This week has brought good news and bad news.
First the good news, preliminary data on two vaccines (from Pfizer and Moderna) show 95% efficacy. Today Pfizer applied to the FDA for EUA (Emergency Use Authorization) for their mRNA VACCINE. Both vaccines use an approach never used before. The vaccines both involve injecting messenger RNA (mRNA) which enters human cells where the cell machinery produces a sequence of amino acids which reside on the spike protein of the SARS-COV-2 virus. The immune system then responds to that portion or the virus protein. Both vaccines reduced the rate of moderate to severe illness by about 95% compared to the placebo group. No study subjects were younger than 18. We do not yet know the age distribution or underlying medical condition profile of the vaccine and placebo recipients.
Data are being released to the medical community for review. Hopefully there will be a broad representation of our population in the study groups.
If approved for Emergency Use Pfizer estimates that about 40 million doses could be produced by year’s end. That would cover 20 million people (each person receives a series of two shots).
- So far safety looks good, but rare complications will not be known for a long time.
- Safety and efficacy in folks younger than 18 not known.
- The Pfizer vaccine requires very cold storage which is not available in pharmacies, doctor’s offices and clinics. Distribution logistics will be complicated and will require storage in hospitals or other facilities that have minus 70 degree F capability.
- We do not know if the vaccine reduces death rate with infection, that will not be known for at least a year or two.
- We do not know how long immunity will last.
- It will take more than a year to ramp up production and administer the vaccine to adequate numbers of people to achieve herd immunity.
- Even after large numbers of people are vaccinated, masks, social distancing and hand washing will remain important parts of protecting the public.
- If availability of a vaccine causes people to be less adherent to behavioral guidelines, the net effect could be greater illness and death rather than less protection.
You can listen to an interview with vaccine specialist Dr. Paul Offit here:
http://For COVID-19 Vaccines, ACIP Will Be a Critical Gatekeeper
A transcipt is also available at that site.
The interview describes how the vaccine trials were designed and discusses the independent groups of scientists and doctors who review data on vaccines. The important roles of the DSMB (Data Safety Monitoring Board) and ACIP (Advisory Committee on Immunization Practices) are discussed. Many areas are covered. They include problems with previous vaccines, realistic expectations about production and distribution, the many kinds of vaccines still under various stages of study, the process of EUA and the differences between EUA and FDA final approval.
There’s a DSMB for each of these phase 3 trials, which is a multidisciplinary group,
including people who are experienced with clinical trials, biostatisticians, bioethicists,
immunologists, vaccinologists, and virologists. You have this big crew, they’re reviewing the blinded data, and they have a pre-programmed time of review. Also, they have stopping rules that are defined ahead of time for both futility and for overwhelming efficacy.
Drugs for Covid:
Dexamethasone, an anti-inflammatory steroid, has been demonstrated to reduce death rates in very sick patients.
The study, published in The New England Journal of Medicine in July, found the drug cut mortality by a third among severely ill COVID-19 patients who were on ventilators, and by a fifth for patients receiving supplemental oxygen. It was found not to have any benefits for patients with mild illness, and there was some evidence of potential harm.
So far, no other drugs have been shown to reduce risk of death. Remdesivir at best reduces duration of illness.
But today a combination drug (Baricitinib plus Remdesivir), was granted an EUA by the FDA. Like Remdesivir, the combination reduced length of illness. In the case of the combination, the duration of illness was reduced by only ONE DAY which is less than the reduction previously reported with Remdesivir alone (3 days). This discrepancy has not been explained and it concerns me. Why would an effective drug combination produce less reduction in duration of illness than one of the drugs used alone? Hmmmmmmmmmmmm
But more importantly:
“The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo + remdesivir, the press release said without providing specific data. For all of these endpoints, the effects were statistically significant.”
Data on the actual reduction in risk of death has not yet been released for scientific review.
Remember EUA was previously granted for Hydroxychloroquine, then revoked when larger controlled studies showed no benefit and possible harm. Likewise, use of convalescent plasma from recovered COVID patients was granted EUA but the data so far do not support its use.
So we have very hopeful preliminary data on 2 vaccines and we have dexamethasone and a new combination drug reported to reduce mortality in very sick patients. The data on dexamethasone is convincing. All we have on the combination treatment is a press release so far.
Now the bad news.
Hospitalization rates and infection rates are at record highs.
One out of five hospitals this week in the US anticipate a critical staffing shortage of health care workers within a week.
Last week I heard an interview with an ICU doctor in Billings Montana. The ICU COVID-19 cases were so great in number that in order to meet the demand the hospital did the following:
- Converted single bed ICU rooms to doubles
- Converted the cardiac care unit to a COVID ICU
- Converted recovery room beds to ICU beds
- Converted ER beds to ICU beds.
All of those ICU beds were full. The doctor said if the growth in cases did not slow down they would be left with “difficult choices”. Read that as triage. Patients most likely to survive get critical care, those less likely get comfort measures. Meanwhile non-COVID patients who need critical care may not get the level of service they need.
Doctors and nurses across the country are suffering burnout. Many have become infected. Some have died. The American Nurses Association report over 1200 nurses have died from COVID-19 in the US.
In a survey of hospital nurses conducted last week 80% reported inadequate PPE.
Interviews with nurses reveal that some patients dying of COVID do not believe they have the disease. There is a cult of Trump followers who believe his dangerous lies, misinformation and conspiracy theories. Despite death staring them in the face, some still refuse to believe the virus is real. Amazing.
So it will get worse before it gets better.
Next post will discuss “Long Covid”.
In the context of the COVID 19 pandemic I will close with the usual summary.
- Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
- Get plenty of sleep (without adequate sleep your immune system does not work well )
- Follow good sleep habits
- Exercise, especially out of doors in a green space, supports the immune system
- Get some sunshine and make sure you have adequate Vitamin D levels.
- Eat an anti-inflammatory diet rich in micronutrients.
- Practice stress reduction like meditation and yoga which improves the immune system
- Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
- Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
- Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)
THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.
Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.