“Patience and fortitude conquer all things.” Ralph Waldo Emerson
“We could never learn to be brave and patient, if there were only joy in the world.” Helen Keller
We need to be patient a while longer and exercise common sense and good judgement while we are still in the midst of this pandemic. To date more than 53 million Americans are now fully vaccinated, according to the latest CDC data. The Population of the United States is 330 million.
In Pennsylvania as of March 31,2021 there are 2,084,919 people fully vaccinated. The population of Pennsylvania is 12.8 million.
Effectiveness of the Pfizer and Moderna Vaccines: The United States Centers for Disease Control and Prevention (CDC) reports that both the Pfizer and Moderna vaccines are highly effective at preventing both symptomatic and asymptomatic SARS-CoV-2 infections. The CDC has found that both vaccinations offer 90% efficacy 2 weeks after the second shot is given, and 80% efficacy 2 weeks after the first shot is given. Public health officials suggest that it is very unlikely vaccinated individuals will spread the novel coronavirus to others. The CDC’s study of more than 3,900 people was conducted while variants of the virus were in circulation, suggesting that the Pfizer and Moderna vaccines offer protection against these mutations.
Children and the COVID -19 Vaccine: New data from Pfizer show that its COVID-19 vaccine is highly protective against infection with the novel coronavirus among children ages 12 to 15. The study of more than 2,200 subjects found zero cases of COVID-19 among those who received both shots of the Pfizer vaccination while there were 18 COVID-19 cases among the subjects who received a placebo. This news bodes well for middle and high school students returning to traditional in-person school this fall. Pfizer will now request an EUA amendment.
For Emergency Use Authorization of the three vaccines that are in use in the United States: Pfizer, Moderna and J&J, each vaccine's clinical trial had 30,000-40,000 participants and was required to produce data for at "least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-risk profile."
Today with more vaccine distribution we are getting more and more real-world data from a larger and more diverse group than any clinical trial could ever hope to produce. And hopefully soon we will be able to answer questions like “How long does immunity last, will it work against the variants and do I need to get a vaccine every year?”
Oral Connection to COVID -19: A group of researchers has discovered that SARS-CoV-2 infects cells in the mouth, making the oral cavity a possible transmitter of the viral infection to other parts of the body. Published in the journal Nature Medicine on March 25, the research suggests that this fact may be the reason why COVID-19 has such a wide range of symptoms, affecting myriad parts of the body. Oral symptoms, such as loss of taste, xerostomia, and mouth ulcers, may be due to the presence of the virus in oral cells. Increased understanding of the role of the oral cavity in COVID-19 illness could support additional strategies to reduce transmission and improve treatment. This is why we have you rinse with peroxide for 1 minute before the start of your dental appointment
How long does COVID 19 immunization last? Thousands of college students participating in a new trial called PreventCOVIDU will help determine how well COVID-19 vaccines diminish risk of transmitting the infection, officials said Friday.
That the vaccines are highly effective at preventing symptomatic illness is well established.
"But the prevailing question is, when these people get infected, how often is that, if they're asymptomatic, how much virus do they have in their nose?" said Anthony Fauci, MD during a White House briefing. "And do they transmit it to people who are their close contacts?"
This study will test whether vaccine prevents both infection and transmission of SARS-CoV-2 among college students, and will "help inform science-based decisions about mask use and about social distancing post-vaccination," Fauci added.
The NIH-funded study will include 12,000 college students ages 18 to 26 from more than 20 universities, and is expected to last 5 months, Fauci said. One group of 6,000 students will receive their first dose of the Moderna vaccine immediately. The others will serve as controls and will receive their vaccine 4 months later.
All participants will ultimately receive the usual two doses.
Participants will swab their noses daily for SARS-CoV-2 infection, provide blood samples periodically, and complete surveys through an electronic diary app. They will also be asked to follow their university's SARS-CoV-2 protocols and get tested twice each week, according to the study's website.
Give COVID-19 Vaccine to All Patients Before Surgery: Patients undergoing elective surgery should be prioritized for COVID-19 vaccination over the general population, a global modeling study suggested.
Such a policy could avert over 56,000 deaths from COVID-19 worldwide, reported the COVIDSurg Collaborative, a multi-national group of surgeons and anesthetists in more than 80 countries. "Preoperative vaccination could support a safe re-start of elective surgery by significantly reducing the risk of COVID-19 complications in patients and preventing tens of thousands of COVID-19-related post-operative deaths," said co-author Aneel Bhangu, PhD, of the University of Birmingham in England, in a statement.
The researchers added that patients who develop COVID-19 infection are at a four- to eight-fold increased risk of death within 30 days of surgery, and that a patient over age 70 requiring cancer surgery would usually have a 2.8% mortality rate, but that rises to 18.6% if patients have COVID-19.
The authors said that elective surgeries may be cancelled or postponed once again if waves of COVID-19 persist throughout 2021, and hypothesized that prioritizing this population for vaccination could even decrease post-operative pulmonary complications, ICU use, and overall healthcare costs.
Viable Therapies that work for COVID -19 recognized by NIH and the FDA:
Remdesivir, an antiviral, is currently the only FDA-approved therapy for COVID-19. It prevents SARS-CoV-2 from replicating by binding to RNA-dependent RNA polymerase, a key enzyme the virus needs to propagate.
Dexamethasone, a corticosteroid with potent anti-inflammatory effects, is recommended for use in many categories of patients hospitalized with COVID-19, but not for those with mild-to-moderate disease who aren't in the hospital. Dexamethasone use in those who required mechanical ventilation cut the risk of death by about 35% compared with usual care. Overall mortality also was lower in all hospitalized patients who received the drug.
Tocilizumab, the anti-interleukin-6 (IL-6) monoclonal antibody in combination with dexamethasone in certain hospitalized COVID patients exhibiting rapid respiratory decompensation. That includes those who have been admitted to the ICU within the previous 24 hours who require invasive mechanical ventilation, noninvasive mechanical ventilation or high-flow nasal cannula oxygen, or -- outside the ICU -- patients with rapidly increasing oxygen needs who require noninvasive ventilation or high-flow oxygen and have significantly increased markers of inflammation.
Anticoagulation NIH recommends that all adults hospitalized for COVID-19 who aren't pregnant should receive prophylactic anticoagulation to prevent venous thromboembolism (VTE). (Pregnant patients hospitalized for severe COVID-19 should also get prophylactic anticoagulation unless it's contraindicated.)
Convalescent plasma has an FDA emergency use authorization to treat hospitalized COVID-19 patients. Only high-titer plasma is now authorized, however, and with restriction to hospitalized patients who are early in their disease course or those who have impaired humoral immunity.
Treatments not recognized to work by NIH or FDA:
Hydroxychloroquine -- with or without azithromycin
Ivermectin: The antiparasitic drug has shown some potential to inhibit SARS-CoV-2 replication in cell cultures. However, according to the NIH, achieving the plasma concentrations necessary to achieve the antiviral efficacy detected in vitro would require doses up to 100-fold higher than those approved for use in humans.
Vitamin C (ascorbic acid) Vitamin D and Zinc in COVID-19. NIH states that there is insufficient data to recommend for or against the use of either Vitamin C (ascorbic acid) and Vitamin D in COVID-19.
Protease Inhibitors: The NIH recommends against using lopinavir/ritonavir and other HIV protease inhibitors to treat COVID-19 in hospitalized and non-hospitalized patients because clinical trials have not shown clinical benefit in COVID patients.
The drugs did not demonstrate efficacy in two large randomized controlled trials of hospitalized patients
Colchicine: Neither the NIH nor WHO have any guidelines concerning this oral anti-inflammatory drug often used to treat gout, although it is still being investigated as a potential COVID treatment.
Until next time Stay Safe, Stay Well, Stay Distant, Avoid Crowds and Wear your Mask.
James A Vito, D.M.D.