Severe Covid cases more likely in highly polluted areas – The Guardian

Severe Covid cases more likely in highly polluted areas – The Guardian

When Will This COVID Wave End? – The Atlantic

When Will This COVID Wave End? – The Atlantic

June 5, 2022

In mid-March, I began to notice a theme within my social circle in New York, where I live: COVIDit finally got me! At that point, I didnt think much of it. Only a few of my friends seemed to be affected, and case counts were still pretty low, all things considered. By April, images of rapid tests bearing the dreaded double bars were popping up all over my Instagram feed. Because cases had been rising slowly but steadily, I dismissed the trend to the back of my mind. Its presence nagged quietly throughout May, when I attended a party at a crowded hotel and hurled myself into a raging mosh pit. As I emerged, sweating, cases were still creeping upward.

Only last week, more than two months later, did cases finally stop rising in New Yorkbut theyve plateaued more than theyve fallen back to Earth. If you simply look at the case counts, this surge is not even in the same stratosphere as the peak of Omicron during the winter, but our current numbers are certainly a massive undercount now that rapid tests are everywhere. The same sort of drawn-out wave has unfolded across the Northeast in recent months, and frankly, its a little weird: The biggest waves that have struck the region have been tsunamis of infections that come and go, as opposed to the rising tide were seeing now. Other parts of the country currently seem poised to follow the Northeast. In the past two weeks, cases have noticeably increased in states such as Arizona, South Carolina, and West Virginia; Californias daily average case count has risen 36 percent. In April, I called the coronaviruss latest turn an invisible wave. Now Im starting to think of it as the When will it end? wave.

Read: Is America in the middle of an invisible wave?

Consider New York City, which by this point has been the epicenter of several waves, including the one were dealing with now. When Omicron arrived last fall, cases jumped very quickly as the new, more transmissible variant broke through existing immune defenses and infected lots of people, who spread the virus like wildfire. A combination of factors quickly extinguished the flame: People got boosted, the public-health messaging changed and some people changed their behaviors, and eventually so many had gotten sick that the virus had fewer people to infect. Thats not what seems to be happening now. For one thing, the shape of the curve feels different: From December 2021 to mid-February 2022about two and a half monthsOmicron erected a skyscraper on the charts. Since March, the current wave has drawn just the rising half of what looks to be a modest hilland, again, the true shape is much taller. Broadly, the same trends have played out elsewhere, too. Now its June, and fresh images of rapid-test results are still circulating within my social circle. Why has this wave felt so different?

The major reason, public-health experts told me, is that Americans, on the whole, are more protected against COVID now than they were during previous times when infections have soared. Omicron was a completely new variant when it first hit during the winter, and it swept through a large chunk of the country. We built a lot of immunity due to so many people getting sick, Marisa Eisenberg, an epidemiologist at the University of Michigan, told me. So far, that immunity seems to dampen the spread of the two new forms of Omicron that are behind the current, stretched-out wave of cases. Its imperfect, but its at least some protection, Joe Gerald, a public-health professor at the University of Arizona, told me. As we take people out of the susceptible pool, basically the math works against a large and fast outbreak, so it would tend to slow transmission and make the size of the wave smaller.

Another major factor at play is the onset of warmer weather, especially in colder parts of the country. Schools nearly out, if it isnt already, and though people are getting together and traveling more, theyre likely doing so outdoors. In other words, even if people are getting infected with new Omicron strains, theyre not able to spread it as efficiently. These arent ideal transmission conditions for this usually winter virus, Gerald said. Seasonality may also be one reason that cases first rose in the Northeast, given that the When will it end? wave began when it was relatively cooler and people were inclined to gather indoors.

Read: COVID sure looks seasonal now

The UCLA epidemiologist Tim Brewer said hes confident that COVID is settling into similar seasonal patterns as illnesses such as the flu and the cold. Weve seen smaller waves before outside of the winter months, he pointed out. Whats going on right now is very similar to what happened if you look back at 2020, around June through July. It had this gradual rise in cases and then things kind of leveled off for a while. Hopefully [soon] theyll level off. That being said, what were seeing now is not identical to earlier stages of the pandemic: Reported cases are much, much higher now versus in summer 2020, and thats before you account for all the missed infections right now. Also the onset of the summer 2020 wave was not as maddeningly slow as this one has been.

Meanwhile, reported cases are continuing to climb in other regions, namely the South and Southwest. That raises the uncomfortable, frustrating possibility that well be stuck in this wave for quite some time. But then again, even that is hard to know right now, especially as our view of basic pandemic numbers is so murky. What makes it difficult to understand how a new wave might play out is that were still struggling to understand what the size of our susceptible population is, how many people have truly been infected, and how quickly immunity wanes from both vaccination and prior infection, Gerald said. Eventually, as we learn more about this virus, we might get better at predicting its next turn. But for now, theres also going to be weirdo surges that happen whenever they happen, Eisenberg added.

Theres no sugarcoating it: The When will it end? wave is frustrating. Were entering our third pandemic summer, and yet again cases are high enough that activities such as indoor dining and weddings can come with a real fear of getting sick. But that pattern of slow and steady spread has benefits as well. Its exactly what we need to prevent our health-care system from getting overwhelmedwith all the side effects of delayed procedures and hospital burnout that comes along with that. Some 25,000 Americans are currently hospitalized with COVID, compared with more than 150,000 at the height of Omicron. Theres a reason flatten the curve became an early pandemic sloganby drawing out infections, were helping to ensure that hospitals have space for us when we need it, whether thats for COVID or any other reason.

But we shouldnt get too comfortable. This winter could be bad once againthe Biden administration predicts that well see 100 million new cases during the fall and winter, and a new variant could still worsen that outlook. Such a dire situation is not inevitable, though. If anything, the When will it end? wave is a reminder that dramatic, all-consuming surges are not necessarily our destiny. Slowing this virus down, whether thats through vaccinations or ventilation upgradesor, in this case, the fortunate coincidence of immunity and weathercan go a long way. The more we interfere with the ability of this virus to replicate and transmit, the fewer the cases will be, and the less we interfere with its ability to replicate and transmit, the more cases there will be, Brewer said. Its just as simple as that.


Read this article:
When Will This COVID Wave End? - The Atlantic
The 10-year-olds symptoms passed  but then worse ones set in. Her case shows how little we know about long COVID in kids – San Francisco Chronicle

The 10-year-olds symptoms passed but then worse ones set in. Her case shows how little we know about long COVID in kids – San Francisco Chronicle

June 5, 2022

Shyne Staples leaps up and executes a flawless forward roll across a gym mat. She flips into a cartwheel, stands on her hands, then climbs a rope before spinning around a high bar in her San Mateo gymnastics class.

Like many 10-year-old girls, Shyne likes flying around the gym, Simone Biles-style. But unlike most of them, Shyne begins class already in pain, and the exertion puts her to sleep 90 minutes after its over.

Shyne has long COVID.

Lingering, debilitating effects of the coronavirus were identified early in the pandemic, and new studies suggest that at least 1 in 5 adults has ongoing symptoms. But few studies have focused on children who, like Shyne, find their childhood disrupted by COVID months after recovering.

Theres pain. And sometimes children have headaches. But fatigue is characteristically the most common persistent symptom, said Dr. Roshni Mathew, a pediatric infectious disease expert at Stanford Childrens Health who doesnt treat Shyne but sees other children with long COVID in her practice.

Shyne Staples, 10, exercises on a rope at Peninsula Gymnastics in San Mateo.

The World Health Organization defines long COVID as symptoms lasting at least two months after probable or confirmed coronavirus infection that cannot be explained by an alternative diagnosis. The National Institutes of Health is spending $1.15 billion to spur research into the phenomenon that can cause a wide range of symptoms, including brain fog, loss of smell, racing heart and chronic fatigue. In April, President Biden unveiled the National Research Action Plan on long COVID to accelerate the research effort.

Studies indicate that millions of people around the world are plagued by long COVID. Vaccination before infection appears to reduce but not eliminate the risk. A new study from the Centers for Disease Control and Prevention estimates that 20% of adults under 65 who had tested positive for the coronavirus developed persistent symptoms, as did 25% of those over 65. A large national survey from 23andMe released in May roughly echoed the findings.

But how many children are affected by long COVID and for how long remains elusive. In the U.S. alone, children represent 19% of all COVID cases more than 13 million kids.

A pediatric study of long COVID published in February in the journal Lancet Child & Adolescent Health compared more than 3,000 British 11- to 17-year-olds who tested positive against a similar group that did not. Neither group reported feeling entirely healthy three months after testing. But researchers found that nearly 30% of the adolescents who had tested positive for the coronavirus experienced multiple symptoms, including fatigue, headaches and shortness of breath, compared with 19% for those who had not.

Shyne Staples, 10, takes a class at Peninsula Gymnastics in San Mateo.

Long COVID Kids, a support group in the U.K., features photos of 50 children from around the world on its website holding placards identifying their ongoing symptoms. The youngest is 5, and the oldest 16.

The sign held by one 12-year-old American girl lists memory loss, heart damage and passing out among her symptoms all devastating for a person of any age. A U.K. 10-year-old peeks out from behind a lineup of 17 symptoms, including nausea and chest pain, under the heading Day 293.

Shyne is not on the page. But she could be.

She tested positive for COVID-19 on Jan. 9, a few days after her adult brother. Her fraternal twin sister, Samantha, stayed healthy, as did her parents. But after Shynes COVID infection faded, along with her sore throat and stuffy nose, other, worse symptoms set in.

Deseree Solano of San Mateo is the mother of fraternal twins Samantha and Shyne Staples. Shyne, 10, got COVID-19 in January and continues to experience symptoms.

I started getting pain in my arms, my neck and my shoulders and legs, she said, as she practiced backbends on the living room rug of the familys home in San Mateo. Before that, the pain was, like, here, she said, pointing to a spot on her forehead just above her gold-rimmed glasses.

The first pains appeared on Jan. 16. For a while, her mother, Deseree Solano, kept a symptom diary. Feb. 16: Neck and shoulder pain. Feels like she has bruises everywhere. Feb. 19: Face started throbbing ... very winded. Blank staring. March 10: Ear pain, armpit pain, legs. Shoulders, hair loss and now depression. April 20: Leg and back pain. Last week lips started bleeding again. Very tired. Still has hair loss.

Shynes thick brown hair continues to fall out. We thought it was the shampoo, said Samantha, her twin. But it wasnt, because my hair was fine.

Its all since COVID, Solano said. Before then, Shyne would be the first person up and ready for school. Now I have to wake her up numerous times, and Samantha is up before her and ready. Shyne is not a kid to be lazy or get up late.

She stayed home from school for two months before feeling ready to return, despite the pain and other symptoms that persist even now, more than four months later.

Sometimes its, like, burning and pain at once. Its always there, Shyne said of the discomfort in her arms, shoulders and calves. I cant eat a lot. Like I want to throw up.

Solano said her daughter sometimes has difficulty breathing but tries to hide it because she dreads going back to the doctor.

At many medical centers, including Kaiser, where doctors diagnosed Shyne with the post-viral syndrome, patients are not treated specifically for long COVID but are sent to specialists for the individual ailments they complain about.

Krista Prasadi, 10, chats over FaceTime with her best friend, Shyne Staples. Krista often provides a shoulder for her friend to lean on when Shyne is having painful symptoms of long COVID.

A kid with persistent headaches may land in the neurology clinic, said Mathew, the pediatric infectious disease expert at Stanford, who said she often sends children back to their pediatrician after ensuring that no active disease is causing their symptoms.

Its a common experience of long COVID sufferers of all ages that their medical tests come back normal, suggesting nothing is wrong. Shyne, for example, feels like she has bruises but there are none to be seen.

Researchers, including those at UCSFs Long-term Impact of Infection with Novel Coronavirus, or LIINC, study, point to three likely causes for long COVIDs odd symptoms: persistent inflammation caused by the coronavirus, hidden bits of the virus that remain in the body and autoimmunity when the bodys own immune system turns on itself.

In February, researchers at the State University of New York reported the case of an 11-year-old girl with persistent abdominal pain and nausea in the Journal of Pediatric Gastroenterology and Nutrition. After an endoscopy, colonoscopy and other therapies found nothing wrong, doctors wondered if the coronavirus infection she had had three months earlier could still be causing trouble. They looked for evidence and found it.

Twins Samantha (left) and Shyne Staples, 10, at their San Mateo home. Shyne got COVID-19 in January and continues to experience symptoms.

They discovered nucleocapsid proteins, which are associated with the coronavirus, in the lining of her gastrointestinal tract. Her prolonged symptoms, with evidence of chronic inflammation, strongly suggests a direct consequence of COVID, they wrote.

University of Southern California researchers also found evidence of a COVID connection in three children with brain inflammation autoimmune mediated encephalitis and published their study in January in the Journal of Child Neurology. All three improved after receiving high-dose intravenous corticosteroids, which reduce inflammation, the study said.

Yet clear, clinical evidence of a connection between the coronavirus and ongoing symptoms is often lacking or hard to find, leading some doctors to be skeptical about whether children actually experience long COVID.

Dr. Geraldina Lionetti, a pediatric rheumatologist at UCSF Benioff Childrens Hospitals, said she wasnt comfortable saying whether long COVID in children was real because there may be other potential causes for their symptoms including physical and psychological aftereffects of the pandemic itself.

Twins Samantha and Shyne Staples as babies.

Its very difficult to distinguish between symptoms of long COVID and being on lockdown, Lionetti said.

Megan Carmilani, who founded a support group called Long COVID Families, used to find such skepticism infuriating but has made peace with it. To me, all the doctor is saying is, I dont have the knowledge or skills to help, she said.

Carmilani, 43, never had long COVID, but she strongly relates to children who do, because she has had post-viral symptoms since getting mononucleosis at age 14. It wasnt until 2017 that doctors made the connection between her ongoing symptoms and her adolescent illness.

I dont want another child to wait decades for proper medical care, Carmilani said from her home near Pittsburgh.

She points to research showing that ongoing illnesses prompted by initial viral infections are not uncommon. They include long COVID, chronic fatigue syndrome (myalgic encephalomyelitis) and Epstein-Barr, which can cause mononucleosis, among others. Yet the mysterious aftereffects have been ignored and underfunded, she said, especially in pediatrics.

Carmilani founded Long COVID Families to give children the support she lacked, she said. I needed an adult to say: Your symptoms are real. There is a community to support you, and we are going to work together to get you the care you need.

Today, the group has about 2,000 participants and easily 500 children with long COVID, Carmilani said.

Shynes mother has appreciated the community. Its been helpful mentally to have a group of other people that understand what I am going through, she said.

As for Shyne, understanding comes from Krista Prasadi, 10, who is as caring a friend as a kid could hope for.

She tells me how much pain shes in, said Krista. I ask her if shes OK.

And I hope, like, she can feel better.

Nanette Asimov is a San Francisco Chronicle staff writer. Email: nasimov@sfchronicle.com Twitter: @NanetteAsimov


Go here to see the original: The 10-year-olds symptoms passed but then worse ones set in. Her case shows how little we know about long COVID in kids - San Francisco Chronicle
Travel Agents Pushing for Change in International COVID-19 Testing Policy – NBC Connecticut

Travel Agents Pushing for Change in International COVID-19 Testing Policy – NBC Connecticut

June 5, 2022

You can drive from Mexico or Canada into the United States without proof of a negative COVID-19 test, but you cant fly into the states without one.

Travel agents in Connecticut and around the country say its an executive order that needs to change.

No other countries are requiring this testing. Other countries have realized that its not going to change the spread of infection and its not required to go out of the country, said Amanda Klimak, president and co-owner of Largay Travel in Waterbury.

Klimak is also a member of the American Society of Travel Advisors.

Shell be with fellow agents lobbying on Capitol Hill for change later this month.

Probably one of the most absurd, irrational pieces of legislation that Ive ever witnessed in my time, said Paul Largay, CEO of Largay Travel, whose family business has spanned three generations.

Largay has not only heard of his clients having to quarantine overseas, but he was in the same boat too after disembarking from a river cruise in Lisbon, Portugal.

Full coverage of the COVID-19 outbreak and how it impacts you

And the doctor told me I had to quarantine for seven days. The concierge corrected him and said, No, no, theyve changed that to five, he said. This is the greatest frustration we have is that no one really knows the rules -- including the doctors.

Its not just confusion and stress in countries overseas with the U.S. policies, but local agents say its also impacting business and making people rethink their trips.

Agents here in Connecticut have heard of folks faking doctors notes or even flying into Canada or Mexico and driving across the border to avoid getting stuck abroad since driving into the U.S. doesnt require a test like flying does.

When you do come back into the country, no one in the U.S. checks those test results, its all dependent on people overseas when you check in for your flight, said Klimak.

Its not just Largay Travel that tells us the executive order is ineffective.

Frenchs Worldwide Travel says its a nightmare.

And even a Wethersfield Travel agent and her family were stuck in Aruba after her daughter tested positive mid-trip.

NBC Connecticut reached out to the White House and Centers for Disease Control and Prevention about the executive order.

At this time our international travel guidance remains the same. CDC is evaluating all guidance and orders based on the latest science and state of the pandemic, and we will communicate any updates publicly if and/or when they change, a CDC spokesperson said.

The fact that they reduced the mask mandate on domestic flights and yet they still keep the testing, it just doesnt make sense. I dont know why a flight from New York to LA doesnt require testing, but if youre flying from Paris to New York somehow thats a higher risk, said Klimak.

Agents NBC Connecticut heard from say having to quarantine is costing travelers thousands of dollars to extend their trip.

It was a great trip, but an unhappy ending, said Dan DeSoto of Sarasota, Florida.

A birthday and anniversary bucket list adventure to Scotland and Ireland for the DeSotos had a less than desirable ending when they got their COVID-19 tests the day before their return trip home.

Low and behold she comes out positive. Im negative, said DeSoto, So were like shocked because she has no symptoms.

Two days later, DeSoto says he tested positive, and his wife tested negative, which meant extending their trip for a week to quarantine, costing $5,000 more before he could go home.

Largay Travel agents say they've seen significant others leave their loved ones abroad only to get COVID-19 when theyre back in the states or quarantine days continue to stack up in a foreign country because another family member gets sick.

How do you reconcile that the government will allow people to drive across the border, to sail into the country, but if you want to fly into the country you have to test negative. Where is the rational reasoning behind that?, said Largay.

Desoto is the first to tell you he doesnt want to spread the coronavirus, but he says the rule just doesnt seem to make sense.

When I tested negative, I couldn't get out of the hotel fast enough.

Travel agents we spoke to say they dont want to discourage anyone from traveling abroad. Theyre just hoping the rule gets changed.

In the meantime, they urge travelers to get travel insurance that protects them if they get sick before or during their trip.

They suggest taking a test before leaving for the trip and mid-trip so if youre positive, you can start your quarantine then instead of the hours before your flight.

And of course, they say having an agent is a perk because they can help you rebook if necessary.


Go here to see the original: Travel Agents Pushing for Change in International COVID-19 Testing Policy - NBC Connecticut
Alexander Litvinenko assassination suspect dies of Covid – The Guardian

Alexander Litvinenko assassination suspect dies of Covid – The Guardian

June 5, 2022

Dmitry Kovtun, one of the two Russian men accused of assassinating the former spy and Kremlin critic Alexander Litvinenko in London, died of Covid in a Moscow hospital on Saturday.

Litvinenko died in 2006, weeks after drinking tea laced with the radioactive isotope polonium 210 at a London hotel, where he met Kovtun and the other suspect, Andrei Lugovoi. The case has since weighed on relations between Britain and Russia.

After Litvinenkos death detectives found polonium in all the hotel rooms where Kovtun and Lugovoi had stayed in London, as well as on Lugovois plane seat from Moscow and in numerous other locations including at Arsenals Emirates stadium.

Kovtuns death aged 56 was first reported by Lugovoi, a former KGB bodyguard who is now a Russian MP, who wrote on his Telegram page on Saturday: This is an irreplaceable and difficult loss for us.

Sad news came today, as a result of a serious illness associated with a coronavirus infection, my close and faithful friend suddenly died, Lugovoi added.

A British inquiry in 2016 concluded that the Litvinenko murder was an operation of Russias FSB spy agency and that the assassination was probably approved at the time by the Russian president, Vladimir Putin.

One of the key findings presented by the British inquiry led by Sir Robert Owen were phone records that showed Kovtun made a phone call to another FSB colleague saying he was looking for a cook to put a very expensive poison in Litvinenkos food or drink.

Last year, the European court of human rights also ruled that Russia was responsible for the killing of Litvinenko, ordering Moscow to pay 100,000 (85,000) in non-pecuniary damages to his widow, Marina.

In a deathbed statement, Litvinenko accused Putin of being behind his killing.

The Kremlin has always denied the charges and refused to extradite the two suspects to face trial.

Before the fall of the Soviet Union, Kovtun is believed to have served in the communist east at the KGBs ninth directorate, which was charged with the protection of top Kremlin officials. After the breakup of the Soviet Union, Kovtun and his then German wife, Inna Hohne, moved to Hamburg and claimed political asylum, with him working as a waiter. He eventually left Germany for Russia where he was involved in various businesses.

In contrast to Lugovoi, who became a prominent politician following the poisoning of Litvinenko, Kovtun kept a low profile in Russia and not much is known about his private life.

Hohne previously told German detectives during the inquiry into Litvinenkos death that Kovtun was a heavy drinker who shifted between badly paid jobs and dreamed of being a porn star.

Litvinenko, who was dismissed from the FSB after publicly criticising the security services connection to organised crime, is believed to have been killed over his work for the British intelligence agencies and his claims that the FSB was responsible for the bombing of apartment blocks in Moscow and two other cities in 1999.

The Litvinenko killing was followed by a series of other poisonings of Kremlin critics that the west blamed on Russia, including the attempted poisoning of the former double agent Sergei Skripal in Britain in 2018 and the opposition leader Alexei Navalny in Siberia in 2020.


See original here:
Alexander Litvinenko assassination suspect dies of Covid - The Guardian
Coronavirus smell test: If you have COVID-19, here’s how your coffee may smell – Times of India

Coronavirus smell test: If you have COVID-19, here’s how your coffee may smell – Times of India

June 5, 2022

This is solid evidence that its not all in the head, and that the sense of disgust can be related to the compounds in the distorted foods. The central nervous system is certainly involved as well in interpreting the signals that it receives from the nose. The parosmic experience is a combination of the two mechanisms which produces the distorted perception of everyday foods, and the associated sense of disgust," says Doctor Jane Parker, Associate Professor of Flavour Chemistry and Director of the Flavour Centre at the University of Reading.

We can now see that certain aroma compounds found in foods are having this particular effect. It will, we hope, be reassuring for those with parosmia to know that their experience is real, that we can identify other foods which may also be triggers and, moreover, suggest safe foods that are less likely to cause a problem. This research provides useful tools and strategies for preventing or reducing the effect of the triggers," she adds.

Another researcher Mr Simon Gane from the Royal National Ear, Nose and Throat and Eastman Dental Hospital said, "We still have a long way to go in understanding this condition, but this research is the first to zoom in on the mechanism in the nose. We now know this has to be something to do with the nerves and their receptors because thats how these molecules are detected."


Read the rest here:
Coronavirus smell test: If you have COVID-19, here's how your coffee may smell - Times of India
Public attitude toward Covid19 vaccination: The influence of education, partisanship, biological literacy, and coronavirus understanding – John Wiley
FDA advisers to weigh risks and benefits of Novavax’s Covid-19 vaccine – CNN

FDA advisers to weigh risks and benefits of Novavax’s Covid-19 vaccine – CNN

June 5, 2022

Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine's efficacy was 90.4% overall against mild, moderate or severe Covid-19 for a period of 2 months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.

Those efficacy numbers were collected before the emergence of the Omicron coronavirus variant. It remains unclear how long protection lasts or how well the vaccine will protect against Omicron.

Novavax's vaccine, called NVX-CoV2373, is given as two doses three weeks apart for the primary vaccination series.

Although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, the FDA did describe rare events of myocarditis and pericarditis -- inflammation of the heart muscle and inflammation of tissue surrounding the heart -- associated with the vaccine.

"Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373," the FDA's briefing document says.

The document describes six cases that happened after vaccination with Novavax. Five were among males ranging in age from 16 to 67. Of the six cases, five were hospitalized but have since recovered.

An increased risk of myocarditis and pericarditis has been identified among people who received the mRNA Pfizer/BioNTech and Moderna Covid-19 vaccines now used in the United States.

The company added, "we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis."

The most common adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle ache. Reactions were reported more commonly in younger participants in the vaccine's clinical trials.

In its briefing document, the FDA summarized, "The known benefits among vaccine recipients 18 years of age and older relative to placebo are reduction in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination."

In Tuesday's meeting, the FDA's vaccine advisory committee members will vote on the question: "Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in individuals 18 years of age and older?"

'We believe our vaccine offers a differentiated option'

In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use in the United States.

In November, Indonesia became the first country to grant emergency use authorization of Novavax's vaccine. It has since been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.

Even though most adults in the United States have been vaccinated against Covid-19, the head of the company has said that it sees Novavax's vaccine as a potential option for booster doses, regardless of which type of vaccine was given for a person's initial doses.

Novavax's protein-based coronavirus vaccine relies on something called recombinant nanoparticle technology and Novavax's adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.

Protein-based vaccines like Novavax's work by getting the body's immune system to recognize little modified pieces of the virus it's targeting. In Novavax's case, that means pieces of the coronavirus spike protein.

Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells -- specifically, cells from the fall armyworm -- prompting them to produce the coronavirus spike protein.

These virus-like nanoparticles were harvested to make Novavax's vaccine.

"It's not infectious. We never touch the coronavirus itself," Glenn added. "Then that is given to people, and they make an immune response that's very much focused just on the spike -- and I would say, the hallmark of our vaccine is, it gives a very strong immune response with very few side effects, and the dose is very small and the vaccine can be stored with normal refrigerated temperatures."

Novavax starts Phase 3 trial of Omicron-specific booster

"The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine," Novavax said in a news release.

The trial will analyze the Omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.

Two doses of either the Omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of either the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.

Similarly, two doses of the Omicron-specific vaccine or the original NVX-CoV2373 will be given after two doses of either mRNA vaccines received at least six months before joining the trial.

Two doses of the bivalent vaccine will be administered in participants vaccinated with three doses of either mRNA vaccine at least three months before joining the trial.

The trial will last about 10 months, and initial results are expected in the second half of this year.


Read the original:
FDA advisers to weigh risks and benefits of Novavax's Covid-19 vaccine - CNN
White House says Covid-19 shots for kids under 5 could begin as soon as June 21 – CNN

White House says Covid-19 shots for kids under 5 could begin as soon as June 21 – CNN

June 3, 2022

CNN

Covid-19 vaccination shots for the youngest Americans could begin as soon as June 21, the White House said on Thursday.

The vaccination program for children younger than 5 would come more than 18 months after vaccines were first authorized for adults.

Dr. Ashish Jha, White House coronavirus response coordinator, laid out a timeline for authorization of vaccines for children younger than 5 at an afternoon news briefing. The US Food and Drug Administrations vaccine advisers will review data submitted by Pfizer and Moderna during a meeting on June 14-15, and the agency will then decide whether to authorize the vaccines for emergency use.

We expect an FDA decision shortly after the advisory committee meeting, and we look forward to this process playing out, Jha said. The FDA authorization is not the final step in the process before vaccinations can begin. CDC must also issue its recommendations. If the FDA authorizes the vaccines, the CDC will have its advisory committee meetings and ultimately the CDC director will make her recommendations.

Jha said the White House was not going to prejudge the outcome of the process, but was already hard at work planning for the process to play out.

Weve been working very closely with states with local health departments, with pediatricians, family physicians, other health care providers and pharmacies to get ready, he said, adding the administration expected the vast majority of kids would be vaccinated by their primary care providers.

The good news, Jha said, is the US has plenty of supply of both the Pfizer and Moderna vaccines to start the vaccination program for kids younger than 5, and 10 million additional doses would be made available for states, pharmacies, community health centers and federal entities to order starting this Friday. Jha said those doses were expected to start arriving at their destinations after the long Juneteenth weekend.

The Monday after the FDA advisory committee meeting is June 20, when the US celebrates Juneteenth, so Jha said the White House expects that vaccinations will begin in earnest as early as Tuesday, June 21. He noted it will take some time for the program to ramp up and for vaccines to be more widely available.

CORRECTION: A previous version of this story incorrectly stated when the first Covid-19 vaccines were made available to adults. They were authorized 18 months ago.


See the article here:
White House says Covid-19 shots for kids under 5 could begin as soon as June 21 - CNN
COVID-19 Vaccine Clinics for the Week of June 4 – Tarrantcounty.com

COVID-19 Vaccine Clinics for the Week of June 4 – Tarrantcounty.com

June 3, 2022

June 2, 2022 - (Tarrant County) Tarrant County Public Health hosts numerous pop-up COVID-19 clinics across Tarrant County each week in partnership with public and private organizations listed below. Each site has the Moderna and Pfizer vaccines and at times the Johnson & Johnson. Children five and older are eligible for the vaccination. Parents need to bring proof of the childs age and their own ID for the vaccination. Booster vaccinations are available at all of the vaccination locations.

TCPH would like to bring a COVID-19 vaccination clinic to businesses, churches and organizations in the community who are interested in hosting a pop-up clinic. Its easy and free to host a clinic.In addition to the vaccination opportunities below, the cities of Arlington, Fort Worth, Mansfield, North Richland Hills, Hurst, and Tarrant County College have also added opportunities for vaccinations. To find a local vaccine site, the County created a vaccine finder page:VaxUpTC website.

Pop-Up COVID-19 locations:

Shadow Brook ApartmentsSaturday, June 4: 1 p.m. to 5 p.m.2020 South Cooper St.Arlington, TX 76013

Saginaw Fire StationTuesday, June 7: 8 a.m. to 12 p.m.400 South Saginaw Blvd.Saginaw, TX 76179

Tandy Village Assisted LivingTuesday, June 7: 10 a.m. to 2 p.m.2601 Tandy Ave.Fort Worth, TX 76103

Vaxmobile True Vine Missionary Baptist Church Thursday, June 9: 9 a.m. to 4 p.m.3732 Miller Ave.Fort Worth, TX 76119

Cornerstone Assistance NetworkThursday, June 9: 10 a.m. to 4 p.m.3500 Noble Ave.Fort Worth, TX 76111

Stonegate Nursing and RehabilitationFriday, June 10: 1 p.m. to 3 p.m.4201 Stonegate Blvd.Fort Worth, TX 76109

Tarrant County Public Health CIinics:

Northwest Public Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.3800 Adam Grubb RoadLake Worth, TX 76135

Bagsby-Williams Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.3212 Miller Ave.Fort Worth, TX 76119

Southeast Public Health CenterMonday to Friday:9 a.m. to 12 p.m.and1 to 5 p.m.536 W Randol MillArlington TX, 76011

Main Public Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.1101 S. Main StreetFort Worth, TX 76104

Southwest Public Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.6551 Granbury RoadFort Worth, TX 76133

Watauga Public Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.6601 Watauga RoadWatauga, TX 76148


Link:
COVID-19 Vaccine Clinics for the Week of June 4 - Tarrantcounty.com
COVID-19 Vaccination Associated with Higher Incidence of DLLR in Women – MD Magazine

COVID-19 Vaccination Associated with Higher Incidence of DLLR in Women – MD Magazine

June 3, 2022

According to a new cross-sectional study from Japan, the initial dose of the SARS-CoV-2 mRNA-1273 vaccine was associated with a higher incidence of delayed large local reactions (DLLR) in female patients and individuals 30-96 years old, which suggested a type IV allergic skin reaction due to the vaccine.

Instances of DLLR- which typically manifest 7 days after vaccination and persists for roughly 4 days- have occurred following vaccination against COVID-19 with the Moderna vaccine, and have been referred to as COVID arm and Moderna arm in the United States and Japan, respectively.

Despite being rare, little is known regarding the pathophysiology of DLLR following COVID-19 vaccination.

In this retrospective cross-sectional study, an investigative team led by Toshihide Higashino, MD, PhD, of the Department of Dermatology at Self-Defense Forces Central Hospital, analyzed medical examination data in a large-scale population in Japan to assess the associations of sec and age with susceptibility to DLLR.

Eligible participants received their second dose of the COVID-19 vaccine after receiving the first dose of the same vaccine 4-6 weeks earlier, and were interviews by 5 dermatologists from the investigative team to assess adverse skin reactions to the first dose at the Self-Defense Forces large-scale vaccination center in Tokyo. These assessments occurred from May 24 to November 30, 2021.

Delayed large local reactions were considered if a participant reported erythema, tenderness, itchiness, induration, burning sensation, or swelling around the injection site that were noted on or after the sixth day after injection following a patients first vaccination.

The incidence rate of DLLR stratified by sex and age group was the primary outcome of the study, and odds ratios (ORs) were calculated to evaluate the differences between groups. Meanwhile, multiple linear regression analyses were conducted to evaluate the association between the time of onset and duration of DLLR.

Among the 650,532 recipients of the second dose that were featured in the large-scale vaccination center population. 5893 were interviewed. Among these recipients, 56.3% were male and 43.7% were female, with the median age being 55 and 50 years old, respectively.

The incidence rate of DLLR was significantly higher among female participants (22.4%) than males (5.1%). Generally speaking, the incidence rate was also significantly higher in patients 30-39 years old (14.3%), 40-49 years (15.8%), 50-59 (14.9%), and 60-69 years (12.6%), when compared to patients 18-29 years.

The mean time of onset was significantly earlier among males (6.97 days) than females (7.32) after adjusting for age (P=.005). However, the mean duration of symptoms was significantly shorter among males (4.83 days).

"The association between demographic characteristics and susceptibility of DLLR suggests that the condition is a type IV allergic skin reaction," the team wrote.

The study, "Assessment of Delayed Large Local Reactions After the First Dose of the SARS-CoV-2 mRNA-1273 Vaccine in Japan," was published online in JAMA Dermatology.


The rest is here: COVID-19 Vaccination Associated with Higher Incidence of DLLR in Women - MD Magazine