June 18 in a group of 18 volunteers who were vaccinated against the virus. The second group involving 20 participants were administered the vaccine on June 23.

Russia is one of the several nations racing against time to develop a safe vaccine against COVID-19, which has so far claimed at least 569,879 lives and infected about 12,992,640 people worldwide.