Category: Covid-19 Vaccine

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What is the ‘new normal’? What the future holds after COVID-19 vaccine – CBS19.tv KYTX

May 7, 2020

TYLER, Texas With restaurants, movie theaters and now salons reopening, people are starting to wonder what life is going to be like after we've developed a vaccine for COVID-19.

RELATED: REOPENING TEXAS: Salons, barber shops can reopen May 8 with strict guidelines; gyms, workout facilities may reopen May 18

The phrase "new normal" is constantly getting tossed around, but how "new" will life be after social distancing be?

"I think it's contingent on whether the new normal includes having a virus that we're concerned about because if we don't, I bet the new normal is pretty much the old normal," said Tom Guderjan, chairman of the Social Sciences department at the University of Texas at Tyler.

Also an anthropologist, Guderjan says throughout history, humans have had to be isolated for one reason or another and respond the same way after that period of isolation is over.

"I have friends and loved ones who I speak with, I email with, I text with and I want to hug them and say 'Good to see you're okay,'" said Guderjan. "I think that, that need is going to be very much played out by by all of us. We all have friends and family that we're not seeing."

RELATED: Start of May brings reopenings from coronavirus around the world

However medical experts say not everything will return to the way it was.

Dr. Scott Smith, Senior Vice President at CHRISTUS Health Clinic says there will be several safety measures that we all should keep doing.

"I think the new normal will include being more attuned to hand washing and personal hygiene when you're out in public places, airplanes, stadiums, restaurants, all of that," Dr. Smith said.

Smith says though he thinks it is fine for everyone to be back out and about during this time, it is important that we continue to wear masks in public and keep up with social distancing guidelines.

"The new normal is still not yet known but we're learning," Dr. Smith explained. "As we're learning, we're learning that we do need to be safer when we're out and about by paying attention to what we touch using good hand hygiene and social distancing."

RELATED: From masks to money, Sen. Cornyn is answering COVID-19 questions

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What is the 'new normal'? What the future holds after COVID-19 vaccine - CBS19.tv KYTX

University of Maryland testing vaccine on COVID-19 patients developed by drug companies – WUSA9.com

May 7, 2020

The experimental vaccine developed by Pfizer and BioNtech is being used on patients who have the COVID-19 coronavirus.

WASHINGTON The very first patients in the state of Maryland got a COVID-19 vaccine injection at the University of Maryland School of Medicine.

The experimental vaccine developed by Pfizer and BioNtech is being used on patients who have the COVID-19 coronavirus. While it is still in the experimental stage, it is progress that health experts and government officials are looking for, as states look towards a path of reopening.

Gov. Larry Hogan broke the news about the vaccine testing during a press conference Wednesday afternoon.

Aside from his announcement about the vaccine testing, Hogan said that remdesivir doses have also been donated to Maryland. The doses are reportedly going to Prince George's County and Montgomery County, where the highest number of positive cases in the state have been seen.

Hogan said health officials are hoping that remdesivir will help with curbing the coronavirus in Maryland, along with residents continuing social distancing.

The announcement by Hogan about the vaccine being used in Maryland came as he also announced that he would be allowing certain outdoor activities to resume starting May 7. This includes golfing, fishing, camping and tennis, as well as the reopening of state parks and beaches.

While the announcement brought some hope for the opening up of Maryland, schools in the state are closed for the rest of the academic school year, State Superintendent Karen Salmon announced. Distance learning and online curriculum will continue for the remainder of the school year.

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University of Maryland testing vaccine on COVID-19 patients developed by drug companies - WUSA9.com

ENC doctor’s opinion on fast tracking COVID-19 vaccine – WITN

May 7, 2020

GREENVILLE, NC (WITN) - Many people question how long it will take for researchers to find a vaccine for COVID-19.

Dr. Rachel Roper with the Brody School of Medicine said, It depends on how urgently it's needed and you know, theyre moving this one along quite quickly."

About 60 different vaccines are racing to the finish line. Roper said this urgency comes with some risks though.

"A new vaccine has less safety data that's true, you have to compare that to the likelihood of being infected and dying from COVID-19, said Dr. Roper.

Some say getting the vaccination is a risk theyre willing to take for their health. "I think if you take a risk to help you potentially be healthy, I think its worth it," said Timothy Harris.

Roper explained some of the vaccinations have already been given to a few people, but to see if it works those people need to be exposed to the virus, an experiment that comes with some concerns. "So that's a very big ethical concern. I'm not sure if they will end up doing that or not." Roper said. While some folks may be hesitant to get a brand-new vaccination, Roper said you have to weigh it out. "You have to weigh it against the likelihood of people dying from the infection and how much the vaccine could save people from that, and that makes it worth doing and worth taking some risks."

Some say the future vaccination is an option they are willing to explore. "I think people should be open to it, but again look into your options, educate yourself before you just go in for a vaccination," said Steven Brauer. While Roper said, "I would certainly get the vaccine," She added its still important to maintain physical distancing and wearing masks.

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ENC doctor's opinion on fast tracking COVID-19 vaccine - WITN

I got an experimental COVID-19 vaccine. Im willing to put it to the ultimate test. – The Boston Globe

May 5, 2020

This is not how vaccines are normally tested. What usually happens is that after a vaccine is deemed safe in Phase 1, vaccinated subjects in Phases 2 and 3 carry on with their day-to-day lives. Months later, scientists check to see whether the vaccinated group as a whole got fewer infections than a group that got a placebo. This is safe, but takes time. In a challenge study, there is no waiting around. Vaccinated volunteers would be exposed to or injected with live virus in a controlled setting.

With limited treatments for COVID-19, such an experiment would obviously be risky. Even so, I would be willing to sign up if conditions were right.

I do not consider myself a big risk-taker. I am a teetotaler, I follow speed limits, and my last broken bone was in middle school. I did not sign up to be in a Phase 1 study because I do not care about my health; I did it because by taking on a small amount of risk, I might be able to help many others. Im not alone in this thousands applied to be in the study I am in, though just 45 volunteers were needed for this stage of this particular trial.

The vaccine injection could have caused an immediate allergic reaction. I had no issues. It may cause my body to produce antibodies that make later coronavirus infection more likely, as has rarely happened with other experimental vaccines. But I am 29 years old and in good health. Even if my odds of catching COVID-19 go up, I would likely have mild illness and then fully recover.

Which brings me to challenge studies.

The idea of exposing volunteers to an infectious agent to definitively assess whether a vaccine is working is not new. It has been done in the United States for influenza and typhoid fever, yielding approved vaccines, and across Africa for malaria, though that parasitic infection can be managed with known antibiotics, which lowers risk for volunteers. All told, more than 6,500 people have participated in challenge studies for diseases other than COVID-19.

Not all challenge studies are ethically equivalent. For each, potential benefit must be weighed against potential harm. A planned challenge study for Zika virus was called off in 2018 in part over objections from a panel of bioethicists who found substantial uncertainty about the risks to would-be volunteers. These concerns extended to those in the community where such a trial might take place. Zikas spread is difficult to detect and is linked with birth defects. Can a challenge study be ethical if it puts additional children at risk?

There is a lot we do not know about SARS-CoV-2, the virus behind COVID-19. A challenge study would clearly need to omit pregnant women and people most likely to die from infection. Volunteers would have to be kept in strict isolation, potentially for weeks or months. Experts estimate that 100 healthy subjects would be needed.

A growing number of bioethicists argue that we should seriously consider COVID-19 challenge studies. The public health and economic burden of the pandemic is extraordinary. Even one day shaved off vaccine testing could save many lives.

I would agree to participate in such a challenge trial if three conditions were met.

First, the Food and Drug Administration would have to sign off. This would signify both that the conditions for preparing and handling the virus are up to par with other approved challenge studies and that the countrys chief regulatory body is willing to accept the results.

Second, it would need to be clear that no matter the outcome, the experiment would have value. If all the subjects in a challenge avoid infection, then clearly the vaccine should be fast-tracked. If they all get sick, it should be scrapped. But what if protection is only partial, as is the case with many vaccines? Would traditional testing of the vaccine resume? If so, what really would have been gained by the challenge trial? The answers to these questions would need to be decided ahead of time.

Third, I would need to know that I had a good chance of avoiding infection altogether. As of today, I am making no assumption that I am immune. My experimental vaccine, made by Cambridge-based Moderna, may not produce any effect. But if laboratory testing could indicate before a challenge trial that my immune system is already producing neutralizing antibodies as a result of the vaccination, I would consider the personal risk low enough. I know lab testing isnt foolproof, but it would at least put my mind at ease.

You might disagree with the moral calculus Ive laid out. To some, human challenge trials are clearly too dangerous, making informed consent impossible. To others, the need to act swiftly even if it means that exposing 100 volunteers to the coronavirus leads to 100 more COVID-19 cases makes human challenge studies the obvious choice. In the end, its a judgment call.

Though no human challenge studies are being planned at the moment, the organization 1DaySooner has begun soliciting volunteers online. More than 10,000 people have said that if enough precautions were in place, they would be willing to sign up including me.

Ian Haydon is a press officer at the University of Washington in Seattle. Follow him on Twitter @ichaydon.

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I got an experimental COVID-19 vaccine. Im willing to put it to the ultimate test. - The Boston Globe

Inside the Maryland military lab working on a COVID-19 vaccine and treatment – WUSA9.com

May 5, 2020

The institute is known as the "Birthplace of Medical Biodefense Research." Scientists and service-members there do research and work to protect the American soldier.

FREDERICK, Md. Just outside of Frederick, Maryland, is Fort Detrick the home of the U.S. military lab where researchers are working on COVID-19 treaments, and even possible vaccines.

Welcome to the U.S. Army Medical Research Institute of Infectious Diseases usually shortened to USAMRIID. It's a place where lab coats and camouflage go hand-in-hand, where microscopes and test tubes replace guns and where HAZMAT suits protect government scientists from the danger of biological threats and infectious diseases.

It's known as the "Birthplace of Medical Biodefense Research." That means the scientists and service members there do research and help develop treatments and vaccines to protect the U.S. soldier around the world.

But if you think the work done there is just to help the military, Chief of Viral Immunology Dr. John Dye has an eye-opener about their mission.

"[It's] also, to help protect the globe, in that what we develop will eventually be mainstreamed into normal society, he said.

USAMRIID said their new building is the largest and most complex bio-containment facility ever designed.

These guys know what they're doing. They've played crucial roles with research on the Ebola, SARS and MERS outbreaks. Right now, they're focused on COVID-19.

Just the significant impact it's having not only on the United States but across the world, right, USAMRIID Commander Col. Darrin Cox said. And so, there's a sense of urgency.

In particular, USAMRIID is trying to find a vaccine for the novel coronavirus that has, as of May 4, killed nearly 70,000 Americans.

We are currently working with multiple entities in academia, industry and U.S. government where those vaccines can be provided to USAMRIID for us to assess in animal models, Dye said. The gold standard that most people use are monkeys or non-human primates.

Theyre collaborating on treatments, as well.

Right now, our institute and many other institutes are currently testing, in culture or in flasks, different small molecules and drugs that are currently on the market and also in development, Dye said.

Multiple options are also going into clinical trials to figure out how the drugs and vaccines will work in the human body not just in the lab. Dye thinks that data will start coming in over the next couple months.

In this situation, Cox explains the collaboration is critical.

Often in science you sort of do some discovery on your own, then you publish it, then you talk to others about it, he expanded. This is more sort of a parallel process amongst a lot of collaborators because of the sense of urgency that we have right now.

We asked Dye what kind of pressure scientists feel when they see just how contagious COVID-19 is.

We know that for every day we take longer, we're allowing this virus to take a greater hold on the world and on our country, he said.

We also wanted to know how it feels to know the work theyre doing inside the lab could help their neighbors, family members, friends and people they might pass on the street.

It's very emotional, Dye said. This disease is in our own backyard. It reminds us why we keep coming into work every day, why we keep doing this, that we're doing it for the greater good and for a global effort.

We also asked Dye when a treatment or vaccine would be available to the general public. He said the time frame they're talking about is six months to a year. While that might seem like a long time off, its important to have some perspective. Normally, this kind of work takes two-to-five years.

Last summer, the Centers for Disease Control and Prevention shut down the lab at Fort Detrick because structural defects led to some violations. Brig. Gen. Michael J. Talley, commander of U.S. Army Medical Research and Development Command and Fort Detrick, said there was never any danger to the community, but changes had to be made. The lab was restored in February.

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Inside the Maryland military lab working on a COVID-19 vaccine and treatment - WUSA9.com

Trump ‘very confident’ of Covid-19 vaccine in 2020 and predicts up to 100,000 US deaths – The Guardian

May 5, 2020

Donald Trump has said he is very confident there will be a vaccine for coronavirus by the end of the year, revising up his estimate of the final US death toll as several European countries prepare for a cautious easing of lockdowns.

The president used a Fox News virtual town hall on Sunday night to repeat his regular virus talking points, including that a vaccine was not far away, Covid-19 was Chinas fault and the economy would not only recover but grow like crazy.

We are very confident we are going to have a vaccine by the end of the year, Trump said. Scientists have repeatedly warned that a vaccine may take 12-18 months or longer.

Trump in April predicted 60,000 American lives would be lost but on Sunday said: Were going to lose anywhere from 75, 80 to 100,000 people. Thats a horrible thing.

Trump indicated that intelligence agencies would release further information on Monday about the virus but failed to give details. Asked why he didnt act earlier on the epidemic, the president said that on 23 January he was in told in briefings there could be a virus coming, but it was of no real import.

In other words, it wasnt: Oh, weve got to do something, weve got to do something. It was a brief conversation.

His comments came amid reports that US officials believed China intentionally covered up the extent and severity of the virus while increasing its imports and decreasing exports of medical supplies.

The Associated Press said a four-page Department of Homeland Security intelligence report dated 1 May found China held off informing the World Health Organization (WHO) that the coronavirus was a contagion for much of January so it could order medical supplies from abroad, and that its imports of face masks and surgical gowns and gloves increased sharply.

Those conclusions were based on the 95% probability that Chinas changes in import and export behaviour were not within normal range, the report said.

Asked about the the viruss origins, Trump again suggested it came from a Wuhan lab. I think they made a horrible mistake and they didnt want to admit it, he said.

On Sunday the US secretary of state, Mike Pompeo, said there was enormous evidence the coronavirus outbreak originated in a laboratory in Wuhan, China, but did not provide evidence for his statement.

The presidents appearance came as several European nations cautiously prepared to ease lockdown restrictions. Italy, which reported its lowest daily toll since stay-at-home orders were imposed on 10 March, is set to follow Spain in allowing people outside. From Monday Italians will be permitted to go to parks and visit relatives. Restaurants can open for takeaways and some shops will be able to resume business, but there has been confusion over the rules.

On the one hand were super excited for the reopening, were already organising various activities the kids will be able to do with their grandparents outdoors, said Rome resident Marghe Lodoli, who has three children. On the other hand its disorientating. The rules are not clear and were not sure if just using common sense will do.

Italian authorities have said some preventative measures are still needed in a country that has the second-highest number of virus deaths.

Germany will continue its easing on Monday while Slovenia, Poland and Hungary will allow public spaces and businesses to partially reopen. In another sign of life returning, an influential German minister said on Sunday that he supported a resumption of the countrys football season this month as long as teams respected hygiene conditions.

Officials in Moscow, however, urged residents to stay home. With cases increasing by several thousand each day, Russia is now the European country registering the most new infections, with Moscow at the centre of the contagion.

The British government said the easing of coronavirus lockdown measures was likely to be gradual. The UK death toll had reached 28,446 according to the Johns Hopkins tracker, putting the UK just behind Italy on 28,884 and the US with 67,680 deaths.

In other developments:

Global coronavirus cases have surpassed 3.5 million with more than 247,000 deaths.

In New York, the centre of the US outbreak, an emergency field hospital erected in Central Park is set to close. Dozens of New Yorkers were fined for violating social distancing guidelines as they flocked to beaches and parks in balmy weekend weather.

China reported three new coronavirus cases, versus two the day before.

Japans state of emergency is expected to be extended until the end of the month.

France will not quarantine anyone arriving from the EU, the Schengen area or Britain due to the coronavirus.

New Zealand has reported no new coronavirus cases for the first time.

South Korea plans to ease a ban on some gatherings and events as long as they follow disinfection measures.

Brazil has become the first country in Latin America to report more than 100,000 cases.

The Iranian president, Hassan Rouhani, announced mosques will reopen across large parts of the Islamic republic after they were closed in early March.

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Trump 'very confident' of Covid-19 vaccine in 2020 and predicts up to 100,000 US deaths - The Guardian

COVID-19 vaccine to take longer than one year – BioPharma-Reporter.com

May 5, 2020

With a number of big pharma companies announcing efforts and partnerships to rapidly develop vaccines, hopes of an effective one emerging within the year is running high.

GlobalData, a data analytics company, conducted a poll asking its healthcare readership the likelihood of a vaccine being developed in the next 12 months, with 52% being very confident and a further 28% being somewhat confident.

With 80% of respondents optimistic about the potential for the successful development of a vaccine in the next year, Michael Breen, associate director of infectious diseases at GlobalData, moved to calm such expectations.

Part of the reason for such confidence is the number of developments that have moved rapidly into the clinic, he suggested.

For example, Moderna became the first company to administer a vaccine to a person, after only 63 days.

It was not long before Moderna was followed by the University of Oxford, which then saw AstraZeneca quickly move to partner on the vaccine.

Moving slightly slower, with a Phase I study slated for September 2020, was Johnson & Johnson however, the pharma giant subsequently backed its vaccine by announcing a number of partnerships to bolster vaccine capacity to ready it for commercialization, ahead of any in-human readouts.

Though these efforts are reasons for hope, Breen noted that they were running at substantially shorter R&D timespans than usual and have utilized new vaccine technology.

As a result, Breen cautioned that this technology is still in its infancy: No vaccine using these technologies has ever been commercialized and data supporting their efficacy is thin, thus enthusiasm surrounding their likelihood of success may be met with disappointment.

Further than this, there is still the issue of manufacturing at scale and then the difficulty in distributing the vaccine hurdles that Breen suggested could add further delays.

Ultimately, while it is technically possible for a COVID-19 vaccine to be available in 12 months, several factors portend this to be closer to wishful thinking than anything remotely certain, Breen concluded.

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COVID-19 vaccine to take longer than one year - BioPharma-Reporter.com

Grove: Pharmacists should be allowed to administer COVID-19 vaccine – ABC27

May 5, 2020

Posted: May 5, 2020 / 10:50 AM EDT / Updated: May 5, 2020 / 10:54 AM EDT

HARRISBURG, Pa (WHTM) Representative Seth Grove plans to introduce legislation that would allow pharmacists to administer COVID-19 vaccine once they become available.

Pharmacists are highly trained and are currently allowed to administer flu immunization shots, Grove said. My bill addresses the potential issue of long lines of people awaiting a COVID-19 vaccine at their doctors offices before the problem arises.

According to a press release from Groves office, the bill would allow pharmacists to administer a federally approved vaccine in a manner which complies with the rules and regulations established by the Center for Disease Control and Prevention.

By increasing the accessibility of a vaccine, once approved, the Commonwealth would be able to leverage skilled pharmacists as a force multiplier to save lives and improve public health according to Grove.

Grove says in order to immediately increase the Commonwealths testing capabilities during the time of a disaster declaration, the legislation would also allow pharmacists to conduct testing during a public health emergency, such as the COVID-19 pandemic.

Grove recently circulated the co-sponsorship memo for the bill.

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Grove: Pharmacists should be allowed to administer COVID-19 vaccine - ABC27

US Preps For COVID-19 Mass Vaccination With $110 Million Spent On Needles And Syringes – Forbes

May 5, 2020

COVID-19 vaccines are in development, but to meet the demand of over 300 million doses, the ... [+] government is spending big on needles and syringes.

The U.S. government is getting its vaccine supplies ready in anticipation of a working cure. Two separate orders signed off on May 1, 2020, total $100 million and specify needles and syringes for a COVID-19 Mass Vaccination Campaign.

One $27.5 million order went to Colorado-based Marathon Medical, the other $83.7 million to Texan business Retractable Technologies. The orders were placed by the Health and Human Services (HHS) departments Office of the Assistant Secretary for Preparedness and Response (ASPR).

The orders come as a raft of different vaccines are under development and testing. The U.S. government has backed a handful, including a $450 million deal with Johnson & Johnson arm Janssen Pharmaceutical for its COVID-19 cure. That vaccine could be ready by early 2021.

Oxford Universitys vaccine could be given to millions of people even earlier. AstraZenecas chief executive, Pascal Soriot, suggested toward the end of last week that the cure could be ready for a limited rollout before the close of 2020. That would be a remarkable turnaround, given that vaccine testing and release can take over a decade.

Its unclear just how many needles and syringes have been ordered. Its estimated as many as 300 million will need to be inoculated in the U.S., but a report in the New York Times last week cited industry sources expressing concern about Americas urgency to produce the myriad parts required to deliver the medicine.

HHS announced at the end of March it was working with Janssen and Massachusetts-based Moderna on fast-tracking vaccine production. HHS said it would accelerate advanced clinical trials, regulatory support and large-scale manufacturing to produce up to 300 million doses of vaccine in the United States each year.

Neither HHS nor the manufacturers had responded to requests for more details on how many needles and syringes were being produced.

But the latest orders should go some way to alleviating concerns about preparedness to deliver vaccines to Americans.

Full coverage and live updates on the Coronavirus

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US Preps For COVID-19 Mass Vaccination With $110 Million Spent On Needles And Syringes - Forbes

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