We have received some At Home Rapid Antigen Tests! $24.99 while supplies last!
We have received some At Home Rapid Antigen Tests! $24.99 while supplies last!
CDC expands COVID-19 booster recommendations for Pfizer and Moderna vaccines: The U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for the Pfizer and Moderna COVID-19 Vaccines, shortening the time to five months between completion of a primary series of vaccine and a booster dose and allowing for immunocompromised children, ages 5-18, to receive a third primary series dose.
The CDC recommends:
Visit www.fda.gov/covid19vaccines for additional vaccine information.
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.
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.
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
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:
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
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.
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
About Pfizer: Breakthroughs That Change Patients’ Lives
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
For Immediate Release: Tuesday, April 13, 2021
Contact: Media Relations
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.
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:
While more pharmacies could become eligible in the future, the full list of pharmacies is as follows:
Recently Added Pharmacies
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.
We will have more Moderna appointments for March 13 and March 14 but the Janssen order wasn’t fulfilled and no expected date has been given to us.
Click on following link to see if you are in Phase 1B: You are now eligible to sign up for a Covid -19 Vaccine. We will have both Moderna and Janssen (Johnson and Johnson) appointments available when we get more in. Check back after 9:30am on 3/10/21 to see available times.
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
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
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!