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Saturday, July 31, 2021

Study: Vaccinated People Can Carry as Much Virus as Others

 In another dispiriting setback for the nation’s efforts to stamp out the coronavirus, scientists who studied a big COVID-19 outbreak in Massachusetts concluded that vaccinated people who got so-called breakthrough infections carried about the same amount of the coronavirus as those who did not get the shots.

Health officials on Friday released details of that research, which was key in this week's decision by the Centers for Disease Control and Prevention to recommend that vaccinated people return to wearing masks indoors in parts of the U.S. where the delta variant is fueling infection surges. The authors said the findings suggest that the CDC's mask guidance should be expanded to include the entire country, even outside of hot spots.

The findings have the potential to upend past thinking about how the disease is spread. Previously, vaccinated people who got infected were thought to have low levels of virus and to be unlikely to pass it to others. But the new data shows that is not the case with the delta variant.

The outbreak in Provincetown — a seaside tourist spot on Cape Cod in the county with Massachusetts’ highest vaccination rate — has so far included more than 900 cases. About three-quarters of them were people who were fully vaccinated.

Travis Dagenais, who was among the many vaccinated people infected, said “throwing caution to the wind” and partying in crowds for long nights over the July Fourth holiday was a mistake in hindsight.

“The dominant public messaging has been that the vaccine means a return to normal,” the 35-year-old Boston resident said Thursday. “Unfortunately, I’ve now learned it’s a few steps toward normal, not the zero-to-sixty that we seem to have undertaken.”

Dagenais credits being vaccinated with easing the worst of the flu-like symptoms in a couple of days. He has recovered.

Like many states, Massachusetts lifted all COVID-19 restrictions in late May, ahead of the traditional Memorial Day start of the summer season. Provincetown this week reinstated an indoor mask requirement for everyone.

Leaked internal documents on breakthrough infections and the delta variant suggest the CDC may be considering other changes in advice on how the nation fights the coronavirus, such as recommending masks for everyone and requiring vaccines for doctors and other health workers.

The delta variant, first detected in India, causes infections that are more contagious than the common cold, flu, smallpox and the Ebola virus, and it is as infectious as chickenpox, according to the documents, which mentioned the Provincetown cases.

The documents were obtained by The Washington Post. As they note, COVID-19 vaccines are still highly effective against the delta variant at preventing serious illness and death.

The Provincetown outbreak and the documents highlight the enormous challenge the CDC faces in encouraging vaccination while acknowledging that breakthrough cases can occur and can be contagious but are uncommon.

The documents appear to be talking points for CDC staff to use with the public. One point advised: “Acknowledge the war has changed,” an apparent reference to deepening concern that many millions of vaccinated people could be a source of wide-ranging spread.

An agency spokeswoman declined to comment on the documents.

The White House on Friday defended its approach to rising virus cases and shifting public health guidelines, repeatedly deferred to the CDC while stressing the need for vaccinations.

“The most important takeaway is actually pretty simple. We need more people to get vaccinated,” White House spokeswoman Karine Jean-Pierre said.

Pressed about the changing guidance, Jean-Pierre repeatedly said, “We don’t make those types of decisions from here.”

People with breakthrough infections make up an increasing portion of hospitalizations and in-hospital deaths among COVID-19 patients, coinciding with the spread of the delta variant, according to the leaked documents.

Although experts generally agreed with the CDC’s revised indoor masking stance, some said the report on the Provincetown outbreak does not prove that vaccinated people are a significant source of new infections.

“There’s scientific plausibility for the (CDC) recommendation. But it’s not derived from this study,” said Jennifer Nuzzo, a Johns Hopkins University public health researcher.

The CDC report is based on about 470 COVID-19 cases linked to the Provincetown festivities, which included densely packed indoor and outdoor holiday events at bars, restaurants, guest houses and rental homes.

Researchers ran tests on a portion of them and found roughly the same level of virus in those who were fully vaccinated and those who were not.

Three-quarters of the infections were in fully vaccinated individuals. Among those fully vaccinated, about 80% experienced symptoms with the most common being cough, headache, sore throat, muscle aches and fever.

Dagenais said he started to feel ill the evening he returned home and initially chalked it up to long nights of partying in packed Provincetown nightclubs.

But as the days wore on and the fever, chills, muscle aches and fatigue set in, he knew it was something more.

In the report, the measure researchers used to assess how much virus an infected person is carrying does not indicate whether they are actually transmitting the virus to other people, said Dr. Angela Rasmussen, a virologist at the University of Saskatchewan.

CDC officials say more data is coming. They are tracking breakthrough cases as part of much larger studies that involve following tens of thousands of vaccinated and unvaccinated people across the country over time.


https://www.usnews.com/news/health-news/articles/2021-07-30/cdc-team-war-has-changed-as-delta-variant-dangers-emerge

Germany could make unvaccinated pay for COVID tests

 The German government plans to end free coronavirus tests once enough Germans are vaccinated, according to a newspaper report. Although 51% of the population is fully inoculated, the pace is slowing.

The government will stop paying for rapid antigen tests after sufficient numbers of German residents have been fully vaccinated, according to the Bild newspaper. 

The tabloid cited unnamed government sources as saying that two ministers were pushing for the change, possibly from the end of September.

At present, Germans are required to present a negative coronavirus test if they want to enter offices, some shops and restaurants and can get tested for free.

Testing sites have been expanded in recent months to include pharmacies.

Scholz and Söder back the plan

Finance minister and the center-left Social Democrat (SDP) chancellor candidate Olaf Scholz and Bavaria's premier Markus Söder have strongly endorsed the measure, according to Bild.

Scholz reportedly supported the measure because progress in getting people vaccinated meant that public funds shouldn't be used to test those who are unvaccinated for free.

Free tests are costing the government €3.4 billion ($4 billion dollars), according to Bild.

Separately, Scholz has reminded the public to get vaccinated. 

"We have to convince our friends to get vaccinated. This is a matter that touches every one of us," Scholz told newspapers of the Funke media group.

Politicians call for faster vaccination 

German politicians are also actively encouraging people to get their shots asthe school year, which typically begins in August, is drawing closer.

SPD leader Saskia Esken and the German Association of Cities have called for vaccination campaigns at schools. Esken said she supported mobile vaccination teams at education establishments.

Thorsten Frei, the deputy leader of the CDU/CSU parliamentary group for law and consumer protection, told Bild that free tests ought to continue for children since they're not eligible for vaccination yet.

 

Meanwhile, Germany is preparing for federal elections in September and the officer responsible for overseeing them has maintained that all necessary precautions for poll workers have been taken into account. 

So far, 51% percent of Germans have been fully vaccinated, but experts say it isn't enough to prevent the fourth wave of the pandemic.

https://www.dw.com/en/germany-could-make-unvaccinated-pay-for-covid-tests-report/a-58713602

'CDC encourages use of new tests that detect both COVID-19 and flu'

 


 ' CLAIM: The Centers for Disease Control and Prevention revoked Emergency Use Authorization for coronavirus PCR tests because they were inaccurate, led to false positives and confused positive influenza cases with COVID-19.

AP’S ASSESSMENT: False. PCR tests are considered the gold standard for coronavirus testing. CDC announced after this year it will be withdrawing its request to the FDA for Emergency Use Authorization for one early PCR test, not because that test is inaccurate, but because it can only detect coronavirus. Newer tests can now also test for influenza at the same time.

THE FACTS: The FDA has approved roughly 280 PCR coronavirus tests, which determine whether sequences from the viruses’ RNA genome are present in a patient’s nasal swab. Early in the pandemic, in February 2020, the CDC introduced a COVID-19 PCR test, known as the “CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel.”

Some newer coronavirus tests can now also simultaneously test whether a patient is positive for influenza, but the CDC’s February 2020 PCR test only has the capacity to detect signs of a COVID-19 infection.

On July 21, the CDC announced that after this year, it would no longer request an Emergency Use Authorization from the FDA for that one test, which means laboratories will stop using it.

Kristen Nordlund, health communication specialist at the CDC, told The Associated Press the move was because newer PCR testing options now exist.

“The CDC 2019 Novel Coronavirus (2019 nCoV) Real-Time RT-PCR Diagnostic Panel met an important unmet need when it was developed and deployed and has not demonstrated any performance issues,” Nordlund said.

She said the agency was encouraging labs to switch to tests that can also detect influenza at the same time, since it will “save both time and resources.”

But social media users misinterpreted and misrepresented the announcement. False claims circulated on Twitter, Facebook and Instagram that the CDC’s move meant the agency and the FDA had admitted PCR tests do not work. Some posts online falsely said the test was unable to differentiate between coronavirus and influenza, leading to inflated COVID-19 counts and depressed flu counts.

In fact, PCR tests are designed to detect very specific areas of the viral genome, so tests do not get confused between which virus is present, said Matthew Binnicker, director of the clinical virology lab at the Mayo Clinic in Rochester, Minnesota.

“PCR tests, including the one developed by the CDC, are highly accurate and are able to differentiate between SARS-CoV-2 and influenza,” Binnicker said. “In other words, a COVID-19 test will not be positive if a person really has influenza, and vice versa.”

Binnicker said there are benefits to having one test that can detect both viruses, since the symptoms for both illnesses are often similar early on.

Furthermore, neither the CDC nor the FDA has cast any doubts on the effectiveness of PCR technology. “PCR tests are generally considered to be the ‘gold standard’ for COVID-19 diagnosis,” said James McKinney, a press officer for the FDA.

___

This is part of The Associated Press’ ongoing effort to address widely shared misinformation, including work with Facebook and other platforms to add context to misleading content and reduce its circulation online.

Here’s more information on Facebook’s fact-checking program: https://www.facebook.com/help/1952307158131536 '

https://www.kbtx.com/2021/07/29/cdc-encourages-use-new-tests-that-detect-both-covid-19-flu/

Labor’s Lockdown Losses

 Count organized labor among the groups slammed by the Covid-19 pandemic. The economic slowdown prompted by virus lockdowns has cost the union movement hundreds of thousands of private-sector members, wiping out years of gains in which labor had managed to recapture some of its membership after the dramatic losses of the 2008 recession. States with the highest degree of unionization, including those that have undergone long, severe lockdowns, such as California and New York, saw the greatest declines. Public unions, by contrast, managed to hold the line last year, thanks partly to growth in organized labor at the federal level, though they’ve never recaptured the membership that they lost a decade ago.

In 2020, the number of union members in the private sector fell by 428,000, to 7.08 million, a 5.7 percent decline. That’s now only slightly above the low for the last 70 years of 7.03 million members, recorded in 2012, when unions were still feeling the effects of the last recession and the slow economic recovery that followed it. The largest 2020 losses came in the broad category known as leisure and hospitality, which encompasses everything from sports venues, theaters, and amusement parks to hotels, casinos, and restaurants, all of which require most workers to perform their jobs on site. In these industries, over 40 percent of union jobs disappeared—a total of 161,000 members. Next hardest-hit was manufacturing, still one of the largest areas of private-sector union membership. Some 110,000 union positions, about 9 percent of the total, vanished last year. Another major union employer, the construction industry, shed 61,000 organized labor positions, while some 23,000 jobs disappeared in broadcasting and another 13,000 in the motion-picture business.

Only a few industries managed to increase union membership last year, including retailing, where the rise of e-commerce helped offset job losses among traditional stores; and transportation, where the growth of logistics firms helped deliver all those goods bought online. Public-sector unions also registered slight gains, as union members apparently kept their jobs even as the total number of government positions shrank. The largest area of public-sector gains came in federal employment during Donald Trump’s last year in office, as the number of unionized federal workers rose by some 40,000. Still, those small gains did little to reverse more than a decade of bad news for public-sector unions, which reached a membership peak in 2009, only to see a steady decline in virtually every year since then. Even with gains last year, membership in public unions remains more than 700,000 below its peak; today, some 34.8 percent of government workers are unionized, compared with 37.4 percent in 2009, according to unionstats.com.

The most heavily unionized states absorbed the biggest declines. Washington State, one of the earliest states affected by the pandemic and lockdowns, shed 81,000 union positions. New York, where Governor Andrew Cuomo earned a reputation as one of the strictest lockdown advocates, recorded a loss of 71,000 union positions, followed by California, which absorbed a net loss of 63,000.

The severe lockdowns in some states have sent union leaders scrambling for solutions. In September, California union leaders joined industry executives to push Governor Gavin Newsom to reopen amusement parks like Disneyland and Knott's Berry Farm and expressed frustration at the continuing lockdowns. “This is about preserving and retaining union jobs,” Ernesto Medrano, a representative for the Los Angeles/Orange Counties Building and Construction Trades Council, told the press. “We don’t want any more layoffs. It’s time to go back to work.” But the parks remained closed well into 2021, even as Disney’s Magic Kingdom in Florida reopened in July 2020. Meanwhile, as vaccines became available in late 2020 in New York State, union leaders in industries devastated by Covid struggled in vain to persuade Cuomo to declare their members emergency workers so that they could get vaccinated and back on the job. “These workers have continued to put themselves at risk and have worked throughout this pandemic performing services that are critical to the State of New York,” an official with the Hotel Trades Council told Cuomo.

In one of 2020’s ironies, several states without a reputation as union strongholds managed to see their organized-labor ranks grow because of the nature of their economies. Texas led the way, with 66,000 new union positions. North Carolina, with just 3.1 percent of its private-sector workers organized, added 27,000 union positions. Another gainer was Pennsylvania, which added 41,000 union jobs and, along with Texas, almost certainly saw increases in union membership in the industries of gas and oil extraction—probably led by fracking activities.

Union leaders might take some comfort in predictions by economists that the post-pandemic rebound will be swift and robust. They’re also banking on a Democratic Congress to pass the so-called PRO Act, a union-friendly bill that would roll back state right-to-work laws and make organizing easier. Even so, the pandemic may have also caused structural changes in the economy that could undermine a union comeback. Bankruptcies have risen swiftly, undermining established companies. It’s possible that newer, nonunionized firms will step up to lead the post-pandemic rebound.

NBER: Effects of Legalizing Pot

 Since 2012, 18 states and the nation’s capital have legalized recreational marijuana, even as it remains illegal under federal law. A new working paper released through the National Bureau of Economic Research has made a few of the consequences of this policy shift clearer.

The upshot is that marijuana legalization poses an obvious tradeoff: marijuana use goes up, while marijuana arrests go down. Most other hypothesized consequences, good and bad, remain uncertain. Alongside some clear conclusions, the paper has lots of imprecise, statistically insignificant findings.

In general, papers like this one analyze how trends differed between states that changed their marijuana laws and those that did not. For each outcome, the authors run the numbers a few ways, allowing readers to see how sensitive the results are to changes in the statistical models.

One commonsense effect of these policies is that pot use increases—at least according to self-report surveys, which remain (unfortunately) the best method we have for measuring the phenomenon. With legalization, the share of adults reporting pot use in the past 30 days increases by 1.6 to 3.6 percentage points, a 20 percent–40 percent gain from previous levels. This is concerning because, while pot is nowhere near as dangerous as some other drugs, it does have some negative effects on health and behavior.

The other obvious consequence of legalizing pot is that, well, pot is legal, and people aren’t arrested for it anymore, so long as they are of age and stay within the confines imposed by the new laws. According to the study, pot-possession arrests decline by more than 90 percent after legalization. Other drug arrests might decline somewhat as well, suggesting that states that legalize pot may also start taking a generally more lenient stance toward drugs.

The situation is less clear when it comes to other consequences that supporters and critics of these laws have suggested. For example, legal pot could in theory change arrest rates for other crimes, because legal pot drives people to commit crimes; because police have the resources to pursue other problems; or because diminishing the black market reduces crime. But the study detects little change in arrests for violent or property crime. Further research might also consider reports of crime, both to the police and in victimization surveys, to disentangle effects that might cut in opposite directions.

Another common theory is that legal pot will affect the use of harder drugs, either via a “gateway” effect (graduating from pot to worse things) or via “substitution” (using marijuana instead of other drugs). The authors report that legal pot doesn’t seem to increase use of, treatment admissions for, or deaths from hard drugs in general, and that the laws might even reduce opioid deaths.

However, the results on opioid deaths are imprecise and mostly statistically insignificant. This idea also has a tricky history in the literature. A 2014 study claimed that medical-marijuana laws reduced the toll of the opioid epidemic, but a 2019 study using the same methods found that, when later data were added to the model, the relationship not only weakened but reversed. There are various reasons why the effect might change over time or why recreational and medical pot laws might have different effects. Skepticism is warranted.

Further, while numerous studies have reported that users substitute marijuana for alcohol, this study finds no measurable change in binge drinking, alcohol-treatment admissions, or alcohol-related deaths for states that legalize pot.

Recreational-marijuana laws are less than a decade old. As time passes, we will learn more about longer-term effects and collect enough data to detect smaller effects than we can now. For the time being, we know that the tradeoffs suggested by common sense are real: fewer arrests, more pot smoking.

AstraZeneca CEO: 'Not clear yet' if boosters needed

 The CEO of AstraZeneca said it is “not clear yet” if booster shots will be needed to maintain protection with its COVID-19 vaccine.

Pascal Soriot told CNBC on Thursday that the company does not have a “precise answer” on if booster shots will be needed because there are “two dimensions” to the shot’s immunity: antibodies and T-cells.

Soriot said that while antibody levels typically decline over time, the AstraZeneca vaccine has a “very high production of T-cells” with the technology they use.

He later noted, however, that the company has not yet seen a decline in efficacy, adding that “it’s a little bit early to judge, only time will tell.”

“So we are hoping that we can have a durable vaccine that protects for long period of times. So whether we will need a third booster or not is not clear yet, only time will tell,” Soriot said.

“The only way to know is really to watch whether efficacy declines over time,” he added.

The AstraZeneca vaccine has not yet been approved in the United States. A number of countries limited the use of the vaccine in past months because of a potential link to rare blood clots.

The conversation surrounding the possibility of COVID-19 vaccine booster shots has increased in recent weeks as new studies are finding that the efficacy of coronavirus vaccines may decline after a few months.

There is also increased concern about the highly infectious delta variant, which has spread rapidly in the U.S. and is now the dominant strain in the country.

Pfizer on Wednesday said a third shot of its COVID-19 vaccine “strongly” boosts protection against the delta variant. The company earlier this month said it will be applying to the Food and Drug Administration for authorization for a third shot.

Anthony FauciPresident Biden’s chief medical adviser, said on Sunday it is likely that vulnerable people who have already been inoculated against COVID-19 will need a booster shot.

“You have got to look at the data. And the data that's evolving from Israel and from Pfizer indicates that it looks like there might be some diminution in protection. And when you have that, the most vulnerable people are the ones that you were talking about a moment ago, namely, people who have suppressed immune systems, those who are transplant patients, cancer chemotherapy, autoimmune diseases, that are on immunosuppressive regimens,” Fauci said.

“Those are the kind of individuals that, if there's going to be a third boost, which might likely happen, would be among first the vulnerable. And the ACIP, which met on July 22, they discussed that in some detail and continue to look at the data that might push us in that direction,” Fauci added, referring to the Advisory Committee on Immunization Practices, which publishes recommendations on utilizing vaccines to control diseases in the U.S.

https://thehill.com/policy/healthcare/565433-astrazeneca-ceo-not-clear-yet-if-boosters-are-needed

COVID-19 news is confusing — but vaccination is still the answer

 With a recent rise of COVID-19 cases, the Delta variant and the return of certain restrictions, there is a lack of clarity in many people’s minds about breakthrough infections, vaccine efficacy, the pandemic’s trajectory and other issues. The Center for Disease Control and Prevention's (CDC) masking guidance update, driven by concern over breakthrough infections, is emblematic of this.

One of the biggest misunderstandings that persists is regarding rare breakthrough infections that occur and their importance. These rare events were always expected but perhaps poorly communicated, as no vaccine is 100 percent efficacious. Vaccines are not bug-zappers or “forcefields.”

What a vaccine does accomplish is remarkable: A vaccine primes the immune system to spring into action upon exposure to the virus and derail an infection before it has the chance to be as productive, to cause as many symptoms or to cause as much damage as it would have in the absence of this immunity. (Natural immunity also operates this way and is important.) 

The early steps of the thwarted infection are what alert the immune system to the intruder, and the aftereffects of the incident are a boost to immunity. Vaccinated people are likely going through this process frequently, especially in places where COVID-19 prevalence is high. Sometimes, if testing occurs during the right window after exposure, with sensitive PCR tests, viral genetic material will be present in a high enough quantity for a test to be positive.

As most breakthrough infections do not result in symptoms, they cannot be classified as disease and are, to the individual involved, medically insignificant. However, a positive test, even if without clinical value, will be disruptive because it is a positive test.

While there are important scientific questions regarding symptom-less breakthroughs (including how frequently it occurs, which variants are present, how much virus was present, and time post-vaccination) from a clinical perspective there is no treatment.

In the extremely rare cases in which symptoms occur — true breakthrough disease — it is crucial to realize that were it not for the immunity that existed, things would have been worse. This is very apparent with influenza vaccines, which are very good at blunting the risk for hospitalization but do not stop all infections.

The fact is that mild breakthrough infections are a vaccine success — not a short-coming.

COVID-19 has become an endemic infection much like the other four coronaviruses that cause about 25 percent of common colds. Because it is an efficiently spreading respiratory virus with a wide spectrum of symptoms and animal hosts, we will not eliminate it. It is with us. This means that we will always have some baseline level of cases, hospitalizations and deaths with season-to-season variation. The goal is not to achieve some fantastical “COVID zero” status but to deny the virus the ability to cause serious disease, with hospitalization and death on a scale that could threaten hospital capacity.

In states where vaccination rates are high, the vaccines we have in the U.S. are performing tremendously. Vaccines are taming the virus by relegating to the status of other respiratory viruses we deal with year in and year out. This was largely achieved by vaccinating those at highest risk for hospitalization.

In the U.S., tens of thousands of cases of COVID-19 occur daily. These cases are being driven by unvaccinated people spreading the more fit Delta variant of the SARS-CoV-2 virus. It is no coincidence that the states with the highest cases are the states with the lowest vaccination rates. As CDC Director Dr. Rochelle Walensky and President Biden have both stated, we are now in a “pandemic of the unvaccinated.”

Attesting to the power of the available vaccines, virtually everyone hospitalized with COVID-19 currently is unvaccinated. This is true even in states with low vaccination numbers.

The uptake of the vaccine is not uniform, however, and in those regions with substantial and high spread, breakthrough infections will be more common because it will be more likely that one run into the virus in their daily life. It makes sense for immunocompromised individuals, for whom standard vaccination doses may not be sufficient, to be vigilant and wear masks in public indoor spaces.

However, it is unclear why the pandemic of the unvaccinated impacts the behavior of the healthy, fully vaccinated. The CDC cited unpublished case studies in which Delta variant breakthrough cases on “rare occasions” in “some vaccinated people may be contagious” but that vaccinated individuals account for a “very small amount of transmission.” These findings, which would be important to publish and have peer-reviewed, prompted the CDC to shift guidance for the fully vaccinated in areas in which substantial or high levels of COVID transmission are occurring.

If vaccinated individuals account for a “very small amount of transmission” when these “rare occasions” occur, is there going to be much impact from this guidance? I believe it will have little impact on case rates.

The virus treats a vaccinated person very differently than an unvaccinated or non-immune person and, therefore, others should treat them differently because they are not the same COVID-19 threat.

An endemic respiratory virus is something that most of us will eventually contract. Some of us have or will get it unvaccinated in its full form, others in a mostly innocuous vaccine breakthrough version.

If we are to concern ourselves perpetually with preventing rare or very small events from happening, seeking to achieve a state of zero risk — where we become overly concerned with preventing a small proportion of the fully vaccinated from experiencing minor cold-like illnesses — then this pandemic can have no off-ramp.

The aim should always have been to guard against hospital capacity concerns and deploy COVID-19 vaccines widely, in combination with natural immunity. Now, the focus must be in addressing the clusters of the high-risk unvaccinated individuals. Hopefully, with full  Food and Drug Administration approval, with more businesses and organizations requiring a COVID-19 vaccine, and with persuasion from trusted community leaders and primary care physicians, vaccinations will rise, and the less effective substitute of masks will no longer be part of the discussion.

Amesh Adalja, M.D., is an infectious disease physician and a senior scholar at the Johns Hopkins Center for Health Security. 

https://thehill.com/opinion/healthcare/565495-covid-19-news-is-confusing-but-vaccination-is-still-the-answer