Tag: COVID-19 vaccine

First COVID-19 vaccine human trial finds it is safe, induces immune response

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The first COVID-19 vaccine to reach phase I clinical trial is safe, well-tolerated, and capable of generating an immune response against the novel coronavirus in humans, says a new research published in The Lancet journal.

According to the study of 108 adults, the vaccine produced neutralising antibodies, and a response mediated by the immune system”s T-cells against the novel coronavirus, SARS-CoV-2.

However, the scientists, including those from the Beijing Institute of Biotechnology in China said further research is needed to confirm whether the vaccine protects against SARS-CoV-2 infection.

In the trial, carried out in 108 healthy adults, the vaccine demonstrated promising results after 28 days, with the final results to be evaluated in six months, the study said.

“These results represent an important milestone. The trial demonstrates that a single dose of the new adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine produces virus-specific antibodies and T cells in 14 days,” said study co-author Wei Chen from the Beijing Institute of Biotechnology.

Based on the results, Chen said the vaccine is a potential candidate for further investigation.

However, the researchers cautioned that the results should be interpreted carefully.

“The challenges in the development of a COVID-19 vaccine are unprecedented, and the ability to trigger these immune responses does not necessarily indicate that the vaccine will protect humans from COVID-19,” Chen explained.

The Ad5 vectored COVID-19 vaccine used in the trial is the first to be tested in humans, the scientists said.

It uses a weakened common cold-causing adenovirus — which infects human cells readily, but is incapable of causing disease — to deliver genetic material that codes for the SARS-CoV-2 spike protein to the cells, the study noted.

The scientists said these cells then produce the spike protein, and travel to the lymph nodes where the immune system creates antibodies.

These then recognise the spike protein and fight off the coronavirus, the researchers explained.

In the trial, they assessed the safety and ability of the new Ad5-nCoV vaccine to generate an immune response of different dosages in 108 healthy adults between the ages of 18 and 60 years.

The volunteers were assigned to receive either a single injection of the new Ad5 vaccine at a low dose, middle dose, or a high dose, they said.

According to the study, the volunteers’ blood was checked at regular intervals following vaccination to see whether the vaccine stimulated two parts of the immune system.

These are the body’s ‘humoral response’, which is the part of the immune system that produces antibodies to fight infection, and the ”cell-mediated” arm, which depends on a group of T cells to fight the virus, the scientists said.

They added that an ideal vaccine candidate generates both antibody and T cell responses to defend against SARS-CoV-2.

Based on the results, the researchers said the vaccine was well tolerated by the volunteers at all doses with no serious adverse events reported within 28 days of vaccination.

They said most adverse events were mild or moderate, with 83 per cent of those receiving low and middle doses of the vaccine and 75 per cent in the high dose group reporting at least one adverse reaction within 7 days of vaccination.

These reactions were mild pain at the injection site reported in over half of vaccine recipients, fever in 50 per cent of them, fatigue, headache, and muscle pain as well.

Within two weeks of vaccination, the study noted that all dose levels of the vaccine triggered some level of immune response.

Some of the participants, the researchers said, also exhibited a form of neutralising antibodies against SARS-CoV-2.

After 28 days, they said most participants had a four-fold increase in binding antibodies.

The scientists also added that 50 per cent of the participants in the low- and middle-dose groups, and three-quarters of those in the high-dose group showed neutralising antibodies against SARS-CoV-2.

In the majority of volunteers, they said the vaccine also stimulated a rapid T cell response.

On further analyses, the researchers said the majority of recipients showed either a positive T cell response, or had detectable neutralising antibodies against SARS-CoV-2 as much as 28 days after vaccination.

However, they said high pre-existing immunity to adenovirus type 5 — the common cold virus vector used in the study, may have reduced both the antibody and T-cell response in the participants.

“Our study found that pre-existing Ad5 immunity could slow down the rapid immune responses to SARS-CoV-2 and also lower the peaking level of the responses,” said Feng-Cai Zhu from the Jiangsu Provincial Center for Disease Control and Prevention in China, who led the study.

Citing the main limitations of the trial, the authors said the study had a small sample size and was conducted in relatively short duration, with a lack of randomised control group.

They said further research will be needed before this trial vaccine becomes available to all.

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How this Indian company could be world’s door to a COVID-19 vaccine

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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If the world is to gain access to a vaccine for COVID-19, there’s a good chance it will pass through the doors of Serum Institute of India.

Serum Institute, the world’s largest manufacturer of vaccines by volume, is working on several candidates for the novel coronavirus – including potentially mass-producing the AstraZeneca/Oxford university one that has garnered global headlines – as well as developing its own.

The efforts are partly being shepherded by Umesh Shaligram, the head of research and development. His employer is a private company but every day, shortly before midnight, he receives a WhatsApp message from the government asking for updates, and about any new hurdles he faces.

The message is usually from K. VijayRaghavan, Prime Minister Narendra Modi’s top scientific adviser – an indication of the critical, and even strategically important, nature of the race to develop the vaccines the whole world is waiting for.

Shaligram promptly responds with a progress report and details any bottlenecks.

“Any delays, you just tell them,” said Shaligram, adding the government has been doing everything it can to fast-track clearances, and resolve import delays and other issues.

“We have begun to see approvals come through in days, even on a Sunday night, for trials and things like that,” he said, noting some of these processes typically took 4 to 6 months.

While most of the attention regarding vaccines typically goes to the pharmaceutical developer, India quietly plays a key role in manufacturing 60%-70% of all vaccines sold globally with the Serum Institute playing a lead role, said the company’s Chief Executive Adar Poonawalla.

At the company’s sprawling, 150-acre campus in the western Indian city of Pune, Shaligram and his team are working flat-out. Dozens of buses ferry in hundreds of workers each day to the grounds, which are buzzing with activity even as the city around it remains largely under lockdown.

The push comes as the number of cases of COVID-19, both globally and domestically, continue to surge and world leaders look to vaccines as the only real way to restart their stalled economies, even though none have yet been proven to be effective against the coronavirus.

Poonawalla, whose family owns he vaccine maker, said scientists, drugmakers and manufacturers were collaborating at an unparalleled scale to spur development and availability.

“We are all in a race to battle the disease, there is no one-upmanship here,” he told Reuters, sitting in his office beside his family’s 74-year-old stud farm.

VACCINE CANDIDATES

Serum, founded in 1966 by Adar’s father Cyrus Poonawalla, has partnered with U.S. biotech firm Codagenix, its U.S. rival Novavax and Austria’s Themis to potentially manufacture three COVID-19 vaccine candidates that are still in development.

Another candidate in the works is the experimental vaccine developed by a team at the University of Oxford and now licensed to drugmaker AstraZeneca, with whom Serum are in talks to mass produce the vaccine, which is now in the clinical trial stage.

The United States has secured almost a third of the first 1 billion doses planned for the potential vaccine, initially known as ChAdOx1 and now as AZD1222, by pledging up to $1.2 billion.

Poonawalla aims to initially produce 4-5 million doses a month, beginning from June, and then gradually ramp up to 350-400 million doses a year.

“Hopefully we will build a stock of a few million doses to give to our country and other high-risk areas across the globe come October-November when the trials ought to be concluded,” the 39-year-old said, while giving Reuters rare access to tour his facilities.

He added he had been given to understand by the development team that the trials had an 80% chance of success, given that the vaccine is based on a tried-and-tested platform.

Based on the information currently available, Poonawalla also said he anticipated AZD1222 would be a single-dose vaccine and not require a booster dose.

He sees AZD1222 potentially priced at about 1,000 rupees ($13) per dose in India, but expects it will be procured and distributed by governments without charge.

Serum is also working on developing its own in-house vaccine options to tackle the disease, Poonawalla said.

VIALS, TUBES, CHEMICALS

Even if a vaccine does succeed, a treatment to fight COVID-19 would still be required, said Poonawalla, noting some people do not get the desired immune response, even if vaccinated.

“You may get mild symptoms, you may get severe symptoms. It depends on your system, but there is a chance,” he added. “Not all vaccines are fully effective.”

The Serum Institute produces more than 1.5 billion doses of vaccines every year, for everything from polio to measles.

Poonawalla says that gave the company an edge in securing supplies of vials and high-quality chemicals required to make a vaccine in bulk once all approvals are in place.

“We have partnered with many of our suppliers to have one to two-year inventories of glass vials and tubing glass stocked in advance, so luckily for us that won’t be an issue.”

Any successful vaccine is however bound to be in short supply at first, he stressed.

India recorded more than 6,000 new cases of the coronavirus on Friday, bringing its total to over 118,000 cases with more than 3,500 deaths, even as it gradually begins to ease its nearly two-month long nationwide lockdown.

There have been more than 5 million infections and over 330,000 deaths reported worldwide.

The Indian government stands ready to cover the costs of trials of any vaccine in the country, said Poonawalla, adding that the government had also expressed interest in placing advance orders for a potential vaccine.

“We’ve reached out and they have been very positive,” he added. “But we’ve said hold on … as we don’t want to take government money until we are very confident we can deliver.”

UNLOCKING VALUE IN THE ‘HYPE’

Serum, one of the few companies ramping up hiring during the health crisis, is also designing a separate facility to make vaccines for pandemic-level diseases that could handle 90% of the current vaccine candidates being developed, beyond just the COVID-19 ones.

That facility, which will be ready in the next two to three years, would be able to potentially churn out 700-800 million doses a year, according to Poonawalla.

The CEO said he considered taking the company public some years ago to fund some large acquisitions, but changed course when the deals fell through.

Now he’s considering a different approach. He is exploring creating a holding entity that will host the company’s pandemic-level technologies, including manufacturing rights, intellectual property and the sale of all of Serum’s COVID-19-related candidates, and selling a minority stake in the venture.

“That will unlock value in the main hype,” he said.

Poonawalla said he had engaged bankers to test the waters on this, but stressed he would only consider selling a stake to ethical, long-term funds or sovereign funds that do not expect huge returns and want to “make a difference to the world”.

“After getting them onboard, I don’t want to be in a situation where I have to charge high prices to give them returns.”

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Oxford’s COVID-19 vaccine moves to next stage of human trial

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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University of Oxford researchers working on a vaccine to protect against coronavirus on Friday confirmed that they are moving to the next level as they begin recruiting over 10,000 people for the second phase of human trials.

The first phase of the trial began last month with 1,000 healthy adults aged 55 and under as volunteers. Now more than 10,200 people, including over 70s and five to 12-year-olds, will be enrolled in the study, to see the effects on their immune system.

A recent study had found that the vaccine, named ChAdOx1 nCoV-19, had shown some promising results in a small study with monkeys.

The COVID-19 vaccine trial team have been working hard on assessing the safety and immunogenicity of ChAdOx1 nCoV-19, and preparing to assess vaccine efficacy, said Sarah Gilbert, professor of vaccinology at the university’s Jenner Institute who is leading the research.

We have had a lot of interest already from people over the age of 55 years who were not eligible to take part in the phase I study, and we will now be able to include older age groups to continue the vaccine assessment. We will also be including more study sites, in different parts of the country, she said.

ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to replicate in humans.

For the latest set of volunteers, researchers will be assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children.

“The clinical studies are progressing very well and we are now initiating studies to evaluate how well the vaccine induces immune responses in older adults, and to test whether it can provide protection in the wider population, said Professor Andrew Pollard, head of the Oxford Vaccine Group.

The Phase III part of the study involves assessing how the vaccine works in a large number of people over the age of 18.

This group will assess how well the vaccine works to prevent people from becoming infected and unwell with COVID-19. Adult participants in both the Phase II and Phase III groups will be randomised to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a control for comparison, the university said.

Mene Pangalos, Executive Vice President for BioPharmaceuticals R&D at AstraZeneca, which has a partnership with the university for the production of the vaccine if it is proved effective, said: The speed at which this new vaccine has advanced into late-stage clinical trials is testament to Oxford’s ground-breaking scientific research.

We will do everything in our power to engage with governments, multilateral organisations and partners around the world to increase production and distribution and ensure rapid, fair and equitable distribution of a globally accessible vaccine.

The study aims to assess how well people across a broad range of ages could be protected from Covid-19 with this new vaccine. It will also provide valuable information on the safety aspects of the vaccine and its ability to generate good immune responses against the virus.

The team behind the vaccine have previously said they are aiming to have at least a million doses of a coronavirus vaccine by September this year.

However, the UK government has repeatedly warned that there are no guarantees a vaccine will be discovered against the deadly virus.

The Oxford University trial is among several experimental vaccines being developed worldwide to try and combat the spread of Covid-19 and help lift strict restrictions on human movement in place in most countries.

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It’s dangerous for investors to follow a coronavirus ‘vaccine playbook,’ strategist warns

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Investing by a “vaccine playbook” is a dangerous approach to take, one strategist has warned, after news flow from the pharmaceuticals industry bolstered market volatility earlier this week.

Speaking to CNBC’s “Squawk Box Europe” on Wednesday, Fahad Kamal, chief market strategist at Kleinwort Hambros, said recent market moves had demonstrated “how dangerous it is to follow any kind of vaccine playbook.”

Biotech firm Moderna sent markets higher on Monday after reporting positive data on an early stage trial for its Covid-19 vaccine. However, markets snapped back later in the week after vaccine experts expressed skepticism about Moderna’s data, and the economic damage from the crisis reentered focus.

The firm’s chairman told CNBC that it would never put out data on its potential vaccine that was different from “reality.”

Kamal noted that most scientific experts believe it will take at least 12-to-18 months for a safe-to-use vaccine to be rolled out to the market.

“The few people who seem to be more optimistic than that appear to have political agendas,” he told CNBC. “So I would err on the side of science and say we’re still quite a way away from that.”

President Trump has voiced ambitions for a vaccine to be developed and distributed by the end of this year, in a project dubbed “Operation Warp Speed.”

However, medical experts — including Dr. Anthony Fauci, the U.S. government’s top infectious disease expert — have cast doubt on Trump’s goal, expressing skepticism over the timeframe.

Kamal also emphasized that a vaccine would not be a miracle fix for all problems created by the coronavirus outbreak.

“Even if a vaccine was to be developed by the end of this year, we’re already seeing such dramatic scarring in the economy that it’s not going to be just as simple as flipping a switch and coming right back to where we were at the beginning of this year,” he told CNBC. “There is going to be residual damage that’s going to take a lot longer to work out.”

World Bank President David Malpass said on Tuesday that the organization expected the global economy to contract by 5% this year, resulting in the loss of millions of jobs and a rise in worldwide poverty.

Dead cat bounce
Wall Street saw its worst first-quarter on record as the new coronavirus became a worldwide pandemic, but shares rallied in April and have been volatile in May on the back of news around the virus and potential vaccines and treatments. European and Asian markets have followed a similar pattern.

While stocks have generally showed signs of a recovery since their dramatic decline in March, however, Kamal warned investors on Wednesday not to be too optimistic about the bounce back.

“This is classic dead cat bounce,” he told CNBC. “Of course we don’t have a crystal ball, but if you look at the speed of this rally, if you look at the valuations from when the March 23 trough occurred to where we are right now, and given the general state of the wider economy and (the fact that) earnings are still going down, it would have been extremely unusual for us to have reached a bottom on the 23rd of March.”

Government-imposed lockdown measures, coupled with supply and demand shocks from the coronavirus crisis, hit corporate earnings in the first quarter, and a number of analysts have warned that companies could take longer than markets are anticipating to recover.

Describing the corporate landscape as “Darwinian,” Kamal advised investors to look at companies on a case-by-case basis, considering their balance sheet, market position and resilience. He also cautioned against tarring firms with a broad brush based on industry, noting that some tech firms — like Uber or WeWork — were not faring well, despite tech stocks often being seen as a safe bet.

“On the other hand, there are going to be some airlines and others, those which have cash, those which can manage to survive now, which will be looking to consolidate their market positions, gain market share, and really come out of this entire crisis much stronger,” he said. “If you think about the well-capitalized Qatar Airways-type players in the world, they could probably be stronger in a few years.”

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

US secures 300 million doses of potential AstraZeneca COVID-19 vaccine

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The United States has secured almost a third of the first 1 billion doses planned for AstraZeneca’s experimental COVID-19 vaccine by pledging up to USD 1.2 billion, as world powers scramble for medicines to get their economies back to work.

While not yet proven to be effective against the coronavirus, vaccines are seen by world leaders as the only real way to restart their stalled economies, and even to get an edge over global competitors.

After President Donald Trump demanded a vaccine, the US Department of Health and Human Services (HHS) agreed to provide up to USD 1.2 billion to accelerate British drugmaker AstraZeneca’s vaccine development and secure 300 million doses for the United States.

“This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021,” US Health Secretary Alex Azar said. The first doses could be available in the United States as early as October, according to a statement from HHS.

The vaccine, previously known as ChAdOx1 nCoV-19 and now as AZD1222, was developed by the University of Oxford and licensed to AstraZeneca. Immunity to the new coronavirus is uncertain and so the use of vaccines is unclear.

The US deal allows a late-stage, or Phase III, clinical trial of the vaccine with 30,000 people in the United States.

Cambridge, England-based AstraZeneca said it had concluded agreements for at least 400 million doses of the vaccine and secured manufacturing capacity for 1 billion doses, with first deliveries due to begin in September.

Now the most valuable company on Britain’s blue-chip FTSE 100 Index, AstraZeneca has already agreed to deliver 100 million doses to people in Britain, with 30 million as soon as September. Ministers have promised Britain will get first access to the vaccine.

VACCINE SCRAMBLE

With leaders across the world surveying some of the worst economic destruction since at least World War Two and the deaths of more than 327,000 people, many are scrambling for a vaccine.

The US government has struck deals to support vaccine development with Johnson & Johnson (J&J), Moderna and Sanofi, sparking fears the richest countries will be able to protect their citizens first.

Sanofi’s chief angered the French government earlier this month when he said vaccine doses produced in the United States could go to US patients first, given the country had supported the research financially.

“We have a lot of things happening on the vaccine front or the therapeutic front,” Trump told reporters at the White House when asked about the AstraZenca announcement. “You’re going to have a lot of big announcements over the next week or two” on therapeutics.

Trump, during a Thursday visit to a Ford Motor Co plant in Michigan, said the US military is “in gear so we can give out 150 to 250 million shots quickly.”

AstraZeneca said it was in talks with governments and partners around the world – such as the Serum Institute of India – to increase access and production and is speaking to various organisations on fair allocation and distribution.

“We would like to thank the US and UK governments for their substantial support to accelerate the development and production of the vaccine,” AstraZeneca Chief Executive Pascal Soriot said.

The Serum Institute of India, the world’s largest maker of vaccines by volume, has dedicated one of its facilities with a capacity to produce up to 400 million doses annually to producing the Oxford vaccine.

“We are scaling up on a conservative basis of about 4 to 5 million doses a month to begin with,” Chief Executive Adar Poonawalla told Reuters, adding the company was in discussions with AstraZeneca.

Also Read: Coronavirus treatment from Moderna vaccine appears safe, shows positive results in 8 people

COVID-19 PROTECTION?

A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 across several trial centres in southern England. Data from the trial is expected shortly.

There are currently no approved treatments or vaccines for COVID-19.

Governments, drugmakers and researchers are working on around 100 programmes. Experts are predicting a safe, effective means of preventing the disease could take 12 to 18 months to develop.

Only a handful of the vaccines in development have advanced to human trials, an indicator of safety and efficacy, and the stage at which most fail.

“AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk,” it said.

Other drugmakers including Pfizer Inc, J&J and Sanofi are in various stages of vaccine development.

US -based Inovio Pharmaceuticals said Wednesday its experimental vaccine produced protective antibodies and immune system responses in mice and guinea pigs.

Also Read: Early-stage trials for coronavirus vaccine developed in Singapore could start next month, says professor

And Moderna this week released positive data for its potential vaccine, which it said produced protective antibodies in a small group of healthy volunteers.

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Moderna says its experimental COVID-19 vaccine could ‘neutralise’virus

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Moderna Inc said on Monday its experimental COVID-19 vaccine produced antibodies that could “neutralize” the new coronavirus in patients in a small early stage clinical trial, sending its shares up 25%.

The levels of the antibodies were similar to those in blood samples of people who have recovered from COVID-19, early results from the study conducted by the National Institutes of Health showed.

Participants were given three different doses of the vaccine and Moderna said it saw dose-dependent increase in immunogenicity, the ability to provoke an immune response in the body.

The vaccine, mRNA-1273, was also found to be generally safe and well tolerated in the early-stage study, the drug developer said.

Moderna leads global efforts in developing a vaccine for the new coronavirus and last week, won the U.S. health agency’s “fast track” label to speed up the regulatory review. It is looking to begin late-stage trials in July.

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Pfizer, BioNTech begin coronavirus vaccine trial in the US

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Pfizer Inc and BioNTech on Tuesday announced that they have begun initial human trial of their coronavirus vaccine. If the vaccine proves to be safe and effective in trials, it could potentially be ready for US distribution by the end of the year.

In the first stage of study, the vaccine will be administered on healthy adults of 18-55 years of age. Older adults will only be immunised with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity, Pfizer said in a statement.

The first participants have been dosed in the US in a clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.

“The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study. The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age).”

“With our unique and robust clinical study program underway, starting in Europe and now the US, we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most,” said Albert Bourla, chairman and CEO, Pfizer.

“ The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19,”

Pfizer and BioNTech’s development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen.

The novel design of the trial allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers, in a manner that will facilitate the sharing of data with regulatory authorities in real time, it said.

“It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period. We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19,” said Ugur Sahin, CEO and co-founder of BioNTech.

During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

In anticipation of a successful clinical development program, Pfizer and BioNTech are working to scale up production for global supply.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

COVID-19: KGMU, CDRI collaborate for vaccine

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The King George’s Medical University (KGMU) in Lucknow is now collaborating with the Central Drug Research Institute (CDRI) here for three major research projects, including development of a vaccine for the coronavirus.

The university, which is conducting highest number of corona tests in the state, has also been approached for the use of natural herbal products in the treatment of the disease by the Central AYUSH ministry.

According to KGMU Vice-Chancellor Prof M.L.B. Bhatt, there are at least seven research projects initiated simultaneously by the KGMU in collaboration with other scientific institutes.

“With CDRI we have three research projects – one is a molecular research to know the reasons for disease causation, second one is for finding treatment methodologies and a third project is to develop a vaccine for the virus. We have also submitted confidential proposals on novel coronavirus to the ICMR for its approval.”

The KGMU is the first medical facility in the state to start convalescent plasma therapy.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

IIT Guwahati joins hands with Hester Biosciences to develop COVID-19 vaccine

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Indian Institute of Technology Guwahati (IITG) on Wednesday said it has joined hands with Ahmedabad-based Hester Biosciences to develop a vaccine for COVID-19 and animal trials are likely to start by the end of this year.

The vaccine will be based on recombinant avian paramyxovirus-based vector platform, IITG said in a statement.

“IITG and Hester Biosciences expect the vaccine to be ready by the end of this year to start animal studies. The work is currently in its early stage of development,” it added

The premier educational institute said that the recombinant avian paramyxovirus-1 will be used to express the immunogenic protein of SARS-CoV-2. “The team at IITG has generated the recombinant avian paramyxovirus-1 based vaccine platform for Classical Swine Fever and Japanese Encephalitis. The role of the institute is to produce the recombinant vaccine candidate,” it added.

“The recombinant avian paramyxovirus-1 expressing the SARS-CoV-2 protein could be used as a vaccine candidate for further study,” it added.

Head of the research team Sachin Kumar, who is Associate Professor in the Department of Biosciences and Bioengineering at IIT Guwahati, said It is too early to comment on the efficacy and immunogenicity of the vaccine, however, we will be able to reveal more details about this vaccine after the results of animal studies are obtained .

IITG and Hester have collaborated to develop and manufacture a recombinant vaccine against COVID-19 disease as a preventive measure. Hester’s involvement would be from master seed development up to release of the commercial vaccine,” Rajiv Gandhi, CEO and MD, Hester Biosciences said.

The agreement between the two organisations was signed earlier this month.

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China approves third COVID-19 vaccine for clinical trials

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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China has approved its third coronavirus vaccine for the second phase of clinical trials as it reported 12 new COVID-19 cases, taking the total number of infections in the country to 82,816.

China has approved three coronavirus vaccines, including the one developed by Chinese military, the People’s Liberation Army (PLA) for clinical trials.

An “inactivated” vaccine developed by Wuhan Institute of Biological Products under the China National Pharmaceutical Group (Sinopharm) and the Wuhan Institute of Virology (WIV) started its clinical trials, state-run Xinhua news agency reported.

An “inactivated” vaccine consists of virus particles, bacteria, or other pathogens that have been grown in culture and then lose disease producing capacity. In contrast, live vaccines use pathogens that are still alive.

WIV has been in the eye of the storm in recent weeks as US President Donald Trump and top American officials alleged that the coronavirus may have escaped from there and demanded a probe into it. An official of the WIV denied it, terming the allegation “entirely based on speculation”.

A total of 96 persons in three age groups have received the vaccine in the first phase of clinical trial as of April 23. The vaccine has shown good safety results so far and vaccine receivers are still under observation, said the Chinese pharmaceutical company Sinopharm.

The randomised, double-blind and placebo-controlled clinical trials of the inactivated vaccine are conducted in Jiaozuo, central China’s Henan Province, and the second phase of clinical trial will focus on the vaccination procedure, it said.

The vaccine will also go through the third phase of the clinical trial, and it may take about one year to complete the clinical trial before finally reaching the conclusion on the vaccine’s safety and efficacy, it said.

China has approved three COVID-19 vaccine candidates for clinical trials.

An adenovirus vector vaccine, developed by Institute of Military Medicine under the Academy of Military Sciences, was the first to be approved to enter a clinical trial.

The first phase of the clinical trial was completed at the end of March, and the second phase started on April 12.

Meanwhile China’s National Health Commission, (NHC) said on Saturday that 12 newly confirmed COVID-19 cases were reported in the country on Friday, of which 11 were imported.

The other one was domestically transmitted in Heilongjiang Province bordering Russia.

The death toll in the country remained at 4,632 people as no fatalities were reported due to coronavirus on Friday, it said.

The overall confirmed cases on the mainland had reached 82,816 by Friday, including 838 patients who were still being treated and 77,346 people discharged after treatment.

The total number of imported cases of the coronavirus in China increased to 1,629 on Friday, of this 909 had been discharged from hospitals after recovery, and 720 were being treated with 25 in severe conditions, it said.

Also on Friday, 29 asymptomatic cases were reported. So far, 983 suspected asymptomatic cases, including 150 from abroad, were still under medical observation, it said.

Coronavirus’ first epicentres Hubei and its capital Wuhan had 553 asymptomatic cases under medical observation, state-run Xinhua news agency reported.

The asymptomatic cases were a cause of concern as the government has lifted over two-month lockdown in Hubei and Wuhan after cases abated.

Asymptomatic cases refer to people who are tested positive for the coronavirus but develop no symptoms such as fever, cough or sore throat. They are infectious and pose a risk of spreading to others.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow