The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, MODERNA COVID-19 VACCINE, for active immunization to prevent COVID-19 in individuals 18 years of age and older.
Moderna – Vaccination for COVID-19
MODERNA COVID-19 VACCINATION
What to Expect
Vaccines (shots) are one of the tools we have to fight the COVID-19 pandemic.
To stop this pandemic, we need to use all of our prevention tools. Vaccines are one of the most effective tools to protect your health and prevent disease. Vaccines work with your body’s natural defenses so your body will be ready to fight the virus, if you are exposed (also called immunity). Other steps, like wearing a mask that covers your nose and mouth and staying at least 6 feet away from other people you don’t live with, also help stop the spread of COVID-19.
Studies show that COVID-19 vaccines are very effective at keeping you from getting COVID-19. Experts also think that getting a COVID-19 vaccine may help keep you from getting seriously ill even if you do get COVID-19. These vaccine cannot give you the disease itself.
The vaccines are safe. The U.S. vaccine safety system makes sure that all vaccines are as safe as possible. All the COVID-19 vaccines that are being used have gone through the same safety tests and meet the same standards as any other vaccines produced through the years. A system in place across the entire country that allows CDC to watch for safety issues and make sure the vaccines stay safe.
Different types of COVID-19 vaccines will be available. Most of these vaccines are given in two shots, one at a time and spaced apart. The first shot gets your body ready. The second shot is given at least three weeks later to make sure you have full protection. If you are told you need two shots, make sure that you get both of them. The vaccines may work in slightly different ways, but all types of the vaccines will help protect you.
The vaccines may cause side effects in some people, like sore muscles, feeling tired, or mild fever. These reactions mean the vaccine is working to help teach your body how to fight COVID-19 if you are exposed. For most people, these side effects will last no longer than a day or two. Having these types of side effects does NOT mean that you have COVID-19. If you have questions about your health after your shot, call your doctor, nurse, or clinic. As with any medicine, it is rare but possible to have a serious reaction, such as not being able to breathe. It is very unlikely that this will happen, but if it does, call 911 or go to the nearest emergency room.
When you get the vaccine, you and your healthcare worker will both need to wear masks.
CDC recommends that during the pandemic, people wear a mask that covers their nose and mouth when in contact with others outside their household, when in healthcare facilities, and when receiving any vaccine, including a COVID-19 vaccine.
Even after you get your vaccine, you will need to keep wearing a mask that covers your nose and mouth, washing your hands often, and staying at least 6 feet away from other people you do not live with. This gives you and others the best protection from catching the virus. Right now, experts don’t know how long the vaccine will protect you, so it’s a good idea to continue following the guidelines from CDC and your health department. We also know not everyone will be able to get vaccinated right away, so it’s still important to protect yourself and others.
Bamlanivimab is authorized for use under an Emergency Use Authorization (EUA) for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
A Neutralizing Monoclonal Antibody Treatment for COVID-19
WHAT IS BAMLANIVIMAB?
Clinical trials have shown that monoclonal antibodies may be effective in treating COVID-19. Lilly in partnership with AbCellera has developed a monoclonal antibody called bamlanivimab. Bamlanivimab is a recombinant neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARSCoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus.
Healthcare providers must submit a report on all medication errors and ALL serious adverse events potentially related to bamlanivimab
*Denotes incidence lower than placebo
- Nausea (3%)*
- Dizziness (3%)
- Headache (3%)
- Pruritus (2%)
- Immediate nonserious hypersensitivity (2%)
- Diarrhea (1%)*
- Vomiting (1%)*
IV Bamlanivimab must be administered immediately after a positive COVID-19 test and within 10 days of onset of symptoms
Patients must have at least one of the following:
- Body Mass Index greater to or equal to 35
- Chronic Kidney Disease
- Immunosuppressive Disease (i.e. CVID)
- Currently receiving immunosuppressive treatment
- ≥ 65 years of age
- ≥ 55 years of age, AND have at least one of the following: Cardiovascular disease, Hypertension, COPD or other respiratory disease
Patients meeting any of the following criteria are NOT ELIGIBLE for Bamlanivimab therapy
- Hospitalized due to COVID-19
- Require oxygen therapy due to COVID-19
- Require an increase in baseline oxygen flow rate due to COVID-19 and those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
Bamlanivimab – Important Resources
Listed below are links to informative websites and PDFs containing important information intended for healthcare providers or patients
State, territorial, and local public health officials along with individual sites of care looking for assistance with operationalizing the administration of bamlanivimab may view the Bamlanivimab Antibody Playbook.
These PDFs and links will help provide more details of Eli Lilly’s efforts to respond to the COVID-19 pandemic.
These hyperlinks will take the viewer to a website external to Lilly.com