Category: Covid-19 Vaccine

What's the outlook for really fending off the novel coronavirus? Small molecule drugs and other therapeutics will obviously beat vaccines to market, and Gilead's remdesivir, if effective, could scale up fast, experts said.

Vaccines are likely further off than quoted timelines suggest. It's "overly optimistic"to expect them in 12 to 18 months, two opinion leaders told SVBLeerink analyst Geoffrey Porges.

They're"relatively optimistic" about Gilead's remdesivir "being effective and rapidly scaled to global demand for severe patients," the analyst wrote in a note to clients.

Use Serialization Data to Maximize Performance and Minimize Risks

Serialized products generate a wealth of data as they move through the supply chain. What if you could access and analyze this data to gain operational visibility and powerful business insight? Its time to put your serialization investment to work for you.

Gilead has started phase 3 studies ofremdesivirin COVID-19 patients whilefederal health officials and others conducttheir own studies. WHO officials have said the drug, originally developed for Ebola,is the most promising treatment. In Japan, the drug was given to some American cruise ship passengerswho "were probably going to die in a short amount of time," an NIH doctor told the Wall Street Journal;none had died two weeks later.

Aside from that medicine, the expertsdon't believe existing HIV meds will be "viable therapies," Porges wrote. They do, however,seea rationale to explore whether ACE inhibitors orangiotensin receptor blockers could help fight the infection. The experts said a monoclonal antibody therapymight reach the market "even before a vaccine," Porges wrote.

Worldwide, the biopharma industry is responding to an outbreak that has spread to more than 100 countries. The novel coronavirus has infected more than 130,000 people and killed more than 4,900 as of Friday.The World Health Organization declared it a pandemic earlier this week.

RELATED:Coronavirus tracker: Gottlieb says postpone gatherings; travel clampdown forces Novartis to change Kymriah shipments

Aside from Gilead's virus-fighting work, Sanofi and Regeneron this week said they're gearing up to test arthritis med Kevzara in certain patients with severe disease. Chinas National Health Commission recommended Roche's Actemra for patients with serious lung damage earlier this month. Other drugmakers working on therapeutics or vaccines include Vir Biotechnology, Johnson & Johnson, Takeda, and many others.Eli Lillyjust entered a deal with AbCellera in a push to enter the clinic within four months.

Some government officials have said a vaccine could be available within 12 to 18 months, but the experts told Porges that's "overly optimistic." Moderna's novel vaccine has been prepared forphase 1 testing in record time, but as the MIT Technology Review reminded its readers, that platform is unproven. As for therapeutics, analysts have said Gilead could have remdesivir data to report yet this month, but they're unsure whether early trial results would be conclusive.

Read the original here:

Look for novel coronavirus treatments first, experts say, and vaccines are further off than you think - FiercePharma

Senior health officials have said a COVID-19 vaccine will take at least two years to develop even with expedited clinical trials and approvals. The virus has affected 74 people in the country, including 17 foreign nationals (16 Italians and a Canadian).

Raman. R. Gangakhedkar, head of the Epidemiology and Communicable Diseases-I (ECD-I), Division of the Indian Council of Medical Research (ICMR), said Indian scientists have managed to successfully isolate the COVID-19 virus. This is needed for making a vaccine. There are two ways of going for vaccine preparation either you look at the sequences of the gene which then may lead to development of antibodies, or you actually have the strain and then you try to develop a vaccine which is always an easier option, he said.

Dr. Gangakhedkar said the COVID-19 virus is difficult to isolate.

But the efforts of Indian scientists have been successful and about 11 isolates are available which is a prime requisite for doing any kind of research related to viruses, he said.

He cautioned that in certain viruses even if vaccines are given, when the infection tends to occur, there could be a flare-up and the severity of the infection is likely to increase. This is an evolving virus and we are still learning about it. We would say right now we must try to prevent it as much as possible, contain it and wait for things to happen.

Asked if high temperature kills the virus, a senior health officials said there is no study or evidence to suggest that.

He said those avoiding quarantine are not only risking their life but also that of the loved ones in their family. The ICMR will start surveillance to examine whether any infected person has been left undetected.

So far there is no evidence that we are missing any cases, he said.

You have reached your limit for free articles this month.

Register to The Hindu for free and get unlimited access for 30 days.

Find mobile-friendly version of articles from the day's newspaper in one easy-to-read list.

Enjoy reading as many articles as you wish without any limitations.

A select list of articles that match your interests and tastes.

Move smoothly between articles as our pages load instantly.

A one-stop-shop for seeing the latest updates, and managing your preferences.

We brief you on the latest and most important developments, three times a day.

Not convinced? Know why you should pay for news.

*Our Digital Subscription plans do not currently include the e-paper ,crossword, iPhone, iPad mobile applications and print. Our plans enhance your reading experience.

See more here:

COVID-19 vaccine will take at least two years to develop: health officials - The Hindu

As more Covid-19 cases appear in the United States and around the world, the need for fast, easy-to-use diagnostic tests is becoming ever more pressing. A startup company spun out from MIT is now working on a paper-based test that can deliver results in under half an hour, based on technology developed at MITs Institute for Medical Engineering and Science (IMES).

Cambridge-based E25Bio, which developed the test, is now preparing to submit it to the FDA for emergency use authorization, which would grant temporary approval for using the device on patient samples during public health emergencies.

Elsewhere around MIT, several other research groups are working on projects that may help further scientists understanding of how coronaviruses are transmitted and how infection may be prevented. Their work touches on fields ranging from diagnostics and vaccine development to more traditional disease prevention measures such as social distancing and handwashing.

Faster diagnosis

The technology behind the new E25Bio diagnostic was developed by Lee Gehrke, the Hermann L.F. von Helmholtz Professor at IMES, and other members of his lab, including Irene Bosch, a former IMES research scientist who is now the CTO of E25Bio.

For the past several years, Gehrke, Bosch, and others in the lab have been working on diagnostic devices that work similar to a pregnancy test but can identify viral proteins from patient samples. The researchers have used this technology, known as lateral flow technology, to create tests for Ebola, dengue fever, and Zika virus, among other infectious diseases.

The tests consist of strips of paper that are coated with antibodies that bind to a specific viral protein. A second antibody is attached to gold nanoparticles, and the patients sample is added to a solution of those particles. The test strip is then dipped in this solution. If the viral protein is present, it attaches to the antibodies on the paper strip as well as the nanoparticle-bound antibodies, and a colored spot appears on the strip within 20 minutes.

Currently, there are two primary types of Covid-19 diagnostics available. One such test screens patient blood samples for antibodies against the virus. However, antibodies are often not detectable until a few days after symptoms begin. Another type of test looks for viral DNA in a sputum sample. These tests can detect the virus earlier in the infection, but they require polymerase chain reaction (PCR), a technology that amplifies the amount of DNA to detectable levels and takes several hours to perform.

Our hope is that, similar to other tests that weve developed, this will be usable on the day that symptoms develop, Gehrke says. We dont have to wait for antibodies to the virus to come up.

If the U.S. Food and Drug Administration grants the emergency authorization, E25Bio could start testing the diagnostic with patient samples, which they havent been able to do yet. If those are successful, then the next step would be to talk about using it for actual clinical diagnosis, Gehrke says.

Another advantage of this approach is that the paper tests can be easily and inexpensively manufactured in large quantities, he adds.

RNA vaccines

On Feb. 24, only about a month after the first U.S. case of coronavirus was reported, the Cambridge-based biotech company Moderna announced it had an experimental vaccine ready to test. That speedy turnaround is due to the unique advantages of RNA vaccines, says Daniel Anderson, an MIT professor of chemical engineering, who also works on such vaccines, though not specifically for coronavirus.

A key advantage of messenger RNA is the speed with which you can identify a new sequence and use it to come up with a new vaccine, Anderson says.

Traditional vaccines consist of an inactivated form of a viral protein that induces an immune response. However, these vaccines usually take a long time to manufacture, and for some diseases, they are too risky. Vaccines that consist of messenger RNA are an appealing alternative because they induce host cells to produce many copies of the proteins they encode, provoking a stronger immune response than proteins delivered on their own.

RNA vaccines can also be quickly reprogrammed to target different viral proteins, as long as the sequence encoding the protein is known. The main obstacle to developing such vaccines so far has been finding effective and safe ways to deliver them. Andersons lab has been working on such strategies for several years, and in a recent study he showed that packing such vaccines into a special type of lipid nanoparticles can enhance the immune response that they produce.

Messenger RNA can encode the viral antigens, but in order to work, we need to find a way to deliver these antigens to the correct part of the body so that they get expressed and generate an immune response. We also need to make sure that the vaccine causes appropriate immune stimulation to get a strong response, Anderson says.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), has estimated that it will take at least 12 to 18 months to fully test any potential Covid-19 vaccine for safety and effectiveness.

Keep your distance

Over the last decade, Lydia Bourouiba, an associate professor directing the Fluid Dynamics of Disease Transmission Laboratory at MIT, has focused on characterizing and modeling infectious disease dynamics and transmission at various scales. Through experiments in the lab and clinical environment, she has reported that when a person coughs or sneezes, they do not emit a spray of individual droplets that quickly fall to the ground and evaporate, as scientists had once thought. Instead, they produce a complex cloud of hot and moist air that traps droplets of all sizes together, propelling them much further through the air than any individual droplet would travel on its own.

On average, her experiments have revealed that a cough can transmit droplets up to 13 to 16 feet, while a sneeze can eject them up to 26 feet away. Surrounding air conditions can act to further disperse the residual droplets in upper levels of rooms.

Bourouiba notes that the presence of the high-speed gas cloud is independent of the type of organism or pathogen that the cloud may contain. The droplets within it depend on pathogenesis coupled with a patients physiology a combination which her laboratory has focused on deciphering in the context of influenza. She is now expanding her studies and modeling to translate the work to Covid-19, and says now is a critical time to invest in research.

This virus is going to stay with us for a while and certainly data suggest that it is not going to suddenly disappear when the weather changes, she says. Theres a fine and important balance between safety, precautions and action that is important to strike to enable and dramatically accelerate research to be done now so we can be better prepared and informed for actions in the weeks and months to come when the worst of the pandemic will unfold.

She is also working with others to evaluate ways to limit a clouds dispersal and slow Covid-19 transmission to health care workers and others in shared spaces. A surgical mask is not protective against inhalation of a pathogen from the cloud, she says. For an infected patient wearing it, it can contain some of the forward ejecta from coughs or sneezes, but these are very violent ejections and masks are completely open on all sides, and fluid flows through the path of least resistance.

Based on the data, she recommends that health care workers consider wearing a respirator, whenever possible. And, for the general public, Bourouiba emphasizes that the risk of contracting COVID-19 remains relatively low locally, and that risk should be thought of in the context of the community.

Wash those hands

Another good way to protect yourself against all of those tiny infectious droplets is to wash your hands. (Again, and again, and again.)

Ruben Juanes, an MIT professor of civil and environmental engineering, and of earth, atmospheric and planetary sciences, published a study in December showing the importance of improving rates of handwashing at key airports in order to curtail the spread of an epidemic. Now, he says, following the Covid-19 outbreak, governments around the world have imposed unprecedented restrictions on mobility, including the closure of airports and suspension of flight routes.

At the same time, the World Health Organization, U.S. Centers for Disease Control, and many other health agencies all recommend hand-hygiene as the number one precaution measure against disease spread. Following our recent paper on the impact of hand-hygiene on global disease spreading, Juanes says, we are now investigating the combined effect of restrictions on human mobility and enhanced engagement with hand-hygiene on the global spread of COVID-19 through the world air-transportation network.

Juanes says he and Christos Nicolaides PhD 14, a professor at the University of Cyprus who was the lead author of the previous study, are working with fine-grained, worldwide air-traffic data that accounts for all flights for the period between Jan. 15, 2020 until today (accounting for closures/cancellations) and the corresponding period of 2019 (base level) to elucidate the role of travel restrictions on the global spread of Covid-19 through detailed epidemiological modeling.

Furthermore, he adds, we simulate different hand-hygiene strategies at airports on top of travel restrictions with the goal of proposing an optimal strategy that combines travel restrictions and enhanced hand hygiene, to mitigate the advance of Covid-19 both in the short term (weeks) and the long term (the next flu season).

Juanes says they will make the results immediately available via medarXiv, while the work follows peer-review in a journal. This would also allow the information to reach other academic and government institutions in a more timely way, he says.

Continued here:

Covid-19 diagnostic based on MIT technology might be tested on patient samples soon - The MIT Tech

A team of ten scientific researchers from the Erasmus Medical Center in Rotterdam and Utrecht University say they are the first in the world to discover an antibody capable of fending off an infection by the Covid-19 variant of coronavirus. The discovery could lead to an antiviral medication, and the ability for people to test themselves at home for the presence of the virus.

I am too old to jump on a table, said cellular biology professor Frank Grosveld to Erasmus Magazine. Their article is undergoing a peer review by other researchers on the online platform BioRxiv, and they believe it well then be published by top science journal Nature.

"Here we report a human monoclonal antibody that neutralizes SARS-CoV-2 (and SARS-CoV)," the researchers state in their academic paper's abstract. This is the SARS-2 virus, which causes coronavirus induced disease 19, or Covid-19 for short.

They claim the antibody they found "neutralizes" the virus, and "offers the potential to prevent and/or treat COVID-19, and possibly also other future emerging diseases in humans caused by viruses from the Sarbecovirus subgenus."

"As far as we know, this is the very first antibody that blocks the infection," Grosveld explained to the magazine. "Finding something like this is very rare," he said.

Their research would not necessarily lead to a vaccine, but rather a new medicine that could be used to treat those infected with the current coronavirus strain. It could be developed far faster than a vaccine, but would need months of testing, he stated, adding that it would also be more expensive to produce than a vaccine.

"We are now trying to get a pharmaceutical company on board which is looking promising, by the way that can produce the antibody on a large scale as a medicine," Grosveld said.

"If you were to take this as a patient, it is expected only an expectation right now that the infection will be stopped. And so it can give the patient an opportunity to recover," he told the magazine.

See the original post here:

Dutch researchers first to find Covid-19 antibodies: Report - NL Times

The demographics, virology, and public health dimensions of, and earlier parallels to, the COVID-19 coronavirus pandemic suggest that the current approach to the outbreak in the U.S. and Europe (other than the U.K.) might be on a wrong and dangerous track. In the U.S., this is partly due to Donald Trumps self-serving blunders, but not entirely. While there are no perfect responses in the current environment (the availability of a vaccine would change everything), the following facts need to be considered.

COVID-19 is essentially innocuous in anyone under 50, but is frequently extremely damaging or fatal for those over 60, and particularly over 70. But although it is often claimed (by NIH Infectious Diseases director Anthony Fauci at Trumps Friday the 13th national emergency announcement, for instance) that this is due to their immune systems being weak, or because they are more likely to have underlying conditions, the extreme differential between the impact on this age group and others is reminiscent of an earlier outbreak where those factors did not apply. The 1918 Spanish flu pandemic killed upwards of 50 million people worldwide. Of the half-million estimated deaths in the U.S., 92% were under 65, and a full half were between 20 and 40 years old.

The best theory for this selective impact comes from a research group at the University of Arizona, who note that this cohort was exposed to a virus with related properties that circulated around 1900, when they were children that (instead of protecting them) primed their immune systems to respond to the later virus in an inappropriate and damaging fashion. Older people severely affected by COVID-19 also exhibit such immune hyper-reactivity, suggesting that they may have been primed by a pathogen exposure in the 1950s, before the less vulnerable population was born.

So, while old people must strenuously avoid being infected regardless of their current health status, for everyone else, particularly young adults and children, a different policy should be in effect. Vaccination is the safest way to establish herd immunity, the condition in which the general population is largely resistant to an infection, and its members, even if they become infected, are therefore incapable of spreading it. Until there is a vaccine for COVID-19, however, the only route to herd immunity is for those who can be infected without getting sick, become so.

Thats why closing schools, colleges, theaters, museums, etc. is a bad idea. Of course, older people (including faculty over 60, who could teach by videolink) should stay away from all of these, but young people could attend and participate with little effect. Shutting down these facilities is less a benefit to public health than to the legal exposure of their owners and administrators. Certainly, attendees would become COVID-19-positive, but they mainly would be oblivious to it. They would need to be warned to keep their distance from their elderly relatives, and vice-versa, but this applies to the prevailing shut-down regime as well, where students and thwarted theatergoers are not prohibited from socializing or being at large. However, just as a tiny percentage of people die from the flu, meningitis, and food poisoning in any public and institutional setting, there would inevitably be a few adverse COVID-19-associated events at schools and colleges. This would lead to huge lawsuits, particularly in the U.S., making an open policy, however desirable, difficult to achieve.

Nonetheless, large sectors of the economy, here and abroad, are nearly collapsing because of fears that are not entirely justified. Apart from impeding and prolonging the establishment of herd immunity, misery is being sown in terms of lost education and arts events, scarcity, and loss of employment. Disaster capitalism (in Naomi Kleins coinage) will ensure that the streamlining will be permanent and many of the jobs will not return. Of course, there will be some benefits, like the curtailment of the environmentally devastating behemoth-cruise industry, but many restaurants and cultural institutions will disappear forever.

Its a scandal of major proportions that the Trump administration suppressed evidence of the epidemic at its early stages and abolished, well before that, the Center for Disease Control Pandemic Task Force, making sure that the U.S. was ill-equipped to test people. Clearly, its important to know who has the virus, even if most people wont be affected by it. But Trump was interested in keeping the numbers of confirmed cases down. So now we are saddled with bad policy based on misconceptions, and a venal and incompetent administration poised to make it worse.

The U.K. has implemented a COVID-19 management policy at odds with that in Europe and the U.S., which is designed to accelerate herd immunity, as proposed here. Thegovernment has received pushback for its non-consultative, top-down approach. It would be a mistake to petition for anything of this sort from a government with authoritarian and racist proclivities. The institutional shutdowns in the U.S. have been voluntary, and when they are reversed, as they must eventually be, that will be voluntary as well. The faster that carefully managed social mixing in the low-vulnerability groups occurs, the sooner herd immunity will be achieved. The institutions and their members who are at the vanguard in coming out of the cold, making it easier for others, will earn the gratitude of society as a whole.

More:

Getting Viral: Why COVID-19 is Such a Threat to the 60+ Plus Population and Why the Response May Make It Worse - CounterPunch