Scientific Data for COVID-19 Vaccine Suppliers
Table of Contents
The Facilities for Illness Management and Prevention (CDC) has a number of coaching packages associated to vaccine administration. You should utilize this that can assist you put together to manage the vaccine.
Step-By-Step Information
Step 1: Vaccine producer submits new vaccine knowledge to FDA
Step 2: New vaccine knowledge is reviewed by the FDA, ACIP, and the Western States Scientific Security Evaluation Workgroup (WSSSRW)
Step 3: Approval by the FDA, ACIP, and the WSSSRW
Step 4: Standing orders are up to date at supplier workplaces for administration of vaccine primarily based on new suggestions
- Supplier places providing COVID-19 vaccines might look forward to Facilities for Illness Management and Prevention (CDC) to replace their standing orders or for Washington State signed standing orders, earlier than they’re in a position to administer the vaccine primarily based off the brand new suggestion.
Step 5: Vaccine recipients use Vaccine Locator to find out the place the brand new up to date vaccine suggestion is being provided or contact the supplier location previous to their appointment to verify on availability
What Are Standing Orders?
Standing orders are protocols that permit non supplier medical workers akin to nurses and medical assistants to manage sure vaccines with out examination or direct order from the attending supplier. Below state regulation, nurses and medical help might administer vaccines solely underneath prescription of sure sorts of prescribers akin to a doctor. Standing orders permit physicians to approve vaccination for all eligible sufferers in a given healthcare setting without delay, without having to individually prescribe vaccines to every affected person. The usage of standing orders for vaccination is beneficial by the CDC, the Advisory Committee on Immunization Practices as a result of it may well save time and scale back missed alternatives for vaccination.
Extra Issues
The ACIP might not at all times handle a brand new vaccine suggestion straight away. In these instances, suppliers can replace standing order suggestions after approval from the Western States Scientific Evaluation Workgroup.
An further dose is for sufferers who accomplished the preliminary vaccine collection however did not have a robust sufficient immune response. A booster dose is for sufferers when it is possible that their immunity after the preliminary vaccine collection waned over time.
The Facilities for Illness Management and Prevention (CDC) and the Western States Scientific Evaluation Workgroup suggest a booster dose for everybody 12 years and older.
CDC additionally beneficial an extra dose of mRNA (Pfizer-BioNTech or Moderna) COVID-19 vaccines for sure immunocompromised teams. These sufferers can also get a booster (fourth) dose after getting the extra (third) dose.
| Who Will get It | When to Get It | |
|---|---|---|
|
Extra dose |
People who find themselves immunocompromised and obtained an mRNA COVID-19 vaccine.* See the Facilities for Illness Management and Prevention’s (CDC) interim medical issues for an inventory of immunocompromising situations. |
No less than 28 days after your second dose of mRNA COVID-19 vaccine. |
|
Booster dose |
Folks 18 years and older who obtained the Johnson & Johnson COVID-19 vaccine as their major collection. | No less than two months after your first dose. |
|
Folks 12 years and older who obtained the Pfizer-BioNTech COVID-19 vaccine as their major collection. |
No less than 5 months after your second dose.** For sufferers who’re reasonably to severely immunocompromised, not less than 5 months after the affected person’s further (third) dose. |
|
|
Folks 18 years and older who obtained the Moderna COVID-19 vaccine as their major collection. |
No less than 5 months after your second dose.** For sufferers who’re reasonably to severely immunocompromised, not less than 5 months after the affected person’s further (third) dose. |
*Use the identical vaccine model because the affected person’s preliminary vaccine collection, if potential. If you do not have it obtainable, the opposite mRNA vaccine model could also be used.
**For booster doses, sufferers 18 years and older can get the identical or a unique vaccine for his or her booster dose than they obtained for his or her major collection. Nevertheless, folks ages 17 and youthful might solely get the Pfizer COVID-19 vaccine for his or her booster dose.
Please don’t administer any doses of vaccine past the doses beneficial by CDC, even when your affected person requests it. Additionally, please don’t administer any doses of vaccine to somebody outdoors of the beneficial age vary for that vaccine or dose.
The Facilities for Illness Management and Prevention (CDC) recommends an extra dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines solely to sure immunocompromised teams, together with sufferers who’ve:
- Been receiving lively most cancers therapy for tumors or cancers of the blood
- Acquired an organ transplant and are taking medication to suppress their immune system
- Acquired a stem cell transplant within the final two years or are taking medication to suppress their immune system
- Reasonable or extreme major immunodeficiency (akin to DiGeorge syndrome or Wiskott-Aldrich syndrome)
- Superior or untreated HIV an infection
- Been receiving lively therapy with high-dose corticosteroids or different medication that will suppress your immune system
You will discover extra info on further doses for immunocompromised folks in CDC’s interim medical issues for COVID-19 vaccines.
The Facilities for Illness Management and Prevention (CDC) and the Western States Scientific Security Evaluation Workgroup suggest a booster dose for everybody 5 years and older.
We do not know the protection or efficacy of giving somebody a COVID-19 vaccine approved or accepted in the USA after they obtained a COVID-19 vaccine not approved or accepted by the U.S. Meals and Drug Administration (FDA).
Though they don’t seem to be approved by the FDA, the Facilities for Illness Management and Prevention (CDC) doesn’t suggest revaccinating sufferers who accomplished a COVID-19 vaccine collection approved by the World Well being Group (WHO). Nevertheless, CDC recommends suppliers provide an FDA approved or accepted COVID-19 vaccine to sufferers who:
- Partially accomplished a COVID-19 vaccine collection approved by WHO
- Partially accomplished or accomplished a COVID-19 vaccine collection not approved by the FDA or WHO
For extra info, see the interim medical issues for COVID-19 vaccines.
You’ll have sufferers who accomplished a COVID-19 vaccine collection as a part of a U.S.-based medical trial involving a COVID-19 vaccine not at the moment approved by the U.S. Meals and Drug Administration (FDA).
| Affected person vaccinated with a medical trial COVID-19 vaccine not approved or accepted by the FDA however listed for emergency use by the World Well being Group (WHO), such because the AstraZeneca COVID-19 vaccine. | Lively vaccine |
Don’t give the affected person any further doses. Thought of totally vaccinated two weeks after finishing the collection. |
| Placebo |
Not thought of totally vaccinated. Supply an FDA-authorized or FDA-approved COVID-19 vaccine. Encourage sufferers to observe present prevention measures. |
|
| Affected person vaccinated with a medical trial COVID-19 vaccine not approved or accepted by FDA or listed by WHO, such because the Novavax COVID-19 vaccine. | Lively vaccine |
Test if an impartial group (e.g., a knowledge and security monitoring board) confirmed the vaccine’s efficacy. If confirmed, your affected person is taken into account totally vaccinated two weeks after finishing the collection. Don’t give the affected person any further doses. |
| Placebo |
Not thought of totally vaccinated. Supply an FDA-authorized or FDA-approved COVID-19 vaccine collection. Encourage sufferers to observe present prevention measures. |
For extra info, please see the Facilities for Illness Management and Prevention’s (CDC) medical issues for COVID-19 vaccines.
On Might 6, 2022, the U.S. Meals and Drug Administration restricted the approved use of the Johnson & Johnson (Janssen) COVID-19 vaccine.
Learn their full assertion.
DOH has rescinded standing orders for J&J. There should be conditions the place that is the most suitable choice for vaccination. Please evaluation the FDA steering for additional particulars.
When you want to nonetheless administer J&J, it’s essential to accomplish that underneath your inner ordering course of, which may embody your individual standing orders.
No, the Advisory Committee on Immunization Practices (ACIP) doesn’t suggest titer testing earlier than vaccination
It is best to use the identical vaccine model to manage further doses to immunocompromised sufferers. Nevertheless, if you do not have the identical model obtainable, the opposite mRNA vaccine model could also be used.
For booster doses, sufferers 18 years and older can get the identical or a unique vaccine model than they obtained for his or her major collection. Nevertheless, folks ages 17 and youthful might solely get the Pfizer COVID-19 vaccine for his or her booster dose as a result of it is at the moment the one vaccine approved for this age group.
The Advisory Committee on Immunization Practices (ACIP) beneficial the next age teams to obtain vaccine:
- Pfizer-BioNTech vaccine: 5 years and older
- Moderna vaccine:18 years and older
- Johnson & Johnson – Janssen vaccine: 18 years and older
The Pfizer and Moderna vaccines are beneficial over the J&J vaccine as a result of uncommon threat of TTS (Thrombosis with Thrombocytopenia Syndrome), a situation during which a low blood platelet degree interferes with the formation of blood clots, and GBS (Guillain-Barré Syndrome), an autoimmune dysfunction which may end up in everlasting nerve injury.
Sure. You’ll be able to vaccinate folks ages 5 and over with the Pfizer-BioNTech vaccine. Youth who’re 5 to 17 years of age might have consent from a guardian or guardian to get the vaccine, except they’re legally emancipated.
When you have questions on what you’ll be able to settle for as parental consent, please seek the advice of your authorized counsel. In case your workplace or group already has steering on this for different vaccines, chances are you’ll want to seek the advice of these as effectively. You should utilize this pattern consent for minor vaccination as a place to begin.
Sure, knowledge present that COVID-19 vaccines are protected throughout being pregnant. The Facilities for Illness Management and Prevention (CDC), American School of Obstetricians and Gynecologists (ACOG), and Society for Maternal-Fetal Drugs (SMFM) suggest the COVID-19 vaccine for people who find themselves pregnant, lactating, or planning to get pregnant. Some research present {that a} vaccinated guardian may even go antibodies towards COVID-19 alongside to their child via being pregnant and lactation. Unvaccinated pregnant individuals who get COVID-19 are at elevated threat of extreme issues like preterm beginning or stillbirth. As well as, individuals who get COVID-19 whereas pregnant are two to 3 instances extra prone to want superior life help and a respiration tube.
You’ll be able to learn extra in regards to the suggestion from the American School of Obstetricians and Gynecologists (ACOG) and check with sources on this record from ACOG. You too can use these speaking factors on reproductive well being to reply affected person questions.
Usually, the COVID-19 vaccines shouldn’t be given to anybody who’s underneath the approved age or has a historical past of extreme allergic reactions to an ingredient or earlier dose of the COVID-19 vaccines.
Pfizer-BioNTech
The Pfizer COVID-19 vaccine shouldn’t be given to anybody:
- Below 5 years of age
- With a historical past of extreme or instant allergic reactions to an ingredient of the Pfizer-BioNTech vaccine, akin to polyethylene glycol or polysorbate
- Who had a extreme or instant allergic response to their first dose of an mRNA COVID-19 vaccine (Pfizer or Moderna)
Moderna
The Moderna COVID-19 vaccine shouldn’t be given to anybody:
- Below 18 years of age till additional analysis could be finished on the usage of the vaccine for youngsters
- With a historical past of extreme or instant allergic reactions to an ingredient of the Moderna vaccine, akin to polyethylene glycol or polysorbate
- Who had a extreme or instant allergic response to their first dose of an mRNA COVID-19 vaccine (Pfizer or Moderna)
Johnson & Johnson – Janssen
See the Advisory Committee on Immunization Practices’ (ACIP) interim medical issues for COVID-19 vaccines for extra info.
The COVID-19 vaccines shouldn’t be given to folks with a identified historical past of extreme allergic response, akin to anaphylaxis, to any ingredient or a earlier dose of the COVID-19 vaccines.
Individuals who have had a extreme allergic response to different vaccines or injectable therapies should be capable of obtain this vaccine. Nevertheless, suppliers ought to do a threat evaluation and counsel them in regards to the potential dangers. If the affected person decides to get the vaccine, suppliers ought to observe them for half-hour to watch for any instant reactions. Individuals who report having delicate or childhood allergic reactions to medicines or vaccines should get the vaccine.
See the Advisory Committee on Immunization Practices’ (ACIP) interim medical issues for COVID-19 vaccines for extra info.
Individuals who at the moment have COVID-19 ought to wait to get vaccinated till they really feel higher and their isolation interval is completed if potential. Folks just lately contaminated with COVID-19 can select to attend as much as 90 days after their sickness passes earlier than getting vaccinated.
Individuals who have been just lately uncovered to COVID-19 also needs to wait to get the vaccine till after their quarantine interval, if they can safely quarantine away from different folks. If there’s a excessive threat they may infect others, they could be vaccinated throughout their quarantine interval to forestall spreading the illness. Suppliers ought to take steps to make sure the setting is protected to guard others in the course of the vaccination.
Sure, the Advisory Committee on Immunization Practices (ACIP) recommends anybody who beforehand had COVID-19 to get the vaccine. A historical past of getting COVID-19 does not have an effect on the advice.
Sure. The Advisory Committee on Immunization Practices (ACIP) modified their suggestions on Might 12, 2021. Now you can administer COVID-19 vaccines and different vaccines to sufferers with out ready 14 days.
Sure, you’ll be able to nonetheless get a COVID-19 check after just lately getting vaccinated. It won’t have an effect on the outcomes of a SARS-CoV-2 nucleic acid amplification or antigen check.
No, sufferers don’t have to reschedule their screening mammogram in the event that they have been just lately vaccinated. The COVID-19 vaccine might trigger swollen lymph nodes, or unilateral lymphadenopathy, after administration and in some instances, it will likely be necessary to make sure additional analysis. It is best to:
- Replace your affected person consumption types to ask if sufferers have obtained the COVID-19 vaccine, once they obtained it, and which arm they obtained it in.
- Do a diagnostic work up for the swollen lymph nodes for individuals who obtained the COVID-19 vaccine within the final 4 weeks, however think about scheduling a follow-up examination in 4 to 12 weeks after they end the COVID-19 vaccine collection.
- Whether it is potential and does not delay care, schedule the screening examination earlier than the affected person’s first dose of a COVID-19 vaccination or 4 to 6 weeks after they end the COVID-19 vaccine collection.
You’ll be able to learn extra in regards to the suggestion from the Society of Breast Imaging.
