“This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. Note the spikes that adorn the outer surface of the virus.”  Image Source: Centers for Disease Control

Coronavirus: a family of viruses that can cause illnesses such as the common cold, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome. (Mayoclinic.org) There are many types of human coronaviruses including some that commonly cause mild upper-respiratory tract illnesses and cause mild illness. A ‘novel coronavirus’ is a new coronavirus that has not been previously identified.  (Centers for Disease Control, CDC.gov)

Covid-19 Complications: although most people with COVID-19 have mild to moderate symptoms, the disease can cause severe medical complications and lead to death. Older adults or people with existing chronic medical conditions are at greater risk of becoming seriously ill with COVID-19. Complications can include pneumonia and trouble breathing, organ failure in several organs, heart problems, severe lung condition that causes a low amount of oxygen to go through (the) bloodstream to (the) organs (‘acute respiratory distress syndrome’), blood clots, acute kidney injury, and additional viral and bacterial infections. (mayoclinic.org)

Covid-19 Protection: COVID-19 spreads primarily from person to person. Fighting this disease is our joint responsibility. Protect yourself and others by making (the following) simple precautions your new habits. (World Health Organization, who.int)

Masks: wear a mask over nose and mouth. Masks help prevent getting or spreading the virus. You could spread COVID-19 to others even if you do not feel sick. Wear a mask in public settings and when around people who don’t live in (the same) household, especially when other social distancing measures are difficult to maintain. Masks should not be placed on young children under age 2, anyone who has trouble breathing, or is unconscious, incapacitated or otherwise unable to remove the mask without assistance. (CDC.gov)

Social Distancing: six (6) feet of distance between people who don’t live in (the same) household. Some people without symptoms may be able to spread virus. Keeping distance from others is especially important for people who are at higher risk of getting very sick. Avoid crowds. Being in crowds like in restaurants, bars, fitness centers, or movie theaters put you at higher risk for COVID-19. Avoid indoor spaces that do not offer fresh air from the outdoors as much as possible. If indoors, bring in fresh air by opening windows and doors. (CDC.gov)

Hand Washing: wash hands often for at least 20 seconds especially after (having) been in a public place, or after blowing nose, coughing, or sneezing. It’s especially important to wash before eating or preparing food, before touching face, after using the restroom, after leaving a public place, after handling mask, after changing a diaper, and after caring for someone sick. Avoid touching eyes, nose, and mouth with unwashed hands. wash hands with soap and water for at least 20 seconds (CDC.gov)

Cover Coughs and Sneezes: cover mouth and nose with a tissue when (coughomg) or (sneezing) or use the inside of an elbow. Throw used tissues in the trash. If soap and water are not readily available, clean hands with a hand sanitizer that contains at least 60% alcohol. Cover all surfaces of hands and rub them together until they feel dry. (CDC.gov)

Clean and Disinfect: clean and disinfect frequently touched surfaces daily. This includes tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks. If surfaces are dirty, clean them. Use detergent or soap and water prior to disinfection. Then, use a household disinfectant. (CDC.gov)

CoVid-19 Spread: the virus that causes COVID-19 most commonly spreads between people who are in close contact with one another (within about 6 feet, or 2 arm lengths). It spreads through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads. Droplets can also land on surfaces and objects and be transferred by touch. A person may get COVID-19 by touching the surface or object that has the virus on it and then touching their own mouth, nose, or eyes. Spread from touching surfaces is not thought to be the main way the virus spreads. There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes). In general, indoor environments without good ventilation increase this risk. (CDC.gov)

CoVid-19 Symptoms: symptoms usually begin 2 to 14 days after you come into contact with the virus. (mayoclinic.org) Most people will have mild symptoms and get better on their own. But about 1 in 6 will have severe problems, such as trouble breathing. The odds of more serious symptoms are higher if you’re older or have another health condition like diabetes or heart disease. Some people are infected but don’t notice any symptoms. Researchers in China found that the most common symptoms among people who were hospitalized with COVID-19 include: fever (99% of cases), fatigue (70% of cases), dry cough (59%), loss of appetite (40%), body aches (35%), shortness of breath: (31%), and mucus or phlegm (27% of cases). (WebMd) The most common symptoms of COVID-19 are fever, dry cough, and fatigue. Other symptoms that are less common and may affect some patients include, loss of taste or smell, nasal congestion, conjunctivitis, sore throat, headache, muscle or joint pain, different types of skin rash, nausea or vomiting, diarrhea, chills or dizziness. Symptoms of severe COVID‐19 disease include shortness of breath, loss of appetite, confusion, persistent pain or pressure in the chest, and high temperature. Other less common symptoms are irritability, reduced consciousness, anxiety, depression, and sleep disorders. More severe and rare neurological complications (include) strokes, brain inflammation, delirium and nerve damage. People of all ages who experience fever and/or cough associated with difficulty breathing or shortness of breath, chest pain or pressure, or loss of speech or movement, should seek medical care immediately. If possible, call your health care provider, hotline or health facility first, so you can be directed to the right clinic. Among those who develop symptoms, about 80% recover from the disease without needing hospital treatment. About 15% become seriously ill and require oxygen and 5% become critically ill and need intensive care. (World Health Organization).

CoVid-19 Testing: in most situations, a molecular test is used to detect SARS-CoV-2 and confirm infection. “Polymerase chain reaction” (PCR) is the most commonly used molecular test. Samples are collected from the nose and/or throat with a swab. Molecular tests detect virus in the sample by amplifying viral genetic material to detectable levels. For this reason, a molecular test is used to confirm an active infection, usually within a few days of exposure and around the time that symptoms may begin. (CDC.gov)

Virus Vaccine: a conventional “vaccine” usually contain(s) weakened or inactivated disease-causing organisms or “antigens” to stimulate the “immune response” of the body, which is (then) prepared to react faster and more effectively if it is exposed to the infectious agent in the future. Production of conventional viral vaccines in ‘bioreactors’ is a well established process, though lengthy and cumbersome: it includes several steps like preparation of ‘seed’ virus, fermentation, harvesting and purification and can take several months. Also, the handling of large volumes of live virus is necessary. (CDC.gov) Vaccines help people develop “immunity” to a virus or other germ. A vaccine introduces a less harmful part of that germ — or something created to look or behave like it — into a person’s body. The body’s “immune system” develops antibodies that fight that particular germ and keep the person from getting sick from it. Later, if the person encounters that germ again, their immune system can recognize it and remember how to fight it off. (Hopkinsmedicine.org) Currently, two vaccines are authorized and recommended to prevent Covid-19: Pfizer-BioNTech Covid-19 vaccine and Moderna’s Covid-19 vaccine. As of December 28, 2020, large scale (Phase 3) clinical trails are in progress or being planned for three CoVid-19 vaccines in the United States: AstraZeneca’s Covid-19 vaccine, Janssen’s Covid-19 vaccine, and Novavax’s Covid-19 vaccine. (CDC)

Adenovirus Vaccines: adenovirus based vaccines (carriers) induce both innate and adaptive immune responses in mammalian hosts. They continue to be developed because of their... ability to induce potent cellular as well as humoral (body fluids) responses against “antigens” from target “pathogens.” (nature.com) Adenoviruses are a group of viruses that cause the common cold - so they're good for (carrying) things into humans. (Some carriers) are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease. The technology works by using an adenovirus as a carrier of an antigen’s “genetic code,” to mimic components of a pathogen— a bacterium, virus, or other disease-causing organism. Antigens (components of a pathogen) are produced to mimic the pathogen, without causing severe disease.  When the body encounters the antigen, (it) will induce... a long-lasting cellular immune response against the antigen, by producing immune cells and antibodies. In the future, if the body encounters the actual pathogen, the body will be able to respond faster and more effectively, as immune cells and antibodies specific to the pathogen will be rapidly produced… to prevent the pathogen from inducing disease. (janssen.com)

Johnson and Johnson Janssen COVID-19 Vaccine: The Janssen vaccine was authorized for emergency use (EUA) by the U.S. Food and Drug Administration on February 27, 2021 for individuals 18 years and older for prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The (authorization) allows the Janssen COVID-19 Vaccine to be distributed in the U.S.

On October 20, 2021, the FDA authorized a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older. (fda.gov)

Also on October 20, 2021, the FDA authorized the use of a “mix and match” booster dose for FDA-authorized or approved COVID-19 vaccines. Therefore, Janssen vaccine recipients 18 years of age and older may receive a single booster dose of Janssen, Moderna (half dose) or Pfizer-BioNTech vaccine at least two months after receiving their Janssen primary vaccination. (fda.gov)

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive ‘spike protein’ of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26... has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which...  triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. (fda.com) (Johnson and Johson’s) vaccine program is leveraging Janssen’s AdVac® technology in an effort to help combat the current COVID-19 pandemic. The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination. The vaccine candidate was 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49. The Janssen COVID-19 vaccine candidate demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation) with no reported cases among participants who had received the Janssen COVID-19 vaccine, 28 days post-vaccination. (jnj.com) (The) Vaccine technology platform – AdVac® – offers real hope for the accelerated development of vaccines and is designed to help the global health community better prepare for and combat life-threatening infectious disease outbreaks. This technology was used in the development of our Ebola vaccine regimen, which was approved by the European Commission in July 2020 and has been deployed in the Democratic Republic of the Congo and Rwanda. The AdVac® technology was (previously) used to construct our HIV, RSV, and Zika vaccine candidates. (janssen.com)

Messenger Ribonucleic Acid (mRNA) Vaccines: mRNA vaccines take a different approach (from conventional vaccines). They use the process in which the cells themselves build proteins from the information “encoded” in “messenger RNA.” This ‘blueprint’ is translated by the body to synthesize specific proteins called antigens. (Hopkinsmedicine.org) mRNA is a novel technology that stimulates the body’s own immune response. These vaccines contain information from messenger RNA including the… “genetic code” of a specific virus trait. The information enables the body to produce this antigen on its own. mRNA transfers the information for the production of the antigen to our cell machinery that makes proteins. Cells in our body then present the antigen on their surface and thus trigger the desired specific immune response. When the body comes into contact with the virus, the immune system recognizes the specific antigen and can fight the virus and thus the infection quickly and in a targeted manner. With COVID-19, the entry of the coronavirus into the host cell in humans is (made possible) by the coronavirus ‘spike’ that is located on the surface of the virus. mRNA vaccines against COVID-19 are designed to provide our bodies with the code to produce the (non-infectious) virus spike to instruct the cell’s machinery to help stimulate a natural immune response. This response is achieved primarily through “T-cells” and (through) neutralizing of the “antibody” production. If a vaccinated person later comes into contact with (the virus), the immune system will recognize the surface structure and will be able to combat the virus and eliminate it. (It) will immediately bind to the virus, neutralize it, and prevent it from entering the cell, thus protecting you from getting sick. T cells help the immune system to fight intracellular infections and can also kill the infected cells directly. Thus, in contrast to conventional vaccines, an mRNA vaccine does not contain any (virus) itself, but only the information that our own cells need to produce a virus trait that triggers the desired immune response. mRNA technology has enabled the design of multiple vaccine candidates against COVID-19. (Hopkinsmedicine.org)

Pfizer-BioNTech COVID-19 Vaccine: Pfizer’s vaccine received an emergency use authorization (EUA) by the U.S. Food and Drug Administration on Dec. 12, 2020 for individuals in the US 16 years and older. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product. (fda.gov)

On May 10, 2021, The Pfizer EUA was expanded to include those 12 through 15 years of age.

On August 23, 2021, the Pfizer vaccine was given full authorization by the U.S. Food and Drug Administration for individuals 16 years and older.

On September 22, 2021, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series in: individuals 65 years of age and older; individuals 18 through 64 years of age at high risk of severe COVID-19; and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

On October 20, 2021, the U.S. Food and Drug Administration authorized the use of the Pfizer vaccine as a “mix and match” booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. For example, Pfizer vaccine recipients falling into one of the authorized categories for boosters (see above) may receive a booster dose of the Pfizer vaccine, the Moderna vaccine or the Janssen vaccine at least six months after completing their primary vaccination.

On October 29, 2021 the U.S. Food and Drug Administration authorized the emergency use (EUA) of the Pfizer vaccine to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group. Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In addition, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11. Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study. (fda.gov)

In October 2021 In the United States, COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group.

The Pfizer vaccine consists of a strand of mRNA that codes for a disease-specific protein (antigen). No virus is needed to make a batch of an RNA vaccine. Only small quantities of virus are used for “gene sequencing” and for the vaccine testing. To improve the integration of… mRNA (into) body cells and to increase the vaccine stability, the mRNA is enveloped by certain fatty substances called “lipids.” (Biontech.de, MRNA Vaccines) The Pfizer-BioNTech vaccine is administered by an… injection (into) the deltoid muscle. (The) vaccine must be mixed with a ‘diluent’ before administration. (The) diluent is 0.9% sodium chloride— a normal saline (solution). The dosage (is) 0.3 mL. (The vaccine is administered as a) 2-dose series separated by 21 days. Age Indications are 16 years of age and older. (CDC.gov) The coronavirus that causes COVID-19 has spikes of protein on each viral particle. These spikes help the viruses attach to cells and cause disease. Some of the coronavirus vaccines in development are designed to help the body recognize these spike proteins and fight the coronavirus that has them. An effective vaccine will protect a person who receives it by lowering their chances of getting COVID-19 if they encounter the coronavirus. Both Pfizer and Moderna report that their vaccines show approximately 95% “efficacy” at preventing both mild and severe symptoms of COVID-19. This level of efficacy appears to apply across age groups, racial and ethnic groups, and both sexes, as reported in the Pfizer trial. (Hopkinsmedicine.org) The data to support the emergency use authorization include an analysis of 36,523 participants in the ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants, who completed the 2-dose vaccination regimen and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. Among these participants, 18,198 received the vaccine and 18,325 received saline placebo. The vaccine was 95 percent effective in preventing COVID-19 disease among these clinical trial participants with 8 COVID-19 cases in the vaccine group and 162 COVID-19 cases in the placebo group. Of these 170 COVID-19 cases, 1 in the vaccine group and 3 in the placebo group were classified as severe. (fda.gov) (August 23, 2021) Today, the U.S. Food and Drug Administration (fully) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. (fda.gov, Press Announcements) (August 25, 2021) Pfizer Inc. and BioNTech SE announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for the approval of a booster (third) dose of COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The companies intend to complete submission of the sBLA by the end of this week. (prizer.com, NEWS) The CDC currently recommends a third dose for individuals who have been ‘“mmunocompromised.” (CDC)

Moderna COVID‑19 Vaccine: Moderna’s vaccine was authorized for emergency use (EUA) by the U.S. Food and Drug Administration on Dec. 18, 2020.

On August 12, 2021, the FDA amended the Moderna vaccine EUA to allow for an additional dose to be given to certain immunocompromised individuals.

On October 20, 2021, the FDA amended the Moderna vaccine EUA to allow for a single booster dose of the Moderna vaccine administered at least 6 months after completion of the primary series to individuals: 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. The Moderna COVID-19 single booster dose is half of the dose administered for a primary series dose.

Also on October 20, 2021, the FDA authorized the use of a “mix and match” booster dose for currently FDA authorized and approved COVID-19 vaccines. Therefore, Moderna vaccine recipients falling into one of the authorized categories for boosters, may receive a booster dose of Moderna vaccine (half dose), Pfizer vaccine, or Janssen vaccine at least six months after completing their primary vaccination. (fda.gov)

Like the Pfizer-BioNTech Covid-19 Vaccine, the Moderna vaccine uses mRNA to provide a blueprint for cells to build a body’s defense against... the virus that causes COVID‑19. The vaccine does not contain SARS‑CoV‑2, or any virus—just the blueprint to help fight against it. (It) may not protect everyone. Given... as an injection into the muscle. (The vaccine is administered as a) series of 2 doses given 1 month apart. Does not contain SARS‑CoV‑2 and cannot give you COVID‑19. The vaccine contains no preservatives, no antibiotics, and no products from human or animal origin. The vial stoppers are not made with natural rubber latex. The Moderna COVID‑19 Vaccine contains the following ingredients: messenger RNA, 4 fatty substances, tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose. (modernatx.com) The data to support the emergency use authorization include an analysis of 28,207 participants in the ongoing randomized, placebo-controlled U.S. study who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine. Among these participants, 14,134 received the vaccine and 14,073 received placebo. The vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 cases in the placebo group. At the time of the analysis of these 196 COVID-19 cases, 0 in the vaccine group and 30 in the placebo group were classified as severe. One severe case in the vaccine group was identified after the analysis (and not included among the 196 cases) and was awaiting confirmation at the time the FDA review was conducted. (fad.gov) The CDC currently recommends a third dose for individuals who have been ‘“mmunocompromised.” (CDC)