Monoclonal Antibodies for Post Exposure Prophylaxis of COVID-19 A Crash Course & Update

Posted Posted in Uncategorized

by Mary O’Brien, M.D.

Perspective:

Monoclonal Antibodies (mAB’s) are a form of immunotherapy, manufactured in vitro to target specific antigens. A wide array of mAB’s are used to treat malignancies such as breast, lung, colon, and renal cell cancer, melanoma, multiple myeloma, lymphomas, and leukemia.

Monoclonal antibodies are also used in the treatment of inflammatory autoimmune disorders such Crohn’s Disease, MS, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. These mAB’s can be directed against such targets as specific B cells, T cells, tumor necrosis factor-alpha (TNF-α) interleukins, cytokines, various proteins, and receptor sites on cells

Commonly used drugs such as Humira (adalimumab) and Remicade (infliximab) are mAB’s.

Update:

Since late 2020, a combination of the mAB’s casirivimab and imdevimab, known as REGEN-COV, has had Emergency Use Authorization (EUA) for patients ≥12 years with mild to moderate COVID and a high risk of progression to severe disease or hospitalization. People in the media and others have referred to this as “Regeneron,” since few people can pronounce or remember the actual mAB combination. “Regeneron” is not a drug, it’s the name of the pharma company that makes the drug.

Last week, the FDA expanded this EUA for use as post-exposure prophylaxis of COVID if:

  • The patient is not fully vaccinated (and at high risk) or
  • The patient is unlikely to have an adequate immune response to full vaccination and has been in close contact with a COVID infected person or is likely to be exposed to COVID in an institutional setting (nursing home, military barracks, prison, etc.)

Protocol:

The protocol for REGEN-COV as post-exposure prophylaxis is:

  • Casirivimab 600 mg plus
  • Imdevimab 600 mg

This can be given as either four consecutive shots (SC injections) at one time or as a single IV infusion Either route of administration is fine. There is no preference.

This combination of monoclonal antibodies has retained effectiveness against all COVID variants, including Delta, as of 8/23/2021.

Updated FDA Criteria for High Risk Conditions for COVID-19 Progression (May 2021)

  • Age 65 or older
  • BMI ≥25 (overweight or obese)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Cardiovascular disease
  • Hypertension
  • COPD, moderate to severe asthma, or other chronic respiratory disease
  • Current treatment with immunosuppressive therapy
  • Sickle cell disease
  • Congenital or acquired heart disease
  • Neurodevelopmental disorders (such as cerebral palsy or Down syndrome), or other conditions that confer medical complexity
  • A medical-related technological dependence (such as tracheostomy or gastrostomy)
  • Patients 12 years or older with an overweight BMI, pregnancy, cardiovascular disease, hypertension, or chronic respiratory disease are now considered high risk

Vaccination against COVID-19 is prudent for the vast majority of people, But dealing with COVID is far more complex than screaming at everyone to wear masks and “get the jab.” The age, underlying medical conditions, and living, schooling, or working conditions of the individual patient matter.

Stay tuned. It’s not over yet.

Einstein Was Right!

Posted Posted in Brain Science, Continuing Education, Homestudy, Psychology, Uncategorized

By Mary O’Brien, M.D.

“Everything should be made as simple as possible, but not simpler.”  Albert Einstein said that many years ago.  He was referring to physics, but his wisdom could easily apply to any situation, including COVID-19 vaccines.

Increasing numbers of people in business, politics, education and, of course, the media, are trying to force COVID-19 vaccines on everyone.  “Vaccination or termination” has become the new threat to employees and students.  Most people, regardless of their lofty achievements in other areas, are not well-versed in the fine points of immunology.  Sadly, however, some of them are convinced that they know what’s best for everyone.

Nearly everything in medicine carries potential risk and reward.  Both possibilities must always be considered.  Every prescription we write and every procedure we do has some potential to cause harm.  Every patient is unique.  Every individual has a combination of genetic factors, past illnesses, medications, and allergies.  Also each patient has metabolic, endocrine, hematologic, rheumatologic, neurologic, and cardio-pulmonary conditions that may need to be considered.  For example, patients with rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and other autoimmune disorders produce antibodies that attack their own tissues, hence the need to suppress — with potent drugs such as TNF (tumor necrosis factor) inhibitors — certain parameters of immune function.  Giving such a patient a vaccine, which stimulates the immune system to produce antibodies, can be unwise.  This is usually most problematic with live virus vaccines such as those for varicella, measles, and mumps, and rubella.  The COVID-19 vaccines are messenger RNA-based.  They do not contain live virus.

Pregnant women with COVID-19 illness are at increased risk for serious disease and mortality.  According to the Food and Drug Administration, data on the COVID-19 vaccines are “insufficient to inform vaccine-associated risk in pregnancy”.  Translation:  we don’t know enough yet to be dogmatic about these decisions.

All of COVID-19 vaccines available in the United States (Pfizer, BioNTech, Moderna, and Johnson & Johnson) are safe, effective, and appropriate for the vast majority of people.  But good medical practice is not about the vast majority of people.  Medical decisions are based on the conditions, needs, and details of the individual patient.  Politicians, corporate chief executives, school board members, and media types have no business making (or forcing) medical decisions on other people.

Einstein was right.  Oversimplifying anything is a bad idea.  So is judging others without knowing all the details.

A Class Act

Posted Posted in Continuing Education, Elder Care, Psychology, Seminars, Uncategorized

By Mary O’Brien, M.D.

The lady was a class act.  In a sea of loud, silly, and shallow people, Barbara Bush stood like a lighthouse, radiating wisdom and grace.  She demonstrated remarkable equanimity, regardless of circumstance.  Blessed with razor sharp wit and a penchant for fun, she was nonetheless known to her family as “The Enforcer.”  Candid, caring, committed, and tough, Mrs. Bush had a massive impact on everyone around her.  She set the standards high and refused to indulge any twinge of narcissism in herself or others.  It’s a testament to her character that everyone around her succeeded.  She had the longest marriage (73 years) in American presidential history and was the mother of two governors, one of whom (George W. Bush) was also the 43rd president.

There were, however, those who bemoaned the notion that she was “only” a wife and mother.  Those folks ended up looking foolish.  Mrs. Bush had no misgivings about the value of family.  She was fiercely loyal and protective, but she did have boundaries.  When pestered by the media about her role in the political campaigns of family members, she quipped, “I’ll do anything to help.  But I won’t dye my hair, change my wardrobe, or lose weight.”

The reality was that Barbara and George H.W. Bush, in the late 1950s, lost their three-year-old daughter, Robin, to leukemia.  Barbara’s hair turned white shortly after that tragedy.  She refused to hide her age, stress, or heartache by dyeing her hair.  There was nothing coy, contrived, pretentious, or conniving about Mrs. Bush.  She possessed a refreshing candor and confidence that come from authenticity.  It was clear she had no interest in impressing or manipulating others.  As was the case with Billy Graham, she said what she meant and she meant what she said.  This surely must have perplexed the glitterati in Washington.

Historians will write about Mrs. Bush for years to come.  She was a smart, gracious, strong, and virtuous woman.  Countless children learned to read as a result of her efforts.  No doubt her opinions influenced domestic and foreign policy behind the scenes.  However, Mrs. Bush possessed an uncommon degree of humility, maturity, forgiveness, and forbearance that enabled her to rise above conflict and petty partisanship.  As she once explained, “Politics is what we do.  It’s not who we are.”  Have we ever been in greater need of her example?