Now offering Walk-In Pfizer Covid-19 Vaccines for Ages 5-11! Vaccine Hours are Weekdays 9:30am-11:30, 1:30pm-4:30pm

PFIZER AND BIONTECH RECEIVE FIRST U.S. FDA EMERGENCY USE AUTHORIZATION OF A COVID-19 VACCINE IN CHILDREN AGES 5 THROUGH 11 YEARS

Friday, October 29, 2021 – 05:45pm
  • Emergency Use Authorization (EUA) is supported by clinical data showing a favorable safety profile and high vaccine efficacy of 90.7% in children 5 through 11 years of age during a period when Delta was the prevalent strain
  • With this authorization, the Pfizer-BioNTech COVID-19 Vaccine is currently the only COVID-19 vaccine available in the U.S. for use in this age group
  • FDA action represents an important milestone with the potential to help protect millions of school-aged children from COVID-19 infection

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211029005549/en/

“This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Over 6 million children in the U.S. have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”

“Today’s emergency use authorization is supported by clinical data showing a favorable safety profile and high vaccine efficacy in children, underlining its potential to address a current public health need,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “As children 5 through 11 get reacclimated to the new school year, both in and out of the classroom, our goal is to help keep them safe and protected and get them back to normalcy.”

The FDA based its decision on data from a Phase 2/3 randomized, controlled trial that included ~4,500 children 5 through 11 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Results from this trial were reviewed by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC). In the trial, the vaccine demonstrated a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.

The companies will begin shipping 10-µg pediatric doses immediately, as directed by the U.S. government (ages referred to as 5y to <12y on the vial and 5 to <12 years on the carton). Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines.

As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet next week to discuss a potential recommendation for the use and rollout of the vaccine to children 5 through 11 years of age. Pediatric vaccinations are anticipated to start, subject to, and after, CDC endorses the ACIP recommendation.

Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency. Initial data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children – those 2 to <5 years of age and those 6 months to <2 years of age – are expected as soon as fourth quarter 2021 or early first quarter 2022.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned or ongoing.

U.S. INDICATION & AUTHORIZED USE

HOW IS THE VACCINE GIVEN?
The vaccine will be given as an injection into the muscle.

Primary Series:
In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

  • A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals:
    • 65 years of age and older
    • 18 through 64 years of age at high risk of severe COVID-19
    • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
  • A single booster dose of the vaccine may be administered to certain individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding eligibility for, and timing of, the booster dose

WHAT IS THE INDICATION AND AUTHORIZED USE?

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

  • a 2-dose primary series to individuals 5 years of age and older
  • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
  • a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:
    • 65 years of age and older
    • 18 through 64 years of age at high risk of severe COVID-19
    • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
  • a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series

COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

  • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
  • It is also authorized under EUA to provide:
  • a 2-dose primary series to individuals 12 through 15 years
  • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
  • a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:
    • 65 years of age and older
    • 18 through 64 years of age at high risk of severe COVID-19
    • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
  • a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series

EUA Statement

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com

IMPORTANT SAFETY INFORMATION

Individuals should not get the vaccine if they:

  • had a severe allergic reaction after a previous dose of this vaccine
  • had a severe allergic reaction to any ingredient of this vaccine

Individuals should tell the vaccination provider about all of their medical conditions, including if they:

  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects the immune system
  • are pregnant, plan to become pregnant, or are breastfeeding
  • have receivedanother COVID-19 vaccine
  • Have ever fainted in association with an injection

The vaccine may not protect everyone.

Side effects reported with the vaccine include:

  • There is a remote chance that the vaccine could cause a severe allergic reaction
    • A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
    • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
    • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
  • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
    • chest pain
    • shortness of breath
    • feelings of having a fast-beating, fluttering, or pounding heart
  • Additional side effects that have been reported with the vaccine include:
    • severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite;diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
  • These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away

Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1‐800- 822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

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Fact Sheets and Prescribing Information for individuals 12 years of age and older

Full Prescribing Information (16 years of age and older) 
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap 
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap 
Recipients and Caregivers Fact Sheet (12 years of age and older)

Fact Sheets for individuals 5 through 11 years of age

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap 
Recipients and Caregivers Fact Sheet (5 through 11 years of age)

About Pfizer: Breakthroughs That Change Patients’ Lives

CDC pauses Johnson & Johnson Vaccine 4-13-2021

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

The following statement is attributed to Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research

Media Statement

For Immediate Release: Tuesday, April 13, 2021
Contact: Media Relations
(404) 639-3286

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon.

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.

18+ are eligible to sign up for Covid 19 Vaccines starting 3/29/21!

Federal Retail Pharmacy Program Able To Vaccinate 18 And Older

For Immediate Release: 3/26/2021

MEDIA CONTACTS
Rich Jefferson, (531) 530-7522, rich.jefferson@nebraska.gov
Khalilah LeGrand, (402) 471-9313, khalilah.legrand@nebraska.gov

LINCOLN – With a number of Nebraska’s pharmacies participating in the Federal Retail Pharmacy Program, starting Monday, March 29 these entities will be able to vaccinate residents 18 and older. These sites are all accessible to the public and still vaccinating individuals in the current priority phase, 2A to include 65 and older, along with frontline essential workers in healthcare, EMS, first responders, teachers K-12, grocery workers, public transit workers, law enforcement, childcare workers, food and agriculture workers, and corrections officers/staff.

Doses available at pharmacy locations are in addition to the state’s weekly allocation of first and second doses being administered by Nebraska’s 19 local health departments. Some parts of the state are already vaccinating younger ages and can decrease the age to ensure that schedules remain full. State Directed Health Measure (DHM) changes that will go into effect Monday, March 29 at 12:00 a.m. consist of the following changes to the Federal Retail Pharmacy program requirements:

  • Removing the targeted age groups and critical infrastructure worker criteria, Retail Pharmacy Program partners criteria will be adjusted to allow them to vaccinate anyone 18 and older
  • Removing the requirement for Retail Pharmacy Program partners to coordinating scheduling with their respective local health departments and use the state designated COVID-19 vaccine registration and scheduling system.

While more pharmacies could become eligible in the future, the full list of pharmacies is as follows:

  • 113 South 4th  St., Albion NE 68620 – Wells Drug
  • 2409 Box Butte Ave., Alliance NE 69301 – Alliance Community Pharmacy
  • 1401 Silver St., Ashland NE 68003 – Ashland Pharmacy Inc.
  • 501 Court St., Beatrice NE 68310 – Clabaugh Pharmacy
  • 1882 Holly St., Blair NE 68008 – Walmart
  • 510 Linden St., Chadron NE 69337 – Walmart
  • 818 E 23RD St., Columbus NE 68601 – Walmart
  • 1800 E 29TH St., Crete NE 68333 – Walmart
  • 1003 S Main St. Ste 2, Emerson NE 68733 – Emerson Apothecary
  • 2831 Highway 15, Fairbury NE 68352 – Walmart
  • 3010 E 23RD St., Fremont NE 68025 – Walmart
  • 1014 G St., Geneva NE 68361 – Weaver Pharmacy
  • 1021 W 14TH, Hastings NE 68901 – Bert’s Prescription Pharmacy
  • 3803 Osborn Dr., W Hastings NE 68901 – Walmart
  • 2706 2ND Ave. Ste A, Kearney NE 68847 – Medicap Pharmacy #8342
  • 5411 2ND Ave., Kearney NE 68847 – Walmart
  • 133 S 7TH St., Loup City NE 68853 – Loup City RX Shoppe
  • 200 Frontier St., Lexington NE 68850 – Walmart
  • 1902 W B St., McCook NE 69001 – Walmart
  • 2101 S 11TH St., Nebraska City NE 68410 – Walmart
  • 2400 W Pasewalk Ave., Norfolk NE 68701 – Walmart
  • 1401 S Dewey St., North Platte NE 69101 – Walmart
  • 201 Pony Express Lane, Ogallala NE 69153 – Walmart
  • 15615 Pacific St. Suite 8, Omaha NE 668118 – Medicine Man Pharmacy
  • 710 West Center Road, Omaha NE 68106 – Think Aksarben Pharmacy LLC
  • 825 North 90th St., Omaha NE 68114 – ViaRx
  • 317 East Douglas St., O’Neill NE 68763 – O’Neill Family Pharmacy
  • 3322 Ave. I, Scottsbluff NE 69361 – Walmart
  • 1601 Cornhusker Dr., South Sioux City NE 68776 – Walmart
  • 803 Providence Road Ste 101, Wayne NE 68787 – Providence Medical Center
  • 1024 Ave. E Ste 100, Pender NE 68791 – Wisner Apothecary
  • 101 E David Dr., York NE 68467 – Walmart

Recently Added Pharmacies

  • 2510 Bellevue Md. Ctr. Dr. Ste 100, Bellevue NE 68123 – The Nebraska Medical Center Bellevue Pharmacy
  • 422 5TH St., David City NE 68632 – David City Discount Pharmacy
  • 115 Wilmar Ave., Grand Island NE 68803 – Hy-Vee Pharmacy
  • 500 N Hastings Ave., Hastings NE 68901 – Keith’s Drive In Drug
  • 1221 N Cotner Blvd. Ste 1, Lincoln NE 68505 (Relycare Pharmacy)
  • 5010 O St., Lincoln NE 68510 (Hy-Vee Pharmacy)
  • 5150 Center, Omaha NE 68106 NE – Hy-Vee Pharmacy
  • 1000 South 178th St., Omaha NE 68118 – Hy-Vee Pharmacy
  • 14591 Stony Brook Blvd., Omaha NE 68137 – Hy-Vee Pharmacy
  • 4014 Leavenworth St., Omaha NE 68198 – Nebraska Medicine Pharmacy at Lauritzen Outpatient Center
  • 2915 Leavenworth St., Omaha NE 68105 – Kohll’s Rx
  • 1429 M St., Ord NE 68862 – Anderson Pharmacy
  • 11650 S. 73RD St., Papillion NE 68046 – Hy-Vee Pharmacy
  • 412 S 13th St. Ste. A, Tekamah NE 68061 – Tekamah Drug Company

Opening up the age range for this program allows Nebraskans to visit a pharmacy anywhere regardless of jurisdiction and speeds up vaccination efforts across the state.  For example, if a resident in one district wants to schedule an appointment for vaccination in another county that has availability, they can. Those interested in being vaccinated should check with surrounding pharmacies for scheduling ability as allocations and availability may differ based on demand.

Walmart Kohll’s  and Hy-Vee  are among pharmacies in Nebraska that currently have public scheduling portals. Individuals can also register on the state site, at Vaccinate.Ne.Gov .  Registration for a COVID-19 vaccine allows individuals to receive updates, scheduling information and follow-up reminders about vaccination, as supplies are made available in their area. Pharmacies are to coordinate with their local health department to help ensure doses are distributed appropriately to currently eligible populations, as supplies are available.

DHHS continues to share COVID-19 and vaccine information via its Coronavirus website, as well as Facebook and Twitter. The DHHS COVID-19 information line is available to help answer questions on COVID-19 or vaccination. Available by calling (531) 249-1873 or (833) 998-2275, the line is staffed daily from 8 a.m. to 8 p.m. CT. Relay calls for deaf and hard of hearing and Language Line access is available.

65+ and educators can sign up online now

We are having online scheduling for those 65 years of age and older plus educators.  We currently have Moderna and Janssen (Johnson & Johnson) Covid Vaccines.  Here are EUA’s of each to make an informed decision.  Moderna does require a second appointment for the booster 28 days later.  We will verify at your first appointment.  Janssen is just a one shot vaccine.  We ask that you bring your driver’s license and MedicareB (red white and blue) card or insurance card.  If you do not have insurance, you will still be able to receive it at no cost.

Janssen EUA   https://www.fda.gov/media/146305/download

Moderna EUA https://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdf

1st Vaccine for Moderna Online signup is https://ashlandpharmacy.as.me/covidmoderna

Janssen Johnson& Johnson Covid Vaccine online signup is https://ashlandpharmacy.as.me/covidjanssen

 

Covid-19

Wow! So much is changing daily, so I will post what I know – The only constant is change! We have been selected as a tier 1 Covid-19 Vaccinating Pharmacy! Because of the demand (thank goodness) we are having a Wait List Signup that can be found on our homepage. Just click on it and it will lead you right to the correct site to add your contact information. We will contact you when a) we get the vaccine b) you are eligible by the State of Nebraska protocol guidelines. It is a good day when we can get vaccines in people’s arms! Let’s do this!