On December 20, the U.S. reached 241.6 million persons (72.8% of the total U.S. population) having received at least one dose of a COVID-19 vaccine and 203.9 million persons (61.4% of the total U.S. population) being fully vaccinated (i.e., having received either one shot of the Johnson & Johnson/Janssen vaccine or two shots of either the mRNA Pfizer/BioNTech or Moderna vaccines). Among those individuals aged 65 years and older, 95% have received at least one dose and 87.5% are fully vaccinated. Jurisdictions with the highest percentages of persons 5 years of age and older being fully vaccinated include Vermont (80.2%), Rhode Island (79.7%), Puerto Rico (79.3%), Connecticut (78%), and Massachusetts (77.9%). States with the lowest include Wyoming (50.1%), Alabama (50.2%), Mississippi (51.2%), Louisiana (53.3%), and Georgia (53.7%). As of December 16, the seven-day average number of administered COVID vaccine doses reported was 1.8 million per day, a 3% decrease from the prior week.

Boosters

As of December 20, 60.2 million persons in the U.S. have received a booster (i.e., a third dose following an mRNA primary two-dose series or a second dose following a Johnson & Johnson/Janssen primary one-dose series). This represents 29.5% of those who are fully vaccinated, including 32.1% of those aged 18 years and older, 43.8% of those 50 years and older, and 54.3% of those 65 years and older.

On December 9, the Centers for Disease Control & Prevention (CDC) endorsed the expansion of booster eligibility to persons 16 years and older who received a primary two-dose BioNTech/Pfizer vaccine series. The following table summarizes when and what kind of booster different individuals are now eligible for:

* Immunocompromised individuals (the vast majority of whom received a two-dose primary mRNA series) are recommended to receive a third mRNA vaccine dose 28 days after their second shot. If they are receiving a third Moderna shot, it should be a full-sized dose. At least six months after their third shot, moderately or severely immunocompromised individuals may receive a fourth mRNA dose (either a full dose of Pfizer/BioNTech or a half dose of Moderna).

States with the highest rates of boosters administered among those 18 years and older include Vermont (49.5%), Minnesota (47.1%), Wisconsin (43.7%), Iowa (43.2%), and Michigan (40.9%). Among booster doses administered nationally, the majority (32.4 million or 54%) have been Pfizer/BioNTech followed by Moderna (26.8 million or 44%) and Johnson & Johnson/Janssen (less than half a million or 1.6%). Those who received either a Pfizer/BioNTech or Moderna primary series largely stuck to the same vaccine type for their booster (93.7% and 93.0%, respectively). Individuals that initially received a single shot of the Johnson & Johnson/Janssen vaccine were roughly split between each of the three authorized vaccines with 31.5% receiving a Pfizer/BioNTech booster, 40.8% receiving a Moderna booster, and 27.7% receiving a second shot of Johnson & Johnson/Janssen.

CDC Guidance for the Johnson & Johnson/Janssen Vaccine

On December 16, CDC Director Rochelle Walensky accepted the unanimous preferential recommendation made by the CDC Advisory Committee on Immunization Practices (ACIP) to offer one of the two available mRNA vaccines in the U.S. (i.e., Moderna, Pfizer/BioNTech) over the Johnson & Johnson/Janssen vaccine for either primary series or as boosters. The decision was based on additional evidence presented to the committee regarding cases of a dangerous clotting condition, thrombosis with thrombocytopenia syndrome (TTS), a side effect seen among individuals that received either the Johnson & Johnson/Janssen or AstraZeneca adenovirus vaccines. TTS symptoms typically occur about nine days after vaccination.

In the U.S., 54 cases of TTS have been identified among those who received the Johnson & Johnson/Janssen vaccine to date. Nine of those people have died while another two deaths are suspected to be linked to the vaccine. Cases of vaccine-related TTS were observed in both men and women and across various age groups. That said, vaccine-related cases of TTS remain rare. Even among the most at risk group, women in their 30s and 40s, there have been approximately two deaths from TTS per 1 million doses of the Johnson & Johnson/Janssen vaccine administered.

Per the new CDC guidance, if the individual receiving the vaccine either cannot or will not accept the mRNA options available, providers may offer them Johnson & Johnson/Janssen. During ACIP’s deliberations, participants noted the important and unique role that the Johnson & Johnson/Janssen vaccine has played in vaccinating some communities. As a single dose that can be stored more easily than either of the mRNA vaccines, the Johnson & Johnson/Janssen vaccine has been ideal for “hard-to-reach” communities that may be challenged to receive two doses, including those who are incarcerated and/or those who are unhoused or unstably housed. The CDC hopes to allow enough flexibility within the preferential recommendation to maximize vaccine equity nationally.

Delta and Omicron Variants

On November 22, scientists in South Africa first identified the latest variant of concern, B.1.1.529 or Omicron, as declared by the World Health Organization (WHO). Although first spotted in South Africa where there is particularly robust genetic sequencing and surveillance capacity, it is still unclear where the Omicron variant first emerged or how. South African and WHO officials were quick to raise the alarm, however, due to the extremely high number of genetic mutations identified in the variant.  Particularly concerning is the number of changes observed on the spike protein, the part of the virus targeted by vaccines as well as many treatments for COVID-19.

With the emergence of any variant, three factors are important to consider: (1) how transmissible it is, (2) how virulent it is (i.e., how sick does it make those who are infected), and (3) how much immune escape does it demonstrate (i.e., how well is it able to sicken those who have had a prior infection and/or been vaccinated). Scientists and public health officials have been working to assess these variables for Omicron with what laboratory-based or real-world data is available.

Thus far, there is consensus that Omicron is the most transmissible variant yet, outcompeting Delta in southern Africa and now Europe and the U.S. Early estimates are that Omicron cases double every 1.5 to 3 days. For comparison, Delta cases doubled every two weeks this past summer. According to the CDC, Omicron is now the dominant strain in the United States, making up 73% of all new cases as of December 20 (the remainder are Delta). Omicron has been detected in 48 states as well as Puerto Rico and the District of Columbia though its prevalence still varies. Its increased transmissibility may be due to how much more effectively it replicates in the upper respiratory tract.

It is more challenging for scientists to determine if Omicron produces less severe disease. Real-world data from South Africa reported a lower hospitalization rate and shorter disease course among Omicron cases compared to other variants. Yet researchers in Denmark and the United Kingdom have seen similar hospitalization rates among Omicron vs. Delta cases. There can be several challenges in assessing variants’ disease severity, including that the persons becoming sick from one variant vs. another may be too different to compare (e.g., Omicron may have first spread among younger, healthier individuals who are at less risk of being hospitalized in the first place). Another issue might be that not enough time has passed – hospitalization rates typically lag a few weeks behind cases. Even if Omicron does prove to be less severe, if it is also extremely transmissible, hospital systems may still be inundated with huge numbers of patients.

Lastly, it will also take time to determine how well, if at all, existing immunity from prior infections and/or vaccination will protect against Omicron. Early data from South Africa suggests that Omicron infects those with existing immunity at rates higher than with previous variants. As with Delta, it is uncertain whether Omicron is better at evading immune defenses or if people’s protection is waning to the point that they are more vulnerable. That said, laboratory data from Pfizer/BioNTech and Moderna suggest much lower protection from symptomatic infection after two shots alone, but vast improvement in immune response following a booster. It is still unclear how long existing boosters could provide protection and whether Omicron or other variant-specific boosters may be helpful or necessary in the future.

COVID-19 Vaccines for Younger Children

The pediatric vaccine roll-out was considered fully up and running as of Monday, November 8. As of December 5, 16.7% of 5 – 11 years old children are estimated to have received one or more vaccine doses while 4.3% are considered fully vaccinated. While vaccination rates among these children increased significantly after the CDC first recommended it on November 2, they have steadily decreased since the peak on November 16. There have also been state-by-state variations, with as much as a forty-percent difference between the highest (Vermont, 45.6%) and lowest ranked states (West Virginia, 3.6%). For comparison, about half of parents of adolescents aged 12 – 17 years say that their child has received at least one dose.

The FDA and CDC have continued to closely monitor younger children vaccinated with the Pfizer/BioNTech vaccine via the Vaccine Adverse Event Reporting System (VAERS) and the V-safe After Vaccination Health Checker. According to the Kaiser Family Foundation, most parents still have concerns about their children receiving COVID vaccines and three in ten say they will “definitely not” vaccinate their children. Only about half of parents surveyed said they are confident about the vaccines’ safety among adolescents while 44% said the same for younger children.

On December 17, Pfizer/BioNTech announced preliminary data from their two vaccine trials among (1) children 6 months to 2 years of age and (2) children 2 to 5 years of age. For children 2 to 5 years of age, Pfizer/BioNTech initially administered two 3 microgram doses, 21 days apart. For comparison, persons 12 years of age and older receive two 30 microgram doses, while children 5 – 12 years of age receive two 10 microgram doses. Unfortunately, Pfizer/BioNTech reported insufficient antibody responses among children ages 2 years to 5 years with two doses alone. Instead, Pfizer/BioNTech plans to give these children a third dose of the same size, two months after the second and monitor the results again. Practically speaking, this means Pfizer/BioNTech will need additional time to administer doses and measure the results among these children. Assuming the third dose approach is successful, Pfizer/BioNTech plans to submit for an emergency use authorization (EUA) by the end of the first half of 2022.

Future Considerations

In the weeks ahead, members of the attorney general community should monitor and be aware of the following possible key events related to the vaccines’ rollout:

• Further updated guidance released by the CDC and state/local health departments regarding the need for non-medical interventions (e.g., mask wearing, social distancing) by fully vaccinated, boosted, and unvaccinated individuals generally and within specific settings. For example, the CDC has formally endorsed a “test to stay” strategy in schools based on the results of real-world studies performed in Lake County, Illinois and Los Angeles County, California.
• Potential changes to the definitions of “fully vaccinated” to include a booster dose and impacts that may have on vaccine requirements.
• Additional information on the (1) transmissibility, (2) disease severity, and (3) potential for immune escape of the Omicron variant.
• Release of additional data regarding the safety and efficacy of mixing and matching vaccines for purposes of boosters.
• FDA granting EUAs for two oral antiviral treatments for COVID-19 from Merck and Pfizer. Also, additional data on the efficacy of existing and future treatment options against Omicron.
• Additional vaccine manufacturers possibly seeking authorization in the U.S., including the two-dose AstraZeneca/Oxford University and Novavax.

In 2022, NAAG will continue to provide informational updates and training opportunities to the attorney general community as COVID-19 vaccine distribution and related legal issues evolve. For more information on NAAG’s response to the COVID-19 pandemic, visit NAAG’s public health-related updates.