The Centers for Disease Control and Prevention said at present it looks like anaphylaxis cases are occurring at a rate of about 5.5 per 1 million vaccine doses given, though the agency cautioned that figure may change as the vaccination effort continues.
The allergic reactions do not change CDC’s recommendations on who can be vaccinated against Covid-19, with senior officials stressing that the risk of severe illness and death from the disease still outweighs the risk of developing anaphylaxis after vaccination.
Some vaccine experts, though, said they are not surprised by the speed of vaccine distribution so far. “It had to go this way,” Paul Offit, a professor of pediatrics at Children’s Hospital of Philadelphia, told STAT. “We had to trip and fall and stumble and figure this out.”
Claire Hannan, executive director of the Association of Immunization Managers, said some of the gap between doses administered and delivered is likely due to a program run by CVS and Walgreens to vaccinate those in nursing homes. States participating in the program have to set aside 50% of their doses, which Hannan said could account for a share of the difference between doses shipped and doses administered nationally.
“I don’t think it’s bad,” she said of the pace of distribution so far. “I think it was always going to be like this. And I think that this is actually the easy part.”
In animal tests, NVX-CoV2373 vaccination produced antibodies that blocked the coronavirus spike protein from binding to the cell surface receptors targeted by the virus, preventing viral infection. In results(link is external) of a Phase 1 clinical trial published in the New England Journal of Medicine, NVX-CoV2373 was generally well-tolerated and elicited higher levels of antibodies than those seen in blood samples drawn from people who had recovered from clinically significant COVID-19. NVX-CoV2373 also is being evaluated in a Phase 2b trial in South Africa, now fully enrolled with 4,422 volunteers, and data from a Phase 1/2 continuation trial in the United States and Australia is expected as early as first quarter 2021. Novavax also recently completed enrollment of more than 15,000 volunteers in a Phase 3 trial of the candidate vaccine in the United Kingdom, which is also testing two injections of 5 mcg of protein and 50 mcg of Matrix-M adjuvant administered 21 days apart.
Residents are the lowest-ranking doctors in a hospital. Stanford Medicine has about 1,300 across all disciplines. Only seven made the priority vaccination list, despite the fact that this week, residents were asked to volunteer for ICU coverage in anticipation of a surge in COVID-19 cases.
“Residents are patient-facing, we’re the ones who have been asked to intubate, yet some attendings who have been face-timing us from home are being vaccinated before us,” said Dr. Sarah Johnson, a third-year OB-GYN resident who has delivered babies from COVID-positive patients during the pandemic. “This is the final straw to say, ‘We don’t actually care about you.’”
Stanford Medicine demonstrates how much they care about their residents.
Here’s an interesting breakdown of lessons learned.
In its earliest attempts at explaining the problem, Stanford’s administrators laid blame with the algorithm. Despite best intentions, they explained, the algorithm had made a mistake that the humans had to answer for.
This is a bit like blaming the hammer for missing the nail.
The most common side effects are injection site pain, fatigue, headache, muscle pain, and joint pain. Some people in the clinical trials have reported fever. Side effects are more common after the second dose; younger adults, who have more robust immune systems, reported more side effects than older adults.
To be clear: These side effects are a sign of an immune system kicking into gear. They do not signal that the vaccine is unsafe. To date there are no serious, long-term side effects associated with receipt of these vaccines, which will be closely monitored as their use expands.
Post and link for informational purposes only. I will not waste my time trying to convince people that a virus doesn’t care about your gender, age, sexuality, religion, skin color, politics, net worth, personal freedoms, dietary preferences, or anything else.
They examined the records of nearly 300,000 adults in the U.S. who had an initial atherosclerotic cardiovascular disease event between 2007 and 2016. These were divided into three groups: coronary heart disease, ischemic stroke or transient ischemic attack, or peripheral artery disease.
When people left the hospital or emergency department in 2007 following a first diagnosis in one of these categories, about half began taking statins within 30 days. By 2016, statin use increased to approximately 60%.
“Based on the guidelines, we hoped to see a much higher uptake among this entire group,” says Dr. Noseworthy. “Statin intolerance was only noted for 4%-5% of the patients, which means as many as 35% of patients are not receiving treatment according to the guidelines.”
Xiaoxi Yao, Nilay D. Shah, Bernard J. Gersh, Francisco Lopez-Jimenez, Peter A. Noseworthy. Assessment of Trends in Statin Therapy for Secondary Prevention of Atherosclerotic Cardiovascular Disease in US Adults From 2007 to 2016. JAMA Network Open, 2020; 3 (11): e2025505 DOI: 10.1001/jamanetworkopen.2020.25505
Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
“There was always a discussion: Is the spike protein the right target? Well, now we know it’s the right target,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told STAT on Monday. “So, it’s not only immediate good news, it really is optimistic about what’s going to roll out in the next several months with the other vaccines.”
Attention-deficit/hyperactivity disorder (ADHD) exerts lifelong impairment, including difficulty sustaining employment, poor credit, and suicide risk. To date, however, studies have assessed selected samples, often via self-report. Using mental health data from the entire Swedish population (N = 11.55 million) and a random sample of credit data (N = 189,267), we provide the first study of objective financial outcomes among adults with ADHD, including associations with suicide. Controlling for psychiatric comorbidities, substance use, education, and income, those with ADHD start adulthood with normal credit demand and default rates. However, in middle age, their default rates grow exponentially, yielding poor credit scores and diminished credit access despite high demand. Sympathomimetic prescriptions are unassociated with improved financial behaviors. Last, financial distress is associated with fourfold higher risk of suicide among those with ADHD. For men but not women with ADHD who suicide, outstanding debt increases in the 3 years prior. No such pattern exists for others who suicide.
Then my mind wanders to drugs (to drugs, not due to drugs).
To summarize, the psychiatric side effects of methylphenidate are quite similar to those of cocaine and amphetamines, giving more support to the idea that almost all CNS stimulants will produce a similar clinical picture. A person using cocaine can experience nervousness,57,58 restlessness,58 agitation,57 suspiciousness,60 paranoia,61–63 hallucinations and delusions,61,63 impaired cognitive functions,64 delirium,65 violence,57,58,62,65,66 suicide,67 and homicide.67–70
A high dose of favipiravir, however, had a potent effect. A few days after the infection, the virologists detected hardly any infectious virus particles in the hamsters that received this dose and that had been infected intranasally. Moreover, hamsters that were in a cage with an infected hamster and had been given the drug did not develop an obvious infection. Those that had not received the drug all became infected after having shared a cage with an infected hamster.
Favipiravir: A new and emerging antiviral option in COVID-19
Favipiravir was first used against SARS-CoV-2 in Wuhan at the very epicenter of the pandemic. Then, as the pandemic spread to Europe, this drug received approval for emergency use in Italy, and currently has been in use in Japan, Russia, Ukraine, Uzbekistan, Moldova, and Kazakhstan. Approval has also recently been granted in Saudi Arabia and the UAE. Thereafter, Turkey, Bangladesh, and most recently Egypt have also seen recent commercial launches. In June 2020, favipiravir received the DCGI approval in India for mild and moderate COVID-19 infections. As of the 23rd of July, 2020; there are 32 studies registered on clinicaltrials.gov to assess the utility of this drug in the management of COVID-19 (3 completed, 12 recruiting).1
The current investigators analyzed national healthcare claims from the US Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) diagnosed with depression. Patients with alternative indications for anti-psychotic therapy, such as schizophrenia, psychotic depression or bipolar disorder, were excluded.
After a period of at least 3 months of treatment with a single antidepressant, more than half of the patients (56.6%) augmented their treatment with one of these atypical anti-psychotics: quetiapine, risperidone, aripiprazole or olanzapine. The remaining patients (43.4%) added a second antidepressant. The average chlorpromazine-equivalent starting dose for all atypical anti-psychotics was 68 mg/day, which increased to 100 mg/day during follow-up.
A total of 153 patients died during 13,328 person-years of follow-up, including 105 who augmented with an atypical anti-psychotic and 48 who augmented with a second antidepressant.
Compared with those who added a second antidepressant, those who added an anti-psychotic had a 45% increased risk of dying during follow up (adjusted hazard ratio,1.45; 95% CI, 1.02 – 2.06).
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