2021-The year of the vaccine

We’ve closed the book on an unexpected 2020, where so much of our lives were dominated by the pandemic. COVID-19 will still be with us this year, but we hope our lives will slowly recover in 2021 as vaccines are made available for everyone.

Creating a new vaccine is time-consuming. Unlike the flu vaccine for the H1N1 pandemic in 2009, there is no existing vaccine for coronaviruses to build upon. According to the CDC, COVID-19 vaccines must be developed and tested to ensure they work and are safe. Michal Linial, a professor of biological chemistry at the Hebrew University of Jerusalem said “Classical vaccines were designed to take 10 years to develop.” So a new vaccine process is now being used for the early COVID-19 vaccines.

As of December 15th, three vaccines have been submitted for FDA approval. There are two mRNA (messenger RNA) vaccines by Pfi zer and Moderna, and one DNA vaccine by Oxford-AstraZeneca. Both of these methods are relatively new, and until COVID-19, no DNA or mRNA vaccines had been approved in the US for human use.

The basic concept these vaccines use is to trick your body into producing proteins that appear to be similar to COVID-19 fragments, which will elicit an immune response from your body’s defense system. This response will protect you from infection from the live virus. This is a new process, compared to vaccines based on live or dead pathogen proteins. The new DNA and mRNA vaccines are non-infectious and can be produced faster and economically.

Both mRNA and DNA vaccines use your body to produce the proteins, using the instructions stored in either mRNA or DNA format. DNA instructions are processed inside your body’s cells to produce the proteins designed to emulate fragments from the virus; whereas mRNA is translated into the protein outside of the cell in your body’s intracellular fluid.

Since mRNA does not enter your cell, the chance of your genome being affected is averted. But mRNA is fragile, thus the cold storage requirements for these vaccines: -70 degrees Celsius for Pfi zer, and -20 degrees Celsius for Moderna. The advantage of the DNA vaccine like the Oxford-AstraZeneca version is to reach areas where cold storage is not common.

The minor and moderate side effects reported of these early vaccines are sore arm at the injection site, fever, fatigue, headache, joint pains, and muscle aches. These effects are due to your body ramping up for a virus infection, but because the vaccine is non-infectious, you will not get a case of COVID-19, just the symptoms from your body’s response.

According to Moderna, no one receiving the vaccine in their trials developed a severe case of COVID-19. The reported efficacy rate for these vaccines are in the 90-95% range, which is much higher than your typical flu vaccine.

While the creation and approval of these first sets of vaccines have been completed, the logistics of getting them delivered across the country has just begun. Operation Warp Speed (OWS), is a partnership between the Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD).

OWS aims to accelerate the development, manufacture, and distribution of COVID-19 vaccines. Their stated distribution objective “is for everyone to be able to easily get a COVID-19 vaccine as soon as large quantities are available. Several thousand vaccination providers will be available, including doctors’ offices, retail pharmacies, hospitals, and federally qualified health centers.”

OWS has provided a playbook to state and local jurisdictions on the distribution of the vaccines. In Florida, the Division of Emergency Management (FDEM), an agency headed by Director Jared Moskowitz, a Parkland local, is responsible for the distribution of vaccines across the state. “We went out and bought dry ice machines,” said Director Moskowitz. “We got the ultra-cold freezers that we need. We feel that we’re in a good position.

Gov. Ron DeSantis said the state has been planning since early summer on how best to distribute the vaccines, with initial distribution planned at five Florida hospitals (including Memorial Healthcare System in Broward), and eventually expanding to look like state testing sites. “It may even be the same sites we have now,” Moskowitz said. “Giving out the vaccine in a mass distribution — call it spring, late spring, early summer.”

So we say good riddance to 2020. There is much hope life will start returning to normal as more folks are vaccinated in 2021. As of Dec 15th, 2020, a new hope is slowly arriving in the form of vaccines, and state officials work through the prioritization process. The logistics of successfully implementing a smooth mass vaccination is immense, and we all need to follow the recommendations so we can get back to the OLD normal as quickly as possible.

Welcome to 2021, the year of the vaccine.

What’s the deal with CBD?

CBD oil has recently been heralded as the key to alleviate many ailments for which traditional medicine has not offered reliable cures. So what is CBD?

Cannabidiol, or CBD, is an extract derived from the cannabis sativa plant, sometimes referred to simply as the cannabis plant.

The varieties of c. sativa containing high CBD, and low Tetrahydrocannabinol (THC), are generally called hemp, or industrial hemp. The more famous, or infamous, varieties of c. sativa  with high THC are often generally referred to as marijuana (AKA weed, pot, reefer, grass, dope, ganja, Mary Jane, etc).

Cannabinoid compounds bind with receptors in human cells. Two main types of receptors have been identified, CB(Cannabinoid receptor type)_1 and CB_2. CB_1 is most widely expressed in the brain, and CB_2 are seen expressed in immune cells. Researchers are still working to identify other receptors in human cells.

Medical studies have shown the strongest evidence of CBD benefit is in certain epilepsy syndromes, which don’t respond well to anti-seizure medications. The FDA recently approved the first-ever cannabis-derived medicine, Epidolex, a purified CBD extract.

Other studies suggest CBD can help alleviate anxiety and insomnia. According to the Anxiety and Depression Association of America (ADAA), the studies are not as advanced as for epilepsy. Interestingly, recent studies say THC may increase anxiety as opposed to CBD which reduces it.

Another potential benefit of CBD that is being studied is the anti-inflammatory properties due to its interactions with the immune system. According to Harvard Health, “CBD may offer an option for treating different types of chronic pain.” More studies are ongoing to substantiate the effectiveness of CBD on these difficult to treat conditions.

As the medical community continues to study the benefits of CBD, more and more consumer products are being marketed. CBD products are often used topically, ingested, or inhaled. According to Dr. Junella Chin, an osteopathic physician, topical cream or ointment can be applied to “muscles, joints, and ligaments and still get a nice, localized release.”

Dr. Chin says, when CBD is inhaled, you will feel an impact in 10 minutes, that tends to wear off in two hours. Whereas, if it’s ingested as an edible or liquid, it will last 4-5 hours, but takes half an hour before you feel the effect.

Given the vast number of CBD infused products you can find, you should look for a third party quality assurance stamp or certificate of analysis. A 2017 Journal of American Medical Association study found 26 percent of 84 products tested contained lower doses than stated on the label. So in the wild, wild west of CBD products, it is buyer be aware.

CBD’s legal status is complicated. All 50 states have laws legalizing CBD with varying degrees of restriction. Federally, CBD oil extract from the marijuana plant, is still a schedule I controlled substance, whereas CBD oil extract from hemp (0.3% THC or lower), is legal for cosmetic use only, and not for food, or dietary supplements. In Florida, CBD extract can be legally processed with a state license under SB 1020.

As with all things, there are side effects from CBD that are also being studied. The FDA in their March 2020 statement says, potential side effects “include potential liver injury, interactions with other drugs, male reproductive toxicity, as well as side eff ects such as drowsiness.” The statement acknowledges much we still don’t know about CBD, and as recently as Oct 2019, the FDA and FTC sent warning letters to a Florida company for unproven claims on the benefits of CBD.

The CBD industry is evolving quickly, the FDA stated, and there is “significant public interest in CBD and we must work together with stakeholders and the industry to develop high-quality data to close the substantial knowledge gaps about the science, safety, and quality of many of these products.” So when you are shopping for CBD infused bath salts or other products, keep in mind, there is much we are still learning, both beneficial and potentially harmful.