Virus World
193.7K views | +30 today
Follow
 
Scooped by Juan Lama
onto Virus World
Scoop.it!

Large Antibody Study Offers Hope for Virus Vaccine Efforts

Large Antibody Study Offers Hope for Virus Vaccine Efforts | Virus World | Scoop.it

Antibodies that people make to fight the new coronavirus last for at least four months after diagnosis and do not fade quickly as some earlier reports suggested, scientists have found. Tuesday’s report, from tests on more than 30,000 people in Iceland, is the most extensive work yet on the immune system’s response to the virus over time, and is good news for efforts to develop vaccines. If a vaccine can spur production of long-lasting antibodies as natural infection seems to do, it gives hope that “immunity to this unpredictable and highly contagious virus may not be fleeting,” scientists from Harvard University and the U.S. National Institutes of Health wrote in a commentary published with the study in the New England Journal of Medicine. One of the big mysteries of the pandemic is whether having had the coronavirus helps protect against future infection, and for how long. Some smaller studies previously suggested that antibodies may disappear quickly and that some people with few or no symptoms may not make many at all.

 

The new study was done by Reykjavik-based deCODE Genetics, a subsidiary of the U.S. biotech company Amgen, with several hospitals, universities and health officials in Iceland. The country tested 15% of its population since late February, when its first COVID-19 cases were detected, giving a solid base for comparisons. Scientists used two different types of coronavirus testing: the kind from nose swabs or other samples that detects bits of the virus, indicating infection, and tests that measure antibodies in the blood, which can show whether someone was infected now or in the past. Blood samples were analyzed from 30,576 people using various methods, and someone was counted as a case if at least two of the antibody tests were positive. These included a range of people, from those without symptoms to people hospitalized with signs of COVID-19. In a subgroup who tested positive, further testing found that antibodies rose for two months after their infection initially was diagnosed and then plateaued and remained stable for four months. Previous studies suggesting antibodies faded quickly may have been just looking at the first wave of antibodies the immune system makes in response to infection; those studies mostly looked 28 days after diagnosis. A second wave of antibodies forms after a month or two into infection, and this seems more stable and long-lasting, the researchers report. The results don’t necessarily mean that all countries’ populations will be the same, or that every person has this sort of response. Other scientists recently documented at least two cases where people seem to have been reinfected with the coronavirus months after their first bout. The new study does not establish how much or which type of antibody confers immunity or protection — that remains unknown.

 

The study also found:

— Testing through the bits-of-virus method that’s commonly done in community settings missed nearly half of people who were found to have had the virus by blood antibody testing. That means the blood tests are far more reliable and better for tracking spread of the disease in a region and for guiding decisions and returning to work or school, researchers say.

— Nearly a third of infections were in people who reported no symptoms.

— Nearly 1% of Iceland’s population was infected in this first wave of the pandemic, meaning the other 99% are still vulnerable to the virus.

— The infection fatality rate was 0.3%. That’s about three times the fatality rate of seasonal flu and in keeping with some other more recent estimates, said Dr. Derek Angus, critical care chief at the University of Pittsburgh Medical Center.

Although many studies have been reporting death rates based on specific groups such as hospitalized patients, the rate of death among all infected with the coronavirus has been unknown. The news that natural antibodies don’t quickly disappear “will be encouraging for people working on vaccines,” Angus said.

 

Study in NEJM (September 1, 2020):

https://doi.org/10.1056/NEJMoa2026116 

No comment yet.
Virus World
Virus World provides a daily blog of the latest news in the Virology field and the COVID-19 pandemic. News on new antiviral drugs, vaccines, diagnostic tests, viral outbreaks, novel viruses and milestone discoveries are curated by expert virologists. Highlighted news include trending and most cited scientific articles in these fields with links to the original publications. Stay up-to-date with the most exciting discoveries in the virus world and the last therapies for COVID-19 without spending hours browsing news and scientific publications. Additional comments by experts on the topics are available in Linkedin (https://www.linkedin.com/in/juanlama/detail/recent-activity/)
Curated by Juan Lama
Your new post is loading...
Scooped by Juan Lama
Scoop.it!

Cell-Based Coronavirus Assays for Evaluation of COVID-19 Antibodies, Vaccines, and Antivirals

Cell-Based Coronavirus Assays for Evaluation of COVID-19 Antibodies, Vaccines, and Antivirals | Virus World | Scoop.it

RetroVirox offers a menu of cell-based antiviral services to evaluate experimental therapies and vaccines against coronaviruses, including SARS-CoV-2. The company offers in vitro testing with SARS-CoV-2 pseudovirions and with  live SARS-CoV-2 viruses to evaluate entry inhibitors, neutralizing antibodies, and antivirals against the novel coronavirus causative agent of COVID-19. Multiple viral strains are available for testing, including the South Africa (B.1.351), Brazil (P.1), and the U.K. variant B.1.1.7. Pseudoviruses are coated with the viral spike (S) protein of SARS-CoV-2 to recapitulate the mode of entry of the novel coronavirus. The assay can be used for the following purposes:

 

  • To determine the neutralizing activity of therapeutic antibodies and antisera
  • To test experimental COVID-19 vaccines using antisera from inoculated animals or humans
  • To evaluate small-molecule and other entry inhibitors targeting the S viral protein, the ACE-2 viral receptor, or host proteases and other targets involved in SARS-CoV-2 viral entry

 

Assays with live replicating SARS-CoV-2, and milder forms of seasonal human coronaviruses (hCoV-OC43  and 229E) allow for the evaluation of inhibitors at all stages of the coronavirus life cycle. Additional Information about the coronavirus assays offered at RetroVirox is available here. Request additional information by email at info@retrovirox.com

Andrrey Yatsenko's curator insight, December 26, 2020 1:15 PM
New  immunity  for  people in the  world to COVID -19 is  result of  evolution !!!
Scooped by Juan Lama
Scoop.it!

Powerful New COVID-19 Vaccine Shows 90% Efficacy, Could Boost World's Supply

Powerful New COVID-19 Vaccine Shows 90% Efficacy, Could Boost World's Supply | Virus World | Scoop.it

Practicality of protein-based vaccine by Novavax may help fill a global need, observers say.  The dark horse vaccine company Novavax announced strong results today from a pivotal, 30,000-person trial of its pandemic coronavirus vaccine in the United States and Mexico. The vaccine uses a protein of SARS-CoV-2, a different technology than the COVID-19 vaccines authorized so far, and delivered 90.4% overall efficacy against symptomatic COVID-19 infections, and 100% protection against moderate and severe disease. Against eight viral variants of interest and concern, its efficacy was 93.2%. And the vaccine appeared safe and well-tolerated. “This vaccine looks phenomenal. I am thrilled about these results,” says Monica Gandhi, an infectious disease physician and epidemiologist at the University of California, San Francisco. She notes that the clinical trial was highly diverse, with 44% non-white participants, and that the vaccine’s straightforward storage requirements could speed access to it in remote communities around the globe. The difference of a few percentage points between Novavax’s 90% efficacy and the 95% and 94% efficacy of the Pfizer-BioNTech and Moderna vaccines is explained in part by Novavax’s later trial, which pitted the vaccine against viral variants, says John Moore, an immunologist at Weill Cornell Medicine and a participant in the Novavax trial. The trials of those other companies' vaccines, composed of messenger RNA (mRNA), were completed before such variants were widely circulating. “This is a vaccine whose efficacy is at least on a par with Pfizer and Moderna,” Moore says. “It’s essentially 100% protective against disease.”

 

One expert is less impressed, however. “The data they have [are] nothing spectacular,” says Vijay Samant, CEO of Xiconic Pharmaceuticals and a former chief operating officer of Merck’s vaccine division. “The efficacy overall is couple of notches below the Pfizer and Moderna studies. … It’s a me-too vaccine at best.” Novavax plans to apply to the U.S. Food and Drug Administration and other regulators for an emergency use authorization in the third quarter, once the company completes regulatory requirements aimed at ensuring its product consistently matches the vaccine used in the clinical trials, said President and CEO Stanley Erck. Today’s announcement marks the end of a very long beginning for the once-moribund Gaithersburg, Maryland company, which began to develop a vaccine in January 2020, and that July won $1.6 billion from the U.S. government’s Operation Warp Speed. But the company encountered production problems that delayed the launch of its North American clinical trial until late December 2020.   In the trial, two-thirds of participants at 113 sites in the United States and six sites in Mexico initially received two doses of the vaccine separated by 21 days. One-third of participants received a placebo. Between January 25 and April 30, participants experienced 77 cases of COVID-19, 63 of them in the placebo group. All 14 cases in vaccinated participants were mild. These results are similar to those Novavax reported in January from a  late-stage trial of more than 15,000 people in the United Kingdom. That trial showed the vaccine efficacy was 89% overall, 86% against the Alpha variant that was first identified in the United Kingdom, and 96% against the original virus strain. But in a separate trial involving 4400 participants in South Africa, where the worrisome Beta variant arose and was circulating widely, the vaccine’s overall efficacy sank to 49%. In the new trial, Novavax sequenced 70% of all the coronaviruses that caused illness. In more than half of the sequenced cases, they found the culprit was the Alpha variant, which accounted for 70% of U.S. infections by late April. But the company did not provide specific efficacy data against Alpha or any other variant. (Only two cases of the Beta variant were reported in the trial.) “It doesn’t really address the lingering questions about how well the vaccine would work against ‘escape’ variants” such as Beta, says Natalie Dean, a biostatistician at the University of Florida. The COVID-19 vaccines so far authorized by major Western regulatory agencies deliver genetic material that directs a recipient’s cells to make spike, a surface protein from SARS-CoV-2, that then trains the immune system to respond to the virus. Novavax’s vaccine instead delivers the spike protein itself, carried on soaplike particles and given extra punch by an immune-boosting substance called an adjuvant. Protein technology has been used for decades in vaccines against diseases including hepatitis B.

 

In clinical trials so far, Novovax’s vaccine has produced somewhat fewer powerful, though transient systemwide side effects such as headache, muscle pain, and fatigue, which many recipients of the Pfizer-BioNTech and Moderna vaccines experienced. For instance, 54% of participants who received Moderna’s vaccine as part of a 30,000-person trial reported at least one such effect; in Novavax’s 15,000-person trial in the United Kingdom, that number was 38%.

After a second dose of vaccine in the North American Novavax trial, about 40% of participants who received the active vaccine reported experiencing some degree of headache, muscle pain, or fatigue. But serious reactions were rare. Having relatively mild side effects is a plus, says Mayank Mamtani, a biotechnology analyst who follows Novavax for B. Riley Securities. “This Novavax vaccine is going to be less reactogenic. You don’t have to cancel all your meetings” afterward, he says. He adds that the Novavax jab may find a niche as a booster vaccine in the United States, where he says such boosters may be needed by October or November. “We in this country love choice,” he adds.   Under its 2020 contract with Operation Warp Speed, Novavax committed to deliver 110 million doses to the U.S. government, although the country does not need them for initial vaccinations. Novavax expects to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the fourth quarter of 2021, Erck said.   The company has advance-purchase orders for about 200 million vaccines from another five Western governments and last month signed a deal to supply Gavi, the Vaccine Alliance, with 350 million doses for the COVID-19 Vaccines Global Access (COVAX) Facility, a global vaccine-sharing partnership. The Serum Institute of India, which is also making the Novavax vaccine, is slated to deliver another 750 million doses to COVAX, Novavax says. The Serum Institute plans to start delivering the Novavax vaccine by September, providing regulatory agencies have authorized it, officials there told Science.

 

Novavax’s production projections are substantially dialed back from earlier company predictions that it would ship 2 billion doses in 2021. That reflects the company’s struggle to scale up its manufacturing both at its own facilities and those of contractors and partner companies in 11 nations. “Novavax has been particularly challenged with executing on production scale-up efforts and manufacturing,” Mamtani wrote in a note to investment clients last month. Unlike mRNA vaccines, which need to be stored frozen, Novavax’s protein vaccine can be stored in a refrigerator for up to 6 months, and, once removed, remains viable for 24 hours. Novavax has created a new version of its vaccine, adapted to the Beta variant, that could be used as a 1-year booster, the company says. On Friday, it announced positive results for the adapted vaccine in mice and baboons. Novavax says it is also working to customize its vaccine to other SARS-CoV-2 variants. But Samant cautions that Novavax’s manufacturing struggles and the entrenched advantages of companies whose vaccines were approved months ago may make the small company’s climb to market share and profitability a tough one.

No comment yet.
Scooped by Juan Lama
Scoop.it!

Delta Variant Producing More Severe Illness, Doctors in China Say - The New York Times

Delta Variant Producing More Severe Illness, Doctors in China Say - The New York Times | Virus World | Scoop.it

Four-fifths of symptomatic cases develop fevers, more than in earlier outbreaks. The findings match trends in other countries where the Delta variant is spreading.  As the Delta variant of the coronavirus spreads in southeastern China, doctors say they are finding that the symptoms are different and more dangerous than those they saw when the initial version of the virus started spreading in late 2019 in the central city of Wuhan. Patients are becoming sicker and their conditions are worsening much more quickly, doctors told state-run television on Thursday and Friday. Four-fifths of symptomatic cases developed fevers, they said, although it was not clear how that compared with earlier cases. The virus concentrations that are detected in their bodies climb to levels higher than previously seen, and then decline only slowly, the doctors said. Up to 12 percent of patients become severely or critically ill within three to four days of the onset of symptoms, said Guan Xiangdong, director of critical care medicine at Sun Yat-sen University in the city of Guangzhou, where the outbreak has been centered. In the past, the proportion had been 2 percent or 3 percent, although occasionally up to 10 percent, he said. Doctors in Britain and Brazil have reported similar trends with the variants that circulated in those countries, but the severity of those variants has not yet been confirmed.

 

The testimonies from China are the latest indication of the dangers posed by Delta, which the World Health Organization last month labeled a “variant of concern.” First identified this spring in India, where it was blamed for widespread suffering and death, Delta has since become the dominant variant in Britain, where doctors suggest that it is more contagious and may infect some people who have received only one of two doses of a Covid-19 vaccine. China has uniquely detailed data, however, because it has essentially universal testing in the vicinity of outbreaks, allowing officials to gather detailed information on the extent of cases. Delta’s spread in southeastern China focuses more attention on the effectiveness of China’s self-made vaccines. The Chinese authorities have not indicated how many of the new infections have occurred in people who had been vaccinated. In some other countries where Chinese-made vaccines are in wide use, including the Seychelles and Mongolia, infections among vaccinated people are rising, although few patients have reportedly developed serious illness. Nearby Shenzhen had a handful of cases last week of the Alpha variant, which first emerged in Britain.

As some other parts of the world still struggle to acquire and administer large numbers of coronavirus tests, southeastern China has used its local production of scarce chemicals to conduct testing on a remarkable scale. The authorities said that they had conducted 32 million tests in Guangzhou, which has 18 million people, and 10 million in the adjacent city of Foshan, which has seven million.

 

Guangzhou has also isolated and quarantined tens of thousands of residents who had been anywhere near those infected. The testing and quarantine appear to have slowed but not stopped the outbreak. China’s National Health Commission announced on Friday that nine new cases had been found in Guangzhou the previous day. “The epidemic is not over yet, and the risk of virus transmission still exists,” said Chen Bin, deputy director of the Guangzhou Municipal Health Commission.

No comment yet.
Scooped by Juan Lama
Scoop.it!

F.D.A. Tells J.&J. to Throw Out 60 Million Doses Made at Troubled Plant - The New York Times

F.D.A. Tells J.&J. to Throw Out 60 Million Doses Made at Troubled Plant - The New York Times | Virus World | Scoop.it

The doses, produced at a Baltimore factory under federal review, could have been contaminated.  Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation. The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices. The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns, the people said. The Johnson & Johnson doses administered in the United States so far were manufactured at the firm’s plant in the Netherlands, not by Emergent. For weeks the F.D.A. has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the Baltimore factory.

 

More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s. Federal officials then ordered the plant to pause production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to assert direct control over the manufacturing of its vaccine there. Johnson & Johnson’s vaccine was once considered a potential game-changer in the nation’s vaccine stock because it required only one shot and was particularly useful in vulnerable communities. But the federal government now has an ample supply of the vaccines from Pfizer-BioNTech and Moderna, the two other federally authorized vaccine developers, and no longer needs Johnson & Johnson’s supply. Still, the loss of 60 million Johnson & Johnson doses puts a dent in t