Blood Clots, FDA Approval, and the AstraZeneca Covid Vaccine

Blood Clots, FDA Approval, and the AstraZeneca Covid Vaccine - YouTube

There’s a lot of anxiety about the AstraZeneca vaccine thanks to recent reports of incomplete data, as well as reports on blood clot risks. Let’s take a look at both issues in context, understanding the efficacy data before and after numbers were updated, and understanding blood clot risk in relation to other common situations where blood clots are a potential concern.

India’s devastating outbreak is driving the global coronavirus surge

India's covid surge is bringing its healthcare system to the brink -  Washington Post

NEW DELHI — More than a year after the pandemic began, infections worldwide have surpassed their previous peak. The average number of coronavirus cases reported each day is now higher than it has ever been.

“Cases and deaths are continuing to increase at worrying rates,” said World Health Organization chief Tedros Adhanom Ghebreyesus on Friday.

A major reason for the increase: the ferocity of India’s second wave. The country accounts for about one in three of all new cases.

It wasn’t supposed to happen like this. Earlier this year, India appeared to be weathering the pandemic. The number of daily cases dropped below 10,000 and the government launched a vaccination drive powered by locally made vaccines.

But experts say that changes in behavior and the influence of new variants have combined to produce a tidal wave of new cases.

India is adding more than 250,000 new infections a day — and if current trends continue, that figure could soar to 500,000 within a month, said Bhramar Mukherjee, a biostatistician at the University of Michigan.

While infections are rising around the country, some places are bearing the brunt of the surge. Six states and Delhi, the nation’s capital, account for about two-thirds of new daily cases. Maharashtra, home to India’s financial hub, Mumbai, represents about a quarter of the nation’s total.

Mohammad Shahzad, a 40-year-old accountant, was one of many desperately seeking care. He developed a fever and grew breathless on the afternoon of April 15. His wife, Shazia, rushed him to the nearest hospital. It was full, but staffers checked his oxygen level: 62, dangerously low.

For three hours, they went from hospital to hospital trying to get him admitted, with no luck. She took him home. At 3:30 a.m., with Shahzad struggling to breathe, she called an ambulance. When the driver arrived, he asked if Shahzad truly needed oxygen — otherwise he would save it for the most serious patients.

The scene at the hospital was “harrowing,” said Shazia: a line of ambulances, people crying and pleading, a man barely breathing. Shahzad finally found a bed. Now Shazia and her two children, 8 and 6, have also developed covid-19 symptoms.

From early morning until late at night, Prafulla Gudadhe’s phone does not stop ringing. Each call is from a constituent and each call is the same: Can he help to arrange a hospital bed for a loved one?

Gudadhe is a municipal official in Nagpur, a city in the interior of Maharashtra. “We tell them we will try, but there are no beds,” he said. About 10 people in his ward have died at home in recent days after they couldn’t get admitted to hospitals, Gudadhe said, his voice weary. “I am helpless.”

Kamlesh Sailor knows how bad it is. Worse than the previous wave of the pandemic, like nothing he’s ever seen.

Sailor is the president of a crematorium trust in the city of Surat. Last week, the steel pipes in two of the facility’s six chimneys melted from constant use. Where the facility used to receive about 20 bodies a day, he said, now it is receiving 100.

“We try to control our emotions,” he said. “But it is unbearable.”

Two steps forward, one step back on vaccinations

https://mailchi.mp/94c7c9eca73b/the-weekly-gist-april-16-2021?e=d1e747d2d8

Eradicating global infectious disease: Two steps forward and one step back?  | Science Policy For All

As states rush to fully reopen businesses, and Americans leave their masks at home in greater numbers, it appears that the feared “fourth surge” of COVID is now underway in many parts of the country. Coronavirus cases are up in half of all states, and up nationally by 9 percent compared to last week. While the latest wave appears to be much less deadly—largely targeting younger people who haven’t yet been vaccinated—it adds urgency to the effort to get shots in arms as quickly as possible.

The good news: that’s happening. Today the US surpassed the milestone of 200M vaccinations given, with nearly a quarter of the population now fully vaccinated (including nearly two-thirds of those over age 65). The progress on vaccines comes as the Johnson & Johnson COVID jab is sidelined, over safety concerns stemming from a small number of rare blood-clotting cases in younger women that caused the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to urge states to pause the use of the shot. Wednesday’s inconclusive meeting of the FDA’s Advisory Committee on Immunization Practices meant an additional 7 to 10 days of limbo for the J&J vaccine, drawing criticism from experts who warned that the negative publicity could undermine confidence in vaccines among the general population, both in the US and around the world.
 
Count us among those skeptical of the decision to pull back on the J&J vaccine, which plays a pivotal role in the campaign against COVID, given that it’s a single-dose vaccine that can be stored at normal refrigerator temperatures, making it more easily distributed than the two-dose mRNA vaccines. While the blood clotting cases are serious, and merit investigation, the odds of suffering a vaccine-related blood clot are far outweighed by an individual’s risk of death or severe complications from COVID itself, let alone the chances of getting a blood clot from other medications (such as oral contraceptives). 

It was a big week for innumeracy, unfortunately: headlines abounded about the CDC’s discovery of 5,800 “breakthrough” COVID cases, in which fully vaccinated people still contracted the disease. Unsurprisingly, the numerator got the headlines, not the denominator—the 80M people who’ve been fully vaccinated. Your chances of hitting a hole-in-one as an amateur golfer are better than the chances of getting COVID after being fully vaccinated. Furthermore, of those 5,800 people infected after being fully vaccinated, only 7 percent were hospitalized, and 74 died. Each a tragedy, to be sure—but we’ll take those odds any day.

Get vaccinated as soon as you can.
 

Vaccine Development, Covid-19, and mRNA vaccines

Vaccine Development, Covid-19, and mRNA vaccines | The Incidental Economist

In this last episode of our six-part series on vaccinations, supported by the National Institute for Health Care Management Foundation, we cover vaccine development – particularly in the context of the current global pandemic. We discuss the timeline of Covid-19 vaccine development and the mRNA vaccine approach.

The Infosphere as a SDOH: Leveraging Providers’ Influence to Counter Vaccine Misinformation

The Incidental Economist

The following, which originally appeared on the Drivers of Health blog, is authored by Luke Testa, Program Assistant, The Harvard Global Health Institute.

In 2018, a short video circulated on WhatsApp claiming that the MMR vaccine was designed by Indian Prime Minister Narendra Modi to stop the population growth of Muslims. Subsequently, hundreds of madrassas across western Uttar Pradesh refused to allow health departments to vaccinate their constituents.

In 2020, a three-minute video claiming that the coronavirus vaccination campaign was secretly a plan by Bill Gates to implant trackable microchips in people was one of the most widely shared pieces of misinformation online. Alongside a torrent of online COVID-19 vaccine falsehoods and conspiracy theories, sources of medical mis- and disinformation are fostering distrust in COVID-19 vaccines, undermining immunization efforts, and demonstrating how poor information is a determinant of health.

Medical misinformation, referring to inaccurate or unverified information that can drive misperceptions about medical practices or treatments, has flooded the infosphere (all types of information available online). Examples can vary from overrepresentations of anecdotes claiming that complications occurred following inoculation to misinterpretations of research findings by well-meaning individuals.

Considering the many ways in which medical misinformation can shape health behaviors, researchers at the Oxford Internet Institute recently suggested that the infosphere should be classified as a social determinant of health (SDOH) (designated alongside general socioeconomic, environmental, and cultural conditions). This classification, they argue, properly accounts for the correlation between exposure to poor quality information and poor health outcomes.

The connection between information quality and health has been especially pronounced during the COVID-19 pandemic. A 2021 study found that amongst those who indicated that they would definitely take a COVID-19 vaccine, exposure to misinformation induced a decline in intent of 6.2% in the U.K. and 6.4% in the U.S. Further, misinformation that appeared to be science-based was found to be especially damaging to vaccination intentions. These findings are particularly concerning considering the fact that during the pandemic, the 147 biggest anti-vaccine accounts on social media (which often purport to be science-based) gained 7.8 million followers in the first half of 2020, an increase of 19%.

During an unprecedented health crisis, medical misinformation within the infosphere is leaving both individuals and communities vulnerable to poor health outcomes. Those who are unvaccinated are at a higher risk of infection and increase the likelihood of community transmission. This places undue burden on those who cannot get vaccinated—due to inequities and/or preexisting conditions—and increases opportunities for variants to continue to mutate into more infectious and/or deadly forms of the virus. Poor quality information within the infosphere is undermining immunization efforts and threatens to prolong the ark of the pandemic.

Leveraging Healthcare Provider Influence in the Battle Against Poor Quality Information

Healthcare providers are uniquely suited to respond to this challenge. Throughout the pandemic, majorities of U.S. adults have identified their doctors and nurses as the most trustworthy sources of information about the coronavirus. In fact, 8 in 10 U.S. adults said that they are very or somewhat likely to turn to a doctor, nurse, or other healthcare provider when deciding whether or not to get a COVID-19 vaccine.

This influence is especially pertinent considering the state of vaccine resistance across the globe. In March 2021, a Kaiser Family Foundation poll found that 37% of U.S. respondents indicated some degree of resistance to vaccination. If that percentage of Americans remain unvaccinated, the country will be short of what is needed to achieve herd immunity (likely 70% or more vaccinated). Similar levels of resistance to vaccination remain high in countries across the globe, such as Lebanon, Serbia, Paraguay, and France.

Although medical misinformation is contributing to high rates of refusal, it is important to note that drivers of vaccine resistance are complex and intersectional. Vaccine distrust or refusal may be rooted in exposure to anti-vaccine rhetoric, racial injustice or medical exploitation in healthcare, fears that vaccine development was rushed, and/or other drivers. For this reason, responses must be tailored to unique individual or communal motivations. For example, experts have pressed the critical need for vaccine distrust within Black communities to be approached not as a shortcoming of community members, but as a failure of health systems to prove themselves as trustworthy.

With regard to resistance rooted in anti-COVID-19 vaccine misinformation, healthcare providers are leveraging their unique influence through novel, grassroots approaches to encourage vaccine uptake. In North Dakotaproviders are recording videos and sending out messages to their patients communicating that they have been vaccinated and explaining why it is safe to do the same. On social media, a network of female doctors and scientists across various social media pages, such as Dear Pandemic (82,000 followers) and Your Local Epidemiologist (181,000 followers), are collaborating to answer medical questions, clear up misperceptions about COVID-19 vaccines, and provide communities with accurate information about the virus. Similarly, the #BetweenUsAboutUs online campaign is elevating conversations about vaccines with Black doctors, nurses, and researchers in an effort to increase vaccine confidence in BIPOC communities. This campaign is especially critical considering the fact that BIPOC communities are often the target of anti-vaccine groups in an effort to exploit existing, rational distrust in health systems.

In addition to these timely responses, evidence-based interventions offer promising opportunities for healthcare providers to improve vaccine uptake amongst their patients. For example, there is a growing consensus around the practice of motivational interviewing (MI).

MI is a set of patient-centered communication techniques that aim to enhance a patient’s intrinsic motivation to change health behaviors by tapping into their own arguments for change. The approach is based on empathetic, nonjudgmental patient-provider dialogue. In other words, as opposed to simply telling a patient why they should get vaccinated, a provider will include the patient in a problem-solving process that accounts for their unique motivations and helps them discover their own reasons for getting vaccinated.

When applying MI techniques to a conversation with a patient who is unsure if they should receive a vaccine, providers will use an “evoke-provide-evoke” approach where they will ask patients: 1) what they already know about the vaccine; 2) if the patient would like additional information about the vaccine (if yes, then provide the most up to date information); and 3) how the new information changes how they are thinking or feeling about vaccination. During these conversations, the MI framework encourages providers to ask open-ended questions, practice reflective listening, offer affirmations, elicit pros and cons of change, and summarize conversations, amongst other tools.

Numerous studies show motivational interviewing to be effective in increasing vaccine uptake. For example, one randomized controlled trial found that with parents in maternity wards, vaccine hesitancy fell by 40% after participation in an educational intervention based on MI. Given its demonstrated effectiveness, MI is likely to help reduce vaccine hesitancy during the COVID-19 pandemic.

With infectious disease outbreaks becoming more likely and resistance to various vaccines increasing across the globe, continuing to leverage healthcare providers’ unique influence through grassroots campaigns while honing motivational interviewing skills as a way to combat mis- and disinformation in the infosphere may prove critical to advancing public health now and in the future.

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Young Men Not Immune to Getting COVID Twice

Study in U.S. Marines stresses importance of vaccination, author says

Young adult men who were previously infected with COVID-19 were not completely protected against reinfection, a study of U.S. marines found.

Among 189 Marines who were seropositive but free of current SARS-CoV-2 infection at baseline, 10% tested positive for SARS-CoV-2 via PCR during a 6-week follow-up period, reported Stuart Sealfon, MD, of Icahn School of Medicine at Mount Sinai in New York City, and colleagues.

Not surprisingly, viral loads were about 10 times lower compared with initially seronegative participants who tested positive, and those who tested positive again were more likely to have a weaker immune response, Sealfon and colleagues wrote in Lancet Respiratory Medicine.

Participants were nearly all men, and most were ages 18-20. Notably, only three of 19 seropositive Marines were symptomatic.

The question of natural infection conferring immunity has been central in the discussion over whether to vaccinate previously infected people. Sealfon’s group said most individuals do mount a “sustained serological response” after initial infection, but prior research found that about 10% of individuals with antibodies to SARS-CoV-2, with a weaker immune response, failed to develop measurable neutralizing activity.

They noted that a high proportion of young adults are infected asymptomatically and “can be an important source of transmission to more vulnerable populations.”

“As vaccine rollouts continue to gain momentum, it is important to remember that, despite a prior COVID-19 infection, young people can catch the virus again and may still transmit it to others,” Sealfon said in a statement. “Immunity is not guaranteed by past infection, and vaccinations that provide additional protection are still needed for those who have had COVID-19.”

Sealfon and colleagues examined data from the COVID-19 Health Action Response for Marines (CHARM) study, in which U.S. Marine recruits had a 2-week unsupervised home quarantine, followed by a Marine-supervised 2-week quarantine on a college campus or in a hotel. They were then assessed for baseline SARS-CoV-2 IgG seropositivity and completed a questionnaire that included demographic history, risk factors, medical history, and symptoms. Participants were tested via PCR at weeks 0, 1, and 2 of quarantine and completed follow-up questionnaires about symptoms since last visit.

After quarantine, those testing negative for current SARS-CoV-2 infection entered basic training, and were tested for new infections every 2 weeks for 6 weeks and completed a follow-up symptom questionnaire. Baseline neutralizing antibody titers were performed on all newly infected seropositive participants and selected seropositive uninfected participants.

From May 11 to Nov. 2, 2020, 3,076 participants were followed up after quarantine for 6 weeks. There was a higher proportion of Hispanic and Black participants in the seropositive group.

Nineteen of 189 seropositive participants had at least one positive PCR test for SARS-CoV-2 (1.1 cases per person-year), as did 1,079 seronegative participants (6.2 cases per person-year), for an incidence rate ratio of 0.18 (95% CI 0.11-0.28).

When examining immune response within the seropositive group, Sealfon’s group found a strong link between lower titers of IgG antibodies to full-length spike protein and a subsequent positive PCR test. They also found neutralizing activity above the limit of detection in 83% of seropositive participants who never tested positive again, and in 32% of participants who were reinfected.

“Overall, these results indicate that COVID-19 does not provide an almost universal and long-lasting protective immunity, unlike that seen in measles, for example,” wrote Marìa Velasco, MD, PhD, and Carlos Guijarro, MD, PhD, of Hospital Universitario Fundación Alcorcón in Madrid, in an accompanying editorial.

However, they offered some caveats to the study, namely that a positive PCR test is most likely a new infection, but could also be “viral persistence with reappearance of virus in mucosae, or non-viable viral debris.”

“In the absence of viral sequencing with phylogenetic analyses, viral cultures, or information regarding different SARS-CoV-2 variants, a positive PCR test cannot be assumed to represent new viral infections in all settings,” the editorialists wrote, though they added that strict scientific criteria may also be underestimating the real rate of reinfection, and suggested a “pragmatic approach” for classifying cases as either reinfection, relapse, or “PCR re-positivity.”

Sealfon’s group noted that despite the closed setting, the population is representative of U.S. men ages 18-20, though it is unclear how generalizable it is to young women or older adults.

Other limitations include potential missing data, such as infections occurring between sampling every 2 weeks. The authors added that the study is also likely underestimating risk of reinfection, as the seronegative group “included an unknown number of previously infected participants who did not have significant IgG [titers] in their baseline serum sample.”

Mona Lisa getting her Covid-19 Vaccine

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Mona Lisa getting her Covid-19 Vaccine.

9 hospitals laying off workers

Unprecedented Layoffs among Nonprofits Threaten Deep Community Damage - Non  Profit News | Nonprofit Quarterly

The financial challenges caused by the COVID-19 pandemic forced hundreds of hospitals across the nation to furlough, lay off or reduce pay for workers, and others have had to scale back services or close.

Lower patient volume, canceled elective procedures and higher expenses tied to the pandemic have created a cash crunch for hospitals, and hospitals are taking a number of steps to offset financial damage. Executives, clinicians and other staff are taking pay cuts, capital projects are being put on hold, and some employees are losing their jobs. More than 260 hospitals and health systems furloughed workers in the last year, and dozens of others have implemented layoffs.

Below are nine hospitals and health systems that are laying off employees. Some of the layoffs were attributed to financial strain caused by the pandemic. 

1. Boca Raton, Fla.-based Cancer Treatment Centers of America is selling its hospital in Philadelphia and will lay off the facility’s 365 employees, according to a closure notice filed with the state. Cancer Treatment Centers of America said it anticipates the layoffs in Philadelphia will begin after May 30, according to the Philadelphia Business Journal

2. Providence Queen of the Valley Medical Center in Napa, Calif., will lay off 10 employees, The Napa Valley Register reported April 11. The layoffs will affect six emergency department technicians and four cooks. The COVID-19 pandemic had a “profound effect” on the hospital system, including volume and revenue reductions, a Providence spokesperson told The Napa Valley Register. As a result of volume declines in its ED, the health system is reducing staffing. 

3. Olympia Medical Center in Los Angeles closed March 31. The closure resulted in the layoffs of 451 employees.

4. The outgoing owners of Providence Behavioral Health Hospital in Holyoke, Mass., are laying off the hospital’s 151 employees, effective April 20, according to MassLive. Trinity Health of New England, part of Livonia, Mich.-based Trinity Health, is selling the hospital to Health Partners New England, which plans to take over the hospital April 20. 

5. Boca Raton, Fla.-based Cancer Treatment Centers of America plans to close its hospital in Tulsa, Okla., June. 1. About 400 employees will be affected by the closure. 

6. Plattsburgh, N.Y.-based Champlain Valley Physicians Hospital plans to cut 60 jobs. The hospital, which is facing a $6.5 million deficit in fiscal year 2021, said the cuts include 10 people who were laid off or had permanent hour reductions, 12 people who are planning retirement, and the rest are open positions that will not be filled, according to a March 9 NBC 5 report. 

7. Buffalo, N.Y.-based Catholic Health announced March 19 that it plans to end inpatient services and close the intensive care unit at its St. Joseph campus in Cheektowaga, N.Y. The changes will result in some positions being eliminated. Catholic Health said it will try to find affected employees comparable positions within the system. 

8. Upper Allegheny Health System, a two-hospital system based in Olean, N.Y., plans to reduce acute care and surgical services at Bradford (Pa.) Regional Medical Center. Under the plan, the acute care and surgical services will be moved to the health system’s other hospital, Olean General Hospital, effective May 1. There will be a minimal number of layoffs resulting from the consolidation of services, a spokesperson told WHYY. 

9. Philadelphia-based Tower Health laid off 15 workers at St. Christopher’s Hospital for Children, including four physicians, in March, according to The Philadelphia Inquirer. Tower Health ended the second half of last year with an operating loss of $31 million, according to the report.  

A quarter of the country won’t get the coronavirus vaccine

We’re a year into the coronavirus pandemic, so the math that undergirds its risks should by now be familiar. We all should know, for example, that the ability of the virus to spread depends on it being able to find a host, someone who is not protected against infection. If you have a group of 10 people, one of whom is infected and nine of whom are immune to the virus, it’s not going to be able to spread anywhere.

That calculus is well known, but there is still some uncertainty at play. To achieve herd immunity — the state where the population of immune people is dense enough to stamp out new infections — how many people need to be protected against the virus? And how good is natural immunity, resistance to infection built through exposure to the virus and contracting covid-19, the disease it causes?

The safe way to increase the number of immune people, thereby probably protecting everyone by limiting the ability of the virus to spread, is through vaccination. More vaccinated people means fewer new infections and fewer infections needed to get close to herd immunity. The closer we get to herd immunity, the safer people are who can’t get vaccinated, such as young children (at least for now).

The challenge the world faces is that the rollout of vaccines has been slow, relatively speaking. The coronavirus vaccines were developed at a lightning pace, but many parts of the world are still waiting for supplies sufficient to broadly immunize their populations. In the United States, the challenge is different: About a quarter of adult Americans say they aren’t planning on getting vaccinated against the virus, according to Economist-YouGov polling released last week.

That’s problematic in part because it means we’re less likely to get to herd immunity without millions more Americans becoming infected. Again, it’s not clear how effective natural immunity will be over the long term as new variants of the virus emerge. So we might continue to see tens of thousands of new infections each day, keeping the population at risk broadly by delaying herd immunity and continuing to add to the pandemic’s death toll in this country.

But we also see from the Economist-YouGov poll the same thing we saw in Gallup polling earlier this month: The people who are least interested in being vaccinated are also the people who are least likely to be concerned about the virus and to take other steps aimed at preventing it from spreading.

In the Economist-YouGov poll, nearly three-quarters of those who say they don’t plan on being vaccinated when they’re eligible also say they’re not too or not at all worried about the virus.

That makes some perverse sense: If you don’t see the virus as a risk, you won’t see the need to get vaccinated. Unfortunately, it also means you’re going to be less likely to do things like wear a mask in public.

Or you might be more likely to view as unnecessary precautions such as avoiding close-quarter contact with friends and family or traveling out of state.

About a quarter of adults hold the view that they won’t be vaccinated when eligible. That’s equivalent to about 64 million Americans.

Who are they? As prior polls have shown, they’re disproportionately political conservatives. At the outset of the pandemic, there was concern that vaccine skepticism would heavily be centered in non-White populations. At the moment, though, the rate of skepticism among those who say they voted for Donald Trump in 2020 and among Republicans is substantially higher than skepticism overall.

That shows up in another way in the Economist poll. Respondents were asked whose medical advice they trusted. Among those who say they don’t plan to get the vaccine, half say they trust Trump’s advice a lot or somewhat — far more than the advice of the Centers for Disease Control and Prevention or the country’s top infectious-disease expert Anthony S. Fauci.

If we look only at Republican skeptics, the difference is much larger: Half of Republican skeptics say they have a lot of trust in Trump’s medical advice.

The irony, of course, is that Trump sees the vaccine as his positive legacy on the pandemic. He’s eager to seize credit for vaccine development and has — sporadically — advocated for Americans to get the vaccine. (He got it himself while still president, without advertising that fact.) It’s his supporters, though, who are most hostile to the idea.

Trump bears most of the responsibility for that, too. Over the course of 2020, worried about reelection, he undercut containment efforts and downplayed the danger of the virus. He undermined experts such as Fauci largely out of concern that continuing to limit economic activity would erode his main argument for his reelection. Over and over, he insisted that the virus was going away without the vaccine, that it was not terribly dangerous and that America should just go about its business as usual — and his supporters heard that message.

They’re still listening to it, as the Economist poll shows. One result may be that the United States doesn’t reach herd immunity through vaccinations and, instead, some large chunk of those tens of millions of skeptics end up being exposed to the virus. Some of them will die. Some may risk repeat infections from new variants against which a vaccine offers better protection. Some of those unable to get vaccinated may also become sick from the virus because we haven’t achieved herd immunity, suffering long-term complications from covid-19.

Trump wants his legacy to be the rollout of the vaccine. His legacy will also probably include fostering skepticism about the vaccine that limits its utility in containing the pandemic.

Hospital Volunteers Wanted

May be an image of text that says 'WANTED Volunteers who don '+ believe in COVID19. Activities include transfer of Patients, transfer of the dead, general cleaning on the COVID ward and personal care of COVID patients. OS: It won '+ be a problem that you won + get PPE as you don't believe they are necessary. Signed: Health care Workers'