On November 30, the U.S. reached 232.8 million persons (70.1% of the total U.S. population) having received at least one dose of a COVID-19 vaccine and 196.8 million persons (59.3% 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 Pfizer/BioNTech or Moderna vaccines). Among those individuals aged 65 years and older, 99.9% have received at least one dose and 86.2% are fully vaccinated. Within the first ten days of the vaccine roll-out to kids aged 5 – 11 years of age, 2.6 million children (10%) received their first dose.

Thirty-three states and the District of Columbia have met the Biden Administration’s stated goal of having 70% or more of eligible persons (i.e., persons 12 years or older) with one or more doses (those states are Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Hampshire, Nevada, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Vermont, Virginia, and Washington). American Samoa, Federated States of Micronesia, Guam, Northern Mariana Islands, Puerto Rico, and Palau have also met this milestone. Nineteen states (California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, and Washington), American Samoa, the District of Columbia, Guam, Northern Mariana Islands, Palau, and Puerto Rico have reached 70% or more of all eligible persons being fully vaccinated.

Between November 15 and November 22, thirty states report sustained increases in new COVID-19 cases. Nationally, the CDC reports that the seven-day average of daily new cases has increased by 18% over the previous week and hospitalizations have risen by 6%. The states with the highest rate of change in their 14-day case rate per 100,000 as of November 30 are Connecticut, Massachusetts, Missouri, New Jersey, and Rhode Island. The proportion of their populations that are fully vaccinated range from 50.8% (Missouri) to 72.5% (Rhode Island). Cold weather is likely driving more people to gather inside, leading to heightened transmission particularly among those who remain unvaccinated. Waning immunity among those who are fully vaccinated, particularly those at increased risk, also is likely contributing. The CDC has continued to update and emphasize guidance for holiday celebrations which they plan to update continuously in the weeks ahead as necessary. This guidance now includes recommendations for fully vaccinated individuals to receive a booster.

Boosters

As of November 30, 2021, 40.2 million individuals have received one or more booster dose; this includes anyone who has received an additional dose since August 13, 2021 (i.e., immunocompromised individuals that received a third full mRNA dose and non-immunocompromised individuals that received a dose of any one of the three authorized vaccines). Over forty-three percent of persons 65 years and older have received a booster or additional dose while 21.9% of all persons eighteen and older have received a booster or additional dose.

On November 19, the Centers for Disease Control & Prevention (CDC) endorsed the expansion of booster eligibility to all persons 18 years and older following the Food & Drug Administration’s (FDA) amendments to the emergency use authorizations (EUAs) for the Moderna and BioNTech/Pfizer vaccines. The following table summarizes when and what kind of booster different individuals are 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).

Initially, the CDC’s guidance strongly recommended boosters for older populations (over 50 years of age) and individuals with underlying medical conditions. Persons who were under 50 years of age and without one or more underlying medical conditions were told that they may receive a booster dose at least six months after their second. On Monday, November 29, the CDC strengthened their guidance further to now strongly recommend booster doses for all individuals 18 years of age and older. CDC leadership decided to strengthen this guidance to mitigate confusion and encourage a robust booster campaign ahead of the winter holidays and/or the potential spread of the omicron variant of concern.* 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).

Among booster doses administered, the majority (22.6 million or 56%) have been Pfizer/BioNTech followed by Moderna (17.1 million or 43%) and Johnson & Johnson/Janssen (less than half a million or 1.3%). Those who received either a Pfizer/BioNTech or Moderna primary series largely stuck to the same vaccine type for their booster (95.6% and 94.3%, respectively). Individuals that initially received a single shot of Johnson & Johnson/Janssen’s vaccine were roughly split between each of the three authorized vaccines with 31% having received a Pfizer/BioNTech booster, 43 % having received a Moderna booster, and 26% receiving a second shot of Johnson & Johnson/Janssen. Since October 21, the CDC’s guidance has allowed for “mix and match” boosters in which a person may switch from their primary vaccine series if they choose to do so.

COVID-19 Vaccines for Younger Children

The pediatric vaccine roll-out was considered fully up and running as of Monday, November 8. The Pfizer/BioNTech vaccine for children ages 5 – 11 is administered as two doses twenty-one days apart. Therefore, the first children to receive their first doses will be considered fully vaccinated (i.e., two weeks past their second dose) on December 13. The dose size for these younger children is one-third of that used for individuals 12 years of age and older and will require using smaller needles than those for older persons. The estimated efficacy against symptomatic disease in the Pfizer/BioNTech trial was higher than 90% and the side effect profile is very similar to what was seen with those over 12 years of age. The FDA and CDC will continue 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. Of note, myocarditis after COVID-19 mRNA vaccination is reportedly rarer and typically milder than cardiac complications following a COVID-19 infection.

Pfizer/BioNTech has announced that they will make public initial data from their vaccine trial among children two to five years of age by the end of 2021 with request for authorization to the FDA to follow. Data from their separate trial for children six months to two years of age will be available in the first six months of 2022. Meanwhile, the FDA notified Moderna in October 2021 that the FDA may not complete its assessment of Moderna’s vaccine for adolescents aged 12 to 17 years of age until January 2022. This extension will allow more time for the FDA to review and evaluate data related to risks of myocarditis in this age group. As a result, Moderna has delayed submission of its request for an EUA for a 50-microgram dose vaccine series for children aged 6 to 11 years of age (adult Moderna doses are 100 micrograms).

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 and unvaccinated individuals generally and within specific settings.
• Additional information on the (1) transmissibility, (2) disease severity, and (3) potential for immune escape (i.e., the ability to evade antibodies from prior infection and/or vaccination) of the omicron variant.
• Release of additional data regarding the safety and efficacy of mixing and matching vaccines for purposes of boosters.
• Additional vaccine manufacturers possibly seeking authorization in the U.S., including the two-dose AstraZeneca/Oxford University and Novavax vaccines.

Throughout 2021, 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.