Category: Corona Virus

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CDC coding error led to overcount of 72,000 Covid deaths – The Guardian

March 24, 2022

A quiet change to how the US Centers for Disease Control and Prevention (CDC) publicly reports Covid death details underscores the need for the agency to communicate clearly and transparently about rapidly evolving science, experts say.

The past two years have created numerous communication challenges for the agency, which works with massive amounts of data from scores of different sources, including states and territories.

Mistakes are inevitable because humans are fallible, but there should always be an effort promptly to explain what happened and whats being done to prevent it from happening again, said Tom Frieden, a former CDC director and the president and CEO of Results Save Lives.

You have to over-communicate, basically, he said. Any time there is something that needs to be corrected, be upfront about it: heres what happened, heres what we know, heres what we dont know.

Last week, after reporting from the Guardian on mortality rates among children, the CDC corrected a coding logic error that had inadvertently added more than 72,000 Covid deaths of all ages to the data tracker, one of the most publicly accessible sources for Covid data.

The agency briefly noted the change in a footnote, although the note did not explain how the error occurred or how long it was in effect.

A total of 72,277 deaths in all age groups reported across 26 states were removed from the tracker because CDCs algorithm was accidentally counting deaths that were not Covid-19-related, Jasmine Reed, a spokesperson for the agency, told the Guardian.

The problem stemmed from two questions the CDC asks of states and jurisdictions when they report fatalities, according to a source familiar with the issue.

One data field asks if a person died from illness/complications of illness, and the field next to this asks for the date of death. When the answer is yes, then the date of death should be provided.

But a problem apparently arose if a respondent included the date of death in this field even when the answer was no or unknown. The CDCs system assumed that if a date was provided, then the no or unknown answer was an error, and the system switched the answer to yes.

This resulted in an overcount of deaths due to Covid in the demographic breakdown, and the error, once discovered, was corrected last week. The CDC did not answer a question on how long the coding error was in effect.

Working with near real-time data in an emergency is critical to guide decision-making, but may also mean we often have incomplete information when data are first reported, said Reed.

The death counts in the data tracker are real-time and subject to change, Reed noted, while numbers from the National Center for Health Statistics, a center within the CDC, are the most complete source of death data, despite lags in reporting, because the process includes a review of death certificates.

Reporting on causes of death is difficult even in non-pandemic times, experts said.

Its really hard to get accurate numbers, said Glen Nowak, a former director of media relations at the CDC and co-director of the Center for Health & Risk Communication at the University of Georgias Grady College. Its not just with Covid it happens with pretty much any infectious disease or even foodborne illnesses and waterborne illnesses, where theres a large outbreak.

There are a few reasons for that. Healthcare providers usually report the initial data, but treating patients is a more pressing priority. Death certificates take time to complete, and the cause of death may be subject to political pressure or difficulty determining the underlying reason or reasons. States and other jurisdictions may have lags in sending the data to the CDC; currently, one-third of deaths are reported after 10 days. Then the CDC processes the data, which can also be an involved process.

Most CDC data comes from state and local governments, and the quality can vary widely because there has been a decades-long under-investment in public health at the national, state, city and local levels, Frieden said.

The public health and healthcare system we have in this country makes it extraordinarily difficult to collect data well.

The CDC estimates that more than 968,000 Americans have died of Covid, and this change does not seem to have affected that estimate. The tracker shows demographic data on about 785,000 deaths, which means there may be more than 180,000 deaths not yet tallied in these breakdowns.

The recent change to demographic data shows the difficulty of offering up-to-date assessments while data reporting and analysis have lagged in the face of a massive outbreak. Data on the same topic across the CDC can also vary depending on the source and how numbers were calculated.

The level of precision that you see in these numbers makes you think that they must be really super accurate, Nowak said. Instead, they are informed estimates that help contextualize the scope of Covid compared with other illnesses.

I dont think public health and others do a good-enough job of reminding people that these numbers have significant margins of errors, Nowak said. The caveats need to be clear that these are our best estimates based on the data that has been reported to CDC.

As the scientific evidence accumulates, adjustments and changes are inevitable and frequent. But significant changes in calculations and records need to be explained clearly, particularly in an emergency where the public is frequently attuned to data and to unexplained changes like this.

The best practice, really, is to have virtually daily briefings, so that youre updating daily about what youre seeing and youre answering questions daily, Frieden said. Thats how the agency addressed past outbreaks of Ebola, Zika and H1N1, also known as swine flu.

These briefings should be held by the scientists with expertise in many areas, not just the director of the CDC, he said. The current CDC administration has gradually been getting back in the habit of doing that, and I hope that trend will continue.

The CDC is a government agency that provides data to inform national policy, and public health policies often have some political component, Frieden said. It can never be apolitical. But you should never have any concerns about the accuracy of the data.

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CDC coding error led to overcount of 72,000 Covid deaths - The Guardian

Factbox-Latest on the worldwide spread of the coronavirus – WTVB

March 24, 2022

Factbox-Latest on the worldwide spread of the coronavirus | WTVB | 1590 AM 95.5 FM | The Voice of Branch County Close For the health and safety of everyone, our offices are temporarily closed to the public. If you have won a prize from us we will be mailing it to you or will contact you with specific information needed to redeem your prize. Feel free to call us with questions during weekday business hours at (517) 279-1590.

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Factbox-Latest on the worldwide spread of the coronavirus - WTVB

How delta and omicron made the Frankenstein variant ‘deltacron’ : Goats and Soda – NPR

March 24, 2022

On February 16, Scott Nguyen went hunting. And what he found is a bit surprising: a coronavirus variant that looks like a Frankenstein virus. It has the head of the omicron variant stuck onto the body of the delta variant.

Officially, Scott Nguyen is a bioinformatician at the Public Health Laboratory in Washington, D.C. He tracks emerging coronavirus variants around the city.

But on the side, Nguyen and a handful of scientists around the world have an intriguing hobby: "We're variant hunters," he says. "I think that's a pretty cool way to describe it."

Nguyen and other variant hunters search through millions of SARS-CoV-2 genome sequences in a massive database, called GISAID, looking to uncover strains that could shift the course of the pandemic or simply give scientists a better understanding for how the virus evolves.

For instance, back in November one variant hunter found "a very weird set of ...mutations coming from a variant in South Africa," Nguyen says. "That became omicron."

Then early one morning in February, Nguyen detected not simply another variant but a whole new class of variants: variants that mix together parts of delta and omicron. And not just any parts, randomly put together. In some instances, the virus seems to be optimizing the combinations picking the best traits from each for infectiousness and immune evasion.

Specifically, Nguyen found a variant that's mostly delta but contains the spike protein of omicron the tiny studs on the surface of the virus that initiate infection. "So a good chunk of the virus' spike protein is omicron but the body of the virus is still delta," Nguyen says. "So yes, that's the best way to describe it."

So far, this variant, called XD, is rare. So, scientists have detected it in only France, Denmark, Belgium, the Netherlands and Germany. But there are likely many of these deltracrons out there. Scientists in San Mateo, California, have already found a handful of them in the U.S. At least one has emerged in the U.K. and Brazil.

Health officials, including those at the World Health Organization, are watching these hybrid variants closely. Because they demonstrate how the virus can take its most successful parts and combine them quickly into a supervirus. This process is called recombination, and it's how dangerous strains of flu are made.

"So very often recombination is the way in which we get pandemics of influenza. ," Dr. Mike Ryan with the World Health Organization said on Friday. "So we have to be very cautious ... we have to watch these recombinant events very, very closely."

For instance, omicron's spike protein is especially apt at hiding the virus from our immune system, especially our antibodies. And so the XD variant is essentially the delta variant wearing omicron's invisibility cloak.

"From the variant's perspective, it has the best of worlds," Nguyen says. ""It's surprising that the virus can really do this, and do it very well, as well.

So how does the virus do this? How does it create these Frankenstein hybrids?

For starters, a person has to catch both omicron and delta at the same time, says Shishi Luo, a bioinformatician at the genomics company Helix. "So a person has to be exposed to both variants in a short enough time frame so that they have both of them in this system."

Luo and her colleagues recently analyzed samples from nearly 30,000 Americans infected with SARS-CoV-2 during the rise of omicron in this country, from November until February. They found 20 people co-infected with both delta and omicron. In other words, they were infected twice.

"Omicron happened around Christmas and New Year, when there were many social gatherings," Luo explains. "So you can imagine, you go to one social gathering and got exposed to delta, and then you go to a different social gathering, and you catch omicron."

If both variants manage to infect the same cell, at the same time, then the virus can end up doing recombination, Luo says. In essence, during replication, one variant steals a chunk of genes from another variant. So the delta variant, in way, plagiarized part of omicron's genetic code.

"If you're writing a document, you can have typos where you change a single letter," Luo says. "But you can also copy and paste and move big chunks of text. That's recombination, where one variant, in this case delta, takes a big chunk of text from omicron."

Grabbing chunks of code instead of just single letters makes the virus more malleable or flexible, Luo says, so it can quickly evolve new variants, including ones that can evade our immune protection. "It just shows how SARS-CoV-2 has many tools in its kit for changing itself."

Scientists are just starting to understand how important recombination is for SARS-CoV-2 evolution. "It's been known that coronaviruses, in general, have a lot of recombination. For SARS-CoV-2, this is the first time we've seen so much evidence that it's happening," she adds.

In fact, recombination may be the reason SARS-CoV-2 exists in the first place. Last month, scientists at the University of Glasgow published a study in which they speculate about the origins of SARS-CoV-2. Their analysis suggests an animal in the Wuhan seafood market could have been co-infected with two coronaviruses at the same time and that these two viruses recombined, just like omicron and delta are doing right now, to generate the initial version.

"You know, early on in the pandemic, we were all expecting SARS-CoV-2 to not mutate too much," Scott Nguyen says. "But this virus has surprised us at every corner. So I think these recombinant variants provide some interesting clues to how this virus is going to evolve next" and just how quickly the next variant of concern may appear.

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How delta and omicron made the Frankenstein variant 'deltacron' : Goats and Soda - NPR

How protected are we against Covid-19? Scientists search for a test to measure immunity – CNN

March 24, 2022

CNN

In 2010, doctors told Ben Sobieck, now 37, that his kidneys were inexplicably failing. Shortly after, he had a kidney transplant and started on the lifelong medications that weaken his immune system to keep his body from rejecting the donor organ. They never figured out what caused Sobiecks kidney failure. But a decade later, he confronted another threat to his health: the Covid-19 pandemic.

I am on immunosuppressants that make me more vulnerable for serious Covid complications, said Sobieck, 37, who lives in Minnesota. If youre immunocompromised, you may not have a very good response to the [Covid-19] vaccine.

Seeking evidence that his immune system was working the way it should, Sobieck made an unusual request: He asked his nephrologist to do a blood test that gives a rough measure of antibodies, a type of protein the body creates in response to an infection or vaccine. Antibody titers reveal the concentration of a specific antibody found in someones blood.

Millions of Americans not just those with weakened immune systems are wondering about their protection after a winter of booster shots and Omicron infections. As mask mandates are lifted and restrictions removed in a step toward normalcy, a test to measure immunity would be a powerful tool to measure individual risk.

The biggest reason I wanted to get my antibody titer checked is because I dont know how to assess risk, Sobieck said. Anyone who is immunocompromised, from the beginning of this pandemic right through today, has very few tools to assess risk: if theyre going to leave the house, when theyre going to leave the house, how to interact with other people, which situations are OK.

Sobieck had his antibody levels checked after his second, third and fourth doses of the Moderna Covid-19 vaccine. Each result showed that he had more than the maximum number of antibodies the test could detect, indicating a robust immune response.

Although there is no specific guidance on how to interpret these results to figure out the level of protection against infection or disease, Sobieck felt reassured that his immune system was doing its job.

More than 50% of transplant patients dont have enough immune response to be protected, even if they get not two but three doses of the vaccine that we use in the general population, said Dr. Dorry Segev, professor of surgery at New York University Langone Health. For them, [an antibody titer] is a particularly poignant indicator of whether they have any protection at all.

Segev, a transplant surgeon, advocates using tests that measure antibodies as a way to check immune protection in people who are immunocompromised.

Sobieck says the test results allowed him to make decisions for himself and his family.

Knowing that I had the antibody response that I had meant that my son could go to in-person school. Thats huge, he said.

About 95% of Americans 16 and older have antibodies against Covid-19 as of December, the most recent date that data is available, according to US Centers for Disease Control and Prevention estimates that use information from blood donors.

But its one thing to measure antibody levels. Its another to measure how much they protect you against Covid-19.

The US Federal Drug Administration recommends against checking antibody levels at all because theres no agreed-upon way to calculate how any given antibody level protects you from infection or severe disease. It may also give a false sense of security, the agency says.

There arent good correlates of protection something that says that this is the measurement that one needs to know how well they are protected, Emory University virologist Mehul Suthar said.

Scientists are trying to fill the knowledge gap. Studies measure average antibody levels across a population to check vaccine efficacy, often using antibody levels months after vaccination to determine the need for a booster. One study in people who got the Moderna vaccine found that higher antibody levels after vaccination were associated with lower risk of Covid-19 infection.

But not all antibodies are created the same. Of all the antibodies that the body may make after infection or vaccination, only a fraction are considered neutralizing antibodies, meaning they can actively prevent infection.

Tests to measure antibodies can be either quantitative or qualitative. Quantitative tests provide a specific number, up to a certain point, of antibodies in the blood. Qualitative tests will indicate only whether certain antibodies were detected. Results of qualitative tests are either positive, negative or indeterminate for neutralizing antibodies.

When it comes to measuring neutralizing antibodies specifically, there is only one type of test that has been given emergency FDA authorization to detect them, and it is qualitative.

Several studies have demonstrated that neutralizing antibodies are a strong correlate for protection against symptomatic infection with Covid-19 and its variants, with boosters enhancing neutralization.

Peter Gilbert, professor of vaccine and infectious diseases at the Fred Hutchinson Cancer Research Center and lead author of the Moderna study, says these correlates are useful to apply to large groups. For example, scientists can use data from larger studies about the correlation between antibody levels and vaccine efficacy in adults to make a prediction about vaccine efficacy in children.

However, reaching conclusions based on one persons antibody levels is far more limited. Gilbert compares individual antibody titers with a dipstick for oil in a car.

Is the oil in a particular car low? Therefore, you need to go out and get some new oil, or in this case, get another shot of the vaccine, he said. For that purpose, the markers arent as good.

This is largely due to how antibody levels vary from person to person. That correlate of protection also changes over time and with different coronavirus variants, which makes it hard to define a cutoff for antibody levels above which scientists can confidently say that someone is protected against Covid-19.

Theres a key difference in how antibody levels compare in people who have been vaccinated against Covid-19 versus those who have been infected with the coronavirus.

Whereas a vaccine response, you may have all individuals that got the vaccine have high antibodies and sort of wane over time. With infection, its remarkably heterogeneous. Youll have lots of individuals that have very low and individuals that have very high antibody responses, Suthar said.

According to Marion Pepper, an associate professor of immunology at the University of Washington, location matters, especially for the immune system.

There are different immunological environments that make up your body. When you see an immune response in your arm, its going to be a different cast of characters than if you see an immune response in your lungs, Pepper said.

The immune system is like lots of different neighborhoods, and each one has a different flavor, depending on how an individual gets exposed to the coronavirus, whether its through a vaccine injected into the upper arm or through an infection to the respiratory system.

The CDC cites one study, which is in preprint and has not been peer-reviewed, that found antibody titers waned more quickly in vaccinated people than in people who had been infected. This may help explain the growing evidence of stronger and more durable vaccine efficacy in people who have immunity through both illness and vaccination, called hybrid immunity.

Although they may not provide the best way to tell how protected someone is, antibodies are useful to understanding how we compare people with natural immunity with those with vaccine-acquired immunity.

We know that people who have this hybrid immunity are better protected. So it also really begs the question, which of these parameters is associated with that protection? said Pepper, who leads a lab that is studying hybrid immunity.

Observing levels of immune cells and antibodies as they change over time in different groups of people can help scientists learn how to create vaccines and time vaccinations to replicate the strength of hybrid immunity without the actual infections.

Antibody levels are only one part of the immunity story. There are also T cells, a type of white blood cell that helps fight infection by killing cells that have been infected with a virus or by helping another type of white blood cell, the B cell, create antibodies.

So why do we focus so much on antibodies? One aspect is that antibodies are probably one of the easiest to measure in the laboratory, Suthar said.

I think when you go to the T-cell-based assays, theyre much more challenging, he explained. Each individual has different what are called H.L.A. types that make it a bit more challenging to understand how well ones T-cell responses are against this virus.

Unlike antibodies, which are responsible for preventing an infection, T cells are responsible for destroying cells that are already infected. T cells may play a big role in vaccine efficacy against serious disease from more transmissible coronavirus variants, such as Omicron.

One study showed that while the highly mutated Omicron could evade previously neutralizing antibodies, T cells preserved a strong response.

A memory B cell is a B cell that can get reactivated to make antibodies. It generally doesnt do that unless a T cell tells it to go, so studying the T cells is going to be really important for understanding this immune protection, Pepper said.

However, she said that the complexity of measuring T cells means there isnt going to be a rapid test to measure them any time soon.

The Omicron surge has demonstrated that infection rates can still be high even after a vaccine or a prior infection. With the possibility of more variants forming, Covid-19 has become a moving target requiring a constantly evolving understanding of these correlates of protection.

The biggest question I have and I think everyone else has is: What level of antibody equals protection from serious complications from Covid? Sobieck said.

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How protected are we against Covid-19? Scientists search for a test to measure immunity - CNN

New COVID surge: Why the US wont see the next COVID wave – Deseret News

March 24, 2022

The United States may be vulnerable to an unseen surge of COVID-19 cases right now, according to multiple health experts.

Why it matters: The United States has reached a lull period in the coronavirus outbreak. All of that could be upended without much foresight because of how Americans are currently handling the pandemic.

Driving the news: Experts are worried theres not enough public data on COVID-19 cases and there are fewer COVID-19 testing sites, forcing the U.S. to fly blind in the face of a resurgence.

What theyre saying: Comprehensive case data is critical to an effective response. As we have seen throughout the pandemic, lack of data leads to poor decision making and ultimately costs lives, Dr. John Brownstein, an epidemiologist at Boston Childrens Hospital, told ABC News.

Yes, but: PerBloomberg, data from wastewater testing sites across the country could warn us of a potential rise in COVID-19 infections because traces of COVID-19 end up in peoples waste.

What to watch: Coronavirus cases are expected to rise in the coming weeks because of the BA.2 subvariant, which has been spreading throughout Europe.

What theyre saying:I would expect that we might see an uptick in cases here in the United States because, only a week or so ago, the CDC came out with their modification of the metrics for what would be recommended for masking indoors, and much of the country right now is in that zone, where masking indoors is not required,Dr. Anthony Fauci, the nations top infectious disease expert, toldKGTVlast week.

The bottom line: System-wide modernization and change to benefit all of public health requires CDC to have the authority to coordinate and guide how data are reported and shared for evidence based decision-making, an unnamed CDC representative told ABC News. The nation can no longer continue with the current, fractured approach of collecting public health data to be better prepared for future pandemics.

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New COVID surge: Why the US wont see the next COVID wave - Deseret News

COVID-19: What you need to know about the coronavirus pandemic this week – World Economic Forum

March 22, 2022

Confirmed cases of COVID-19 have passed 470.8 million globally, according to Johns Hopkins University. The number of confirmed deaths has now passed 6.07 million. More than 11 billion vaccination doses have been administered globally, according to Our World in Data.

China's financial hub of Shanghai reported a record daily surge in local COVID-19 infections on Monday as authorities scrambled to test residents and rein in the Omicron variant. Shanghai reported 24 new domestically transmitted COVID cases with confirmed symptoms for Sunday and 734 local asymptomatic infections.

The Chinese city of Shenzhen said it would allow offices and factories to restart operations from Monday and that public transport would also resume, after residents in the city completed three rounds of COVID-19 testing, state broadcaster CCTV reported.

South Korea has reached a deal to buy 10 million doses of the country's first experimental coronavirus vaccine, developed by SK Bioscience, authorities said on Monday.

Hong Kong SAR, China, plans to relax some anti-COVID measures next month, lifting a ban on flights from nine countries, reducing quarantine and reopening schools, after a backlash from business and residents.

France reported an average of close to 90,000 new daily coronavirus infections over the last seven days, a 36% rise from a week earlier when most COVID-19 health protocol measures were lifted by the government just ahead of the country's elections.

The Italian government plans to phase out coronavirus restrictions more than two years after the disease first swept the country. The cabinet said COVID-19 health certificates proving vaccination or recent recovery from coronavirus would no longer be needed to access restaurants, gyms and public transport, from 1 May.

Pharmaceutical company Moderna said on Monday it has signed a new agreement with Switzerland for the supply of another 7 million doses of its COVID-19 booster vaccine for delivery in 2023. The agreement also includes an option of 7 million doses for delivery in 2023 and 2024.

Daily new confirmed COVID-19 cases per million people in selected countries.

Image: Our World in Data

AstraZeneca said on Monday that its antibody-based cocktail to prevent and treat COVID-19 retained neutralizing activity against Omicron coronavirus variants, including the highly contagious BA.2 sub-variant, in an independent lab study.

This is the first data looking at the impact of AstraZeneca's Evusheld treatment on "cousins" of the Omicron variant following a recent global spike in cases. The Anglo-Swedish firm said in December that another lab study found that Evusheld retained neutralizing activity against Omicron.

Data from the latest study by Washington University in the United States showed the therapy reduced the amount of virus detected in samples viral load of all tested Omicron sub-variants in mice lungs, AstraZeneca said. The study has yet to be peer reviewed.

Evusheld was tested against the BA.1, BA.1.1, and BA.2 sub-variants of Omicron and was also shown in the study to limit inflammation in the lungs a critical symptom in severe COVID-19 infections.

"The findings further support Evusheld as a potential important option to help protect vulnerable patients such as the immunocompromised who could face poor outcomes if they were to become infected with COVID-19," said John Perez, Head of Late Development, Vaccines and Immune Therapies at AstraZeneca.

A World Health Organization (WHO) spokesperson has said that the end of the COVID-19 pandemic is a long way off, citing a rise in cases in its latest weekly data.

The UN health agency has previously said that the acute phase of the pandemic could end this year, but it would depend on how quickly the target to vaccinate 70% of the population in each country is met, among other factors.

Asked by a journalist at a Geneva media briefing about the timing of the pandemic's end, Margaret Harris said it is "far from over", adding that "we are definitely in the middle of the pandemic".

After more than a month of decline, COVID cases started to increase around the world last week, the WHO said, with lockdowns in Asia and China's Jilin province battling to contain an outbreak.

A combination of factors is causing the increases, including the highly transmissible Omicron variant and its cousin the BA.2 sub-variant, as well as the lifting of public health and social measures, the WHO said.

The views expressed in this article are those of the author alone and not the World Economic Forum.

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COVID-19: What you need to know about the coronavirus pandemic this week - World Economic Forum

Covid News: Many Adults in U.S. Remain Unvaccinated Amid Warnings of New Surge – The New York Times

March 22, 2022

F.D.A. field inspectors check imported seafood at the Los Angeles International Airport in 2009. The agency is ramping up inspections again.Credit...Food and Drug Administration

The Food and Drug Administration is ratcheting up a wide range of facility inspections that were delayed by travel pauses after the pandemic began.

The inspections have long been a crucial tool to ensure that drugs are contaminant-free, device flaws are fixed and the food supply is sanitary. If agency inspectors find serious problems, they usually require improvements but they also can seize goods, or pursue civil or criminal penalties.

Typically in recent years, the F.D.A. inspected about 12,500 U.S. facilities annually, a number that fell by about half, to about 6,100, in 2021. Foreign inspections the agency visits facilities making products for the American market fell even more precipitously, from more than 3,100 in the years before the pandemic to 167 in 2021.

In recent months, F.D.A. inspections have turned up alarming problems. A consumer complaint led federal inspectors to a Family Dollar distribution facility in Arkansas in January, where they found live and dead rodents in various states of decay.

A review of company documents revealed that 2,300 rodents had been collected since March 2021. A recall of a wide array of food, medications, cosmetics and dietary supplements followed.

F.D.A. inspectors have also been probing Abbott Nutritions baby formula manufacturing facility in Sturgis, Mich., after the company reported finding Cronobactor sakazakii bacteria during its own routine testing.

The company has also issued a recall. The investigation includes five infant hospitalizations and may have contributed to two deaths.

An estimated 73 percent of the facilities making active drug ingredients for the U.S. market are overseas. The federal Government Accountability Office has raised concerns about the inspection lapse and staff vacancies among foreign inspectors.

The F.D.A. said on Friday that mission critical inspections never ceased, even as the agency halted travel to ensure the safety of its work force during virus surges in the pandemic. Domestic inspections resumed again in February after a pause during soaring cases of the Omicron variant. The F.D.A. plans to return to its normal cadence of overseas inspections in April.

The F.D.A. is working as quickly and as safely as possible to resume normal operating status for inspections that prioritize public health, a spokesman, Jeremy Kahn, said in an email.

In the United States and abroad, the dip in inspections came with a drop in enforcement actions, such as warning letters, injunctions and product recalls, according to an analysis by the law firm Skadden, Arps, Slate, Meagher & Flom.

Enforcement shifted focus as well, a partner, Jennifer Bragg noted, zeroing in more on unsubstantiated claims about the testing and treatment of the coronavirus.

One unintended consequence of a new wave of inspections could be that companies halt production while responding to problems that F.D.A. officials find, exacerbating current medication or sterile injection fluid shortages.

That happened years ago, when the agency focused on overseas blood-thinner makers after sterility lapses were tied to dozens of deaths in the United States, said Erin Fox, a drug shortage expert at the University of Utah.

Are we going to have a repeat of that? Ms. Fox wondered. Just quality in general is really important.

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Covid News: Many Adults in U.S. Remain Unvaccinated Amid Warnings of New Surge - The New York Times

Could I have had COVID and not realized it? – ABC4.com

March 22, 2022

(The Conversation) It seems not a day goes by without learning someone in our inner circle of family, friends and colleagues has COVID. When we ask how unwell our acquaintance is, the responses vary from theyre really crook to you wouldnt even know they had it.

This is in line with studies that report moderate to severe illness in a minority of people (usually older with other risk factors) and thatup to one in three positive people exhibit no symptoms.

Given the ubiquitous presence of thishighly infectious coronavirusin our community and the high rate of asymptomatic illness, those who have not been diagnosed with COVID might wonder, how would I know if I had been infected? And, does it matter if I have?.

Most people know theyve had COVID because they had a fever or upper respiratory tract symptoms and/or were exposed to an infected person AND had a swab test (PCR or rapid antigen) that detected the COVID virus (SARS-CoV-2) in the upper airway.

At the beginning of 2022, many people with consistent symptoms or high-risk exposures were not able to access PCRs or RATs to confirm their diagnosis, but instead presumed themselves positive and quarantined.

It is possible to diagnose past infection in those who never tested positive. A blood test can look forSARS-CoV-2 antibodies(also known as immunoglobulins). When we are infected with SARS-CoV-2, our immune system launches a precision counter strike by producing antibodies against viral targets, specifically the Spike (S) and Nucleocapsid (N) proteins. COVID vaccinationinducesa similar immune response against the S protein only. The S antibody neutralizes the invader by preventing the virus from attaching to human cells.

These antibodies can be detected within one to three weeks after infection and persist forat least six months potentially much longer. A blood test that shows antibodies to S and N proteins indicates someone has been previously infected. Detection of antibodies to the S protein only indicates vaccination (but not infection).

Before you rush off to get a COVID antibody test, there are a few notes of caution. There is stillmuch to learn about the characteristicsof the immune response to COVID infection. Not everyone mounts a detectable antibody response following infection and levels can decline to undetectable levels after several months in some people.

Because there are other circulating seasonal coronaviruses (such as those that cause the common cold), tests may also pick up antibodies to non-SARS-CoV-2 strains, leading to false positive results.

Commercial and public hospital pathology labs can perform SARS-CoV-2 antibody testing, but the interpretation of results should be undertaken carefully.

So, antibody testing should really only be done when theres a good reason to: say, when confirming past infection or effectiveness of vaccination is important for the current care of an individual. Diagnosing a post-infectious complication or eligibility for a specific treatment, for example. It could also be useful for contact tracing or for assessing the background population rate of infection.

Seroprevalence studies test for the presence of SARS-CoV-2 antibodies in repositories of stored blood that are representative of the general population, such as from a blood bank. This data helps to understand the true extent of COVID infection and vaccination status in the community (and informs our assessment of population susceptibility to future infection and reinfection). Its more useful than daily reported case numbers, which are skewed towards symptomatic individuals and those with access to swab testing.

Newresearchfrom the World Health Organization, which is yet to be reviewed by other scientists, reported the results of a meta-analysis of over 800 seroprevalence studies performed around the world since 2020. They estimated that by July 2021, 45.2% of the global population had SARS-CoV-2 antibodies due to past infection or vaccination, eight times the estimate (5.5%) from a year earlier.

There areplansto conductfresh seroprevalence studiesin Australia in the coming year, which willupdate local dataand help us understand to what extent the Omicron wave has washed through the population.

For most people, knowing your COVID infection status is unlikely to be more than a topic of dinnertime conversation.

While some studies have pointed to a less robust and durable antibody response followingmildorasymptomaticinfection compared with severe illness, it is not known how this influences protection from reinfection. Certainly, the knowledge we have antibodies from past infection should not deter us from being fully up-to-date with COVID vaccination, which remains the best protection against severe illness.

There are reports of people with mild or asymptomatic COVID infection developinglong COVID persistent or relapsing symptoms that last several months after initial infection. Symptoms can include shortness of breath, physical and mental fatigue, exercise intolerance, headaches, and muscle and joint pain.

However, thelikelihoodof developing this condition appears higher in those who suffer a heavier initial bout of COVID illness. This might be linked withhigher viral loadat that time.

As we enter the third year of the COVID pandemic and given that up to one in three infections may be asymptomatic, it is likely many of us have been infected without knowing it.

If you are experiencing lingering fatigue, brain fog or other symptoms that could be long COVID, you should talk to your doctor. Otherwise, knowing our COVID infection status is unlikely to be of much practical benefit. Antibody testing should be reserved for specific medical or public health indications.

Being up-to-date with COVID vaccination is still our best defense against severe illness moving forward.

See original here:

Could I have had COVID and not realized it? - ABC4.com

Covid absences in schools in England triple in two weeks – The Guardian

March 22, 2022

The number of children in state schools in England who were absent last week because of Covid has more than tripled in a fortnight, confirming headteachers predictions of growing disruption in classrooms as pupils prepare for summer exams.

Figures published by the Department for Education (DfE) on Tuesday showed 202,000 pupils were off school on 17 March because of the virus a dramatic jump from 58,000 two weeks earlier, when attendance was described as returning to something approaching normal.

According to the latest government data, 159,000 pupils were off with a confirmed case of the Covid last week, up from 45,000 on 3 March, with a further 16,000 pupils absent with a suspected case of coronavirus, up from 6,000 earlier in the month.

Overall, attendance in state schools in England dropped from 92.2% two weeks ago to 89.7%, with Covid-related absence up from 0.7% to 2.5%. The government would like to see attendance in schools return to pre-pandemic levels of about 95%.

The latest figures also show increasing absence among staff, with almost one in 10 teachers and schools leaders (9.1%) off on 17 March, up from 5.8% two weeks earlier. About 48,000 teachers and 60,000 teaching assistants were absent last week, with schools struggling to secure supply cover for those missing.

Paul Whiteman, general secretary of the National Association of Head Teachers said: These figures are absolutely in line with what we have been hearing from our members. Covid cases have been spiking again in many schools over the past week or so in line with the rising numbers nationally. The government urgently needs to remind people that just because the legal requirement to isolate has been removed, there is still a duty to take appropriate action to reduce the spread of Covid just like any other illness.

Whiteman said plans to remove free access to lateral flow tests from the start of next month amid rising cases was irresponsible. The government cannot just let Covid rip through schools. Covid hasnt gone away and we need a proper plan for how to live with it long term that is focused on keeping levels low and reducing disruption.

A key concern is pupils preparing for GCSEs and A-levels this summer. Many schools are still finishing teaching the specifications as there has been so much disruption over the two years of exam courses, said Whiteman. More disruption now could be seriously damaging to pupils exam chances and education recovery.

The Department for Education said: Thanks to the hard work of teachers and school staff, over 99.9% of schools have consistently been open this term. We are now moving to living with and managing the virus, while maintaining good ventilation and hygiene as the norm, and continuing to use vaccines to build the populations wall of protection.

Read more from the original source:

Covid absences in schools in England triple in two weeks - The Guardian

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