Category: Corona Virus Vaccine

Development of the hundreds of vaccines and therapies for COVID-19 is by no means confined to metro areas surrounding San Francisco, Boston or Washington, D.C. Borrowing from decades of experience in producing snake antivenoms, scientists, veterinarians and technicians at a scientific and technical institute in Costa Rica have labored nonstop in recent months to produce a therapeutic formulation of equine antibodies against SARS-CoV-2, the coronavirus that causes COVID-19. Similar efforts are underway in Brazil and Argentina to tide these countries over until the arrival of an effective vaccine.

In late March, after the first case of COVID-19 was diagnosed in Costa Rica, Romn Macayaa biochemist and public health expert who heads the Costa Rican Social Security Fund, which runs the nations public clinics and hospitalsissued a call for the research community to join the fight against the then nascent pandemic. Our response to COVID-19 could not be only a health care response, Macaya says. It had to be a scientific response as well.

In making his plea for help, he singled out the antivenom specialists at the University of Costa Ricas Clodomiro Picado Institute, which is named after a renowned Costa Rican scientist. The very next day we got a letter from Henning Jensen, then rector of the University of Costa Rica saying, Were in. Let's get together and work on this, Macaya recalls.

The efforts objective was to harness the technology and experience the Clodomiro Picado Institute has acquired in its work using horse antibodies to fabricate antivenoms for snake bites during the past five decades. Every year, the antivenoms with purified equine antibodies produced at the institute save more than 500 people in Costa Rica and thousands more in other countries around the world.

The Clodomiro Picado Institute has more than 100 horses that have developed strong immunity to snake venoms after being inoculated with small quantities of toxins over a period of weeks to months. Besides their use in antivenoms for snakes, scorpions and spiders, for decades, pharmaceutical preparations of equine antibodies have been employed worldwide as a treatment for rabies, botulism and diphtheria. Clinical trials of the institutes antivenoms conducted in Colombia, Nigeria and Papua New Guinea have shown that these antibodies are safe in humans and rarely induce severe adverse reactions.

More recently, equine immunoglobulin therapy has emerged as a potential treatment for a range of viruses that have limited therapeutic options. Among them are the highly pathogenic avian influenza viruses H5N1 and H7N9 and the coronavirus that causes Middle East Respiratory Syndrome (MERS). All this inspired several research groups to find ways to produce safe and effective COVID-19 equine immunoglobulins, explains Fan Hui Wen, a researcher and project manager at the Butantan Institute in Brazil, which also has long experience in manufacturing such antibodies. She was not involved with the research at the Clodomiro Picado Institute.

The Costa Rican project has an air of familiarity. The idea behind the antibody therapy for patients with COVID-19 is similar to that of treating patients suffering from snakebite poisoning, says Alberto Alape Girn, a microbiologist and lead researcher of the COVID-19 project at the Clodomiro Picado Institute. We want to generate specific antibodies against viral structures in horses, purify the antibodies and give them to patients who are starting to fight the infection but whose immune system still does not produce enough antibodies to clear the viral particles, he adds.

Private citizens who wanted to help with the research donated six horses to the institute. The animals were inoculated with engineered proteins of the SARS-CoV-2 virus. Three of the horses received only S1, a portion of the proteinthat makes up the protruding spikes that stick out from the pathogens surface. The other three animals received a combination of four proteins from the coronavirus, including S1.

After four rounds of inoculations administered every two weeks, the horses produced the desired level of antibodies. At this point, their blood was extracted, and the red blood cells were separated from the plasma and returned to the horses. Plasma is a very complex mixture that has hundreds of proteins, Alape-Girn says. Antibodies are one of the most abundant proteins, but there are others. At the pharmaceutical plant, researchers used a technology developed by the Clodomiro Picado Institute to separate the antibodies from other proteins in the plasma and then purified them to obtain the therapeutic formulation for human testing.

In total, the plant produced 1,000 10-milliliter vials of purified equine antibodies. Half of them had antibodies against the S1 protein, and the other half contained the four proteins present in the coronavirus. Just one 10-mL vial has about 80 times the quantity of antibodies you can find in 800 mL of convalescent plasma, which is the plasma donated by someone who has overcome an infection of SARS-CoV-2, Alape-Girn says.

To test the efficacy of the equine antibodies, a few vials were shipped to George Mason Universitys National Center for Biodefense and Infectious Diseases (NCBID). We wanted to determine if the SARS-CoV-2 virus could be neutralized by the horse-produced antibodies, says Charles Bailey, a professor of biology and executive director of the NCBID. The test we performed on the samples is called a plaque reduction neutralization test, PRNTest. We exposed the antibodies produced in horses, at various dilutions, to the SARS-CoV-2 virus growing on cell culture. The virus was neutralized. The results of the research are expected to be published in the near future.

The next steptesting the equine antibodies in COVID-19 patientswill begin with an accelerated clinical trial this month. The antibodies safety and efficacy will be examined in a group of 26 patients with COVID-19 who have been hospitalized but not placed in an intensive care unit. The results are expected by the end of September. If they are positive, the research will then move to a large-scale trial with hundreds of patients. And if the equine antibodies are shown to be effective, the Clodomiro Picado Institute could immunize more horses to scale up and produce enough of them to cover Costa Ricas demandand probably that of its neighbors. It received a $500,000 grant on Aug. 13 from the Central American Bank for Economic Integration to move ahead with equine antibody research.

Unlike monoclonal antibodies, which are being developed to target a specific molecular region, or epitope, on the surface of SARS-CoV-2 to elicit an immune response, horse polyclonal antibodies against SARS-CoV-2 recognize multiple epitopes. The lower specificity translates into a more inexpensive manufacturing process. Alape-Girn estimates that a vial of equine antibodies will cost $100 to produce, whereas a treatment with monoclonal antibodies could be 10 times more expensive.

Its not the highest technology, Macaya says. Its not a monoclonal antibody, but it allows us the benefit of speed, and its a very pragmatic approach. Further, if this were a monoclonal antibody, you would need a big factory to produce them, he adds. Here, the horses are the factoriesat least for the production part. Then comes the purification part, which is an industrial process, but the Clodomiro Picado Institute already has that infrastructure.

Fansays this description mirrors her experience at the Butantan Institute in Brazil. Polyclonal antibody products can be made in large quantities, and cost-effectively, to respond to large-scale pandemic situations, such as the infection by SARS-CoV-2, she says.

Currently, the Butantan Institute is preparing horses to be immunized with portions of inactivated SARS-COV-2 virus, which were isolated,cultured and purified,using its expertise in the production of influenza virus vaccines. Even though the development protocols differ at the Brazilian and Costa Rican institutes, Fan predicts their antibodies will have equivalent efficiency and safety in the treatment of COVID-19 patients.

Even farther south in South America, scientists in Argentina are also developing a potential therapy for COVID-19 patients using equine antibodies, while other researchers worldwide are exploring antibodies against SARS-CoV-2 from llamas and cows. The objective behind all of these projects is the same: to save lives while waiting for a vaccine to become available.

Costa Rica has more than 28,000 cases of COVID-19. "We have over 100 patients in the ICU," Macaya says. "And our ICU capacity, as with any country, is limited."His hope is that equine antibodies will prove to be a very valuable tool in keeping our health care system from collapsing at the ICU level and, obviously, preventing deaths. Thats the ultimate goal.

Read more about the coronavirus outbreak from Scientific Americanhere. And read coverage from our international network of magazineshere.

More here:

Costa Rica Readies Horse Antibodies for Trials as an Inexpensive COVID-19 Therapy - Scientific American

With thepandemics death toll in nursing homes and long-term care facilities accounting for roughly a third of COVID-19 deaths in the United States, actress Susan Lucci is helping AARP advocate for good care in all facilities. (May 21) AP Domestic

Coronavirus cases in nursing homes have surged to an all-time high, driven by spread of the virus in Sunbelt states, according to a new report.

Ananalysis of federal data shows 9,715 COVID-19 cases during the week of July 26, the most recent data available. The figures eclipsed the previous high of 9,421 cases in the last week of May, according to the report by the American Health Care Association and National Center for Assisted Living.

Nearly four in five of coronavirus infections were at facilitiesin Sunbelt states, where total nursing home casesnearly tripled since mid-June, according to the report.

Deaths are on the upswing with 1,706 COVID-19 fatalities during the week ending July 26, a 22% increase from the previous week, but still well below the 3,130 deaths reported in the last week of May.

Mark Parkinson, president and CEO of the American Health Care Association and National Center for Assisted Living, said community spreadand slow testing turnaround that delays identifying the virus in vulnerable homesremain persistent problems.

"Unfortunately, weve definitely taken a step back," Parkinson said.

'Pushing the frontiers': Long lines for COVID tests, stressed labs delay results as demand spikes

Parkinson said the rise incases reflects last month's spread of the virus in hot-spot communities in the South and West. Nursing homescan be particularly vulnerable because residents live in close quarters and are more likely to have underlying medical conditions that make them susceptible to COVID-19 complications or death.

"The public needs to make the decision that the lives of the people in these buildings matter and then make the simple sacrifice to wear a mask," he said."That would solve a lot of this."

The federal government has provided hundreds of millions in emergency funds to nursing homes and long-term care facilities to prevent infections and protect residents and staff.The U.S. Department of Health and Human Services has said it will ship to all nursing homespoint-of-care testing machines that deliver rapid results.

Centers for Medicare and Medicaid Services Administrator Seema Verma said Thursday she was "deeply concerned' about the upswing in cases. And, on Friday, her agency announced it has leviedmore than $15 million in fines against 3,400-plus nursing homes for infection control lapses and failure to report COVID-19 data.

'States duking it out for supply': Lack of federal plan leads to coronavirus testing delays

Since March, CMS and states have conducted infection-control inspections at more than 15,000 nursing homes. Deficiencies at 180 homes in 22 states triggered "immediate jeopardy" findings, which the agency describes asconditions that caused or were likely to causeserious injury, harm, impairmentor death.

Parkinson said it's the wrong time to fine and shut down homes that are striving to protect workers and residents.

"We dont think the right approach is to issue fines and penalties when people are in a crisis," Parkinson said. "We think the right approach is to offer a helping hand and to collaborate as we get through the crisis."

Parkinson said the next few weeks will be critical to gauge whether the surge in new cases will be followed by more fatalities, which typically lag new cases. But he said drug treatments and care for COVID patients in nursing homes has improved since the early days of the pandemic.Dozens of residents at Life Care Center in Kirkland, Washington, died after the virus swept through the home in February and March, the nation's first warning of how deadly the virus could be in such settings.

Others think testing mandates have identified casesat nursing homes and long-term care facilities sooner.

Pennsylvania required universal testing of staff and residents of nursing homesby the end of July and assisted-living centers by the end of August. Nursing homes have identified far more cases, but most of the cases have been mild or no symptoms, saidDr. David Nace, chief medical officer for University of Pittsburgh Medical Center Senior Communities.

'Totally unacceptable': Testing delays force labs to prioritize COVID-19 tests for some, not others

"Many of these cases would have gone unnoticed otherwise," Nace said.

Nace said UPMC, which manages 35 care facilities in western Pennsylvania, has been able to isolateresidents who've tested for the virus and limit the spread within facilities.

"The arguments always been detect the case early so you can isolate and limit the spread," said Nace, a professor and geriatrics expert. "Maybe thats actually working."

Alltucker is on Twitter as@kalltuckeror can be emailed at alltuck@usatoday.com

Autoplay

Show Thumbnails

Show Captions

Read or Share this story: https://www.usatoday.com/story/news/health/2020/08/17/nursing-home-covid-19-cases-report/5599494002/

See the article here:

'A step back': COVID-19 infections reach all-time high in US nursing homes amid surge of cases in Sunbelt states - USA TODAY

Weve known from the beginning how the end will arrive. Eventually, the coronavirus will be unable to find enough susceptible hosts to survive, fading out wherever it briefly emerges.

To achieve so-called herd immunity the point at which the virus can no longer spread widely because there are not enough vulnerable humans scientists have suggested that perhaps 70 percent of a given population must be immune, through vaccination or because they survived the infection.

Now some researchers are wrestling with a hopeful possibility. In interviews with The New York Times, more than a dozen scientists said that the threshold is likely to be much lower: just 50 percent, perhaps even less. If thats true, then it may be possible to turn back the coronavirus more quickly than once thought.

The new estimates result from complicated statistical modeling of the pandemic, and the models have all taken divergent approaches, yielding inconsistent estimates. It is not certain that any community in the world has enough residents now immune to the virus to resist a second wave.

But in parts of New York, London and Mumbai, for example, it is not inconceivable that there is already substantial immunity to the coronavirus, scientists said.

Im quite prepared to believe that there are pockets in New York City and London which have substantial immunity, said Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health. What happens this winter will reflect that.

The question of what it means for the population as a whole, however, is much more fraught, he added.

Herd immunity is calculated from the epidemics so-called reproductive number, R0, an indicator of how many people each infected person spreads the virus to.

The initial calculations for the herd immunity threshold assumed that each community member had the same susceptibility to the virus and mixed randomly with everyone else in the community.

That doesnt happen in real life, said Dr. Saad Omer, director of the Yale Institute for Global Health. Herd immunity could vary from group to group, and subpopulation to subpopulation, and even by postal codes, he said.

For example, a neighborhood of older people may have little contact with others but succumb to the virus quickly when they encounter it, whereas teenagers may bequeath the virus to dozens of contacts and yet stay healthy themselves. The virus moves slowly in suburban and rural areas, where people live far apart, but zips through cities and households thick with people.

Once such real-world variations in density and demographics are accounted for, the estimates for herd immunity fall. Some researchers even suggested the figure may be in the range of 10 to 20 percent, but they were in the minority.

Assuming the virus ferrets out the most outgoing and most susceptible in the first wave, immunity following a wave of infection is distributed more efficiently than with a vaccination campaign that seeks to protect everyone, said Tom Britton, a mathematician at Stockholm University.

His model puts the threshold for herd immunity at 43 percent that is, the virus cannot hang on in a community after that percentage of residents has been infected and recovered.

Still, that means many residents of the community will have been sickened or have died, a high price to pay for herd immunity. And experts like Dr. Hanage cautioned that even a community that may have reached herd immunity cannot afford to be complacent.

The virus may still flare up here and there, even if its overall spread is stymied. Its also unclear how long someone who has recovered may be immune, and for how long.

The coronavirus crashed this years Purim celebrations in the Orthodox Jewish neighborhoods of New York City, tearing through the parades and masquerades in Brooklyn on March 9 and 10.

Schools and synagogues soon shut down to quell the spread, but it was too late. By April, thousands in the Brooklyn communities were infected, and hundreds had died.

Its like a black hole in my memory because of how traumatic it was, said Blimi Marcus, a nurse practitioner who lives in Borough Park, which was hit hard by the virus.

But all that has changed now, Ms. Marcus added: The general feeling is one of complacency, that somehow weve all had it and were safe.

Is it possible that some of these communities have herd immunity? In some clinics, up to 80 percent of people tested had antibodies to the virus. The highest prevalence was found among teenage boys.

But people at clinics are more likely to be showing symptoms and therefore more likely to be infected, said Wan Yang, an epidemiologist at Columbia Universitys Mailman School of Public Health in New York. Random household surveys would probably find lower rates but still well above the 21 percent average reported for New York City, she said.

Researchers in Mumbai conducted just such a random household survey, knocking on every fourth door or, if it was locked, the fifth and took blood for antibody testing. They found a startling disparity between the citys poorest neighborhoods and its more affluent enclaves. Between 51 and 58 percent of residents in poor areas had antibodies, versus 11 to 17 percent elsewhere in the city.

The lowest-income residents are packed tightly together, share toilets, and have little access to masks. These factors contributed to a silent infection spread, said Dr. Jayanthi Shastri, a microbiologist at Kasturba Hospital in Mumbai who led the work.

Most researchers are wary of concluding that the hardest-hit neighborhoods of Brooklyn, or even those in blighted areas of Mumbai, have reached herd immunity or will be spared future outbreaks.

But models like Dr. Brittons hint that its not impossible. Other researchers have suggested, controversially, that herd immunity can be achieved at rates of immunity as low as 10 or 20 percent and that entire countries may already have achieved that goal.

Criticism trailed Sunetra Gupta, a theoretical epidemiologist at Oxford University, after a widely circulated interview in which she said that London and New York may already have reached herd immunity because of variability among people, combined with a theoretical immunity to common cold coronaviruses that may protect against the new one.

That could be the explanation for why you dont see a resurgence in places like New York, she said.

Most experts reject that notion. Several studies have shown that certain immune cells produced following infection with seasonal coronaviruses may also recognize the new coronavirus.

But where is the evidence that its protective? asked Natalie Dean, a biostatistician at the University of Florida.

Updated August 17, 2020

These cities have not returned to pre-pandemic levels of activity, other experts noted.

We are still nowhere near back to normal in our daily behavior, said Virginia Pitzer, a mathematical epidemiologist at the Yale School of Public Health. To think that we can just stop doing all that and go back to normal and not see a rise in cases I think is wrong, is incorrect.

A second wave might also hit groups or neighborhoods that were spared by the first, and still wreak havoc, she said. Immunity is a patchwork quilt in New York, for instance: Antibodies were present in 68 percent of people visiting a clinic in the Corona neighborhood of Queens, for instance, but in just 13 percent of those tested at a clinic in the Cobble Hill section of Brooklyn.

But another group, led by the mathematician Gabriela Gomes of the University of Strathclyde in Britain, accounted for variations within a society in its model and found that Belgium, England, Portugal and Spain have herd immunity thresholds in the range of 10 to 20 percent.

At least in countries we applied it to, we could never get any signal that herd immunity thresholds are higher, Dr. Gomes said. I think its good to have this horizon that it may be just a few more months of pandemic.

Other experts urged caution, saying these models are flawed, as all models are, and that they oversimplify conditions on the ground.

Jeffrey Shaman, an epidemiologist at Columbia University, said it wasnt clear to him that Dr. Gomess model offered only one possible solution. And he was suspicious of the big ranges among the four countries.

I think wed be playing with fire if we pretended were done with this, Dr. Shaman said.

The new models offer food for thought, he and other experts said, but should not be used to set policy.

Mathematically, its certainly possible to have herd immunity at these very, very low levels, said Carl Bergstrom, an infectious disease expert at the University of Washington in Seattle. Those are just our best guesses for what the numbers should look like.

But, he added, theyre just exactly that, guesses.

But what about immunity at levels lower than those needed for herd immunity?

Definitely the disease would not spread as well if it gets back into New York, said Joel Miller, a mathematical modeler at La Trobe University in Australia. The same level of behavior change will have more effect on the disease now than it did four months ago.

Thinking of a city or country as composed of subgroups, demarcated by age, race and level of social activity, might also help governments protect those with the least immunity.

That perspective also might help put a renewed focus on groups who require the higher levels of immunity, because of greater exposure levels and other inequities, including Black and Latino residents, said Dr. Manoj Jain, an infectious disease expert at Emory University. Thats where this info is very useful, he said.

The models also suggest a vaccination strategy: Rather than uniformly vaccinate all groups, governments could identify and immunize those most likely to be exposed in superspreader events.

Getting those people vaccinated first can lead to the greatest benefit, said Dr. Michael Mina, an immunologist at Harvard University. That alone could lead to herd immunity.

Vaccination schemes for other pathogens have successfully exploited this approach. For example, when children were given the pneumococcal vaccine in the early 2000s, rates of bacterial pneumonia in the elderly rapidly dropped because of a herd effect.

Vaccines that offer just 50 percent protection are considered to be moderately effective, but at that efficiency, even a low herd immunity target would require that a large proportion of the population be immunized, Dr. Bergstrom noted.

If there are early reports of side effects that may scare away some people, he said, wed do well to start thinking about all that now.

Back in Brooklyn, fewer than 1 percent of people tested at neighborhood clinics over the past eight weeks were infected with the virus. But there are still handfuls of cases, Ms. Marcus said, adding that her 10-year-old niece was in quarantine because a counselor at her day camp had tested positive.

Sometimes thats all you need, right? she said. Im still hoping we dont see what we had in March and April, but Im not so sure that weve seen the end of it.

Read the original post:

Covid-19: What if Herd Immunity Is Closer Than Scientists Thought? - The New York Times

SARS-CoV-2, the virus that causes Covid-19, was initially thought to primarily impact the lungs SARS stands for severe acute respiratory syndrome. Now we know there is barely a part of the body this infection spares. And emerging data show that some of the viruss most potent damage is inflicted on the heart.

Eduardo Rodriguez was poised to start as the No. 1 pitcher for the Boston Red Sox this season. But in July the 27-year-old tested positive for Covid-19. Feeling 100 years old, he told reporters: Ive never been that sick in my life, and I dont want to get that sick again. His symptoms abated, but a few weeks later he felt so tired after throwing about 20 pitches during practice that his team told him to stop and rest.

Further investigation revealed that he had a condition many are still struggling to understand: Covid-19-associated myocarditis. Mr. Rodriguez wont be playing baseball this season.

Myocarditis means inflammation of the heart muscle. Some patients are never bothered by it, but for others it can have serious implications. And Mr. Rodriguez isnt the only athlete to suffer from it: Multiple college football players have possibly developed myocarditis from Covid-19, putting the entire college football landscape in jeopardy.

I recently treated one Covid-19 patient in his early 50s. He had been in perfect shape with no history of serious illness. When the fevers and body aches started, he locked himself in his room. But instead of getting better, his condition deteriorated and he eventually accumulated gallons of fluid in his legs. When he came to the hospital unable to catch a breath, it wasnt his lungs that had pushed him to the brink it was his heart. Now we are evaluating him to see if he needs a heart transplant.

An intriguing new study from Germany offers a glimpse into how SARS-CoV-2 affects the heart. Researchers studied 100 individuals, with a median age of just 49, who had recovered from Covid-19. Most were asymptomatic or had mild symptoms.

An average of two months after they received the diagnosis, the researchers performed M.R.I. scans of their hearts and made some alarming discoveries: Nearly 80 percent had persistent abnormalities and 60 percent had evidence of myocarditis. The degree of myocarditis was not explained by the severity of the initial illness.

Though the study has some flaws, and the generalizability and significance of its findings not fully known, it makes clear that in young patients who had seemingly overcome SARS-CoV-2 its fairly common for the heart to be affected. We may be seeing only the beginning of the damage.

Researchers are still figuring out how SARS-CoV-2 causes myocarditis whether its through the virus directly injuring the heart or whether its from the virulent immune reaction that it stimulates. Its possible that part of the success of immunosuppressant medications such as the steroid dexamethasone in treating sick Covid-19 patients comes from their preventing inflammatory damage to the heart. Such steroids are commonly used to treat cases of myocarditis. Despite treatment, more severe forms of Covid-19-associated myocarditis can lead to permanent damage of the heart which, in turn, can lead to heart failure.

But myocarditis is not the only way Covid-19 can cause more people to die of heart disease. When I analyzed data from the Centers for Disease Control and Prevention, I found that since February nearly 25,000 more Americans have died of heart disease compared with the same period in previous years. Some of these deaths could be put down to Covid-19, but the majority are likely to be because patients deferred care for their hearts. That could lead to a wave of untreated heart disease in the wake of the pandemic.

Many patients are understandably apprehensive about coming back to the clinic or hospital. The American Heart Association has started a campaign called Dont Die of Doubt to address the alarming reduction in people calling 911 or seeking medical care after a heart attack or stroke.

Since the beginning of the pandemic, its been clear that people with heart disease or related conditions such as diabetes or high blood pressure are at increased risk for severe Covid-19 illness. The C.D.C. recommends that the more than 30 million Americans living with heart disease practice extra precautions to avoid infection. Hospitals and clinics should work overtime both to ensure they are safe for patients and to bolster telemedicine services so that patients can be cared for without having to leave their homes.

Doctors and researchers should no longer think of Covid-19 as a disease of the lungs but as one that can affect any part of the body, especially the heart. The only way to prevent more people dying of heart disease, both from damage caused by the virus as well as from deferred care of heart disease, is to control the pandemic.

Haider Warraich (@haiderwarraich), the author of State of the Heart: Exploring the History, Science, and Future of Cardiac Disease, is a cardiologist and researcher at the Veterans Affairs Boston Healthcare System, Brigham and Womens Hospital and Harvard Medical School.

Read the original:

Covid-19 Is Creating a Wave of Heart Disease - The New York Times

So now we have some clinical data on yet another category of vaccine: SinoPharms inactivated coronavirus candidate. This is one of the classic vaccine techniques, where an infectious virus is altered by some sort of protein-denaturing treatment (heating or reactive chemistry) to make it noninfectious. But such particles can retain enough of their protein surfaces to set off a useful immune response the tricky part is inactivating the virus enough so that it cant infect cells and replicate, but not so much that it presents totally different proteins to the immune system and raises a response that wont help against the real virus.

In SinoPharms case, they inactivated the coronavirus with beta-propiolactone, which is a classic protein-alkylating compound. BPL is a strained four-membered ring that is ready to be attacked and opened by pretty much any sort of nucleophile, including protein side chains from amino acids such as Cys or Lys. The compound is used for chemical disinfection (surgical instruments and the like), but thats not a casual application, because its carcinogenic by itself. It works out for such applications, though, because its very volatile (and thus easy to remove by vacuum or heating), much like another small reactive and toxi) strained ring compound, ethylene oxide. So theres no danger in using BPL to inactivate a virus the question, as mentioned, is going to be whether youve inactivated it too much.

Patients in the Phase I trial got 2.5, 5, or 10 micrograms of this agent at Day 0, Day 28, and a third time at Day 56. There were 24 patients in each group, plus an equal-sized placebo group that just got alum adjuvant injections. In the Phase II trial, the 5 microgram dose was chosen, and there were two groups: injection at Day 0 and Day 14, or injection at Day 0 and Day 21, with 84 patients in each group and a 28-patient placebo group for each. Median ages were around the early 40s, slightly more men than women. Adverse reactions appear to have been nothing remarkable pain at the injection site mostly, with very little systemic stuff like fever or fatigue, which certainly appears to be the mildest profile of the vaccines that weve seen so far.

As for neutralizing antibodies, it looks like the three-dose Phase I trial had an odd dose-response. The medium dose was actually slightly worse than either the low or high one. Meanwhile, in the Phase II, which was done with that medium five-microgram dose, the antibody response (measured two weeks after the second dose) was not as strong as with the full three-dose schedule, but the 0/21 day dosing schedule led to a better response than the 0/14 one. It appears from the Phase II data that one of the 42 patients who were tested for antibody response in that group did not seroconvert at all. The geometric mean titer values for the neutralizing antibodies (247 for the 0/21 group) appear to be in the range of other Phase I data reported, although its not easy to make a head-to-head comparison with any certainty. There is no comparison in the study with a convalescent plasma group, but as weve been seeing, those samples tend to be pretty variable themselves. There are also no data on T-cell responses.

So this is a rather preliminary report (as the authors themselves note), but its the first one we have on an inactivated vaccine. Like all of the others so far except the J&J Ad26 one, this candidate will also need a booster shot. The small and mild adverse-event reactions here are really the main thing that stands out if youre a glass half full person, then you can be glad about that, but if youre a glass-half-empty one, you might wonder about the overall robustness of the immune response. Were going to need more data to make any calls about that, and (just as with every other vaccine under development!) the real numbers were waiting on for efficacy. How many people will this (or any) vaccine protect, and how well? Stay tuned.

More:

SinoPharm's Inactivated Coronavirus Vaccine | In the Pipeline - Science Magazine

It's the latest development in the effort to use a 19th century treatment to help 21st century patients.

The contract with the DoD's Joint Acquisition Task Force is to develop a new convalescent blood plasma process that makes more serum-derived products, and faster.

President Donald Trump and US health leaders have done a full court press to encourage people who survived Covid-19 to donate plasma to help those who are sick.

Two weeks ago, on a tour of the Red Cross, Trump implored people to volunteer to donate plasma "as soon as you can."

"We have a lot of people that would heal, would get better. As soon as you can, please," Trump said.

A Victorian solution to a modern problem?

Since the Victorian era, doctors have used this treatment to fight severe cases of the flu. The treatment has also shown success with two other deadly coronaviruses - MERS and SARS. Yet it will take studies to prove that it works to treat Covid-19. Absent other treatments, doctors have opted to use the treatment as it was still being studied.

Doctors try the old treatment

When the Covid-19 pandemic hit New York City hard in March, doctors desperate to save patients weren't sure what might help. Plasma from recovered Covid-19 patients showed some early promise. For professionals used to relying on scientific evidence and established facts, there was -- and still is -- little to work with.

"We probably changed what we were doing on a daily basis."

To see what worked, Bouvier and team did a retrospective analysis on data collected from 39 patients.

Even in that small group, convalescent plasma stood out.

"We don't have definitive answers yet, but we are on the way to getting definitive answers and, I would say, that the evidence, while imperfect, is promising," Bouvier said.

Convalescent plasma, Woodcock said, is an option that can be "feasible fairly quickly." Woodcock, said it's a treatment the government is trying to accelerate, even before the government knows if it works.

Early results in China

Early on, a handful of small studies in China looked promising.

Trying the treatment in the US

Among 25 hospitalized patients with Covid-19, seven days after the convalescent plasma treatment, nine showed some improvement and seven were discharged from the hospital. By day 14, 19 had improved and 11 were discharged. There were no safety issues.

Still, it's not clear if the treatment was the reason these patients improved; the study results would need to be reproduced in a larger group of patients.

First 'maybe,' then 'possibly,' now 'probably'

Dr. Arturo Casadevall, one of the researchers, called convalescent plasma the "good news story" of the pandemic.

"When we first started this effort if you had asked 'do you think it's going to work?' I would have said 'maybe,'" Casadevall said. "Since then I progressed to 'possibly,' and now, I am at 'probably.'"

Casadevall wants more research to prove it works.

"To really be certain you need to complete the randomized clinical trials," Casadevall said. "But the good thing has been that there have been multiple reports that have been encouraging, including my clinical trials from Wuhan that had to be stopped prematurely."

That trial was stopped when the flood of patients slowed to a trickle and there weren't enough patients to test the therapy.

The challenges

The number of cases can also impact how much of the therapy is available. Unlike with a monoclonal antibody therapies that can be made in the lab, this treatment relies on volunteers.

"It is a limited resource," Woodcock said Monday. That's why there has been a concerted push to get more donors. Even Dwayne "The Rock" Johnson has been enlisted to urge people to donate.

Typically, one donor's plasma can treat two or three people and the original donor can come back and donate again within a couple of weeks.

But there are only so many donors, Woodcock said, and scientists are starting to think there is only a month-long window in which people have enough antibodies in their blood to help someone else fight the disease. But again, they need more research to know for sure.

But there was no placebo group. Without that comparison, it's hard to know if the treatment made the difference.

The treatment be a difficult one to get right. Monoclonal antibody treatments, by contrast, are made by scientists in the lab. They pick the antibody that works best in the lab to neutralize the virus and reproduce it in the lab. Such Covid-19 antibody therapies are in clinical trials now, too.

With convalescent plasma, patients get all the antibodies in that plasma, not just those carefully engineered to fight the virus. Every donor's plasma is a little bit different and some may have more antibodies that protect against the virus better than others.

"Convalescent plasma, I think we need to have more caution about that," Dr. Anthony Fauci said recently. "You want to make sure you do it right."

The push

Woodcock, who said the US government is trying to accelerate these plasma drives, thinks there may be an additional benefit to convalescent plasma that goes beyond treating someone's symptoms.

"I think people feel very helpless in the face of this," Woodcock said. "This is something that everyone can contribute who's been infected."

Originally posted here:

Researchers hope this old-fashioned treatment will work for coronavirus - CNN

Coronavirus D614G mutation: Will it impact COVID-19 vaccines efficacy? Heres what experts say  |  Photo Credit: iStock Images

New Delhi:Mutations in the spike proteinofSARS-CoV-2, the novel coronavirus that causes COVID-19 disease, have triggered serious concerns about needing different vaccines and therapies for different variants. On Sunday, a mutation of coronavirus, dubbed D614G, that is 10 times more infectious than COVID-10 has been detected in Malaysia, media reported.

According to the World Health Organization (WHO), scientists detected the mutation as early as February 2020 and it has circulated in Europe and the Americas. WHO had said theres no evidence that the mutation can result in more severe illness.

The report cited Malaysias Director-General of Health Noor Hisham Abdullah who urged greater public vigilance after authorities detected the new strain of coronavirus (D614G) in two recent clusters. Similar discoveries in other countries, including India and Japan, were reported amid the pandemic, triggering public concerns over the efficacy of experimental coronavirus vaccines. Noor Hisham also warned COVID-19 vaccines currently being developed may not be effective against the new coronavirus strain.

As the new coronavirus continues to reproduce and spread worldwide, researchers are tracking the mutations to ensure that changes in the virus do not make it more challenging to treat or develop a vaccine. Scientists and health researchers across the world are exploring different methods for investigation - including various small molecule approaches targeting RNA polymerase, 3C-like protease, and RNA endonuclease, as well as exploration of antibodies obtained from convalescent plasma from patients who have recovered from COVID-19.

Researchers studying the virus have found that the coronavirus genome is highly prone to mutations that lead to genetic drift and escape from immune recognition. Therefore, it is imperative that sub-strains with different mutations are also accounted for during vaccine development, noted scientists at the IMB Cambridge Scientific Center. The scientists also noted that the emergence of drift variants may affect vaccine development and antibody treatment.

However, experts from China claimed that mutations in coronavirus would not change the efficacy of drugs.

It is normal for a virus to mutate in different countries and even in different areas of one country, as a virus has to adapt to local people's DNA and the local environment, Yang Zhanqiu, deputy director of the pathogen biology department at Wuhan University, told the Global Times on Monday.

According to the Chinese experts, a certain strain will form a new strain if more than 20 per cent of its genetic information mutates, which may cause current vaccines to lose effectiveness, but there is a low possibility. This is due to the fact that mutations do not necessarily affect the target site of the vaccine, added the report quoting the experts. Further, thevaccines being developed normally cover more than one target site to ensure efficacy, the experts noted.

The Chinese experts also added researchers could make changes to the existing vaccines for new strains - such as the human papilloma virus (HPV) vaccine at different valences to suit different types of HPV.

Also, a study of China WHO showed that the G614 variant remained susceptible to neutralisation by antibodies isolated from infected patients. An amino acid change (D614G) outside the RBD was found to be more infectious, but no evidence of being resistant to neutralizing antibodies has been demonstrated, they said.

A review published in Cell in July by Nathan DGrubaugh, an assistant professor of epidemiology of microbial diseases at Yale School of Public Health, and co-workers remarked antibodies built from natural D614 and G614 infections can cross-neutralise - which means that antibodies made against D614 could work for G614, and vice-versa.

The D614G mutation is therefore unlikely to have a major impact on the efficacy of vaccines currently in the pipeline, some of which exclusively target the RBD, Prof. Grubaugh et al. noted.

Experts also pointed out that there is really no reason for developing two vaccines as almost all circulating SARS-CoV-2 around the world is the G614 variant now.

Besides, Paul Tambyah, senior consultant at the National University of Singapore and president-elect of the US-based International Society of Infectious Diseases, told Reuters that the D614G mutation is not likely to impact the efficacy of a potential vaccine. According to Tambyah, the mutation may be, in fact,a good thing as it appears less deadly although it has been found to be more infectious.

That said, its important to note that the SARS-CoV-2 is a new virus thats evolving rapidly and scientists are still learning about it. Hence, more research is required to know the impactof the virus mutations on the disease, transmission, vaccine and other therapeutic development.

The views expressed by the author are personal and do not in any way represent those of Times Network.

The rest is here:

Coronavirus D614G mutation: Will it impact COVID-19 vaccines efficacy? Heres what experts say - Times Now

(CNN) A virus that didnt even exist a year ago is now killing more Americans than Alzheimers disease, accidents and diabetes.

The novel coronavirus has infected more than 5.4 million Americans and killed more than 170,000, according to data from Johns Hopkins University

Over the past three weeks, the US has averaged more than 1,000 Covid-19 deaths per day.

Covid is now the No. 3 cause of death in the US ahead of accidents, injuries, lung disease, diabetes, Alzheimers, and many, many other causes, said Dr. Thomas Frieden, a former director of the Centers for Disease Control and Prevention.

Heart disease and cancer are the leading causes of death in the US, according to the CDC.

The rate of deaths from Covid-19 is also much greater in the US than in many other countries, Frieden said.

Last week, Americans were eight times more likely to get killed by Covid than were Europeans, he said.

Just as more students head back to school, health experts are worried about a disturbing trend: decreasing testing combined with high test positivity rates.

In other words, Covid-19 is still spreading rampantly, but theres less testing to find and isolate cases.

The number of tests performed each day in the US dropped by an average of 68,000 compared to the daily rate in late July, according to data from the Covid Tracking Project.

Fifteen states conducted fewer tests this past week compared to the previous week: Mississippi, Louisiana, North Carolina, Washington state, Rhode Island, Wisconsin, Minnesota, Colorado, New Mexico, Arizona, Utah, Nevada, Idaho, Montana and Alaska.

Yet test positivity rates the percentage of tests that are positive are still higher than the recommended 5% in more than 30 states, according to data from Johns Hopkins University.

The testing situation is not good in the United States. What were not picking up is people who are contagious, said Dr. William Haseltine, chairman and president of ACCESS Health International.

Were probably missing 8 out of 10 people who are contagious. And any decrease in testing is worrisome because were not already doing well. And if you dont pick people out of a crowd who are contagious, then the epidemic spreads. This epidemic is still spreading widely.

Medical experts say there could be several reasons.

One of the reasons that testing is decreasing is that supplies arent being shipped to places that can test. I think its part of a strategy not to count how many people are infected, Haseltine said.

Another reason is that people may be less motivated to get tested, knowing it can take several days or longer to get results. And major delays can make some tests borderline useless.

Dr. Kent Sepkowitz said hes worried some states may be taking cues from President Donald Trump, who said when you do more testing, you find more cases, which might make the United States look bad.

Sepkowitz noted that several states that have touted decreased case counts also had some of the highest test positivity rates an indicator that the virus is spreading.

So even as the rates are worsening, many states have decided to reduce their efforts to find cases, he wrote. As a result, by looking less, they are finding fewer cases and sure enough, the case numbers are going down.

Florida Gov. Ron DeSantis said the state has seen six consecutive weeks of decline in test positivity rates.

And the number of patients hospitalized with coronavirus has declined by nearly 40% since peaking July 22, he added. The number of ICU patients is down 30% since July 18.

DeSantis said he thinks the downward trends across the state are durable. Were going to continue to work hard to be able to see these good trends.

One of the measures the state took to blunt the number of cases was closing bars in late June.

Halsey Beshears, Floridas top business regulator, is reviewing feedback and ideas from his meetings with bar and brewery owners from across the state, but no timeline for the reopening of bars has been set, according to Karen Smith, a spokeswoman for the Florida Department of Business and Professional Regulation.

While no timeframe for reopening is certain, Secretary Beshears understands the urgency advocated by business owners in these recent meetings, Smith said.

While medical experts hope a vaccine will be publicly available in 2021, researchers have encountered a problem: not enough Black and Latino volunteers have signed up for clinical trials.

Of the 350,000 people whove registered online, 10% are Black or Latino, according to Dr. Jim Kublin, executive director of operations for the Covid-19 Prevention Network.

Thats not nearly enough, as trial participants are supposed to reflect the population thats affected. Research shows more than half of US Covid-19 cases have been among Black and Latino people.

Much of the distrust stems from a history of medical atrocities against minorities. From 1932 to 1972, Black men were subjects in the Tuskegee syphilis study without their knowledge or consent and were not offered penicillin to treat their disease.

In the 1800s, Dr. J. Marion Sims experimented on slaves and performed surgeries without their consent and without anesthesia.

And from the 1940s until the 1970s, researchers in several studies exposed hundreds of subjects mostly Black people to dangerous amounts of radiation.

Health officials are trying to gain the trust of minority communities and recruit more diverse volunteers for Phase 3 coronavirus vaccine trials.

So far, phases 1 and 2 have shown the vaccine to be safe. Some volunteers experienced fever and muscle aches, but they felt better after a day or two.

There is some good news: A new saliva test could give Americans a quick way of learning if they have Covid-19 and if they need to isolate to help prevent the spread.

Researchers from the Yale School of Public Health created the SalivaDirect test, which received emergency use authorization from the Food and Drug Administration on Saturday.

If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine, said Nathan Grubaugh, a Yale assistant professor of epidemiology.

Unlike some other tests that require specialized supplies, the SalivaDirect test doesnt require a specific swab or collection device. It can also be used with reagents from multiple vendors.

We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample, Grubaugh said.

Researchers said the new test can produce results in less than three hours, and the accuracy is on par with results from traditional nasal swabbing. They said SalivaDirect tests could become publicly available in the coming weeks.

Shortly after their classrooms reopened, thousands of students must stay home and quarantine after coronavirus clusters at their schools.

Health experts are urging younger Americans to take precautions seriously, especially after the CDC said Covid-19 cases among children have been steadily increasing from March to July.

Recent evidence suggests that children likely have the same or higher viral loads in their nasopharynx compared with adults and that children can spread the virus effectively in households and camp settings, the CDC said.

Outbreaks have also emerged at colleges and universities.

Oklahoma State University said Sunday that at least 23 sorority members in an off-campus house tested positive for the virus. The entire house is in isolation or quarantine and will be prohibited from leaving the facility, the university said.

Less than a week after starting classes, the University of North Carolina at Chapel Hill announced its fourth cluster of coronavirus. The clusters were located at two residence halls, a private apartment complex that serves students and the Sigma Nu fraternity.

The North Carolina Department of Health and Human Services defines a cluster as five or more cases in proximity. As of Monday morning, 177 students are in isolation and 349 are in quarantine, both on and off campus. About 30,000 students attend the university.

The school has shifted to online learning for now.

The-CNN-Wire & 2020 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

Here is the original post:

Covid-19 is now the No. 3 cause of death in the US. But testing to find and isolate cases has dropped off - WREG NewsChannel 3

I reached for my sterilized Q-tip casually, like an actor accepting a cigarette in an old black-and-white movie.

I had been a little uptight about the procedure, admittedly. Havent we all heard stories about the discomfort (if not the pain) of the original COVID-19 tests? But this newer, gentler procedure to which I am submitting, in a repurposed indoor baseball facility on Northeasterns Boston campus, is self-administered, pain-free, and quick. By the time Ive counted to 10twiceIm all done.

Testing for the coronavirus begins Monday at the Cabot Physical Education Center, which is available for anyone from the Northeastern community on the Boston campus who does not show COVID-19 symptoms. (People with symptoms of illness will be tested elsewhere on campus.)

The testing regimen at Cabot is crucial to the reopening of campus this month. Over the next two weeks, all members of the Northeastern community who are currently working or studying on campus will be asked to take COVID-19 tests to ensure they are healthy.

We want to get everybody on campus tested right now, including all of the graduate students that are in the labs, says David Luzzi, senior vice provost for research and vice president of Northeasterns Innovation Campus. But we also want people to understand that this is our spin-up periodour learning period. We want to use this period to optimize the center, so that when the undergraduate students arrive, starting August 29, the testing center is ready.

When the campus is fully occupied for fall semester, says Luzzi, the goal will be for everyone to go through the testing at Cabot painlessly in 10 minutes, from start to finish.

Faculty and staff will be tested every seven days, or whenever they are on campus if their visits are less frequent than one day a week.

Students will be tested the day they arrive, then on day three, followed by day fiveand will be able to attend classes in person after receiving negative results on all three tests.

The Cabot Center is still fitted with familiar signs of its original purpose. The black netting that protected the facility during batting practice remains gathered in the corners of the lofted ceiling like a quaint pre-COVID decoration. Its folds have been enframed by a half-dozen long, thick ventilation tubes that spasm endlessly while discharging air from the room.

On Wednesday this was an empty space with nothing in it, says Ken Henderson, chancellor and senior vice president for learning. Weve arranged it to get as many as 500 people per hour through the facility.

All appointments must be arranged via the COVID-19 Test Scheduler (no walk-ups are allowed). Tests are available on weekdays between 7 a.m. and 7 p.m., with abbreviated hours on weekends.

The entrance to the testing facility has been outfitted with a large white welcoming tent. It is here that the three-step process begins.

Step One: A greeter in the tent asks if you have made an appointment online (which includes a symptoms checklist that you must complete on the same day as your COVID-19 test). You show your Northeastern ID, and your temperature is taken instantly with an infrared thermometer.

You are invited to enter the Cabot facility, where an usher asks you to follow a path laid out by red ropes. Its a little bit like queuing up for a ride at DisneyWorld (though these lines promise to move much more quickly).

Step Two: You are greeted by a receptionist seated at a computer behind a plexiglass shield. You are asked for your Northeastern ID number and your date of birth. If there are any clerical issues with your appointment, they will be addressed here; otherwise, you are handed a small barcoded sticker and sent onto the final phase of the operation.

At every station throughout the three-step process, you will find an ultraviolet germicidal irradiation lighting (UVGI) with high-efficiency particulate air (HEPA) filtration system. These units, which resemble portable dehumidifiers, have been shown to reduce particulate count, including those potentially containing viruses.

Step Three: You are directed to the first available testing station. There are 16 of them, and each station can accommodate up to three appropriately distanced test-takers.

A worker at your testing station guides you through the following actions:

Thats that. You are done.

If you test positive for COVID-19, then you will receive a phone call within 24-36 hours providing you with the result as well as information on what youll be doing next to keep you and your community safe.

Negative results will be shared with you via email.

Luzzi cites two priorities: Provide quick results that will help limit the transmission rate of COVID-19, and scale the tests in order to account for one-fifth of the Northeastern community every five days.

Streamlining the process is crucial to its success, Luzzi says.

We dont want you to lose a big chunk of your day to being tested, Luzzi says. We want to be executing this process at a very rapid speed, which is why we have so many stations.

Roberto Molar Candanosa contributed to this report.

For media inquiries, please contact Jessica Hair at j.hair@northeastern.edu or 617-373-5718.

Link:

I was tested for COVID-19 on campus. Here's how it went. - News@Northeastern

With a coronavirus vaccine still months off, companies are rushing to test what may be the next best thing: drugs that deliver antibodies to fight the virus right away, without having to train the immune system to make them.

Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help it be eliminated. Vaccines work by tricking the body into thinking theres an infection so it makes antibodies and remembers how to do that if the real bug turns up.

But it can take a month or two after vaccination or infection for the most effective antibodies to form. The experimental drugs shortcut that process by giving concentrated versions of specific ones that worked best against the coronavirus in lab and animal tests.

A vaccine takes time to work, to force the development of antibodies. But when you give an antibody, you get immediate protection, said University of North Carolina virologist Dr. Myron Cohen. If we can generate them in large concentrations, in big vats in an antibody factory ... we can kind of bypass the immune system.

These drugs, given through an IV, are believed to last for a month or more. They could give quick, temporary immunity to people at high risk of infection, such as health workers and housemates of someone with COVID-19. If they proved effective and if a vaccine doesnt materialize or protect as hoped, the drugs might eventually be considered for wider use, perhaps for teachers or other groups.

Theyre also being tested as treatments, to help the immune system and prevent severe symptoms or death.

The hope there is to target people who are in the first week of their illness and that we can treat them with the antibody and prevent them from getting sick, said Dr. Marshall Lyon, an infectious disease specialist helping to test one such drug at Emory University in Atlanta.

Having such a tool would be a really momentous thing in our fight against COVID, Cohen said.

Vaccines are seen as a key to controlling the virus, which has been confirmed to have infected more than 20 million people worldwide and killed more than 738,000. Several companies are racing to develop vaccines, but the results of the large final tests needed to evaluate them are months away. Russia on Tuesday approved a vaccine that hasnt undergone such a test, sparking international concern that it was cutting corners.

The antibody drugs are very promising and, in contrast, could be available fairly soon, said Dr. Janet Woodcock, a U.S. Food and Drug Administration official who is leading government efforts to speed COVID-19 therapies. Key studies are underway and some answers should come by early fall.

One company, Eli Lilly, has already started manufacturing its antibody drug, betting that studies now underway will give positive results.

Our goal is to get something out as soon as possible and to have hundreds of thousands of doses ready by fall, said Lillys chief scientific officer, Dr. Daniel Skovronsky.

Another company that developed an antibody drug cocktail against Ebola Regeneron Pharmaceuticals Inc. now is testing one for coronavirus.

The success with our Ebola program gives us some confidence that we can potentially do this again, said Christos Kyratsous, a Regeneron microbiologist who helped lead that work.

Regenerons drug uses two antibodies to enhance chances the drug will work even if the virus evolves to evade action by one.

Lilly is testing two different, single-antibody drugs one with the Canadian company AbCellera and another with a Chinese company, Junshi Biosciences. In July, Junshi said no safety concerns emerged in 40 healthy people who tried it and that larger studies were getting underway.

Others working on antibody drugs include Amgen and Adaptive Biotechnologies. The Singapore biotech company Tychan Pte Ltd. also is testing an antibody drug and has similar products in development for Zika virus and yellow fever.

Im cautiously optimistic about the drugs, said the nations top infectious diseases expert, Dr. Anthony Fauci. Im heartened by the experience that we had with Ebola, where the drugs proved effective.

What could go wrong?

The antibodies may not reach all of the places in the body where they need to act, such as deep in the lungs. All the antibody drugs must make their way through the bloodstream to wherever theyre needed.

The virus might mutate to avoid the antibody the reason Regeneron is testing a two-antibody combo that binds to the virus in different places to help prevent its escape.

Skovronsky said Lilly stuck with one antibody because manufacturing capacity would essentially be cut in half to make two, and you will have less doses available. If a single antibody works, we can treat twice as many people, he said.

The antibodies might not last long enough. If they fade within a month, its still OK for treatment since COVID-19 illness usually resolves in that time. But for prevention, it may not be practical to give infusions more often than every month or two.

A San Francisco company, Vir Biotechnology Inc., says it has engineered antibodies to last longer than they usually do to avoid this problem. GlaxoSmithKline has invested $250 million in Vir to test them.

Giving a higher dose also may help. If half of antibodies disappear after a month, if you give twice as much, you will have two months protection, Lillys Skovronsky said.

The big fear: Antibodies may do the opposite of whats hoped and actually enhance the viruss ability to get into cells or stimulate the immune system in a way that makes people sicker. Its a theoretical concern that hasnt been seen in testing so far, but large, definitive experiments are needed to prove safety.

As best as we can tell, the antibodies are helpful, Lyon said.

___

Marilynn Marchione can be followed on Twitter: @MMarchioneAP

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

View post:

Companies test antibody drugs to treat, prevent COVID-19 - The Associated Press