COVID-19 vaccine: the challenges of running a trial in the middle of a pandemic – The Conversation CA

COVID-19 vaccine: the challenges of running a trial in the middle of a pandemic – The Conversation CA

Teen’s coronavirus-themed prom dress made of duct tape is a work of art – CNN

Teen’s coronavirus-themed prom dress made of duct tape is a work of art – CNN

July 5, 2020

Manker was not deterred by the fact that she would not get to wear her dress to prom. Instead, she felt inspired to create a dress that "documents a part of history."

Her coronavirus-themed dress features multiple images depicting life during the pandemic. Her vision for the dress began with wanting to capture her own experience. She represents her unforgettable senior year with a vibrant scene of students attending virtual graduation.

Manker's ideas evolved as the pandemic continued to impact people all over the world.

"It wasn't just high schoolers, it wasn't just America, it was the whole world being impacted by the pandemic so I wanted to show that," said Manker.

She does so by showing an image of people running away from the giant coronavirus to signify the world trying to avoid catching the disease. Other designs pay tribute to frontline workers and people suffering from mental health issues as a result of the pandemic.

The Sparta, Illinois, high school graduate omitted no detail from her dress ensemble. She completed the look with a creative array of accessories including a "flatten the curve" face mask. Manker also crafted jewelry, shoes and a hair piece reading, "separately together."

While Manker's favorite creation is her coronavirus-shaped purse, she believes that her anklet displaying the words, "This too shall pass," perfectly encapsulates her message. She wants the people who see her dress to be reminded that "even though it doesn't seem like it right now, the coronavirus pandemic will eventually pass, it will all be okay in the end."

Manker also wants to encourage a spirit of positivity with her work. She believes that "we can have some positive things come out of this whole experience and my dress is an example of that."

It would be difficult to tell from looking at the pictures of her work, but Manker says this is her debut as a duct tape artist. Her previous experience is from making small duct tape wallets and flowers when she was much younger. Four months and 41 rolls of duct tape later, she managed to make something far more elaborate.

As Manker prepares to leave for Southwestern Illinois College in the fall, she says the experience taught her that "you can do a whole lot of things with duct tape."

Duck Brand will be awarding $20,000 in cash scholarships to the winners in July.


Read the original post: Teen's coronavirus-themed prom dress made of duct tape is a work of art - CNN
Coronavirus Testing the Cheap, Simple Way – The New York Times

Coronavirus Testing the Cheap, Simple Way – The New York Times

July 5, 2020

Simple at-home tests for the coronavirus, some that involve spitting into a small tube of solution, could be the key to expanding testing and impeding the spread of the pandemic. The Food and Drug Administration should encourage their development and then fast track approval.

One variety, paper-strip tests, are inexpensive and easy enough to make that Americans could test themselves every day. You would simply spit into a tube of saline solution and insert a small piece of paper embedded with a strip of protein. If you are infected with enough of the virus, the strip will change color within 15 minutes.

Your next step would be to self-quarantine, notify your doctor and confirm the result with a standard swab test the polymerase chain reaction nasal swab. Confirmation would give public health officials key information on the viruss spread and confirm that you should remain in quarantine until your daily test turned negative.

E25Bio, Sherlock Biosciences, Mammoth Biosciences, and an increasing number of academic research laboratories are in the late stages of developing paper-strip and other simple, daily Covid-19 tests. Some of the daily tests are in trials and proving highly effective.

The strips could be mass produced in a matter of weeks and freely supplied by the government to everyone in the country. The price per person would be from $1 to $5 a day, a considerable sum for the entire population, but remarkably cost effective.

Screening the population for infection, however, is different from determining whether someone is infected.

The Food and Drug Administration has recently approved group P.C.R. testing to screen large numbers of people. (Group testing, which is used in other countries, assays multiple swab samples at once and if the virus is found, individuals are tested.) So there is reason to hope that the F.D.A. will also approve paper-strip tests as a way to find out where the virus has spread.

Hope needs to be replaced with surety. Biotech companies are reluctant to take these tests to market for fear that the F.D.A. will disparage them for being less sensitive than the nasal swab tests. The nasal swab test can detect extremely small quantities of viral particles.

But the problem with the nasal swab tests is their cost, which ranges from $50 to $150. They also require laboratory assessment, which can take days. That is why, the Centers for Disease Control and Prevention reports, nine of 10 infected Americans never get tested. Its also why those who do get tested, generally are tested only once.

Clearly, if youre infected and never tested, you can unwittingly spread the virus. And if you are tested, but just once, and the test comes back negative, you may still later become infectious. Finally, if your polymerase chain reaction swab is positive, but it takes five days to learn the result, you may spend those days transmitting the disease.

Group testing can dramatically lower nasal-swab-testing costs for universities and large companies. But absent federal coordination, it cant be used routinely to test all Americans.

We need the best means of detecting and containing the virus, not a perfect test that no one can use. That is where paper-strip testing would have the advantage. Their ability to be used more frequently would trump the nasal swab tests higher sensitivity. Paper-strip testing would also sharply improve diagnosis as those with a positive paper-strip test would still be given a nasal swab test.

Would everyone take a paper-strip test every day? Here market incentives will surely help. Once they are provided to all, employers would likely require their workers to take time-dated pictures of their negative test results before coming to work. Colleges would require students to do the same before coming to class. Restaurants could accept reservations only if accompanied by negative-test pictures. In short, everyone will have an incentive to test themselves daily to participate fully in the economy and return to normal life.

Once paper strips efficacy is definitively proved and they are cleared by the F.D.A., Congress can quickly authorize the production and distribution, for free, of a years supply to all Americans. Then well have not only a true day-to-day sense of Covid-19s path. Well also have a far better means to quickly contain and end this terrible plague.

Laurence Kotlikoff is a professor of economics at Boston University, and Michael Mina is an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health.

The Times is committed to publishing a diversity of letters to the editor. Wed like to hear what you think about this or any of our articles. Here are some tips. And heres our email: letters@nytimes.com.

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Study finds hydroxychloroquine may have boosted survival, but other researchers have doubts – CNN

Study finds hydroxychloroquine may have boosted survival, but other researchers have doubts – CNN

July 5, 2020

A team at Henry Ford Health System in southeast Michigan said Thursday their study of 2,541 hospitalized patients found that those given hydroxychloroquine were much less likely to die.

Dr. Marcus Zervos, division head of infectious disease for Henry Ford Health System, said 26% of those not given hydroxychloroquine died, compared to 13% of those who got the drug. The team looked back at everyone treated in the hospital system since the first patient in March.

It's a surprising finding because several other studies have found no benefit from hydroxychloroquine, a drug originally developed to treat and prevent malaria. President Donald Trump touted the drug heavily, but later studies found not only did patients not do better if they got the drug, they were more likely to suffer cardiac side effects.

The US Food and Drug Administration withdrew its emergency use authorization for the drug earlier this month and trials around the world, including trials sponsored by the World Health Organization and the National Institutes of Health, were halted.

Researchers not involved in the Henry Ford study pointed out it wasn't of the same quality of the studies showing hydroxychloroquine did not help patients, and said other treatments, such as the use of the steroid dexamethasone, might have accounted for the better survival of some patients.

"Our results do differ from some other studies," Zervos told a news conference. "What we think was important in ours ... is that patients were treated early. For hydroxychloroquine to have a benefit, it needs to begin before the patients begin to suffer some of the severe immune reactions that patients can have with Covid," he added.

The Henry Ford team also monitored patients carefully for heart problems, he said.

"The combination of hydroxychloroquineplusazithromycin was reserved for selected patients with severe COVID-19 and with minimal cardiac risk factors," the team wrote.

The Henry Ford team said they believe their findings show hydroxychloroquine could be potentially useful as a treatment for coronavirus.

"It's important to note that in the right settings, this potentially could be a lifesaver for patients," Dr. Steven Kalkanis, CEO of the Henry Ford Medical Group, said at the news conference.

Kalkanis said that their findings do not necessarily contradict those of earlier studies. "We also want to make the point that just because our results differ from some others that may have been published, it doesn't make those studies wrong or definitely a conflict. What it simply means is that by looking at the nuanced data of which patients actually benefited and when, we might be able to further unlock the code of how this disease works," he said.

"Much more work needs to be done to elucidate what the final treatment plan should be for Covid-19," Kalkanis added. "But we feel ... that these are critically important results to add to the mix of how we move forward if there's a second surge, and in relevant other parts of the world. Now we can help people combat this disease and to reduce the mortality rate."

Zervos said hydroxychloroquine can help interfere with the virus directly and also reduces inflammation.

Researchers not involved with the study were critical. They noted that the Henry Ford team did not randomly treat patients but selected them for various treatments based on certain criteria.

The Henry Ford team wrote that 82% of their patients received hydroxychloroquine within the first 24 hours of admission, and 91% within the first 48 hours of admission.

They wrote that in comparison, a study of patients at 25 New York hospitals started taking the drug "at any time during their hospitalization."

"Maybe there's a little bit of a difference, but it's not like patients in New York were being started on day seven. That's not what happened," said Eli Rosenberg, lead author of the New York study and an associate professor of epidemiology at the University at Albany School of Public Health.

Rosenberg also pointed out that the Detroit paper excluded 267 patients -- nearly 10% of the study population -- who had not yet been discharged from the hospital.

He said this might have skewed the results to make hydroxychloroquine look better than it really was. Those patients might have still been in the hospital because they were very sick, and if they died, excluding them from the study made hydroxychloroquine look like more of a lifesaver than it really was.

"There's a little bit of loosey-goosiness here in all this," he told CNN.

Both the Detroit and New York studies were observational: they looked back at how patients did when doctors prescribed hydroxychloroquine.

While helpful, observational studies are not as valuable as controlled clinical trials. Considered the gold standard in medicine, patients in a clinical trial are randomly assigned to take either the drug or a placebo, which is a treatment that does nothing. Doctors then follow the patients to see how they fare.

Two clinical trials on hydroxychloroquine for Covid-19, one in the US and one in the UK, were stopped early because their data suggested hydroxychloroquine wasn't helpful.

The UK trial, run by the University of Oxford, enrolled more than 11,000 patients.

But a White House official praised the Henry Ford team's study.

Peter Navarro, the White House trade adviser, said the study shows hydroxychloroquine works if given early enough.

"This is a big deal," he told CNN. "This medicine can literally save tens of thousands, perhaps hundreds of thousands of American lives and maybe millions of people worldwide."


Read more: Study finds hydroxychloroquine may have boosted survival, but other researchers have doubts - CNN
Texas Medical Association Lists Activities And Their Risks Of Contracting Coronavirus – CBS Dallas / Fort Worth

Texas Medical Association Lists Activities And Their Risks Of Contracting Coronavirus – CBS Dallas / Fort Worth

July 5, 2020

(CBSDFW.COM) The Texas Medical Association is giving residents a way of seeing how at risk they are of contracting COVID-19 while taking part in their favorite activities.

As the state continues to see a surge in new COVID-19 cases, the association posted on social media a visual representation of the current risks of certain activities during the pandemic.

The risk levels were broken up into low, moderate-low, moderate, moderate-high and high and were listed by a scale of one to 10.

Some of the high risk activities listed the association include working out at a gym, attending a large concert and going to a bar.

Low and moderate-low risk activities include playing tennis, grocery shopping and eating in the outdoor area of a restaurant.

The state has recently taken steps in response to the surge. On Thursday, Gov. Greg Abbott issued a statewide face mask requirement for counties with over 20 confirmed cases.

Last week, the governor ordered bars to close for the second time during the pandemic and restaurants to go back to a 50% limited capacity, down from 75%.


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Coronavirus: US reports world’s biggest daily increase in cases with 55,000 – The Guardian

Coronavirus: US reports world’s biggest daily increase in cases with 55,000 – The Guardian

July 5, 2020

The US reported a daily global record of more than 55,000 new coronavirus cases on Thursday as infections rose in the vast majority of states and Americas top public health expert spoke of a very disturbing week.

Hospitals in some of the new hotspots in the US south and west put themselves on a crisis footing and face becoming overwhelmed. Florida reported almost 10,000 new cases in the past 24 hours and that state along with Texas, Arizona and California together made up almost half of the total of new infections.

The daily US tally stood at 55,274 new cases late on Thursday, topping the previous single-day record of 54,771 set by Brazil on 19 June and exceeding single-day tallies from any European country at the height of the outbreak there.

What weve seen is a very disturbing week, Anthony Fauci, a top federal health expert on the White House coronavirus taskforce and longtime director of the National Institute of Allergy and Infectious Diseases, said in a livestream with the American Medical Association.

The surge this month, after a steady improvement in California and a continued improvement in the previous center of the pandemic, New York, has been blamed in part on Americans not covering their faces in public nor following other social distancing guidance or rules as states swiftly lifted their lockdowns.

Fauci warned that if people did not start complying, were going to be in some serious difficulty.

Cases are now rising in 37 out of 50 states. Donald Trump went to the golf club on Friday morning, before planning to fly to South Dakota for a pre-Fourth of July celebration on Friday night at Mount Rushmore, where fireworks will be detonated and no social distancing mandated despite warnings of both wildfires and Covid-19 transmission and also despite protests from Native Americans that the monument is on stolen land.

The US president also tweeted late Thursday night [sic]: There is a rise in Coronavirus cases because our testing is so massive and so good, far bigger and better than any other country. This is great news, but even better news is that death, and the death rate, is DOWN. Also, younger people, who get better much easier and faster!

California has seen positive tests climb 37% but hospitalizations are up 56% over the past two weeks.

Patients with serious cases of Covid-19 are flooding into hospitals across the southern and western states. Mississippi, Tennessee, Texas, Nevada and Arizona set records for hospitalizations on Thursday.

Fauci has warned that the virus is nowhere near under control in the US.

Some Arizona hospitals are rushing to expand capacity in the way many New York City hospitals were forced to at the height of the outbreak there, when up to 800 people were dying every day in April, the Washington Post reported on Friday. That means doubling up hospital beds in rooms, stopping non-essential surgery and recruiting extra health workers from outside their regions.

Arizona officials have activated crisis standards of care protocols for who gets urgent care first or a ventilator. State officials reported a record 3,013 Covid-19 hospitalizations in Arizona on Thursday.

Fauci said of the US situation: Were setting records, practically every day, of new cases in the numbers that are reported. That clearly is not the right direction.

Younger people are accounting for more of the new cases than previously, because of a swift return to social gatherings, against federal guidelines.

But infections and deaths are also increasing overall. A month ago, the US was reporting approximately 20,000 new infections a day and that has more than doubled. Confirmed coronavirus cases in the US have reached 2.75 million. There have been 128,000 deaths and the toll is rising.

We are not flattening the curve right now, Brett Giroir, assistant secretary for health, told a congressional hearing on Tuesday.

Theres a lag between confirmed case and hospitalization, and between hospitalization and death. So you look at the numbers and you can see how hospital capacity could quickly become strained in coming weeks, Saskia Popescu, an epidemiologist at the University of Arizona, told the Washington Post.

The USs neighbor to the north, Canada, has so far flattened its coronavirus curve with early and widespread testing, extensive mask-wearing and social distancing and slow reopening. The US is currently reporting more than 10 times more positive cases per capita than Canada, CNN reported.

Meanwhile, several US Secret Service agents assigned to the vice-president, Mike Pence, tested positive for Covid-19, or exhibited symptoms just before his planned trip to Arizona earlier this week, according to several reports. CNN claimed that eight Secret Service agents had tested positive, causing a delay in the trip while people were replaced.

Pence has recently started wearing a mask in public, after shunning them earlier despite the official federal public health guidance that they help to stop the spread.

Trump has refused to wear a mask in public or actively encourage Americans to do so.

Jonathan Reiner, an adviser to the White House medical team under George W Bush, said the president was clearly flirting with disaster by holding election rallies without social distancing or mask-wearing among the crowds and attending events mask-free.

Just because hes tested frequently, [that] isnt a Superman cape, he told CNN. He can get the virus. The more he flirts with this, the higher the likelihood that hell get it.


Read more here: Coronavirus: US reports world's biggest daily increase in cases with 55,000 - The Guardian
Coronavirus updates: Trump claims vaccine coming ‘long before the end of the year’ – ABC News

Coronavirus updates: Trump claims vaccine coming ‘long before the end of the year’ – ABC News

July 5, 2020

July 5, 2020, 8:59 AM

4 min read

A novel coronavirus pandemic has now killed more than 530,000 people worldwide.

More than 11.2 million people across the globe have been diagnosed with COVID-19, the disease caused by the new respiratory virus, according to data compiled by the Center for Systems Science and Engineering at Johns Hopkins University. The actual numbers are believed to be much higher due to testing shortages, many unreported cases and suspicions that some governments are hiding the scope of their nations' outbreaks.

The United States is the worst-affected country in the world, with more than 2.8 million diagnosed cases and at least 129,676 deaths.

President Donald Trump greets visitors as he walks on the South Lawn of the White House during a "Salute to America" event, Saturday, July 4, 2020, in Washington.

Latest:

Here's how the news is developing today. All times Eastern.

President Donald Trump made remarks on Saturday evening at the second annual Salute to America July 4th event held in Washington, D.C. and claimed that a therapeutic and/or vaccine will be around long before the end of the year.

"I want to send our thanks to the scientists and researchers around the country and even around the world who are at the forefront of our historic effort to rapidly develop and deliver life-saving treatments and ultimately a vaccine.," Trump said. "We are unleashing our nation's scientific brilliance and we'll likely have a therapeutic and/or vaccine solution long before the end of the year."

Trump also said that his administration has tested more than 40 million people around the country.

"We got hit by the virus that came from China," Trump began. "And we've made a lot of progress, our strategy is moving along well. It goes out in one area and rears back its ugly face in another area. But we've learned a lot. We've learned how to put out the flame. We've made ventilators where there were none, by tens of thousands, to the point that we have far more than we need, and we're now distributing them to many foreign countries as a gesture of good will. Likewise, testing -- there were no tests for a new virus. But now we have tested almost 40 million people."

Said Trump: "By so doing, we show cases, 99% of which are totally harmless, results that no other country can show because no other country is testing that we have, not in terms of the numbers or in terms of the quality. And now just like everything else, we have become the manufacturer and record for ventilators. We have the most finest testing anywhere in the world and we are producing gown and masks and surgical equipment in our country we're heretofore it was almost exclusively land in lands in China ironically where this virus and others came from. China secrecy deceptions and coverup allowed it to spread all over the world. 189 countries, and China must be held fully accountable."

The Los Angeles Police Department has announced the first of its employees to die from coronavirus.

Senior detention officer Erica McAdoo died on Friday, according to the department.

There are currently 287 department employees to either test positive or be exposed to someone who tested positive and are in isolation.

While the LAPD, the third-largest police force in the U.S., has only seen one death, the largest in the country, the New York Police Department, has lost 46 employees to COVID.


More here: Coronavirus updates: Trump claims vaccine coming 'long before the end of the year' - ABC News
Oxfords vaccine offers good duration of immunity to COVID-19 compared to no vaccine: lead researcher – Firstpost

Oxfords vaccine offers good duration of immunity to COVID-19 compared to no vaccine: lead researcher – Firstpost

July 5, 2020

The vaccine has been licensed to AstraZeneca and is in its Phase III of its human trials in the UK.

Oxford University, experts think, is the most likely to come up with a viable vaccine candidate forCOVID-19, which has caused havoc around the world. Even the World Health Organisationhas pegged themas the leading candidate for a viable vaccine.

In a recent online call with the Ministers of Parliament of the House of Commons Science and Technology Committee,Dr Sarah Gilbert, thelead researcher for Oxford's COVID-19 vaccine and Professor of Vaccinology at the Jenner Institute & Nuffield Department of Clinical Medicine,spokeabout the ongoing trial.

The coronavirus is a family of viruses and SARS-CoV-2,like SARS and MERS, is part of this one big family, identified in the mid-1960s.Coronaviruses are known tohave symptoms like fever, sore throat, headaches, cough, runny nose, etc and are also very common. People who have been infectedare thought tobe susceptible togetting infected again. This is a major causefor concern with a potential COVID-19 vaccine.

In order to dispel concerns about re-infections, Gilbert said that the Oxford vaccine should be able to provide a good duration of immunity and she is optimistic about it. She also said a vaccine might provide better results than natural immunity acquired when individuals recover from the virus.

"Vaccines have a different way of engaging with the immune system, and we follow people in our studies using the same type of technology to make the vaccines for several years, and we still see strong immune responses," said Gilbert.

"Its something we have to test and follow over time we cant know until we actually have the data but were optimistic based on earlier studies that we will see a good duration of immunity, for several years at least, and probably better than naturally-acquired immunity."

A vaccine candidate against COVID-19 (the SARS-CoV-2 virus), provided by Imperial College London. About a dozen vaccine candidates are in early stages of testing in thousands of people. Image: Imperial College London via AP

The vaccine, which has been given the name AZD1222, islicensed to British biopharmaceutical company AstraZeneca, whichwill be manufacturing it if trials succeed.The vaccine is currently inPhase III human trials,in whichthe vaccine is being administered to around 8,000participants. Thetrial will assess how the vaccine works in a large number of people over the age of 18,and whetherthe vaccine works to prevent people from becoming infected with COVID-19.

Gilbert said, "We're very happy that we're seeing the right sort of immune response that will give protection, and not the wrong sort."

Oxford Universityisalsoslated to conducthuman trials in Brazil with 5,000 individuals, in the US with 30,000participants and another 2,000 in South Africa.

When asked how long will it be till a vaccine is available, Gilbert said she is confident human trials will be completed by the year-end, by which time AstraZeneca plans to manufacture millions of doses in anticipation of approval.

However, Kate Bingham, chair of the UK Government Vaccine Taskforce, said that, excluding the Oxford vaccine program that is on track to be completed by August this year, she hopes for a breakthrough in other COVID-19 trials by early 2021.

"We dont know coronavirus well. Think of examples like HIV and malaria. We know those diseases well, yet we dont have vaccines against them," she told the committee. "So we may never get a vaccine, or we may only get a vaccine that modifies the severity of the disease, or lessens its effects."

Oxford University Regius Professor of MedicineSir John Bellalso echoed similar thoughts as Bingham when he said, "This whole epidemic has relied too heavily on assumptions that have turned out not to be true. So my strong advice is to be prepared for the worst."


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Oxfords vaccine offers good duration of immunity to COVID-19 compared to no vaccine: lead researcher - Firstpost
We will take about three months to finish phase I and II clinical trials: Zydus Cadilas Pankaj R Patel – The Indian Express

We will take about three months to finish phase I and II clinical trials: Zydus Cadilas Pankaj R Patel – The Indian Express

July 5, 2020

Written by Prabha Raghavan | Updated: July 5, 2020 12:24:54 am Pankaj R Patel, Chairman, Zydus Cadila.

The Central Drugs Standard Control Organisation (CDSCO) late on Thursday approved Zydus Cadilas application to move to human trials for its ZyCov-D, hotting up Indias race for a vaccine against Covid-19. The trials will begin this month on over 1,000 patients across multiple sites, said the Ahmedabad-headquartered firms chairman, Pankaj R Patel. In an interview with The Indian Express, Patel discusses how the firm developed its vaccine candidate, the timeline it has in mind for its trials and other vaccine candidates it is considering. Edited excerpts:

What process did you follow in the development of your vaccine?

We started working in early March, when we saw that the S protein epitopes were responsible for this (Covid-19). We basically looked at some of those S protein epitopes and basically selected a few of them to clone into a vector and into a hostwe tested them for the immunogenicity and the expression levels and, based on that, we selected one (from four potential candidates) which was good.

This was then extensively developed in terms of quality standards, purity, etc. Then, once it was completely developed, we administered it to animals to check the immune response and we got a very good immune response in those animals. We actually tested it on four different animal speciesfrom mice to rats, to guinea pigs and rabbits. Then what we did was the sera we collected from the rabbits were tested for virus neutralisation assay. What you do is, you see whether this immune sera can kill the virus or not.

We found that the viruses were being killed. The antibodies were good to kill the virus.

Then we moved to pre-clinical toxicity in two species for 28 days to find out whether the vaccine was safehere also, we found a good immune response. Based on that, we made the application for moving into the clinical phaseand they (CDSCO) approved the protocol we submitted to start the phase I/II trials.

(We received the approval) late last night.

Also Read | Vaccine by August 15: Scientists say ICMR claim absurd and risky

How long are you expecting the first two phases of the trial to take?

We will move into the clinical phase now. We intend to test this vaccine in about 1,000 volunteersWere following the adaptive clinical trial protocol (phase I followed by phase II without much gap in between) which, in a pandemic or emergency area, is permitted by regulators across the world.

We will take about three months to complete the Phase I and II clinical trials, after which we will approach the DCGI for their consideration.

Do you plan on seeking an emergency authorisation for your vaccine, which would allow you to launch the product without phase III trials?

At the end of the phase I and II trials, we will go to our regulator and, whatever the regulator will tell us, we will follow.

By the time we are done with the first two phases of our trial, we will have more clarity (on the data)then we will take a call.

Your vaccines are also being tracked globally by the World Health Organisation. What stage of development is the other candidate at?

One is this plasmid DNA vaccine that is going into (human) clinical trials now. The other one is being developed in our research centre in Italy. We have been updating data to WHO (about them). It is monitoring these developments because it is a global effort that people are trying to put in (to develop a Covid-19 vaccine).

The one in Italy is still in the preclinical stage. It is more challenging. What we are basically doing (with this vaccine) is reverse genetic (technique). We are trying to create a measles virus which can give immunity to Covid-19 and its kind of a challenging task, so we are optimising our yields.

It will take maybe another quarter or so to get some data on that.

Everyone is trying to put in every different kind of effort (to find a vaccine) and if anyone becomes successful, I will be very happy because, ultimately, somebody has to bring the vaccine to the market.

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Who will be the first to get a COVID-19 vaccine? – MassLive.com

Who will be the first to get a COVID-19 vaccine? – MassLive.com

July 5, 2020

Who will be the first to get a COVID-19 vaccine?

Probably people in the country where the first effective vaccine is developed.

About a dozen different vaccines are in various stages of testing worldwide, including in Britain, China and the U.S. This week, Dr. Anthony Fauci, the top U.S. infectious disease expert, said he is cautiously optimistic there will be a COVID-19 vaccine by the end of the year or early 2021.

Several wealthy countries have already ordered millions of doses of those experimental vaccines.

Britain and the U.S., for example, have invested in a vaccine candidate being developed by Oxford University and produced by AstraZeneca. If it works, U.K. politicians have said Britons will be vaccinated with it. The U.S. expects to start stockpiling it this fall and also has invested in other vaccine candidates.

Groups including the vaccine alliance GAVI are also working to buy doses for poor countries and AstraZeneca has agreed to license its vaccine to Indias Serum Institute for the production of 1 billion doses. The World Health Organization is drafting guidelines for the ethical distribution of COVID-19 vaccines.

How vaccines are distributed within a country will vary. Last week, U.S. officials said they were developing a tiered system for that. The system would likely prioritize groups at greatest risk of severe complications from COVID-19 and key workers.


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Panel of experts outside the government could determine who gets the COVID-19 vaccine first, NIH director says – CBS News

Panel of experts outside the government could determine who gets the COVID-19 vaccine first, NIH director says – CBS News

July 5, 2020

Public health officials told a Senate committee Thursday that a panel of experts outside the U.S. government may help decide who gets the eventual COVID-19 vaccine first. National Institutes of Health Director Dr. Francis Collins acknowledged that the public could be wary of the U.S. government having final say on who gets the first doses.

"We think that might be something best done, in a circumstance, by an organization that is not itself governmental," Collins said in a hearing about "Operation Warp Speed," the Trump administration's plan to develop a vaccine by the end of the year. "Because it's still the case, I think, that people are a little uneasy about the government calling the shots here."

Collins said now may be the time "to actually bring together a group of big thinkers who can take a high-level view of this that can lay out a foundation of principles." He said there are already early discussions with the National Academy of Medicine, a non-profit that advises governments and businesses on health issues.

Collins said he hopes to have principles for distribution laid out by Labor Day. "It looks promising," he told the committee.

CBS News has reached out to the National Academy of Medicine for comment.

CDC Director Robert Redfield said the CDC would ultimately have the "prime responsibility" of distributing doses. Redfield emphasized the need for figuring out strategies to help vulnerable and undeserved populations, such as setting up mobile units for vaccine shots.

Collins, Redfield and acting Biomedical Advanced Research and Development Authority Director Dr. Gary Disbrow all expressed cautious optimism that the U.S. government is on track to develop a safe and effective vaccine by the end of 2020, and have 300 million doses ready in early 2021.

They said dozens of vaccine candidates are being tested now, and there could be multiple successful vaccines in the end. One potential vaccine developed by Moderna and the NIH is entering the final stage of human trials this month.

According to current CDC guidance,the first populations to get a new vaccine that's in short supply would be front-line and essential workers such as public health personnel, critical health care employees, law enforcement and the manufacturers of the vaccine. Pregnant women and toddlers are also in the first priority group. Healthy adults between the ages of 19 and 64 are expected to be the last group to get the vaccine.


Read the original: Panel of experts outside the government could determine who gets the COVID-19 vaccine first, NIH director says - CBS News