The COVID-19 pandemic has been with us for more than two years. While vaccination has proved an effective means of preventing hospitalizations and death from SARS-CoV-2 infection, many are still susceptible due to poorly functioning immune systems, an inability to respond to or safely get vaccinated against COVID-19, and vaccine refusal. Seven medications and a few other treatments are available for treating COVID, but they are only for specific people in a few situations.

Recommended Use of Medication Is Restricted

Medications that can affect COVID-19 are now available, but most are limited to specific situations. To understand why there are a few things to understand.

There is a difference between using medications to treat a disease vs to prevent a disease.

• When treating a disease the expectation is that the medication will cure or control that disease enough for the body to finish the job. In many cases with viral infections, there is a “window of opportunity” for effective treatment. For influenza, this is needing to start antiviral medication within two days of flu symptoms appearing. For most COVID-19 treatments this is when the symptoms are mild to moderate, usually 5-7 days.
• Preventing a disease involves receiving a vaccine or medication while you are well to protect you from catching the disease. Examples of preventative medications include post-exposure emtricitabine/tenofovir for HIV/AIDS or anti-malaria drugs to prevent the disease when traveling in endemic areas. For COVID-19, vaccination is the best option.

Most medications are approved for a specific use such as for a specific disease or symptom, a certain stage of a disease, a specific age range, and/or a specific gender. These uses are determined by clinical trials in people with similar demographics and level of disease or symptoms. Medications are usually only approved for people that have the same characteristics as those in the study. When used outside those limits, it is called “off-label use.” Some drugs used for COVID-19 are being used “off-label.” 

The Federal Drug Administration (FDA) is primarily responsible for approving drugs/vaccinations and their uses. While most drugs and vaccinations have been fully approved by the FDA, they can also receive emergency use authorization (EUA). EUA is typically used during public health emergencies and allows the use of unapproved drugs/vaccines or unapproved uses of approved ones.

• In many cases, the use of medications approved by EUA can be more restrictive than ones that are fully approved. The drugs used for COVID-19 are reserved for treating people who are hospitalized or those with mild-to-moderate symptoms who have a positive result on a direct SARS-CoV-2 viral testing and are at high risk for progressing to severe disease, hospitalization, or death — especially those with immunosuppressive disease or receiving immunosuppressive treatment of a medical of condition, such as:
  • Moderate to severe primary immunodeficiency or advanced and untreated HIV;
  • Being on immunosuppressive medications, such as high-dose corticosteroids, treatments for solid-tumor and hematological malignancies, or transplants, chimeric antigen receptor T cell therapy; and/or
  • Being unable to get vaccinated with any available COVID-19 vaccine due to a history of severe adverse reaction to a COVID-19 vaccine or vaccine component or whose immune systems have not mounted responses to one of the three COVID-19 vaccines available in the U.S.
• In most cases the drugs have been well studied, but may still be undergoing testing.

COVID-19 came upon us so quickly that most vaccines and medications for COVID-19 began with or still have EUA. Currently, the Moderna and Pfizer-BioTech vaccines and the antiviral medication remdesivir are approved for use in people with COVID-19; all others have only emergency authorization.

The monoclonal antibody medications sotrovimab, bamlanivimab/etesevimab, and casirivimab/imdevimab previously had EUA for post-exposure prevention or treatment of COVID-19, but are not effective against the Omicron variant and the authorization was revoked.

Approved or Authorized Medication for COVID

Prevention/Prophylaxis

COVID-19 vaccinations

The Moderna and Pfizer-BioTech mRNA vaccines are now approved for the prevention of Covid infection. The Johnson & Johnson vaccine is authorized for emergency use if the mRNA vaccines cannot be tolerated.

Tixagevimab/ciljevima

Tixagevimab/cilgavimab (Evusheld) is a monoclonal antibody drug that has emergency use authorization to be used for pre-exposure prophylaxis in people 12 years old or older and weigh at least 88 pounds that are moderately to severely immunocompromised. A single dose of Evusheld is given intravenously (IV) and is only available at IV infusion centers. 

Treatment

Antiviral Drugs

The following antiviral medications are reserved for the treatment of people with mild-to-moderate COVID-19 symptoms who are at high risk for progressing to severe disease, hospitalization, or death. They should be started as soon as possible — up to five days — after symptoms begin.

Nirmatrelvir/ritonavir (Paxlovid) is an experimental oral drug that has emergency use authorization (EUA) as the initial treatment of COVID-19 in adults and adolescents (12 years old and older) weighing at least 40 kg (88 lbs) at high risk for severe COVID-19. Paxlovid is taken orally twice a day for five days. It has been shown to decrease the risk of hospitalization or death from COVID-19 by about 90% when taken within five days of symptom onset. Although there are limited amounts of nirmatrelvir/ritonavir available, Pfizer — the manufacturer has recently increased production.

Molnupiravir (Lagevrio) is an experimental drug that has EUA as an alternate treatment for COVID-19 in adults. Molnupiravir is taken orally twice a day for five days. It has been shown to decrease the risk of hospitalization or death from COVID-19 by about 30% when taken within five days of symptom onset.

Remdesivir (Veklury) is approved to treat COVID-19 in adults and children down to 28 days old. It is currently recommended as a second treatment option for non-hospitalized people 12 years old and older. However, remdesivir is the only antiviral medication approved for use in hospitalized patients. It is usually given intravenously once per day for 3 days for people in outpatient settings or 5-10 days for hospitalized patients. It has been shown to decrease the risk of hospitalization or death from COVID-19 by about 87%  when taken within seven days of symptom onset. The effect of remdesivir on hospitalized patients is variable. 

Monoclonal Antibodies

Monoclonal antibodies are manufactured medications that help your immune system recognize and defend against COVID-19.

Bebtelovimab is an experimental drug that has EUA for the treatment of COVID-19 in adults and adolescents (12 years old and older) weighing at least 40 kg (88 lbs). It is given once intravenously and is only available at IV infusion centers. It is authorized for treating people with mild-to-moderate COVID-19 symptoms who have a positive result on a direct SARS-CoV-2 viral testing and are at high risk for progressing to severe disease, hospitalization, or death. Effectiveness is not currently known.

Tocilizumab (Actemra) is a monoclonal antibody drug used for treating rheumatoid arthritis and other autoimmune diseases that has EUA to be used “off-label” for the treatment of adults and children 2 years old and older hospitalized with COVID-19. Up to two doses can be given intravenously, depending on the response to the first dose.

Tocilizumab is authorized for the treatment of COVID-19 patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab lowers the risk of death due to COVID-19 and is most effective when used within 10 days of developing symptoms.

Other Treatments

Baricitinib (Olumiant) is an immunosuppressant drug used for treating rheumatoid arthritis that has EUA to be used “off-label” for the treatment of adults and children 2 years old and older hospitalized with COVID-19. Baricitinib is taken orally once a day for 14 days or until discharge from the hospital, whichever comes first.

Baricitinib is authorized for the treatment of COVID-19 of patients who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). It has been shown to lower the risk of death due to COVID-19.

COVID-19 convalescent plasma

COVID-19 convalescent plasma is authorized for the treatment of COVID-19 in people with immunosuppressive disease or receiving immunosuppressive treatment in either inpatient or outpatient settings. COVID-19 convalescent plasma is the liquid part of the blood that is collected from eligible people that have fully recovered from a documented COVID infection and have antibodies (infection fighting proteins) to COVID-19. 

COVID-19 convalescent plasma is most effective when used early on in the illness. Additional doses may be given if there is little to no clinical response. It may not benefit everyone. The World Health Organization (WHO) no longer recommends COVID-19 convalescent plasma to treat COVID-19.

Continuous renal replacement therapy or blood purification

Treatment with continuous renal replacement therapy (dialysis) and blood purification devices may be effective for some patients with confirmed COVID-19 that is damaging their organs. It may work by reducing various pathogens, cytokines, and other inflammatory mediators — small active proteins in the bloodstream that control a cell’s immune response — by filtering the blood and returning the filtered blood to the patient.

Despite information available to the contrary, there are no other medications — approved or otherwise — that are effective against COVID. See BeMedWise blogs Ivermectin, the New Hydroxychloroquine for COVID-19 and Next Up for Anti-vaxxers – Iodine

Long COVID

There are no direct treatments for Long COVID.

While there is one theory that some of the symptoms of Long COVID are caused by the COVID-19 virus persisting in the body, most recent evidence suggests that is primarily the result of:

• Damage to the body during the active infection — such as brain/nerve or other organ damage;
• Persistent overactivity of the immune system attacking parts of the body; and/or
• Ongoing problems with small blood clots.

Since most of the symptoms of Long COVID are unrelated to active COVID-19 virus, the medications for the virus described above are not effective for treatment. Treatments for Long COVID are confined to ways to relieve individual symptoms, such as counseling, antidepressant and antianxiety medications, pulmonary rehabilitation, cardiovascular treatments, and physical therapy.

While there is one drug to prevent COVID disease, convalescent plasma and six medications to treat documented COVID-19 infections, their use is limited to those with severe disease or at risk for severe disease. Most of the treatments have age restrictions and are not available to young children. The bottom line is that medical treatment of SARS-CoV-2 infections is not available to most people who have COVID-19, which is another reason to get vaccinated.

Test to Treat is a federal program that makes it faster and easier for people with COVID-19 to obtain treatment. The Test to Treat web-based locator can be used to locate the nearest Test to Treat site. This information is also available in English, Spanish, and more than 150 other languages by calling 800-232-0233. 

For more information about possible coronavirus therapies currently being investigated visit the FDA’s Coronavirus Treatment Acceleration Program (CTAP) website.

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On March 29, the Food and Drug Administration (FDA) authorized an additional Pfizer-BioNTech or Moderna mRNA booster shot for those who are 50 years old and older and younger people with compromised immune systems. The Centers for Disease Control and Prevention (CDC) then added this second booster to its coronavirus vaccine recommendations.

The second booster can be given as early as four months after the first booster. Individuals aged 12-17 years can only get a Pfizer booster, while those 18 years old and older can get either a Pfizer or Moderna booster. 

The reason for the recommendation is the continued emergence of the highly contagious BA.2 sub-variant of Omicron, which was the cause of 85% of all COVID-19 cases in the United States on April 12, 2022. The recommendation was made despite the fact that the SARS-CoV-2 BA.2 variant is a milder disease — like the BA.1 and BA.1.1 variants and the number of new COVID deaths continues to drop. 

There are three additional reasons why the FDA and CDC made this recommendation:

1. Many countries experienced increased COVID-19 BA.2 variant infection rates before the U.S.  Five weeks later the number of cases and hospitalizations is increasing again in the U.S., primarily due to Omicron’s BA.2 subvariant called BA.2.12.1, which is 25% more contagious than BA.2.
2. A seasonal increase in cases is expected this fall.
3. The reduction of protective measure usage, such as face masks and social distancing, and reduced testing may also increase the risk of a COVID infection surge.

While the second booster dose of an mRNA COVID-19 vaccine is not associated with new safety concerns and it improves protection against severe COVID-19, protection from COVID illness is short-lived — about eight weeks. 

Coronavirus cases have risen in major cities. While hospitalizations have not, it is not a reason to defer boosters. Since there are still so many susceptible to severe illness, any drop in the number of cases is significant.

Rating the Need for a Second Booster

Now that the recommendation has been made, who should consider getting a booster right away if it has been more than four months since their last one and who can wait? It all comes down to the state of your immune system: the weaker your immune system, the greater your need for a second booster. There are a number levels of need.

At the top of the list are those who are immunocompromised, either from an underlying condition or from treatment of a condition, such as an organ transplant, cancer, or autoimmune disease. These people should get a booster as soon as possible and may even qualify for an additional booster at a later date.

Those who have had only Johnson & Johnson shots as primary and booster doses should get an mRNA booster.

As we age, our immune systems weaken. This effect on the immune system becomes relevant for seniors 65 years old and older. While CDC Director Rochelle Walensky recommends that seniors get a second booster, other experts think that it is not so straightforward and that other factors need to be taken into account.

• Because the weakening of the immune system is gradual, most younger seniors still have adequate immune system function and can defer their second booster, while older seniors should not. Unfortunately, there is no specific age cutoff for this distinction.
• Timing of the second booster should come into play, given the short-lived protection against COVID disease. Now that  there is a spike in COVID cases as a result of the increase in the COVID BA.2 variant and Omicron’s BA.2 subvariant called BA.2.12.1, the booster becomes more important. This is especially true since immunization protects against the new variant better than an infection with a previous variant. This would have a greater impact on the spike than spreading them out and having more people susceptible to infection when the spike occurs.
• A longer interval between booster shots produces a stronger immune system response and more cross-reactive defense.
• Other vaccines targeting newer variants, such as the BA.4 and BA.5 variants currently affecting South Africa, may become available before many may need a second booster.

People aged 50-64 years with chronic illnesses such as heart disease, lung conditions, reduced kidney function, diabetes, or obesity are more likely to have weaker immune systems and should get a second booster at some point.

Those who have had a recent COVID-19 infection — especially those who have already had a booster — should have a higher immunity and can consider deferring the second booster, but the recent increases make this riskier.

There are currently no recommendations for those less than 50 years old.

For now, it is evident that all adults 50 years old and older who are immunocompromised and elderly adults with weak immune systems should get a second COVID booster as soon as possible. A second booster is recommended for those aged 50-64 years with chronic illness and younger seniors, but the jury is still out on the timing.

Unfortunately, many of those who qualify for boosters are not getting them. In fact, 82.1 million doses of COVID vaccine were discarded from December 2020 mid-May 2022.

An expert panel of independent advisers met on April 6, 2022 to discuss the future of COVID boosters. The panel was able to identify many issues that need to be addressed, but was unable to offer any solutions. These issues include:

• Given how quickly COVID variants develop, how often it is practical to give boosters, especially those at highest risk;
• The importance and practicality of developing multivalent vaccines to current and future COVID variants that would offer more protection than the currently available vaccines;
• Developing better ways to assess vaccine effectiveness than hospitalization rates and death rates, such as immunological markers or community transmission; and
• What pattern recurrent COVID-19 epidemics will fall into.

Visit COVID Data Tracker for up-to-date information about all aspects of COVID disease and Covid.gov for information about local COVID resources.

The post Do I Need a Second COVID Booster? appeared first on BeMedWise.

COVID-19 has left its mark in more ways than the number  of COVID-19 infections, hospitalizations, deaths, and long-term consequences indicate. While the COVID-19 pandemic is having a direct detrimental effect on public health, the economy, and our social lives, there are many indirect medical consequences as well. 

In 2021, the death rate in the United States was the highest it has ever been — especially in the 15-44 age range. While the death rates for cancer, diabetes, chronic liver disease, and stroke rose slightly, deaths from COVID-19 infection and indirect deaths from other conditions due to COVID-19 were the major contributors to this increase. From 2020 to 2021 COVID deaths increased from 351,000 to 415,000, an 11.8% increase. For every 21 deaths from COVID-19 there were another four deaths from other causes that the COVID-19 pandemic was indirectly responsible for, such as chronic disease — especially diabetes, suicide, drug overdose, and homicide. 

The complications of COVID-19, such as Long COVID syndrome, multisystem inflammatory syndrome in children, damage to the brain and other organs (including the heart, lungs, and kidneys), blood clotting abnormalities, blood vessel problems, and mood disorders are well documented. However, there are multiple other health problems that resulted from the prolonged pandemic.

The ripple effect from the pandemic has resulted in a wide range of other medical consequences, most of which are the result of limited resources in medical centers overwhelmed by patients with COVID and the lockdowns, social isolation and economic insecurity that resulted from attempts to limit the spread.

Reduced access to primary care providers and preventative medical care — much of which has persisted as the measures relaxed — has resulted in many problems, including:

• Poor management of chronic medical conditions and delays in seeking care for non-COVID-19-related illnesses resulting in a higher rate of complications and more emergency room visits, hospitalizations, and deaths;
• Reduction of well-child visits resulted in children and adolescents missing routine vaccinations, less developmental screening and needed referrals for Early Intervention, and many parents without needed guidance to care for their children;
• Reduction of routine check-ups and needed vaccinations in adults;
• More emergency room visits for routine illness;
• Deferred cancer screenings leading to more advanced cancer at the time of diagnosis — the number of appointments for breast, cervical, and colon cancer screening in March 2020 was 86-94% less than the the average monthly screening from January 2017 through January 2020;
• Delayed elective surgeries resulting in increased severity of the condition; and
• Increased rates of sexually transmitted diseases (STD).

Reduced access to services for the elderly and those with low income, disabilities, mental health problems, and substance abuse disorders limited their ability to get necessary help for their healthcare needs.

Reduced access to school and social interaction resulted in anxiety and depression in many children. A higher rate of unhealthy lifestyle behaviors and practices, such as decreased activity, increased screen time, and unhealthy diets, especially in children, created additional health problems. Lockdowns resulted in higher rates of family conflict, domestic violence, and child abuse and online harassment, physical and sexual violence, and unintended pregnancies in adolescents and young adults in their 20s.

Reduced access to medical care due to overwhelmed healthcare systems contributed to reduced urgent visits for diabetes, cancer, respiratory disease, stroke, ischemic heart disease and hypertension disorders, and kidney disease which resulted in increased rates of complications and deaths, specifically deaths at home. Reduced access to medical care during pregnancy and childbirth increased rates of complications and deaths.

While COVID-19 is still having a devastating effect on health and healthcare in this country, it is not the whole medical story. The pandemic itself has negatively impacted health and healthcare by indirectly creating many additional medical problems, usually from limited availability of resources in medical centers overwhelmed by patients with COVID and the lockdowns, social isolation, and economic insecurity that resulted from attempts to limit the spread. The solution to the indirect consequences of COVID-19 pandemic is the same as for COVID-19 illness: a high enough rate of vaccination to achieve herd immunity. Once this happens, hospitals will be more available for non-COVID disease, the healthcare system can get back to preventive care, and social lives can get back to normal.

The post The Hidden Health Consequences of COVID appeared first on BeMedWise.

The COVID-19 pandemic has been fraught with mountains of inaccurate information, so much so that the World Health Organization has declared it a misinformation pandemic or infodemic. 

This has created a widening political and ideological rift that has prolonged the pandemic by: 

• Encouraging vaccine hesitancy
• Increasing distrust in science
• Discouraging the use of effective preventive/safety measures
• Promoting ineffective — sometimes dangerous or deadly — treatments, and
• Encouraging some to believe the pandemic is a hoax or a government plot. 

Researchers at the Center for Health Security at the Johns Hopkins Bloomberg School of Public Health have estimated that up to 12 million people across the country refused vaccinations against COVID-19 because of misinformation or disinformation about the vaccine.

False information seems to increase and decrease according to the fluctuation of COVID cases, as evidenced by the increase of inaccurate information that accompanied the rise in cases during the Omicron surge. The level and volume of inaccurate information is so pervasive that a vast majority of Americans believe or are unsure of at least one COVID-19 vaccine falsehood, including the 20% who still believe the COVID-19 vaccines inject a tracking chip that allows the federal government (or Bill Gates) to track you.

This inaccurate or false information has come about through misunderstanding, junk science, and the deliberate creation of falsehoods. There are two distinct types of inaccurate or false information.

• Misinformation is not having the correct factual information. There’s usually no ill will to being misinformed. Misinformation grows easily in the vacuum of reliable information. It also grows when reliable information is available but is improperly disseminated, misunderstood, or results in inconsistent changes in guidelines. 
• Disinformation is when a person or groups of people are knowingly spreading false information with the intent to mislead and deceive the public. Disinformation is more insidious/malicious since it is biased, deliberately manufactured, and dispersed to cause a specific result, in many cases political advantage, or to get others to ascribe to a particular viewpoint, religious belief, or conspiracy theory. 

Both should be classified as “fake news,” although the term has taken on a new meaning since it was co-opted by former President Trump. Fake news often spreads faster by virtue of being compelling as opposed to accurate information that can often be difficult to fully understand without prior knowledge. 

The pervasiveness of the internet, especially social media sites — some specifically created to spread false COVID-19 information — allows for rapid dissemination of “information.” with few filters for inaccurate or misleading information. It is often difficult to tell the difference between reliable sites and untrustworthy sites. Another contribution is the plethora of news outlets with varying viewpoints that has resulted in a wide range of often conflicting information, much of which can be considerably biased and deliberately misleading. 

There are other reasons ‘fake news’ can be spread even faster. 

• Fake news is often so compelling that it evolves and gets more believable over time, especially when manipulated by politicians for political gains.
• When articles attempting to debunk the inaccurate information are published or posted, the headlines often begin with a summary of the fake news the article is trying to dispute. This repetition of the fake news headline often reinforces the misconception when people only scan the headlines. 
• It spreads faster when coming from healthcare professionals — including doctors/politicians Rand Paul and Roger Marshall in the United States Senate — prominent figures such as former President Trump, teachers, and families.
• False or misleading information from healthcare providers has become a growing problem that pits the first amendment right to free speech against the duty of medical and nursing boards to discipline physicians and nurses for spreading false medical information when it is not in the context of a doctor-patient relationship. Currently, medical boards have taken no action on this issue.

COVID-19 misinformation and disinformation, especially about the COVID-19 vaccine, have resulted in so many COVID cases that the healthcare system has been overwhelmed. Strained healthcare workers are finding it increasingly difficult to do their jobs and many are succumbing to burnout and creating critical staffing shortages by leaving the profession. This has had a profound negative impact on overall patient safety and the COVID-19 epidemic, including unnecessary deaths.

The office of U.S. Surgeon General Dr. Vivek Murthy issued a request on March 3, 2022, for information surrounding health misinformation, seeking input and data from tech companies, healthcare providers, and community organizations. They hope to assess the impact of health misinformation found on those platforms.

While misinformation might be countered by accurate information presented in an understandable manner, attempts to identify, remove, restrict, or flag misinformation and disinformation on internet sources may be the best way to minimize their impact on the COVID pandemic. As with healthcare professionals outside of the doctor-patient setting, disseminators of false information consider any restrictions as a violation of their first amendment rights despite the adverse consequences of their actions on the pandemic and public health. However, commercial social media platforms are private companies that have the right to monitor and regulate the content of their websites and should take responsibility to increase their efforts to stop the spread of harmful COVID-19 misinformation and disinformation.

The Surgeon General’s findings could possibly lead to an independent watchdog group to monitor various sources for inaccurate and false information and make recommendations to remedy the situation.

Individuals can also assist in limiting the spread of this information by thinking critically about any health information they come across. Some of the steps that can be taken include:

• Trying to identify information that is merely an opinion, is not supported by evidence, and/or uses language that is biased, outrageous,  melodramatic, or supportive of conspiracy theories;
• Assessing the reliability of the source of the information, including the author’s credentials and organizations involved;
• Confirming information using trusted sources such as scientific organizations, government websites, healthcare professionals, and unbiased news sources;
• Identifying junk science that has led to inaccurate conclusions or ineffective treatments; and
• Educating others who still believe inaccurate and false information.

Misinformation and disinformation have had a devastating effect on our health and healthcare system. Some of this is due to effects beyond the specific consequences of COVID-19. False information increased the distrust in science and created a widening political rift that has sparked increasing conflicts among politicians and individuals. Both of these have made combating the pandemic more difficult by preventing implementation of effective responses to the pandemic. The most damaging of these was the number of people who refused or avoided the COVID vaccination which could have significantly reduced or even ended the pandemic.

Although we were not able to limit these devastating effects of the COVID pandemic, it is still important to identify and attempt to counter the misinformation and disinformation that is still causing unnecessary death and suffering from COVID-19, undue stress on our healthcare system, rising mental health concerns, and adverse effects on our economy. 

The post Striking Back Against COVID Disinformation appeared first on BeMedWise.

At the time of writing this — with an estimated 43% of Americans having had COVID-19 and many more being immune due to COVID vaccinations, including 65% who are fully vaccinated and 44% who have received boosters — the rate of new COVID infections is dropping. As the COVID-19 pandemic continues to ebb, the Centers for Disease Control and Prevention (CDC) has released new relaxed mask recommendations.

While the recommendations for the type and fit of masks to use has not changed, the circumstances where masks are recommended has changed. The new recommendations are more situational.

Location, Location, Location

As they say in real estate, location is the most important aspect of property value, and location is the major change in the new recommendations. There are still situations where masks are required for anyone — such as planes, airports, trains, train stations, and other modes and hubs of public transit — but they are no longer required on school buses and under certain circumstances, such as:

• While eating, drinking, taking medication, or communicating for brief periods of time with a person who is hearing impaired when their ability to see your mouth is essential for communication;
• If, on an aircraft, wearing oxygen masks is needed because of loss of cabin pressure or other event affecting aircraft ventilation;
• If unconscious (for reasons other than sleeping), incapacitated, unable to be awakened, or otherwise unable to remove the mask without assistance;
• When necessary to temporarily lower or remove the mask to verify one’s identity such as during Transportation Security Administration (TSA) screening or when asked to do so by the ticket or gate agent or any law enforcement official; or
• When experiencing difficulty breathing or shortness of breath or feeling winded, until able to resume normal breathing with the mask; when vomiting until vomiting ceases; or if wearing a mask interferes with necessary medical care such as supplemental oxygen administered via an oxygen mask.

For otherwise healthy people, the recommendation to wear a mask in indoor settings — including  in K-12 schools and early education settings — depends on the level of COVID infection in the community.

Masks recommendations have been rescinded for those in communities with low- or medium-risk COVID levels as outlined below. The recommendation continues for those living in high-risk communities.

The COVID-19 Community Level is determined by the new admissions and inpatient beds metrics, based on the current level of new cases per 100,000 population in the past 7 days.

To find out the COVID-19 community level:

• First determine whether a county, state, or territory has fewer or more than 200 new cases per 100,000 people in the past 7 days.
• Then, determine the level (low, medium, or high) of new admissions, inpatient beds, and population indicators using the scale for the area’s number for new cases.
• The COVID-19 Community Level is based on the number of new admissions and inpatient beds metrics per 100,000 people per week.
• Check your county’s COVID-19 Community Level on the CDC website.

A Few Exceptions

There are a few exceptions to the general recommendation.

• Those who are immunocompromised or at high risk for severe disease should consider wearing a mask even if they live in a medium-risk community. 
• The American Academy of Pediatrics recommends that families consider having their children wear face masks in public indoor settings, including schools, even in low- and medium-risk communities if:
  • Their child is between ages 2 and 5 and currently ineligible for COVID-19 vaccine;
  • Their child is immunocompromised and may not have a protective immune response to the COVID-19 vaccine, or is at high risk for severe illness;
  • Their child is not immunized; or
  • Other family members are at higher risk of severe disease or are not immunized.
• Mask are still not recommended in any situations for:
  • Children under 2 years old;
  • A person with a disability who cannot wear a mask or cannot safely wear a mask due to their disability as defined by the Americans with Disabilities Act; or
  • A person for whom wearing a mask would create a risk to workplace health, safety, or job duty as determined by the relevant workplace safety guidelines or federal regulations.

These are only recommendations, so venues can still set and enforce their own requirements for masks and social distancing. In any situation, people should make their decisions based on their own experience and comfort level and respect the people around them.

The NeedyMeds website has a database of over 100 nationwide resources for those who have been impacted by COVID-19. For those looking for information on receiving a coronavirus vaccine, find your area’s locations and appointment availability at vaccines.gov. There may be options for children to get vaccinated even if their parents don’t grant permission.

The post Understanding the Current Mask Recommendations appeared first on BeMedWise.

The response to COVID-19 is still a political issue and the resulting division between political parties within the United States has persisted and is still having an adverse effect on the pandemic. The division began almost as soon as the presence of the novel coronavirus was confirmed in this country.

Much of this division was the result of some politicians downplaying the pandemic for political reasons by giving false information: it doesn’t look good to voters to have a major pandemic during your term in office. Another contributor is the fact that politicians and scientists don’t speak the same language when it comes to science. While this is true of most people and scientists, politicians have had an undue influence on public opinion when it comes to the ongoing pandemic and the interpretation of science.

Although there is some overlap, the major issues dividing Republicans and Democrats are:

• Interpretation of the impact, risk, and severity of COVID-19 in their lives;
• Vaccine effectiveness, use, and mandates;
• The best way to achieve herd immunity and the end of the pandemic;
• Use of preventive measures, such as masks and social distancing;
• Use of unproven therapies;
• The extent to which they use faith, emotion, and/or evidence to make decisions;
• The level/type of risk and inconvenience they will tolerate; and
• Individual choice and level of responsibility during a public health emergency.

Recognizing that conservatives and liberals may have different levels of trust in science and how to use scientific knowledge to make policy decisions, this blog will focus on how different interpretations of the details of the COVID-19 pandemic may have contributed to the current situation.

To combat false statements, scientists and experts requested that politicians and others “follow the science.” As a physician with a lot of experience doing this, I will be the first to admit that it is not as easy as it sounds. There is a lot to understand before a scientist can make valid conclusions from scientific evidence such as the quality of the study, the balance between risk and benefit, and the practicality/usefulness of method. Here are a few examples.

• Lack of understanding of the quality of evidence contributed to the rush to use hydroxychloroquine and ivermectin based on a few poorly done studies when there were better studies showing such treatments do not work.
• The use of preventive measures is not clear-cut. While masks and social distancing work to prevent the spread of coronavirus, they can also result in isolation, adverse effects on education, economic hardships, and increased mental health problems — not to mention the constant fogging up of eyeglasses.
• While COVID-19 vaccines were effective because they were able to be produced quickly and cost-effectively, treatments such as antiviral and monoclonal antibody drugs are expensive and cannot be produced quickly enough to meet the demand.

Some of this needs to be communicated to non-scientists before they can truly understand where the science leads and that the guidelines/recommendations keep changing because the evidence is accumulating. Although, scientists and non-scientists need to recognize that science doesn’t always have the answer and decisions sometimes need to be made without compelling evidence.

A miscommunication occurred right away when the SARS-CoV-2 coronavirus was first discovered in China and began spreading to other countries. When experts were asked if it would become an epidemic, they answered that “there is no evidence that it would.” Unfortunately, that could be interpreted two ways. While the experts were saying they did not know because the coronavirus was still too new to have been studied, many interpreted it as reassurance that there would be no pandemic. Scientists did not want to make predictions based on the history of another viral epidemic — the flu — although there were similarities.

After reaching the U.S., miscommunication occurred in the form of mask recommendations. Again, the experts were saying they did not know because this new coronavirus was too new to have studied, but many interpreted it as masks will not help. While there was ample historical evidence that masks reduced the spread of influenza, experts were hesitant to make recommendations for masks and social distancing because there was not yet any evidence for COVID specifically. 

Unfortunately, not knowing that the scientists were strictly adhering to the scientific method of only recommending proven methods and not yet recommending methods that haven’t been proven by studies, it looked as though the experts had been wrong when they changed recommendations as the disease evolved. The World Health Organization finally declared COVID-19 a pandemic on March 11, 2020 and the official CDC recommendation for the use of masks did not come until April 3, 2020. This led many to distrust the scientists, especially the science deniers empowered by these perceived mistakes. While there have always been science deniers, the magnitude of the pandemic and the adoption of it as a partisan issue enhanced this perception.

COVID-19 is an example that evidence accumulates too slowly to keep up with changes in an emerging pandemic and how misinformation and fake news can rapidly fill the void. Waiting for this COVID-specific evidence before making recommendations can sometimes result in the experts seeming not to know what they are doing, as happened with the CDC and Dr. Fauci.

Evidence was often misinterpreted, ignored, or denied. Most concerning was the results of the effectiveness of COVID immunization. Some chose to interpret the studies in different ways, such as:

• Because the vaccination that was not 100% effective, it was not useful;
• That evidence of side-effects was a reason to not be vaccinated, even though they were much milder than the active disease; or
• That immunity wearing off was a reason to avoid vaccination, even though in some cases it was better and more persistent than immunity from the disease.

Even the infection, hospitalization, death, and long-term COVID rate statistics have been interpreted differently, at least among those who consider the data accurate. 

• Right-wing sources tend to present the numbers as not being concerning enough to interfere with their individual right to make choices, while liberals are more likely to interpret them as a public health emergency that requires some sacrifices such as getting vaccinated and maintaining protective measures even when not mandated.
• The fact that infection and death rates are higher in those who are unvaccinated and/or don’t use protective measures also prompts different interpretations. Conservatives look at this as an opportunity to end the pandemic by natural herd immunity, while left-leaning people often see it as a reason to get vaccinated and use necessary measures.
• Unfortunately, there are many that consider the available data unreliable/fake news and a way for the government to manipulate them.

When you “follow the science” the most incontrovertible conclusion is that the ultimate solution to the ongoing pandemic is the available vaccines. The vaccines have the benefit of having the best available evidence for effectiveness, have the most benefit for the least amount of risk, and are readily produced and distributed.

The NeedyMeds website has a database of over 100 nationwide resources for those who have been impacted by COVID-19. For those looking for information on receiving a coronavirus vaccine, find your area’s locations and appointment availability at vaccines.gov. There may be options for children to get vaccinated even if their parents don’t grant permission.

The post One Difference In Interpretation of COVID Science Partly Responsible for the State of the Pandemic appeared first on BeMedWise.

Omicron BA.1 has had a major impact on the COVID-19 pandemic. Due to the multiple differences from the Delta variant, the Omicron variant has prolonged and intensified the pandemic, made COVID more difficult to treat, and reduced the effectiveness of currently available coronavirus vaccines and infections from previous variants to prevent further spreading and disease. A new Omicron variant, BA.2, has now entered the picture, although its impact on the epidemic is as yet unknown. The good news is that both Omicron variants are generally milder illnesses.

Omicron BA.1 and BA.2

Omicron BA.1 and BA.2 have three major differences from previous strains of COVID that have impacted the pandemic the most.

1. Omicron reproduces more quickly in the cells of the upper respiratory tract and is more contagious, meaning that it takes less exposure time and lower numbers of virus particles to cause infection. It has been estimated to be 20 times more contagious than Delta and one of the most contagious viruses in the world. Because of the highly contagious nature of the Omicron variant, the prevalence of those infected with COVID went from 0% to 99.9% over the course of two weeks. It is predominately spread by unvaccinated individuals, but vaccinated people can still catch and spread the coronavirus variant.

Not only has Omicron prolonged the pandemic, it has intensified it — partially due to the fact that breakthrough infections were five times more likely with Omicron than previous variants. This resulted in higher peak levels of infection, hospitalizations, and deaths than the Delta variant — 3,400 vs. 2,000 per day. Although Omicron BA.1 has peaked and the number of new cases and hospitalizations is dropping in areas with higher vaccination rates, deaths continue to rise. It is typical for the death rate to continue to rise for a few weeks after the new cases and hospitalizations have peaked.

Some experts predicted that Omicron may infect most susceptible people before it runs its course and it has currently infected over two-thirds of the population — three-quarters of whom were vaccinated. In theory, this could significantly reduce the population of susceptible individuals, and lead to an eventual end to the pandemic, but that has not happened as new variants have arrived on the scene.

2. The symptoms of Omicron are different from previous variants. While the predominant classic symptoms of previously observed COVID-19 infections are high fever, persistent cough, shortness of breath or difficulty breathing, and loss of smell, the predominant symptoms of Omicron are headache, sore throat, night sweats, vomiting, and loss of appetite. 

This contributes to Omicron being more contagious since people may not initially realize they have COVID. This increases the spread of the virus because people delay COVID testing and using preventive measures, such as face masks and isolation. It may also delay the diagnosis beyond the interval where antiviral treatment is effective.

Other symptoms are similar, such as fatigue, muscle or body aches, conjunctivitis, and congestion/runny nose.

3. Omicron has proved to be a milder disease for unvaccinated, incompletely vaccinated/unboosted, and fully vaccinated people alike.

Although it may not seem like Omicron is a less serious illness than previous variants, since the peak levels of infection, hospitalizations, and deaths are higher, the variant’s higher transmissibility and ability to evade immune response from vaccines or previous infections is responsible for the higher hospitalization and death rates.

There are other differences between Omicron and previous variants.

• Like with the Delta variant, the Pfizer and Moderna vaccines offer protection from Omega infections, but it is less. The same is true for keeping people out of the emergency room and from being hospitalized. A study of vaccine effectiveness before immunity starts waning at about 180 days after the second dose showed that the effectiveness for keeping people out of the emergency services was 94% for the Delta variant vs. 82% for Omicron and for keeping people from being hospitalized 94% vs. 90%.

As previously demonstrated, this immunity wanes over time and the protection against breakthrough infection is much less than protection from severe disease

Both Pfizer and Moderna are testing Omicron specific COVID vaccines.

• Like other forms of COVID, Omicron infection offers immunity from illness caused by this variant. For those with previous immunizations, a form of hybrid immunity develops that protects against multiple previous and current COVID variants.

Unfortunately, Omicron has developed ways to avoid some of the immunological measures that protect against previous strains of the SARS-CoV-2 coronavirus. This also makes Omicron easier to catch and spread.

There is much that is currently unknown, such as how well an Omicron infection protects against previous variants if you have not been immunized/boosted (although these variants are unlikely to become dominant again), how quickly immunity from current boosters will wane for Omicron, and if infection will be more protective than immunization with Omicron-specific vaccines.

• Being so new, therapies specific to Omicron have not yet been developed. While it appears that Omicron responds as well as other variants to antiviral medications like remdesivir, it is less susceptible to some of the monoclonal antibody treatments. While sotrovimab remains effective, the FDA is no longer allowing treatment of Omicron with two other monoclonal antibodies used for the Delta variant due to ineffectiveness.

Omicron BA.2.12.1

As of June 4, 2022 there were no COVID infections from the BA.1 Omicron variant and the percentage of cases from BA.2 had dropped to 24.8%. A new Omicron variant, BA.2.12.1, has become the predominant strain. The prevalence peaked at 62.2% in early June. . 

BA.2.12.1 was even more infectious and contagious than the BA.1 Omicron variant, possibly 1.5 times as much.

The symptoms are similar to the BA.1 variant and BA.2.12.2 has a similar severity of illness.

The impact of the BA.2.12.1 was similar to BA.1, a new spike in COVID cases, hospitalizations, and deaths.

There was no significant difference in response to existing treatments.

Omicron BA.4 and BA.5

Omicron BA.4 and BA.5 have now arrived on the COVID scene and made up 5.4% and 7.6% of COVID infections June 4, 2022. They also seem to have similar contagiousness and severity as previous Omicron strains. Time will tell what the impact of these variants will have, but there is no reason to assume it will be any different from the previous Omicron variants.

The Future of COVID

The major impact of Omicron and other variants that are sure to develop comes from the prolongation of the pandemic and all the possible consequences from that. However, any further predictions are speculative and dependent on the development of vaccines to new variants, the effectiveness of antiviral and other COVID treatments, the availability and accuracy of COVID-19 testing, the effectiveness of workplace and restaurant modifications to reduce spread, the number of people who remain unvaccinated or unboosted, and how the novel coronavirus mutates over time.

The milder illness and prediction that most susceptible people will get Omicron has led some to speculate that the pandemic may be winding down, and the “new normal” will be an endemic stage, such as the flu, with regular vaccinations and seasonal use of preventive measures.

There are still numerous hazards, other than the possibility of more virulent variants developing, that can occur even if this “new normal” is achieved. These include many of the things we have already experienced, such as:

• More deaths;
• Continued overwhelming of the medical system and provider burnout;
• Higher rates of mental illness, heart attacks, and stroke;
• More people with long-COVID syndrome or permanent disabilities;
• Continued detrimental effects on jobs, the economy, and our daily lives; and
• Prolonged use of preventive measures, such as face masks and reduced social interaction.

However, many experts are concerned that, as long global vaccine equity remains an issue and the number of unvaccinated and unboosted people remains so high, COVID infection will remain widespread and the possibility for new and more serious variants is significant.

Finally, it is important to remember that the 50% of adults and 74% of children aged 5-11 years  who have not been fully vaccinated and those who cannot be vaccinated, which currently includes all children under 5 years old and those with immune issues will be susceptible to COVID-19 and at higher risk for serious disease and death. This will last until most people have either had the disease or choose to become vaccinated and boosted.

The post Omicron Variant and Beyond appeared first on BeMedWise.

COVID vaccination, especially vaccine mandates, is a polarizing issue for much of the United States. This has resulted in conflicts among politicians and political parties, families — especially divorced parents, parents and teachers, employers and employees, and vaccinated and unvaccinated people. It is such an emotional issue that many of the confrontations involving opposing viewpoints have been bitter, angry, and even violent. Reasons for these differences have been discussed in previous articles — Myths About COVID Vaccines and No End In Sight for COVID.

A common rationale among those who refuse the COVID vaccine is ‘my body, my choice.’ While this is true, there are repercussions to consider. For COVID, those consequences go beyond the significantly increased risk of unvaccinated individuals getting and dying from COVID. They extend to infecting many of those around them — especially the elderly, the immunocompromised, and young children — prolonging the pandemic, taking up medical resources, and the likelihood of new possibly more contagious and virulent variants of COVID-19.

Most of this is unnecessary due to the many facts and reality that clearly COVID-19 is a public health crisis and that vaccination is an extremely effective method of preventing severe COVID disease or death. This article will look at what is known about the consequences that choosing not to be vaccinated has on those individuals, those around them, and the current COVID situation.

Individual Consequences for the Unvaccinated

At the beginning of the COVID-19 pandemic, it was people over 65 and/or people with underlying medical problems that were at the highest risk for severe COVID disease including hospitalization and death. Fast forward 21 months, and now the vast majority of those experiencing COVID illness, hospitalizations, and deaths are 11% of those who are partially vaccinated and 29% of those who are unvaccinated.

From April 4 to July 17 (most recent 3 month data available), partially vaccinated and unvaccinated individuals accounted for 87% of all COVID cases, almost 70% of intensive care unit (ICU) admissions, 90% of hospitalization, and 91% of COVID deaths. They are five times more likely to become infected with COVID-19, 29 times more likely to be hospitalized, and 13 times more likely to die as a result. Most of this — including about 90% of the deaths — could have been prevented if these individuals had opted to be vaccinated.

After a mild flu season last year — most likely due to masks and social distancing measures taken to slow the spread of COVID — this year’s flu season is predicted to be much worse as these measures have been relaxed or actively discouraged in parts of the country. This creates the possibility of getting COVID and the flu at the same time, a so-called twindemic, which is a much more serious and deadly situation.

Another consequence is the number of unvaccinated who have had serious complications after choosing to use unproven and dangerous measures, such as hydroxychloroquine, ivermectin, and iodine.

Some survivors are even developing post-traumatic stress disorder (PTSD) as a result of COVID-19.

Consequences for Others Due To the Unvaccinated

Going unvaccinated would not be an issue if the consequences were limited to those individuals who made that choice, but they don’t. The consequences affect their families and those around them, the duration of the pandemic, the nature of the COVID virus, access to medical care and resources, and overall medical costs.

Although children and vaccinated individuals can spread the SARS-CoV-2 coronavirus, it is the unvaccinated who are most responsible for spreading the disease. Those most affected are those on chemotherapy or have other causes of immunodeficiency that prevent immune response from vaccination, the elderly, and those with pre-existing conditions that affect immunity who may still be susceptible to severe COVID-19 and death. COVID-19 could only affect children under 5 years old after November 3^rd when the vaccination of those aged 5-11 years began.

The number of infections, hospitalizations, and deaths is not trivial. The result of having 139,000,000 unvaccinated individuals in this country is estimated to be an additional 166,800 COVID infections, 12,500 COVID hospitalizations, and 1,100 COVID deaths per day. Since 68,000,000 of those are currently eligible to be vaccinated, those who choose not to be vaccinated are responsible for almost half of that number.

Having such a significant number of unvaccinated individuals will continue to prolong the COVID-19 pandemic. There are major consequences from prolonging the pandemic that will affect everyone.

1. As discussed in the article ‘No End In Sight for COVID,’ ongoing coronavirus mutations will produce new, potentially more dangerous, variants that are more contagious or more harmful. The likelihood increases the longer the pandemic drags on.
   1. The Delta variant mutation is much more contagious than the original COVID Alpha strain, quickly overtook this strain after it got to this country, and is currently responsible for 99.9% of all COVID cases.
   2. The new Omicron strain has now reached the United States and may even be more contagious than the Delta strain. At this time it is uncertain if or how quickly the Omicron variant will overtake the Delta variant and what protection the available vaccines offer. However, it is likely that having had a COVID with the current strains will offer limited protection against the Omicron variant.
   3. The likelihood of more significant mutations increases the longer the pandemic drags on.
2. Aside from all the medical issues that have resulted, the COVID pandemic continues to take a significant toll on the mental health of people in our country, especially increased depression (7% to 30.2%) and anxiety (6.1% to 35.9%). Some of the most significant include depression, stress, and burnout in medical care providers, grief and depression over a loved one’s death from COVID, anxiety of parents with school children, moderate to severe anxiety in young adults (69% of women and 54% of men aged 18-29 years), and disproportionately higher rates in women and minority communities. There have also been reports of increased rates of insomnia, substance abuse, domestic violence, and suicide.
3. The number of people severely ill with COVID-19 are still taking up medical resources — especially emergency room and ICU beds — that those with other conditions need and creating ethical situations for emergency care providers. As insurance companies resume charging COVID-19 patients for copays and other out-of-pocket expenses, they are increasing all of our overall medical costs. Since no one is going to (as suggested by some) make unvaccinated patients pay for their COVID-related medical bills, we all share some of this cost when our premiums and out-of-pocket expenses increase.
4. The restrictions on visits to pediatric healthcare providers has significantly reduced the rate of routine vaccinations in children and subsequently increased for those diseases. See ‘COVID in Children Is Not Insignificant’ for additional information on the consequences of COVID in children and adolescents.
5. The COVID pandemic continues to have an adverse effect on the economy. Many economic indicators use unemployment and jobs creation numbers to assess the health of our economy. While traditionally these numbers have been attributed to the economic policies of the current administration, it is the COVID pandemic that has been the major determinant in the current job market, including the record number of job openings. Consequences for individuals include lost jobs and income. For numerous reasons, unemployment continues to remain high even after the pandemic unemployment benefits expired, including: 
   1. Fewer jobs and less interest in low-wage/high-risk jobs in the retail and restaurant industries due to workers and customers wanting to avoid potential exposure;
   2. People who have needed to quit their jobs to take care of their children due to school closures and lack of daycare;
   3. The many businesses that failed during the pandemic;
   4. Burned out healthcare workers no longer able to endure their jobs; and
   5. Workers quitting as a result of vaccine mandates.
6. The need for protective measures such as masks, social distancing, limited social events, and plastic shields will persist until the pandemic is under control, which may not be for years.

A problem that will most likely emerge is the novel coronavirus becoming resistant to existing forms of treatment. As has been seen with antiviral treatment for the flu, resistance ultimately reduces the effect of treatment and the return of more severe disease. While the cause with the flu is overuse of oseltamivir (Tamiflu) in patients that wouldn’t benefit from it, the resistance to COVID-19 will most likely result from the sheer number of cases that will be treated in the unvaccinated. The more that monoclonal antibodies, antiviral medications, and even the upcoming Merck antiviral pill are used to treat and prevent COVID-19, the more opportunity there is for the virus to become resistant.

Another problem that might emerge is limited supplies and high cost of COVID treatments. This is already occurring with ventilators, but if the COVID disease rate continues, manufacturers of anti-COVID medications may not be able to keep up. This could result in rationing or prioritizing the medications to those at risk for or with severe COVID-19 or those who can afford them.

Many who refuse the vaccine do so based on misinformation. While this may be seen as an individual issue, many of these people spread this misinformation in an attempt to convince or coerce others to remain unvaccinated.

Assigning Blame

Most unvaccinated individuals consider their reasons to avoid the vaccine to be valid, such as lower levels of concern about the effect of coronavirus on them, concern over the side effects of the vaccine and skepticism about the benefits, guidance from politicians, or a willingness to risk COVID-19 for a sense of personal freedom, so they are surprised when they are being blamed for much of the current situation with the ongoing pandemic. Whether it is called blame or a consequence of their decision, it is crucial for those who choose to remain unvaccinated to understand that their decision has a significant impact on others. This is especially true for young children, those who are not able to be vaccinated, and many who have already been vaccinated.

Even if someone is reluctant, they need to acknowledge that vaccination is not a political issue. If they expect others to respect their decision, they must respect the choices made by others to have the vaccine. Anger, protests, and violence will only make the situation worse. Additionally, they should not prevent willing family members from being vaccinated; when all other family members are vaccinated, an unvaccinated person has a significantly reduced risk of contracting COVID-19. There may be options for children to get vaccinated even if their parents don’t grant permission. 

I find it curious that a country that has accepted other mandatory public health measures to protect fellow citizens such as mandatory seat belt use, bans on indoor smoking in public spaces, laws making driving while under the influence and discharging a firearm in public places illegal, restrictions from playing music above certain volumes or at specific hours, and even many other vaccines, has drawn a line for this particular issue. It’s past time to stop the rhetoric that is drowning out scientific facts and common sense, and for those who have rejected vaccination to accept that they are a danger to others and assume the same civil responsibility for COVID as they have for past public health mandates.

The NeedyMeds website has a database of over 100 nationwide resources for those who have been impacted by COVID-19. For those looking for information on receiving a coronavirus vaccine, search online for your state’s requirements, area’s locations, and appointment availability.

The post The Unvaccinated Bear the Brunt of the Consequences of COVID and Much of the Responsibility for the Current COVID Situation in U.S. appeared first on BeMedWise.

When it comes to COVID vaccine boosters, until recently, it was all about Pfizer. Now the FDA has approved both Moderna and Johnson & Johnson boosters for those adults initially vaccinated with the corresponding vaccine. CDC approval followed quickly on October 21, 2021. This decision involved giving boosters to high risk individuals who had received either Pfizer or Moderna vaccines and all individuals who got the Johnson & Johnson booster. A November 19, 2021 decision by both the FDA and CDC further endorsed booster for all remaining adults who had received either Pfizer or Moderna vaccines. On November 29, 2021,  due to the emergence of the Omicron variant in South Africa and the evidence that it is spreading to other countries, the CDC strongly encouraged all adults to get a COVID booster.

In addition, new evidence has resulted in the FDA and CDC approving the use of any of the three COVID vaccines as a booster no matter which of them was used for the initial series. This is referred to as mix and match boosters.

This is based on a recent study from the National Institutes of Health looking at the effectiveness of booster shots that was presented at an FDA Vaccines and Related Biological Products Advisory Committee meeting on October 14-15, 2021. The study included 450 fully vaccinated individuals, divided into three groups of about 150 each. The groups differed only in what vaccine they originally got, Pfizer, Moderna, or Johnson & Johnson. Each group was further divided into three groups of 50, where each group got one of the three COVID vaccines as a booster. The overall result was that, no matter what vaccine you originally received, a booster shot increased your antibody response significantly without any unexpected side-effects. Three results were worth noting:

• A booster shot from a different COVID vaccine than originally received resulted in a similar or higher antibody boost compared to using the originally used vaccine.
• While a booster from the Johnson & Johnson increased COVID antibodies by four times, boosters given with the mRNA vaccines — Pfizer and Moderna — were much more effective. The Moderna vaccine increased them 76 times and the Pfizer vaccine increased them 35 times.
• mRNA vaccines worked faster and resulted in higher antibody levels in the first 28 days after the boost.

Based on the results of the study, it appears that the mRNA vaccines are interchangeable and those initially immunized with the Johnson & Johnson vaccine will have a better response with one of the mRNA vaccines.

This study supports the mixing and matching of primary series shots and booster shots from the different vaccine makers that has been done by several countries — including the United Kingdom, Germany, and Canada — for months. The success of this program is evidence that the approach works.

Preliminary evidence supports the use of a different vaccine type for COVID boosters. The most obvious benefit may be the higher antibody increase achieved with mRNA vaccines as boosters for those who initially received Johnson & Johnson, although there is no evidence that higher antibody levels are more protective against COVID-19. 

As of this moment, the FDA is not recommending any specific booster, but is allowing the individual and their provider to determine which type of vaccine to use as a booster. The CDC followed suit and gave final approval to mix and match boosters which then became available the following day. 

Although it is likely that mix and match boosters are safe and effective, there are three reasons to be cautious.

1. The study was not the highest quality, being neither randomized nor blinded, has not been reviewed by other experts, and has yet to be confirmed by additional studies.
2. The experience from other countries has only been a few months, which may not be long enough to identify all the potential problems with the mix and match strategy.
3. There is no evidence that the higher antibody levels seen in those immunized with the Johnson & Johnson vaccine and boosted with an mRNA vaccine are any more resistant to COVID-19 than those getting a Johnson & Johnson booster.

There appears to be no advantage to using the other mRNA vaccine for a booster in those who received an mRNA vaccine initially. However, due to an increased risk of blood clots linked to the Johnson & Johnson vaccine, the CDC has recommended the preferred use of Moderna or Pfizer vaccines, including as a booster for those who had the Johnson & Johnson vaccine initially.

The NeedyMeds website has a database of over 100 nationwide resources for those who have been impacted by COVID-19. For those looking for information on receiving a coronavirus vaccine, all adults and children over 12 years old can receive the vaccine free of charge. There may be options for children ages 12-18 to get vaccinated even if their parents don’t grant permission. Search online for your state’s requirements, area’s locations, and appointment availability.

The post Mix and Match COVID Boosters appeared first on BeMedWise.

Iodine seems to be the newest alleged remedy for COVID-19. Anti-vaxxers are using iodine solutions to gargle, spray up their noses, and even swallow as a way to prevent COVID infections. This is predominantly based on a YouTube video from an emergency room doctor in Thailand that went viral on Facebook and Twitter.

While some iodine is necessary in development and bodily functions, taking too much can result in significant medical problems. Fetuses and infants need some iodine for bone and neurologic development, and iodine is a necessary part of thyroid gland function. Complications can result from excessive iodine, especially from ingesting over-the-counter povidone-Iodine solutions such as betadine used to treat mild cuts and scrapes on the skin. The most common complications are related to the thyroid gland including goiter, hypothyroidism, thyroiditis, and thyroid papillary cancer. Acute poisoning can result in burning of the mouth, throat, and stomach, fever, pulmonary irritation and shortness of breath, abdominal pain, nausea, vomiting, diarrhea, weak pulse, kidney damage, neurologic changes, and/or coma.

Like ivermectin and hydroxychloroquine before it, there is no compelling evidence that iodine provides any benefit for preventing or treating COVID-19. Any assertions to its effectiveness comes from poorly done studies, studies not done in people, and studies not done with the novel coronavirus. In the case of iodine, some of the basis for its use is mere speculation based on the properties of iodine or studies done with bacteria or other viruses. 

Only In Vivo Studies In Humans Matter

The most important aspect of any medical study or trial is that the results only apply to people when they are done on humans. While evidence from in vitro (test tube, culture dish, or other medium outside a living organism) and in vivo (within the living) animal studies can provide clues to the possible effectiveness of a medication, it is vital to not make any decisions about using the medication in people based on these types of studies. The same is true of any studies not specific to COVID-19. 

There have been numerous studies that hint at iodine being effective for viruses, but most are quite a stretch to effectiveness to prevent or treat COVID in people. For example, a 2011 study using respiratory cell cultures showed that substituting iodide in a respiratory mucosal protein could boost immunity and inactivate adenoviruses and respiratory syncytial viruses. This led to a 2014 study in newborn lambs showing that injection of potassium iodide reduced the number of respiratory syncytial viruses in their respiratory system. Somehow this led to a letter to the editor in November 2020 suggesting that iodine could be a “magic bullet” to treat and prevent COVID-19, despite the fact that a coronavirus — especially SARS-CoV-2 — has never been tested.

Even in vitro studies specific to the effect of iodine on COVID are only preliminary until verified in clinical trials involving people.

Although there have been some studies done in people that show povidone-iodine can inactivate coronavirus in the mouth, the effect does not last long enough to stop coronavirus infection or reduce the severity of the disease in those already infected.

Quality Studies Are Essential

Aside from being tested in humans, before any medication can be used in people there has to be convincing evidence that it is safe and effective. This comes down to the type and quality of study done, which is a very complicated topic. For those who are able to evaluate the quality of medical studies, it is clear that the studies indicating that iodine is effective provide low-quality evidence or are poorly done. There are no studies of acceptable quality studying iodine’s effectiveness.

The lowest quality evidence for human studies try to draw conclusions based on looking at an individual person (case study) or a small group of people (case series). For example, the “magic bullet” conclusion was also based on a study showing that Mandl’s paint (composed of 1.25% iodine and 2.5% potassium iodide in peppermint oil and 90% alcohol in glycerin) may have prevented some people from getting the H2N2 influenza virus during the 1957-1958 flu pandemic and an undocumented assertion that Japanese people have less COVID-19 due to higher quantities of iodine in their diet.

The highest quality evidence comes from randomized placebo controlled trials, but there have been none studying iodine for prevention or treatment of COVID-19 in people.

All Risk with No Benefit

Infectious disease experts, other healthcare providers, and even the manufacturers of betadine are warning people not to ingest, spray, or gargle iodine as a prevention or treatment for COVID-19. It is not surprising since there is no reliable evidence to prove any benefit and many known complications.

What has been shown to be of significant benefit are the COVID vaccines, which are highly recommended by public health agencies, infectious disease experts, and other healthcare providers. Believing one physician/news networks/YouTube videos over the recommendations of the entire public health community and the overwhelming success of the vaccine seems extreme to all but the most indoctrinated anti-vaxxers.

The NeedyMeds website has a database of over 100 nationwide resources for those who have been impacted by COVID-19. For those looking for information on receiving a coronavirus vaccine, all adults and children over 12 years old can receive the vaccine free of charge. There may be options for children ages 12-18 to get vaccinated even if their parents don’t grant permission. Search online for your state’s requirements, area’s locations, and appointment availability.

The post Next Up for Anti-vaxxers – Iodine appeared first on BeMedWise.