Four New COVID Vaccines Being Tested in the Netherlands

Four New COVID Vaccines Being Tested in the Netherlands

The world is rushing to develop a vaccine against Covid-19—and in the Netherlands, several partnerships between public institutions and private companies show promising signs.

Four studies are underway in collaboration with the Dutch government, the U.S. Department of Health and Human Services, university researchers, multinational health care company Johnson & Johnson, and nonprofit research and development vaccine institute Intravacc.

Researchers at Wageningen Bioveterinary Research and Utrecht University are collaborating with Intravacc to develop an intranasal Covid-19 vaccine.

The vaccine uses a Newcastle disease virus vector, an important target for neutralizing antibodies. Intravacc will use its U.S. Federal Drug Administration-approved Vero cell platform to develop a process that can be scaled quickly for mass production.

Dr. Jan Groen, CEO of Intravacc, said he expects some results by the end of the year. He believes the potential coronavirus vaccine “is quite disruptive compared to all the other candidate concept vaccines.”

“Intravacc is a cutting-edge vaccine development organization with an outstanding track record in vaccine development,” Groen said. “Today 40 percent of all childhood vaccines contain know-how or technology from Intravacc or its predecessors. The world is waiting for a safe and reliable vaccine against Covid-19. We are hopeful that our collaborative effort can be part of the solution.”

Groen claims close collaboration between the private and public sectors is crucial to quickly control virus outbreaks. “Where the private sector plays a key role in large scale production and distribution of a vaccine, the public sector, including universities and government institutions, is quite often in the driver’s seat to develop new and innovative vaccine concepts,” he said. “In case of a pandemic, governments can fast track the registration and approval of emerging vaccines.”

Another potential vaccine is undergoing early human clinical trials. In March, the U.S. Department of Health and Human Services and Johnson & Johnson announced an investment of $1 billion into a possible vaccine developed by the pharmaceutical giant’s subsidiary Janssen Vaccines & Prevention, in the city of Leiden.

Biomedical Advanced Research and Development Authority— an Health & Human Services department— worked with the Beth Israel Deaconess Medical Center to identify a vaccine candidate earlier this year. Johnson & Johnson announced in June that trials will include more than than 1,000 participants in Belgium and the U.S. would begin in July.

“To make our vaccine candidate, we use a piece of DNA specifically — one that codes for the coronavirus ‘spike’ protein that latches on to human cells — and we place it inside a dead adenovirus,” said Jake Sargent, senior director of corporate media relations at Johnson & Johnson.

Adenoviruses are a group of viruses that cause the common cold. Adenovirus vectors—gene carriers—are altered forms and lack the DNA to replicate; therefore, the vaccine cannot cause a cold, and the protein it produces cannot cause harm either.

“When a person receives the vaccine, their cells will make the spike protein, which is recognized by the immune system as foreign, stimulating the production of antibodies and additional immune responses to fight off the virus,” said Sargent. “The process creates an immune memory, which ultimately teaches the body to both recognize and attack the virus.”

Meanwhile, Erasmus Medical is investigating Covid-19 patient reactions to blood plasma from survivors of COVID-19. The ConCoVID study, in partnership with blood bank nonprofit Sanquin, takes place at 15 locations across the Netherlands.

Furthermore, Utrecht University and Erasmus Medical are collaborating with biopharmaceutical companies Harbour BioMed and AbbVie to develop a human monoclonal antibody therapy for COVID-19. The antibody discovery was published in the scientific journal Nature Communications May 4.

In an update on its website, Utrecht University reported that the antibody “targets the conserved domain of the spike protein of SARS-CoV-2.”

The report explained, in cell culture studies, the antibody “blocked infection by the SARS-CoV-2 and a second coronavirus SARS-CoV. The antibody is fully human, facilitating its development and minimizing immune-related side effects.”

(Edited by Ruth Doris and Blake French.)



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India Gauges Herd Immunity

India Gauges Herd Immunity

More than half of the slum population in Mumbai, India’s financial capital, is infected with coronavirus. These findings, culled from a serological prevalence study undertaken in three wards of the city in July, signal the possible presence of herd immunity.

To drill down into results, researchers have undertaken a second round of serosurvey in the same wards. They hope to better gauge the prevalence of the virus and analyze how long immunity lasts.

Initial findings provide some hope for the future.

“Prevalence in India is dependent on population density, with non-slums being low and slums being high. It will be important to know which shows the maximum change in the repeat study and what are the reasons,” said Professor Ullas S. Kolthur of the Tata Institute of Fundamental Research.

The first round of serosurvey in Mumbai covered nearly 7,000 people. The findings revealed that 57% of the slum population and 16% of the non-slum population were infected with the virus. In the repeat survey, Kolthur will study 6,000 more people.

Seroprevalence surveys identify people in the community who have developed antibodies against the disease. Blood samples of the participants are collected and tested for the presence of the Immunoglobulin G antibody.

“We don’t know how long the immunity lasts,” said Kolthur. “Based on the second survey results, we will select a cohort and study this aspect.”

In the city of Pune, a Covid-19 hotspot 150 miles east of Mumbai, the recently released serosurvey data showed 51% of people have antibodies. In Delhi, the country’s capital, the second round of serosurvey concluded recently and results are expected soon.

The first round, carried out in July, showed 23% of people had antibodies. It is estimated that India would need 60% to 70% of the population to have antibodies to achieve herd immunity. But this may vary, given the vast differences in the country’s urban and rural populations and their living conditions.

“Herd immunity cannot be a fixed number for the whole country,” said Dr. Jayaprakash Muliyil, a leading epidemiologist in India. “Each section of the country will have herd immunity coming in its own time. In certain slum clusters, it has already set in.” He cited Dharavi, one of the world’s densest slums, that managed to bend the curve and even garner praise from the World Health Organization.

The slum is home to 900,000 people crammed into a mere 2.5 sq km area. One toilet seat is used by 200 people daily in Dharavi, which recorded nearly 2,300 cases and more than 200 deaths at the height of infections but has seen numbers drop, reporting daily positive cases in a single digit.

“Clusters like Dharavi, which were containment areas once, have stopped recording cases — that means the prediction there will be herd immunity is correct,” said Muliyil. “By the time 45% to 50% of people have antibodies, new cases stop emerging. The virus can’t find a susceptible person easily in a crowd of immune people.”

“Dharavi also saw aggressive testing and efforts to isolate the infected patients, which helped to a very large extent,” said Kiran Dighavkar, assistant municipal commissioner of the G-North ward in Mumbai, which covers the slum pocket. “Concentrated actions were initiated to break the chain of infection.”

As India crosses 2.7 million cases and more than 50,000 deaths, what does it mean to have such a large population carry antibodies?

“It tells you that many people are now resistant to Covid,” said Muliyil. “By all our knowledge of science so far, a viral infection like this should give lasting immunity. Once you get the infection, you will not get the disease again.”

However, there is a concern that people who have recovered can become transient carriers of the infection.

“We don’t know that,” said Muliyil. “What we know is they can’t get the disease again. We say this based on the knowledge that they have demonstrated an excellent cell-mediated response. In people who were infected during the previous outbreak of SARS, it was found their bodies could remember the virus and mounted immunity even after 18 years.”

The serological studies have economic implications. Experts say that limited economic activity, with proper precautionary health measures, given crowding conditions, could be permitted.

“Section by section,” Muliyil said, “India will go low in the number of cases.”

(Edited by Siddharthya Roy and Fern Siegel.)



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Large-Scale COVID-19 Vaccine Set for Human Trials in India Within Days

Large-Scale COVID-19 Vaccine Set for Human Trials in India Within Days

India is gearing up for large-scale human trials of a vaccine as the Covid-19 pandemic continues to claim lives across the globe.

Russia claimed this month that it has made strides, and pharmaceutical makers in the United States and Europe are also working feverishly to find a cure. Governments and private foundations are devoting huge sums to financing research and prepare for the distribution of medications that pass trials.

A vaccine being tested in India was produced by a partnership of the pharmaceutical giant AstraZeneca and Oxford University. The Serum Institute of India has begun phase 2 and 3 clinical trials of the experimental serum at seventeen sites across the country. Recruitment of volunteers is likely to begin this week.

Vaccines that the institute produces are now used in 170 countries. It announced Aug. 7 that it has entered into a partnership with Gavi, the vaccine alliance, and the Bill & Melinda Gates Foundation to manufacture and deliver up to 100 million doses of an approved Covid-19 vaccines in India and other low- and middle-income countries.

The partnership is also providing billions of dollars to accelerate the manufacturing process for the Oxford-AstraZeneca vaccine and another under development by the U.S.-based drug maker Novavax.

Their goal is to cap the price of a mass-produced vaccine at $3 per dose, making it among the cheapest in the world.

Of 17 approved vaccine testing sites, eight trial sites are in Maharashtra, the state in western India that has recorded more than 600,000 cases and more than 20,000 deaths—the highest in India. Those Maharashtra sites include two in Mumbai, four in Pune and one each in Wardha and Nagpur. The other trial sites include two in Chennai and one each in Visakhapatnam, Mysore, Jodhpur, Patna, Chandigarh, Delhi and Gorakhpur.

India has recorded more than 2.6 million confirmed cases of Covid-19, and more than 500,000 deaths. That’s the world’s third-highest tally, after the United States and Brazil.

The vaccine trials will cover 1,600 healthy Indians over seven months.

In Mumbai they will be conducted at the BYL Nair Hospital and the King Edward Memorial Hospital.

“Each hospital will recruit 160 volunteers,” said Mumbai additional municipal commissioner Suresh Kakani. “Both hospitals will start recruiting volunteers as soon as the ethics committees give a go-ahead this week.”

He said they will be screened for pre-existing conditions like HIV and hepatitis. They must be 18 or older.

Dr. Ramesh Bharmal, dean of Mumbai’s BYL Nair Hospital, said participants “will be screened for the presence of antibodies to ascertain if they have already had the Covid-19 infection.” Women “will have to be on contraception for at least 28 days before and 57 days after the inoculation,” he said.

In the north, the Post Graduate Institute of Medical Education and Research, Chandigarh, another one of the 17 trial sites, volunteer recruitment is likely to begin in the next two days.

“The initial round will have a sample size of 250. Once the staff is trained, advertisements calling for volunteers to participate in the study will be put out. The institute plans to screen at least 350 volunteers to reach the target sample size of 250,” said Dr. Madhu Gupta, principal investigator of the trial.

Gupta described a two-part process involving a second dose four weeks after the first.

A World Health Organization draft assessment lists 29 potential vaccines in the clinical trial stage and 138 pre-clinical candidates. Two of those are made in India.

The assessment, last updated on Aug. 13, includes a Russian vaccine named Sputnik V, saying it’s in phase 1 clinical trials. A Russian government website, however, claims phase 1 and 2 trials were completed Aug. 1, and that the Russian Ministry of Health announced on August 11 that “under emergency rules adopted during the COVID-19 pandemic,” the vaccine “can be used to vaccinate the population in Russia..”

“[A]ll the volunteers are feeling well,” Moscow reports, and “no unforeseen or unwanted side effects were observed.”

(Edited by Matthew Cooper and David Martosko.)



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Large-Scale Human Trials of COVID-19 Vaccine to Begin Soon in India

Large-Scale Human Trials of COVID-19 Vaccine to Begin Soon in India

India is gearing up for large-scale human trials of a vaccine as the Covid-19 pandemic continues to claim lives across the globe.

Russia claimed this month that it has made strides, and pharmaceutical makers in the United States and Europe are also working feverishly to find a cure. Governments and private foundations are devoting huge sums to financing research and prepare for the distribution of medications that pass trials.

A vaccine being tested in India was produced by a partnership of the pharmaceutical giant AstraZeneca and Oxford University. The Serum Institute of India has begun phase 2 and 3 clinical trials of the experimental serum at seventeen sites across the country. Recruitment of volunteers is likely to begin this week.

Vaccines that the institute produces are now used in 170 countries. It announced Aug. 7 that it has entered into a partnership with Gavi, the vaccine alliance, and the Bill & Melinda Gates Foundation to manufacture and deliver up to 100 million doses of an approved Covid-19 vaccines in India and other low- and middle-income countries.

The partnership is also providing billions of dollars to accelerate the manufacturing process for the Oxford-AstraZeneca vaccine and another under development by the U.S.-based drug maker Novavax.

Their goal is to cap the price of a mass-produced vaccine at $3 per dose, making it among the cheapest in the world.

Of 17 approved vaccine testing sites, eight trial sites are in Maharashtra, the state in western India that has recorded more than 600,000 cases and more than 20,000 deaths—the highest in India. Those Maharashtra sites include two in Mumbai, four in Pune and one each in Wardha and Nagpur. The other trial sites include two in Chennai and one each in Visakhapatnam, Mysore, Jodhpur, Patna, Chandigarh, Delhi and Gorakhpur.

India has recorded more than 2.6 million confirmed cases of Covid-19, and more than 500,000 deaths. That’s the world’s third-highest tally, after the United States and Brazil.

The vaccine trials will cover 1,600 healthy Indians over seven months.

In Mumbai they will be conducted at the BYL Nair Hospital and the King Edward Memorial Hospital.

“Each hospital will recruit 160 volunteers,” said Mumbai municipal commissioner Suresh Kakani. “Both hospitals will start recruiting volunteers as soon as the ethics committees give a go-ahead this week.”

He said they will be screened for pre-existing conditions like HIV and hepatitis. They must be 18 or older.

Dr. Ramesh Bharmal, dean of Mumbai’s BYL Nair Hospital, said participants “will be screened for the presence of antibodies to ascertain if they have already had the Covid-19 infection.” Women “will have to be on contraception for at least 28 days before and 57 days after the inoculation,” he said.

In the north, the Post Graduate Institute of Medical Education and Research, Chandigarh, another one of the 17 trial sites, volunteer recruitment is likely to begin in the next two days.

“The initial round will have a sample size of 250. Once the staff is trained, advertisements calling for volunteers to participate in the study will be put out. The institute plans to screen at least 350 volunteers to reach the target sample size of 250,” said Dr. Madhu Gupta, principal investigator of the trial.

Gupta described a two-part process involving a second dose four weeks after the first.

A World Health Organization draft assessment lists 29 potential vaccines in the clinical trial stage and 138 pre-clinical candidates. Two of those are made in India.

The assessment, last updated on Aug. 13, includes a Russian vaccine named Sputnik V, saying it’s in phase 1 clinical trials. A Russian government website, however, claims phase 1 and 2 trials were completed Aug. 1, and that the Russian Ministry of Health announced on August 11 that “under emergency rules adopted during the COVID-19 pandemic,” the vaccine “can be used to vaccinate the population in Russia..”

“[A]ll the volunteers are feeling well,” Moscow reports, and “no unforeseen or unwanted side effects were observed.”

(Edited by Matthew Cooper and David Martosko.)



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