MCESDA Disaster Digest

The World Health Organization (WHO) has recently announced the emergence of a new concerning strain of COVID-19.  It has been named the Omicron variant, and while it may take weeks to know the full scope of what to expect from this variant, here is some of what we know.

• Omicron has been found in many countries.  The Omicron variant was initially reported to WHO by South African doctors who noticed a drastically different symptom profile among some patients.  However, with further investigation, Omicron has been found in Australia, Canada, Hong Kong, and many Western European countries.  This has lead to travel restrictions between the United States and African countries, which can be found in more detail on the CDC webpage (link).
• Symptoms are different than other strains.  Patients with the Omicron variant have reported milder symptoms.  This variant does not produce the loss of taste or smell that has been characteristic of other COVID-19 variants.  Instead, there may be a throat soreness or “scratchiness”, much like some other respiratory diseases.  Fatigue and body aches are also reported by patients.
• Possibility of Reinfection.  While the milder symptoms of Omicron are promising, the mutation of the virus means that less immunity for those who have had other variants of COVID-19.  It has also led to increased infectivity and less effectiveness from the available vaccines.
• Treatable and Preventable.  The good news is that treatment and prevention of the Omicron Variant is the same as other forms of COVID-19.  The vaccine still reduces transmission and severity of the illness, particularly for those with a 3rd dose “booster”.  Transmission can be prevented by the same behaviors the CDC has recommended throughout 2020: socially distance when possible, wash your hands, and wear a mask in public.

The Omicron Variant has yet to enter McDonough County, but we will keep you updated on any announcements and best practices to keep you safe during this holiday season.

Stay Well!

Information originally published through AP News

As of today, November 3rd, Pfizer has been approved for use in children 5-11 years old.  The pediatric Pfizer, like the adult dose, requires two shots three weeks apart.  While the dose is lower, it has still been proven to be 91% effective in preventing symptomatic COVID-19.  No major side effects have been found in this age group, but mild fever and aches may occur.

We are excited for this latest development and will keep you up to date on when the pediatric doses of Pfizer arrive in McDonough County.

We are still celebrating National Preparedness Week, and week 2’s theme is “Make a kit”.  Here is a sneak peak into what I have in my preparedness kit.  What’s in your kit?

Information adapted from Ready.gov

Every good Emergency Plan starts with one question…

No, not what if T’Challa was a Starlord or if Peggy became Captain Carter.  We’re talking about the “What if’s” that you and your family can plan for.  “What if something happens when I’m not with my family?”, “How will I know they are safe?”, “How will I reach them?”.  Planning in advance can help keep your family calm, safe, and together in the event of a disaster.  Here are three easy steps to start the process of answering your “what if’s”.

1. Collect

Collect any relevant information you would need in a disaster.  Start with important contact information, not only for relatives and other loved ones, but also for important service providers, such as doctors, caregivers, and your workplace.  Collect information on designated gathering places if you had to leave your area in an evacuation.

2. Share

Now that you have your information, share it with those who need it.  It’s best to have both digital and paper copies of this information, because a disaster can make accessing computers or reliable phone signals difficult.  Give paper copies to family, friends and caregivers who may need to assist in a disaster.  Perhaps leave copies at your workplace or other important locations.  On our website we have handy printable versions that can be filled out and kept in a wallet, purse or backpack (check it out here!).  You may also want to have a contact saved as “In case of emergency” saved in your phone to make accessing your emergency contacts easy for those who may be responding.

3. Practice

Communications is a great start for your plan, but now it’s time to commit to it with practice.  Create small drills where your household family members practice what you would do during an emergency.  This can be done as creatively as you want!  You can create a monthly routine of sending out a test message and seeing how long it takes to respond, or have a yearly drill of practicing getting to your emergency location destinations.  You might want to memorize some of the most important numbers on your contact lists, and quiz each other over dinner.  The point is that your plan is not just sitting in your wallet or purse, but being practiced and adapted until you know it well.

This is just a shortened explanation of how you can get started in creating family emergency plans.  For more extensive reading, I highly recommend this nifty Family Communication Plan (link).  It also comes with a checklist and a printable contact list.

Stay safe and happy National Preparedness Month!

Today is September 1st, which means it’s the first day of National Preparedness Month.

The 2021 theme is “Prepare to Protect. Preparing for disasters is protecting everyone you love.”  All month long we will be sharing tips and preparedness information on how to protect you and the important people in your life.

Check in tomorrow where we dive into the first week’s theme: Make a Plan

Take care of yourselves, and each other, McDonough County!

Good news, McDonough County.  The Pfizer vaccine is officially FDA approved!  The Pfizer vaccine has been safely administered with Emergency Use Authority (EUA)  in McDonough County since the beginning of 2021.  Hopefully even more of the population will be reached now with FDA approval.  McDonough County offers the Pfizer vaccine, i.e. Comirnaty, at walk-in clinics.  More information can be found at getyourcovidshot.com.

Below is the official FDA press release, which can also be read on the FDA’s website:

FDA APPROVES FIRST COVID-19 VACCINE

Today, the U.S. Food and Drug Administration 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 (koe-mir’-na-tee), 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.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. 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-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

Related Information