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COVID-19 Vaccination - Phase Ib Begins

Jan 04, 2021 2:01 pm

The U.S. Centers for Disease Control and Prevention (CDC) has issued a timeline guidance document on when, how and who should get the commercially available COVID-19 vaccines. 

This begain on December 1, when the Advisory Committee on Immunization Practices (ACIP) recommended that health care personnel and long-term care facility residents be offered COVID-19 vaccination first (Phase 1a).  The results of this early phase has been underwhelming, given the US COVID's task force early projections that 20 million would be vaccinated by the end of the year.  To date, only 14 million doses have been distributed and as of today, just over 4 million (mostly healthcare workers) have received their first dose of the vaccine.   (Editors note: there are some disturbing surveys showing that between 29-50% of US healthcare workers do not intend to take the COVID-19 vaccine).

Because it was assumed that the demand for COVID-19 vaccines may exceed supply during the first months of the national COVID-19 vaccination program, the ACIP has issued guidance on which population groups and circumstances should be eligible for vaccine use.  Some states have begun phases Ib and even Ic - consult your local health authority.

Phase Ib

Phase 1b was rolled out on 12/26/20, when the CDC advised that the COVID-19 vaccine should be offered to persons aged ≥75 years and non–health care frontline essential workers, and in Phase 1c, to persons aged 65–74 years, persons aged 16–64 years with high-risk medical conditions, and essential workers not included in 

During Phase 1b, approximately 49 million persons, including frontline essential workers (non–health care workers) and persons aged ≥75 years are recommended to receive vaccine in Phase 1b of the COVID-19 vaccination program. Essential workers perform duties across critical infrastructure sectors and maintain the services and functions that U.S. residents depend on daily.

ACIP has classified the following non–health care essential workers as frontline workers: first responders (e.g., firefighters and police officers), corrections officers, food and agricultural workers, U.S. Postal Service workers, manufacturing workers, grocery store workers, public transit workers, and those who work in the education sector (teachers and support staff members) as well as child care workers.

Persons aged ≥75 years are at high risk for COVID-19–associated morbidity and mortality. As of December 20, 2020, the cumulative incidence of COVID-19 among persons in this age group was 3,839 per 100,000 persons, with a cumulative hospitalization rate of 1,211 per 100,000, and a mortality rate of 719 per 100,000.

Phase 1c

In Phase 1c, vaccine should be offered to persons aged 65–74 years, persons aged 16–64 years with medical conditions that increase the risk for severe COVID-19, and essential workers not previously included in Phase 1a or 1b. Approximately 129 million persons are included in Phase 1c (Table), accounting for the overlap between groups in Phase 1c and earlier phases (eg, those in long-term care facilities, or those with high-risk medical conditions). Persons aged 65–74 years are at high risk for COVID-19–associated morbidity and mortality. As of December 20, 2020, the cumulative COVID-19 incidence in this age group was 3,109 per 100,000 persons, with a cumulative hospitalization rate of 642 per 100,000, and a mortality rate of 188 per 100,000.

CDC studies have shown that the risk for COVID-19–associated hospitalization increases with the number of high-risk medical conditions, from 2.5 times the risk for hospitalization for persons with one condition to 5 times the risk for those with three or more conditions. According to a recent analysis of 2018 Behavioral Risk Factor Surveillance System data, at least 56% of persons aged 18–64 years report at least one high-risk medical condition. 

Essential worker sectors recommended for vaccination in Phase 1c include those in transportation and logistics, water and wastewater, food service, shelter and housing (e.g., construction), finance (e.g., bank tellers), information technology and communications, energy, legal, media, public safety (e.g., engineers), and public health workers.

Phase 2

Phase 2 includes all other persons aged ≥16 years not already recommended for vaccination in Phases 1a, 1b, or 1c.  The ACIP is closely monitoring clinical trials in children and adolescents and will consider recommendations for use when a COVID-19 vaccine is authorized for use in persons aged <16 years.

Underlying Medical Conditions

The CDC definition of adults with "underlying medical conditions" includes the following:

  • People who have weakened immune systems.
    • People with HIV and those with weakened immune systems due to other illnesses  or medication might be at increased risk for severe COVID-19. They may receive a COVID-19 vaccine. However, they should be aware of the limited safety data:
    • Information about the safety of mRNA COVID-19 vaccines for people who have weakened immune systems in this group is not yet available.
    • People living with HIV were included in clinical trials, though safety data specific to this group are not yet available at this time.
    • People with weakened immune systems should also be aware of the  potential for reduced immune responses to the vaccine, as well as the need to continue following all current guidance to protect themselves against COVID-19 (see below).
  • People who have autoimmune conditions
    • People with autoimmune conditions may receive an mRNA COVID-19 vaccine. However, they should be aware that no data are currently available on the safety of mRNA COVID-19 vaccines for them. Individuals from this group were eligible for enrollment in clinical trials.
  • People who have previously had Guillain-Barre syndrome
    • Persons who have previously had GBS may receive an mRNA COVID-19 vaccine. To date, no cases of Guillain-Barre syndrome (GBS) have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials. With few exceptions, the independent Advisory Committee on Immunization Practices (ACIP) general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.
  • People who have previously had Bell’s palsy
    • Cases of Bell’s palsy were reported in participants in the mRNA COVID-19 vaccine clinical trials. However, the Food and Drug Administration (FDA) does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell’s Palsy may receive an mRNA COVID-19 vaccine. 

After vaccination, current guidelines to prevent the spread of COVID-19 should be followed

Until experts learn more about the protection that COVID-19 vaccines provide under real-life conditions, people who decide to get vaccinated should continue to follow all current guidance to protect themselves against COVID-19 after they are vaccinated. That means:

  1. Wearing a mask
  2. Staying at least six feet away from others
  3. Avoiding crowds 
  4. Washing hands with soap and water for 20 seconds or using hand sanitizer with at least 60% alcohol 
  5. Following CDC travel guidance 
  6. Following quarantine guidance after exposure to COVID-19
  7. Following any applicable workplace guidance
TABLE. Advisory Committee on Immunization Practices recommendations for allocation of COVID-19 vaccines to persons aged ≥16 years — United States, December 2020Return to your place in the text
Phase Groups recommended to receive COVID-19 vaccine No. (millions)
Total persons in each group* Unique persons in each group Unique persons in each phase
1a Health care personnel 21 21 24
Long-term care facility residents 3 3
1b Frontline essential workers§ 30 30 49
Persons aged ≥75 years 21 19
1c Persons aged 65–74 years 32 28 129
Persons aged 16–64 years with high-risk medical conditions 110 81
Essential workers§ not recommended for vaccination in Phase 1b 57 20
2 All persons aged ≥16 years not previously recommended for vaccination All remaining All remaining All remaining

Abbreviation: COVID-19 = coronavirus disease 2019.

 

Disclosures
The author has no conflicts of interest to disclose related to this subject

Rheumatologists’ Comments

Ekaterina Soforo

| Jan 11, 2021 10:27 am

Hi,
Is it becoming a common practice to recommend to hold MTX for 2 weeks after the first dose of COVID vaccine?

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