USFDA Advisory Committee Meets to Discuss and Vote on Pfizer Vaccine for Emergency Approval

USFDA Advisory Committee Meets to Discuss and Vote on Pfizer Vaccine for Emergency Approval

With the United Kingdom’s recent rollout of the Pfizer/BionTech Covid-19 vaccine, and Canada expecting to follow suit before the end of December, the U.S. Food and Drug Administration will meet today on whether the vaccine should be approved for use in the U.S.

The meeting consists of a panel of outside experts that advises the government. The experts will discuss the efficacy of the vaccine in terms of safety and effectiveness. One of the issues that is likely to be discussed is adverse allergic events and how to address them, after two nurses in the UK had severe allergic reactions to the vaccine.

There also will be a public hearing, followed by a committee discussion and vote.  The meeting is expected to take the entire day.

If the FDA clears the drug for use, the rollout for administration  could come as early next week.

Two UK Nurses Presented with Severe Allergic Reactions Following Administration of the Pfizer Covid-19 Vaccine

Just a day after the United Kingdom implemented its national rollout of the Pfizer/ Covid-19 vaccine, health officials warn people with a history of severe allergic reactions not to participate. This warning came after two nurses suffered an allergic reaction to the vaccine.

The nurses experienced an “anaphylactoid” reaction characterized by rashes and shortness of breath. Both nurses have a history of allergic reactions and carry an EpiPen, which is a device that looks like a fat pen and delivers a dose of epinephrine. People with severe allergic reactions keep EpiPens nearby for emergency use. Both nurses recovered quickly.

The UK health officials reacted immediately with the following guidance: those with significant allergies to food, medicine, and vaccines, should not take the Pfizer vaccine. There are no preservatives in the vaccine, so more studies will be needed to determine possible causes since the clinical trials did not study individuals with a history of severe allergies.

As other companies are also producing a Covid-19 vaccine, people with severe allergic reactions may tolerate one of the other vaccines. Meanwhile, in the US, the Food and Drug Administration will convene an expert panel meeting on December 10, 2020, to determine if emergency use of the Pfizer vaccine should be approved, given its high effectiveness rate. If approved, health officials are likely to disseminate similar warnings.

A Breakthrough for the Most Serious Patients Affected by COVID-19

Drug is Available Worldwide and Inexpensive

There appears to be a significant breakthrough in the fight against COVID-19, and it comes in the form of a relatively inexpensive drug that has been available worldwide for years.


British scientists at Oxford University report Dexamethasone has reduced death rates by 35% for patients on ventilators and by 20% for those on oxygen.


Dexamethasone is a generic steroid that’s been used for 60 years to reduce inflammation in conditions such as arthritis and asthma. It is inexpensive, costing about one dollar per day in the U.S. and in many other parts of the world.

To date, it is the only drug that has shown to reduce mortality. However, the scientists noted that the drug does not appear to help patients with milder Coronavirus symptoms and who are not experiencing breathing problems.

Still, the findings represent a significant breakthrough in trial research. There has been a worldwide race to find a vaccine or cure for COVID-19, which has affected more than 8 million people and is responsible for more than 430,000 worldwide, as of this writing. Researchers remain hopeful about Remdesivir, an anti-viral drug created to fight Ebola, shown thus far, to reduce the duration of severe COVID-19 symptoms from 15 to 11 days.

Findings from the Oxford research study are in the process of being published.

Updates on this research will be published here.

Preparing for COVID-19 in Nursing Homes and Long-term Care Facilities


Nursing homes and other long-term care facilities can take steps to assess and improve their readiness to respond to the novel Coronavirus disease (COVID-19). The Centers for Disease Control (CDC) has formulated a checklist for facilities to assist in the development of a comprehensive response plan that includes these key areas:


Rapid identification and management of ill residents

Considerations for visitors and consultant staff

Supplies and resources

Sick leave policies and other occupational health considerations

Education and training

Surge capacity for staffing, equipment and supplies, and postmortem care

This tool, in conjunction with other assessments, identifies strengths and weaknesses of a facility’s current preparedness efforts. It does not describe mandatory requirements or standards. Rather, it highlights important areas for facilities to review to in order to prepare for the possibility of residents testing positive for COVID-19.

Additional information is available on the CDC website.

This link will take you to the checklist: https://www.cdc.gov/coronavirus/2019-ncov/downloads/novel-coronavirus-2019-Nursing-Homes-Preparedness-Checklist_3_13.pdf

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You can also use this short-cut: bit.ly/2vB2gaW

Edited for clarification on April 1, 2020

NOT Your Typical Coronavirus: The Difference Between a Cold, the Flu, and COVID-19

NOT Your Typical Coronavirus: The Difference Between a Cold, the Flu, and COVID-19

The Coronavirus, or COVID-19, is a new strain of coronavirus and is spreading quickly worldwide. China was the first to report the viral strain. We first heard of the outbreak in December 2019.

COVID-19 is the most serious and deadliest strain of coronavirus that scientists have identified to date. Yes, there are other strains in existence. The most common, a milder form of coronavirus, is one we are all familiar with: the common cold.

COVID-19, however, can cause severe illness and even death. The elderly and people with compromised health and immune systems, like heart and lung disease, hypertension, and diabetes, are at serious risk. Children and younger adults appear to be less affected by the virus. Many young adults exhibit mild symptoms, and some report having no symptoms despite being tested positive for the virus. But be aware– they can pass the virus on to others. Scientists don’t know why children and young adults are not as strongly affected. However, those with pre-existing health conditions may be have different risk factors.

So how can you determine if your symptoms are related to the common cold, the flu, or is COVID-19? If you have traveled out of the country where COVID-19 is quickly spreading, and it’s been within the past 14 days or less, you should seek medical treatment. 

However, do not go directly to the hospital without contacting either your physician or the hospital first. If you have COVID-19, there’s a good chance you will infect others. Healthcare professionals will ensure you get the appropriate testing and treatment, and protect other staff and patients.

Here is a symptom chart to help you determine the difference between a cold, the flu and COVID-19. It was developed by the World Health Organization and Centers for Disease Control and Prevention.

Updated Links – CNA State Requirements

In our book, “The “How-to” Guide on Becoming a Certified Nursing Assistant, we provide links to CNA resources for each state and U.S. territories.  We thought it would be cool to have this information literally at your fingertips. Very ambitious of us, indeed, because frequently websites get updated and pages are moved or links are changed.

Since our ebook was published, we’ve noticed a dozen or so URLs have changed. We updated the first group in the e-book, but have decided that we will put future updates on our blog. If the url is very long, we’ll include a short-cut or bitlink.  If the URL doesn’t work, we encourage you to try the bitlink because we noticed that it will often get you there when the organizational link won’t.

It’s our goal to check and post changes at least twice a year; quarterly if we’re really ambitious and if there’s interest.

Here’s the group of updated links for this period.

District of Columbia 

https://doh.dc.gov/service/certified-nurse-aides-licensing

http://bit.ly/2vpowyT

Georgia

https://www.mmis.georgia.gov/portal

http://bit.ly/2ujsNGS

Iowa 

http://www.dia.iowa.gov

Illinois

http://dph.illinois.gov

Kansas  

http://Kansas.gov

http://bit.ly/2bXBI87

Massachusetts 

http://mass.gov/portal

 Michigan  

http://www.michigan.gov/lara/0,4601,7-154-63294_74190—,00.html

http://bit.ly/2teE8IF

Nebraska  

http://dhhs.ne.gov/publichealth/Pages/crlCNAHome.aspx

http://bit.ly/ 2d9ZfAC

Texas  

https://hhs.texas.gov/doing-business-hhs/licensing-credentialing-regulation/nurse-aide-training-competency-evaluation-program-natcep

http://bit.ly/2tWyWGD

West Virginia  

http://ohflac.wvdhhr.org/

 

National Mental Health Awareness Month

MAY IS NATIONAL MENTAL HEALTH AWARENESS MONTH.

Mental health is often referred to as behavioral health.  Whichever you prefer, get involved.

                UNDERSTAND, EDUCATE, OBSERVE, REACH OUT, TAKE ACTION!

What can you do:

  • Raise awareness and educate the public about various mental or behavioral health disorders.
  • Understand what it’s like to live with these conditions
  • Learn how to maintain good behavioral health and wellness.
  • Take action to reduce the stigma that surrounds mental illness.
  •  Know that suicide is a precursor to some forms of behavioral health problems, such as depression or drug abuse.  Be observant and reach out.

This year’s theme is Risky Business.  As a healthcare professional, learn to recognize habits and behaviors that increase the risk of developing or exacerbating a mental illness, or possible  signs of  a behavioral health problem. Examples of risk factors include

— prescription drug misuse

— internet addiction

— excessive gambling or spending

— risky sexual behaviors.

Mental health organizations across the country are sponsoring events to raise awareness.  Check with your local mental or behavioral health organization for information and how you can help.

 

New Year New Career!

(c) Can Stock Photo/michaeljung

Hi Everyone!

If you are interested in pursing a career in health care, maybe as a Certified Nursing Assistant, and have limited knowledge or experience about the occupation, please check out our new eBook, currently on Amazon.com.

It’s called The “How-to” Guide on Becoming a Certified Nursing Assistant: Find a School, Pay for Training, Prepare for the Exam, Get a Job, Jump-start Your Career. Now through January 8, we are offering a sale on our Kindle version for .99 cents.  It’s our gift to help you get off to a great start for the New Year.

When you’re done, don’t forget to leave us feedback on Amazon and Goodreads! We would greatly appreciate it.

Enjoy!