Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States
By Nufactor, Inc. - March 5, 2021   | Download Article |

Some patients and prescribers have contacted us asking if a patient should receive the COVID-19 vaccine and the timing in relation to their Nufactor therapy. While it is generally thought everyone should be vaccinated to protect against COVID-19, we know it is important to consider each patient's medical history and risks and therefore have been directing patients back to prescribers.

We would like to share the CDC's link to Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. The information is frequently updated so it is important to check for current information. Some highlights as of March 5, 2021 are below.

Administration

Currently there are three vaccines approved by the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). There are other vaccines being tested and they may soon be approved.

• Pfizer-BioNTech (mRNA type): 30 μg/0.3 ml; two doses 3 weeks (21 days) apart; authorized in ages >16 years
• Moderna (mRNA type): 100 μg/0.5 ml; two doses 1 month (28 days) apart; authorized in ages >18 years
• Janssen [Johnson & Johnson] (viral vector type): 5×1010 viral particles/0.5 ml; one single dose; authorized in ages >18 years
• For vaccines requiring 2 doses, persons should be scheduled to receive the second dose on time. However, second doses may be administered within a grace period of 4 days earlier than and up to 42 days after the first dose

Interchangeability with other COVID-19 vaccines

Vaccines are not interchangeable. In exceptional situations in which the vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the 2nd dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time.

Vaccination of persons with COVID-19 infection or exposure

Vaccination should be offered to persons even if they have previously had COVID-19 infection (symptomatic or asymptomatic). Vaccination of persons with known current infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and criteria have been met for them to discontinue isolation. This recommendation also applies to those who experience infection after the first dose but before receipt of the second dose.

While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of reinfection is low in the months after initial infection but may increase with time due to waning immunity. While vaccine supply remains limited, it may be appropriate for persons with recent documented acute infection to temporarily delay vaccination.

Vaccination while receiving immune globulin therapy (IVIG, SCIG, HyQvia)

Immune globulin and COVID-19 vaccine can be administered either at the same time or at any time before or after receiving immune globulin.

Coadministration with other vaccines

There is not a lot of information on receiving COVID-19 vaccine and other vaccines. Vaccines should be administered alone, with a minimum of 14 days before or after administration of any other vaccine. However, vaccines may be administered within a shorter period in situations where the benefits of vaccination are thought to outweigh the potential unknown risks.

TB testing

The vaccine should not be delayed because of testing for TB infection. Testing for TB infection with one of the immune-based methods, either the tuberculin skin test (TST) or an interferon release assay (IGRA), can be done before or during the same encounter as the mRNA COVID-19 vaccination. When testing with TST or IGRA cannot be done at the same time as vaccination, these tests should be delayed ≥4 weeks after the completion of vaccination but generally should not be cancelled.

Certain underlying medical conditions

Nufactor treats patients with autoimmune conditions, including CIDP, myasthenia gravis, MMN, pemphigus, dermatomyositis, polymyositis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, and others. Currently there is no data on safety and effectiveness of COVID-19 vaccination in persons with autoimmune conditions. However, persons with autoimmune conditions who have no contraindications to vaccination may receive the COVID-19 vaccine.

Persons with HIV infection or other immunocompromising conditions, or who take immunosuppressive medications or therapies might be at increased risk for severe COVID-19. Immunocompromised persons may receive COVID-19 vaccination if they have no contraindications to vaccination. There is no vaccine safety and efficacy data in these groups. Refer to full information in the CDC link.

Patient counseling

mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna)

• Preliminary data suggest high vaccine efficacy in preventing COVID-19 following receipt of two doses of mRNA COVID-19 vaccine (Pfizer-BioNTech: 95.0%; Moderna: 94.1%).
• Before vaccination, persons should expect local (e.g., pain, swelling, erythema at the injection site, localized axillary lymphadenopathy on the same side as the vaccinated arm) and systemic (e.g., fever, fatigue, headache, chills, myalgia, arthralgia) post-vaccination symptoms. Approximately 80–89% of vaccinated persons experience at least one local symptom and 55–83% experience at least one systemic symptom post-vaccination.
• Most systemic post-vaccination symptoms are mild to moderate in severity, occur within the first three days of vaccination, and resolve within 1–3 days of onset. These symptoms are more frequent and severe following the second dose and among younger persons compared with older persons. People with prior SARS-CoV-2 infection may be more likely to experience symptoms such as fever, chills, and myalgia after the first vaccine dose. Unless persons experience a contraindication to vaccination, they should be encouraged to complete the series even if they experience local or systemic symptoms following the first dose to optimize protection against COVID-19.

Viral vector COVID-19 vaccine (Janssen/Johnson & Johnson)

• Preliminary data suggest an overall efficacy of 66.3% against symptomatic, laboratory-confirmed COVID-19 and 93.1% in prevention of COVID-19-associated hospitalization ≥14 days after vaccination.
• Most systemic post-vaccination symptoms are mild in severity and resolve within 1 – 2 days of vaccination Overall symptoms are more frequent in younger persons compared with older persons.
• Before vaccination, persons should expect local (e.g., pain, swelling, erythema at the injection site, localized axillary lymphadenopathy on the same side as the vaccinated arm) and systemic (e.g., fever, fatigue, headache, chills, myalgia, arthralgia) post-vaccination symptoms. 50% of vaccinated persons experience at least one local symptom (injection site pain is most common) and about 55% experience at least one systemic symptom post-vaccination.

All vaccines

• Routine prophylactic administration of antipyretic or analgesic medications for the purpose of preventing post-vaccination symptoms is not currently recommended, because information on the impact of such use on vaccine-induced antibody responses is not available at this time. These medications can be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate.