I believe that medicine’s potential is much more than the version we see in the world today. A doctor should be an educator with the goal of bringing patients to a place of deeper understanding of who they are in the world. To me, medicine is ultimately about self-empowerment through self-knowledge and growth.
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In this edition we have:
An advisory committee to the FDA will meet to discuss EUA for children 5-11 on October 26th.
In the Pfizer study, 2,268 children, ages 5 to 11, received two doses of the COVID-19 vaccine, spaced three weeks apart, while a smaller group of children received a placebo. The children in this study were given 10 microgram doses of the vaccine, which is lower than the 30 microgram doses being given to Pfizer vaccine recipients ages 12 years and older. (Earlier results had found increased side effects for the younger children at the higher dose.) Antibody responses and side effects in the 5-to-11-year-olds were compared to those of 16-to 25-year-old participants from a previous study.
The trial results showed that the antibody response in 5-to-11-year-olds was similar to the antibody response in teens and young adults. Side effects were also comparable. There were not enough COVID cases in the study population to tell whether the vaccine protected against infection or illness.
Harvard Health Publishing blog 10/7
Critics take note of the smaller patient sample size: only 2,300 patients. Concern still exists for the heart tissue effects that have been higher than expected in the older children and adolescents. Some datasets show the rate of myocarditis in children to be in the neighborhood of 1 in 4000 vaccinations. This is a consideration with an idea to vaccinate this age group on a large scale.
Most children who become infected with the COVID-19 virus have no symptoms, or they have milder symptoms such as low-grade fever, fatigue, and cough. Early studies suggested that children do not contribute much to the spread of coronavirus. But more recent studies raise concerns that children could be capable of spreading the infection.
Risk and benefit are always the considerations. This is another topic to watch closely.
Merck and Ridgeback Biotherapeutics on October 11 submitted an application with the US FDA for Emergency Use Authorization (EUA) of molnupiravir, an investigation oral antiviral medication, for the treatment of mild-to-moderate COVID-19 in adults at high risk of severe disease. Notably, if authorized by the FDA, the drug would be the first COVID-19 treatment to be administered orally, as all other authorized or approved medications are delivered intravenously or via injection. The companies’ submission is based on a Phase 3 clinical trial interim analysis showing molnupiravir reduced the risk of hospitalization or death by about half when compared with people who received a placebo. The data are not yet published or peer-reviewed. An effective therapeutic that is taken by people recovering at home could relieve some pressure on hospitals, particularly in areas with low vaccination rates.
However, not all data appear full steam ahead for molnupiravir. ‘Two Indian generic drug manufacturers this month requested permission to end late-stage clinical trials of generic versions of molnupiravir, after the drug did not show “significant efficacy” among people with moderate COVID-19 disease. A Merck spokesperson noted that the Indian studies defined moderate disease differently than the FDA and included patients with more severe disease. The Indian companies are continuing to research the treatment among people with mild COVID-19.
What is also notable is a trial by the drug maker in late stage COVID was stopped for “business reasons,” presumably indicating it was not successful. No data is available. It doesn’t sound like a panacea. Its place in helping move us through will be relegated to certain circumstances, it sounds like. This class of drugs also has an undesired effect profile that is being watched closely. Lots to keep an eye on these days!
Take a breath.
…because too much thinking about COVID causes indigestion.
This week I have been observing the nature of the thoughts which establish expectations and hopes for what comes to us in our lives.
Thoughts have such a large power over our experience. Certain thoughts can be toxic and others can offer protection. Healthy thought patterns give perspective. They to bring us into our wholeness.
I am struck by the arbitrary nature of the thought complex that establishes an editorial on our circumstances. Often fear plays a large role in what we hope to find in our experience (comfort) or avoid (challenges, illness, etc). Life unfolds, and it’s often different than our desires for ourselves. After we meet what unfolds in our lives, I would offer that our initial expectations are meaningless. We are best to let go of them entirely and focus on the reality of what is manifesting before us. We cause tremendous suffering when we stay attached to a certain expectation that differs from what occurs.
Our plan is simply our best guess to get us started, and nothing more. It really doesn’t mean anything. I would argue it’s meant to be thrown away. I recommend the daily practice of consciously connecting to the standpoint that every encounter has a place, regardless of whether it’s ugly or heavy or totally destabilizing. Every encounter matters. It should be honored like an important guest in our home. All of our experiences play a roll in our development. The proof something belongs? Simply its existence in our lives.
That fluidity and appetite for spontaneity is a central component of a healthy inner life. That’s what ‘letting go’ means to me. Letting go enables us to conserve any energy lost on disappointment and put it towards the work that needs to be done.
The more strength we have to face our circumstances and challenges, the better.
True protection lies not in planning and avoiding adversity (although that attempt is relevant) but rather in having a philosophy that enables you to handle whatever comes your way.
