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‘I needed something good to happen’ (nationthailand.com)

‘I needed something good to happen’

Health & BeautyDec 20. 2020Dr. Val Briones-Pryor, an internal medicine specialist, is pictured outside of the University of Louisville hospital in Louisville, Ky., on Dec. 17, 2020. MUST CREDIT: Photo by Luke Sharrett for The Washington Post 

By The Washington Post · As told to Eli Saslow · NATIONAL, HEALTH, SCIENCE-ENVIRONMENT, HEALTH-FEATURES 

I was one of the first people to get vaccinated in Kentucky. The whole thing was surreal. It happened in a small auditorium, and the governor gave a speech. I walked onstage and pulled up my sleeve with the cameras rolling. A few people clapped when the needle went in. Some of us were crying. It felt like this amazing victory celebration, and then I went back to check on my patients.

One coded on me that morning. Oxygen deprivation. He was my 27th covid death. Then I had another guy who’s been with me 14 days, and I thought he was finally getting better, but covid schools me all the time. Suddenly, he couldn’t breathe while he was doing physical therapy, and we had to rush him onto 100 percent oxygen to get him stabilized. Then I checked on a patient who can’t keep anything down. She’s young, and her breathing is fine, and she should have gone home by now, but that’s not how this virus works. Lately, it feels like my batting average isn’t very good. I sent one patient home, but I had four more going in the other direction and getting worse, so I transferred them to the ICU.

So, yeah. That’s how it’s gone lately. I guess the best part of my day was a little arm soreness.

I’m desperate for this to be over. That’s why I’m so thankful for this vaccine. It’s safe. It’s effective. It’s incredible. I wish I could sit here and say: “OK! That’s it! We’re done!” But even with the vaccine, the reality in our hospital hasn’t changed, and we’ve got months more to go. I’ve been in charge of our covid unit since we opened March 17th. It’s wave after wave. Treat covid. Study covid. Worry about covid. That’s all I do. I shower at work, change clothes, and wrap my son in a blanket before I give him a hug so I don’t bring covid home.

We started our covid unit with 15 beds, and that was enough for a while. Then we moved to another unit that had 22 beds, and now we need both. I usually get patients in that eight-to-14-day window after they’ve contracted the virus, when they could go either way. They come through the emergency room and get admitted to me. Most of them are here for a while – could be a week or 10 days. We use steroids and sometimes an anti-viral, but a lot of hospital medicine comes down to observation. You’re examining a patient and looking for clues. What are their breathing patterns? How do they look when they’re eating? Has their color started to change? Our nurses are so dedicated, and they monitor these patients 24 hours a day. They’re not allowed to have any visitors, so I try to sit in their rooms when I can. I get to know them. I do a lot of watchful waiting.

I started thinking back over some of my patients while I was getting the vaccine – my list of 27. In a normal year, I might lose a total of four or five. It’s been a lot to handle. A few weeks ago, I had nine deaths in nine days. It’s been a lot of older people, and some had made the decision that they didn’t want to be on a ventilator. We had an older Hispanic gentleman, and he didn’t speak English, so I had to communicate to him using an iPad as our interpreter. He got so scared at the end that he couldn’t be alone. He didn’t want the nurses to leave his room. I had a 33-year-old who kept getting worse for a while, and then I had to tell him he was going to the ICU. He tried to negotiate with me. He was wearing this high-flow oxygen mask, and he was crying all over it. He said: “Please, give me one more day. I know I can get better.”

One of my first deaths was a Catholic priest. He’d come from a nursing home that had an outbreak, and four of those patients died. It was my mission to make sure he got anointed before he passed. I called up my supervisor and said, “I know we’re not allowing visitors, but I really need this favor.” Luckily, we were able to get a priest who volunteered to come, and we got him all dressed up in PPE, and he gave last rites. It was beautiful. I’m Catholic, and after everybody left, I sat there and held his hand. I’m a cantor at my church. I sang to him and told him it was okay to go.

I try my best to be connected. It’s an honor to be with someone in those last moments, but it should be a loved one. It shouldn’t be me.

This pandemic has taken me through the stages of grief. There was that initial denial, and some people got stuck there. Then it was anger, and I definitely had that. I was mad at my neighbors because they were having people over. Then I was bargaining – maybe if we lock down or do this or that, it won’t be so bad. Then depression. Then acceptance.

But the problem with acceptance when you’re in the middle of a pandemic is you start to get numb. I’ve gotten numb to where I almost couldn’t feel anything. For a while, I could just come in to work and do my job and put that smile on my face and deal with it, but eventually it gets to you. I worked 21 days in a row at one point. You get beaten down. It’s never-ending. You discharge four people and then five more cases come in. At some point, you almost have to depersonalize it, and that doesn’t feel right, either. You start thinking: “I’m done. I’m on empty. I don’t know how much longer I can do this.”

A few weeks ago, I started having heart palpitations. It’s something I see in my patients, because covid can impact your heart, so the first thing I thought was: “Oh no. What if I finally got it?” My son overheard me talking to my husband, and he started to cry. He said, “I don’t want you to die.” He’s 7, but he’s smart, and he pays attention to everything. He sees how we’ve changed everything to avoid this virus, so now he thinks that way.

I got tested and it was negative. I went to see my cardiologist. My blood pressure was up. My doctor said it was probably stress built up over all these months. We were up to having, like, 35 covid patients between the two units at that point. My husband was getting worried about me. One of my partners said: “You can’t keep going like this. It’s too much.” We decided I’d hand over the second covid unit, so now I’m just in charge of one, and that’s enough. I’m exhausted.

I needed something good to happen – something to pull me out. As soon as I heard we were getting a shipment of the vaccine, I put my whole heart into that. I’ve been waiting for this a long time. I mean – I’m tearing up now just thinking about it. It’s great to know I’ll have protection against this virus, but it’s more than that. It’s a profound relief. I can finally see a way out of this, even if we aren’t there yet. It’s a reason to hope.

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Britain tightens lockdowns over virus mutation with ‘significantly faster’ transmission (nationthailand.com)

Britain tightens lockdowns over virus mutation with ‘significantly faster’ transmission

Health & BeautyDec 20. 2020

By The Washington Post · William Booth · WORLD, HEALTH, EUROPE 

LONDON – Faced with a newly emerging coronavirus mutation with “significantly faster” transmission rates, Britain on Saturday announced tightened pandemic restrictions that returned London and parts of the country to virtual lockdown and reversed earlier promises for relaxed rules over the holidays.

The new mutation, or variant, was first detected in southeast England in September and is quickly becoming the dominant strain in London and other regions in Britain. Experts said it does not appear more deadly or resistant to vaccines.

At a news conference from 10 Downing Street, British Prime Minister Boris Johnson said the new variant “may be up to 70 percent more transmissible” than previous versions of the virus here.

“This is spreading very fast,” he said, announcing local and international travel bans and other extreme measures for about 18 million people in England beginning Sunday. Wales and Scotland followed with their own tightened restrictions, including banning all but essential movement around the isle.

Many countries have reimposed tough social distancing measures as coronavirus cases roared back in second and third waves. Britain, however, appears to be the first to point to a specific coronavirus variant for a surge in infections and the need to bring back the toughest measures.

“We have alerted the World Health Organization and are continuing to analyze the available data,” said England’s chief medical adviser, Chris Whitty. It was not immediately clear if the new variant had moved beyond Britain.

Britain’s chief science adviser, Patrick Vallance, said the “virus has taken off” after being observed for months.

“And it’s moving fast and has led to a sharp increase in hospitalizations,” he said, calling the need for new restrictions a “horrible moment.”

He went on, however, to say that the outbreak of the new strain “is controllable and there is light at the end of the tunnel with the vaccinations having started.” Britain was the first to approve the new Pfizer-BioNTech vaccine and the first to begin a mass immunization program earlier this month.

The researchers stressed that this kind of mutation is not surprising. Sharon Peacock, director of the Covid-19 Genomics UK Consortium and a professor of microbiology at the University of Cambridge, stressed that thousands of mutations in the coronavirus have been identified since it emerged.

“The vast number have no impact,” she said. “Mutations are a part of natural life.”

Many viruses mutate and evolve, becoming more transmissible but less deadly. But to date, the decline in mortality among infected people during the pandemic has been attributed to improvements in treatments.

Johnson and his government have been fighting to “save Christmas.” They put Britain in countrywide lockdown in November, hoping that would slow transmission and allow for a greater relaxation of restrictions for a five-day period during the holidays, to allow families and friends to gather.

Now London and the southeast and east of England will enter the highest level of “Tier 4” restrictions.

That means all nonessential shops will be closed, as will gyms, hair salons, pubs, restaurants and theaters. Travel to and out of the Tier 4 areas will not be allowed. People should leave their homes only to shop for food and medicines, attend medical appointments, take outdoor exercise and travel to and from work, if they cannot work from home. Gatherings are banned, though there are exceptions for religious services. People will be able to meet only one other person from another household in an outdoor space only.

Christmas gatherings of more than one family will be banned in the Tier 4 zone – but permitted for one day in other areas.

“We, of course, bitterly regret the changes,” Johnson said.

“When the virus changes its method of attack, we as a country have to change our method of defense,” he said.

British scientists have been following the spread of the new variant for nearly three months, eventually seeing it in samples taken from more than 1,100 people, most of whom lived in the southeast of England.

John Edmunds, an infectious diseases expert at the London School of Hygiene & Tropical Medicine, told reporters that scientists need to answer three questions: Is the variant more deadly, can it bypass previous infection antibodies or vaccination, and is it transmissible? 

“At present we have no information on the first two questions, but over the last few days we have begun to get an answer for the third, and the answer is very bad news,” he said. “It looks like this virus is significantly more infectious than the previous strains.”

On Saturday, the chief science adviser said there were 23 different mutations in this new variant. Most were in a segment of the virus’s genome that encodes for the spike protein, the protruding structure essential to the pathogen’s ability to bind with the receptor cells in a person who gets exposed and then infected. 

The virus trackers briefed reporters from various media, including The Washington Post, in recent days. What surprised them was the sudden prevalence of the variant. 

“This lineage came up quite rapidly,” said Nick Loman, a professor of microbial genomics at the University of Birmingham.

Peter Openshaw, professor of experimental medicine at Imperial College London, called the British government’s data on the new variant “of great concern,” noting that the “variant does seem about 40 to 70 percent more transmissible.”

He said the number of cases could double in “just six or seven days” at the current rate.

“So it is really vital that we get this under control,” he told science reporters on Saturday.

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FDA authorizes a second coronavirus vaccine, a turning point in the pandemic (nationthailand.com)

FDA authorizes a second coronavirus vaccine, a turning point in the pandemic

Health & BeautyDec 19. 2020

By The Washington Post · Carolyn Y. Johnson, Laurie McGinley

WASHINGTON – A second coronavirus vaccine received emergency authorization Friday, an unprecedented scientific feat that gives the United States two powerful tools to fight a pandemic that emerged almost exactly a year ago, sparked by a few cases of mysterious pneumonia that exploded into the biggest global public health crisis in a century.

The Food and Drug Administration’s decision to clear the vaccine, developed by Massachusetts biotechnology company Moderna in partnership with the National Institute of Allergy and Infectious Diseases, arrives at the end of a historic week in medicine – as health-care workers began receiving inoculations of the first coronavirus vaccine, developed by Pfizer and BioNTech, which was cleared by the agency Dec. 12.

The first shots in a national mass vaccination campaign this week delivered great hope but also exposed the distribution and supply challenges that will now move to the forefront, as companies, the federal government and states attempt to work in concert to maintain ambitious timelines. Two health-care workers in the United Kingdom had treatable allergic reactions after being vaccinated with the Pfizer-BioNTech shot a little over a week ago. In the United States, the FDA said Friday night, the agency is investigating “about five” reports of allergic reactions. The cases highlight the challenges that could lie ahead as public health experts work to build trust in the vaccines.

“To get another very important vaccine into play is just, yet again, another step toward what the ultimate goal is: to get enough people vaccinated so you could essentially end the epidemic as we know it in this country,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said. “I believe that’s possible.”

The authorization of a second vaccine – which came as the death toll from the virus in the United States surpassed 312,000 – will have an immediate practical impact that may begin to ease some of the logistical challenges, doubling to roughly 20 million the number of people government officials say they can vaccinate with a first shot before the end of the year. It will free the country from the precarious position of being reliant on a single manufacturer as production ramps up of a type of vaccine that has never been made on a massive scale. And it adds a vaccine that can be stored in a regular freezer, making it easier to distribute to large swaths of the country, in contrast to the specialized ultracold freezers and dry ice coolers needed for the Pfizer-BioNTech vaccine.

The successes also represent a decisive moment in scientific history. Scientists took a novel technology and leveled it against a new virus, developing and deploying in under a year two vaccines that are 94% to 95% effective in clinical trials, rivaling some of the most effective vaccines in the world’s medicine cabinet.

“It’s astonishing. Not in our wildest dreams would we imagine the results that we received,” said Lisa Jackson, a senior investigator at Kaiser Permanente Washington Health Research Institute who has worked on more than 60 vaccine trials. In mid-March, she launched what could be the most consequential one – a small safety test of the Moderna vaccine in 45 healthy, young volunteers. “To have two such vaccines – it’s just amazing.”

In a media call Friday night, FDA officials called the authorization of a second vaccine a milestone and said they are looking into reports of allergic reactions related to the Pfizer-BioNTech vaccine. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which regulates vaccines, said the FDA and the Centers for Disease Control and Prevention have met daily to evaluate the reports, including a case in Alaska in which a woman was hospitalized.

He said scientists don’t know what might be causing the reactions but speculated a possible “culprit” could be polyethylene glycol, a component in both the Pfizer-BioNTech and Moderna vaccines. The substance is commonly used in pharmaceutical preparations, and scientists are wondering if more people react to it than was thought.

The FDA, in its patient information sheets, says individuals who know they are allergic to any components in the authorized vaccines should not receive the shots. The government requires that medical supplies to treat severe allergic reactions be available wherever vaccines are being administered.

The development of the vaccines is a testament to a single-minded focus by private industry and the government, which built on decades of basic research to accomplish an urgent goal. Tens of thousands of volunteers agreed to roll up their sleeves in hopes they could play a small part in bringing the world back to normal. One of those volunteers was Jennifer Haller, 44, of Seattle, who was the first person to receive the Moderna vaccine March 16 – at a time when it remained unclear what trajectory the pandemic would take.

“This was a way that I could contribute,” Haller said. “I have a lot of stability in my life – I have a full-time job, friends and family nearby. I wanted to take a risk like this when so many others can’t. They have so many more pressing, immediate needs that they need to take care of.”

The first doses of the Moderna vaccine, which is authorized for people 18 and older, will probably ship this weekend, with nearly 6 million expected to be distributed during the first week to health-care workers and nursing home residents. An additional 2 million doses of the Pfizer-BioNTech vaccine are expected to be shipped. The clearance of both vaccines marks a transition from an uncertain scientific quest to a massive logistics enterprise – one that already experienced missteps this week as several trays of the Pfizer-BioNTech vaccine shipped to Alabama and California got too cold, and had to be returned, and states questioned why their shipments for next week had been slashed.

In that way, the Moderna vaccine offers a clear advantage. While the Pfizer-BioNTech vaccine must be kept at ultracold temperatures in specialized freezers or carefully maintained dry ice containers, the Moderna vaccine can be stored at regular freezer temperatures long-term and at refrigerator temperatures for up to a month. That will expand the settings where it can be used to rural areas, pharmacies or medical offices that lack specialized equipment.

“Moderna is much easier in terms of transportation; it has a more forgiving cold chain. It doesn’t have to be kept as cold,” Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, said.

At an FDA advisory committee meeting Thursday on the Moderna vaccine, Gwen Schell, a nurse from Panhandle Health District’s home health care in Idaho, said the shots are desperately needed in rural areas. “We have very limited nursing staff in this part of the United States,” Schell said. “We have seen an uptick in people being sent home from the hospital who are not meant to be home.”

Having a second supplier, particularly at a time when there are not enough doses, could ease the delays and hiccups that many vaccine experts think are likely to occur over the next months. Bloomberg News reported Thursday that 400,000 doses of a recent manufacturing batch from Moderna had to be tossed after a filtration problem.

Bruce Lee, a professor of health policy and management at City University of New York Graduate School of Public Health and Health Policy, said that during the 2009 H1N1 pandemic, he was part of a team trying to project where limited vaccine doses could have the greatest impact. A recurring theme was vaccine companies missing their targets, requiring last-minute recalculations.

“On a weekly basis, we would get updated vaccine production numbers – and it was consistently, week after week, delayed,” Lee said. “We would basically run scenarios to show folks at [the Department of Health and Human Services], ‘This is what it means, given the fact you have limited vaccines, about who should get the vaccines first: In these neighborhoods, it would have a greater impact on the pandemic.'”

Kendall Hoyt, a vaccine and biosecurity expert at Dartmouth College, said the addition of vaccine manufacturers such as Moderna to Pfizer-BioNTech’s pioneering effort is badly needed because there is no way to know how vaccine makers will be affected by what she predicted could be severe supply shortages.

“There is going to be a global crush of demand for all the ingredients – the vials, the syringes, the raw materials,” she said. “We have never tried to make as much vaccine at once.”

One of the challenges of scaling up vaccine production is that the technology in the Pfizer-BioNTech and Moderna vaccines has never been used in approved medical products or produced in such large amounts at pharmaceutical quality standards.

Since 1961, scientists have known about messenger RNA, genetic material that makes life possible, taking instructions inscribed in DNA and delivering them to the protein-making parts of the cell. Both the Moderna and Pfizer-BioNTech vaccines harness this natural process in a vaccine, delivering to the body’s cells synthetic RNA that carries the blueprint to build the spiky proteins on the coronavirus surface. The cells follow the instructions to make the spike proteins, and the immune system learns from those spikes to recognize the real thing.

There isn’t yet a long safety track record for the technology, but the platform has been in human tests for years, including in tens of thousands of people in the coronavirus vaccine trials in recent months. While most infectious-disease experts are focused on finding ways to deploy the technology as quickly as possible so that vaccines can begin to blunt the crisis this winter, many are also thinking of the inevitability of the next pandemic – and the proof-of-concept that these two successes represent.

“This is all we’ve been doing for nine months: It’s eat, sleep, vaccinate, and that’s been an exhilarating but exhausting time for all of us,” said Buddy Creech, director of the Vanderbilt Vaccine Research Program. “When we got word that the vaccines were over 90% effective, I think there was a collective sigh across all of vaccinology that recognized both the impact for this pandemic but also how we can respond very quickly to future pandemics.”

Krutika Kuppalli, an infectious-disease specialist at the Medical University of South Carolina, said there is intense interest among health workers to be vaccinated quickly. She said 600 to 700 health-care workers were vaccinated with the Pfizer-BioNTech shots Tuesday, the first day of inoculation. Slots for coming days are filling rapidly, she said.

With demand for coronavirus vaccines sure to outstrip demand for many months and beyond, Kuppalli welcomed the authorization of the Moderna product. “We are going to need multiple vaccines” to inoculate the nearly 8 billion people on Earth, she said.

The FDA authorization capped months of frenzied activity at the agency, whose vaccine experts have been working intensely with manufacturers to bring coronavirus vaccines to market.

Pfizer-BioNTech applied to the agency for emergency authorization Nov. 20, and Moderna filed its request just 10 days later. Federal officials have said two more manufacturers – Johnson & Johnson and AstraZeneca – could seek FDA clearance early next year. Novavax is expected to start its large trial in coming weeks, but a sixth vaccine backed by the U.S. government from Sanofi and GlaxoSmithKline has been delayed after its shot failed to trigger a strong enough response in older adults.

Operation Warp Speed, the Trump administration’s initiative to accelerate the availability of vaccines, has invested almost $4.1 billion in Moderna’s vaccine development, clinical trials and manufacturing. The government has bought 200 million doses of the vaccine and retains options for hundreds of millions more. In a break from traditional practice, manufacturing began while the vaccine still was being tested in a clinical trial – to speed distribution once cleared by the FDA.