On October 22, the U.S. reached over 611.0 million total COVID-19 vaccine doses administered with 219.6 million persons (66.2% of the total U.S. population) having received at least one dose and 189.9 million persons (57.2% 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, 96% have received at least one dose and 84.5% are fully vaccinated. Meanwhile, less than half of adolescents aged 12 – 15 years of age are fully vaccinated although the Pfizer/BioNTech vaccine has been authorized for use in this group by the Food & Drug Administration (FDA) since May 10, 2021. Among pregnant persons 18 years of age and older, 34.3% are fully vaccinated.

Thirty-two 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, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Hampshire, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Vermont, Virginia, and Washington). American Samoa, Guam, Northern Mariana Islands, Puerto Rico, and Palau have also met this milestone. Fifteen states (California, Colorado, Connecticut, Maine, Maryland, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Rhode Island, Vermont, Virginia, and Washington), the District of Columbia, Guam, Northern Mariana Islands, Palau, and Puerto Rico have reached 70% or more of all eligible persons being fully vaccinated.

On September 1, the seven-day average of new daily COVID-19 cases in the U.S. reached the highest peak since January 25, 2021. The Delta variant is believed to be the most contagious yet, spreading two to three times faster than the original version of the virus and now representing over 95% of cases in the U.S. Persons infected with the variant are believed to be more infectious sooner as compared to previous versions of the virus. Although cases have been falling nationally since early October, twenty-one states reported increases in cases and hospitalizations as of October 1, many of which are in the north.

The five states with the highest case count per 100,000 as of October 24 are Alaska, Montana, Wyoming, Idaho, and North Dakota. The proportion of their populations that are fully vaccinated range from 43% (Idaho and Wyoming) to 52% (Alaska). Cold weather is likely driving more people to gather inside, leading to heightened transmission particularly among those who remain unvaccinated. Although several models predict that the U.S. could still be heading toward a steady decline in cases, hospitalizations, and deaths through the rest of the calendar year, some experts caution that winter- and/or holiday-driven increases are still possible. As a result, the Centers for Disease Control & Prevention (CDC) have already begun to distribute updated guidance for holiday celebrations which they plan to update continuously in the weeks ahead as necessary.

Delta Variant and Breakthrough Cases

Thus far, the Pfizer/BioNTech, Moderna, and Johnson & Johnson/Janssen vaccines appear to largely be effective against the Delta variant in preventing severe disease, hospitalization, and death. Vaccinated individuals seem to play a limited role in transmission and breakthrough infections, defined as any infection, including an asymptomatic or very mild case, that occurs at least fourteen days after an individual has received their final vaccine dose, are still uncommon. However, there is evidence to suggest an increase in breakthrough cases in the U.S. and globally. Data suggests those experiencing breakthrough cases may also be able to transmit COVID to others though their infections are much more likely to be mild and shorter-lived. Breakthrough infections could be increasing because of waning vaccine efficacy over time, Delta’s increased infectiousness, relaxing non-medical interventions such as masking or social distancing, or a combination of these factors. The CDC has reported that vaccine efficacy appears to be waning for all three vaccines available in the U.S. Two large, real-world studies have shown evidence of waning vaccine efficacy in preventing infections (but no waning of efficacy in prevention of hospitalization or death) for Pfizer/BioNTech. Although there is not yet similar real-world data available for Moderna and Johnson & Johnson/Janssen, studies conducted by the manufacturers and reviewed by the FDA are available here.

Boosters

On August 12, the FDA amended the EUAs for both the Pfizer/BioNTech and Moderna vaccines to allow for a third dose to be administered to persons with certain immunocompromising conditions in response to growing evidence that they do not get adequate protection from the previous two-dose regimens for the mRNA vaccines. The third dose is recommended to be given at least 28 days after the second dose in the series.

On September 22, the FDA authorized Pfizer/BioNTech booster doses be given to: (1) individuals 65 years and older, (2) those who are 18 – 64 years old and at high risk for severe COVID-19, and (3) those who are 18 – 64 years old whose frequent institutional or occupational exposure puts them at high risk of serious COVID-19 complications at least six months after their second shot in their primary series. Subsequently, the CDC Advisory Committee on Immunization Practice (ACIP) agreed with advising booster doses for all these groups, except for those who are frequently exposed to COVID-19 as part of their occupation, such as health care workers, educators, and grocery store workers. Dr. Rochelle Walensky, CDC Director, ultimately decided to align CDC’s guidance with FDA for Pfizer/BioNTech booster doses. This guidance did not apply to those individuals who received either of the other two COVID-19 vaccines authorized in the U.S.

On October 20, however, the FDA greatly expanded access to booster doses by amending their authorizations for all three vaccines by: (1) authorizing any of the three vaccines be administered as a booster for at least some populations; and (2) allowing for a “mix and match approach” where individuals might receive any one of the three vaccine boosters regardless of what their primary vaccine series was. The following day, Dr. Walensky formally endorsed ACIP’s recommendation for boosters for all individuals that received a Johnson & Johnson/Janssen vaccine and some populations that received one of the two available mRNA vaccines, which now makes millions more individuals immediately eligible for boosters. The following table details the latest guidance from FDA/CDC regarding boosters.

As of October 26, over thirteen million (7%) of all fully vaccinated individuals in the U.S. have received a booster shot. Among those who are 65 years or older, 18% have done so.* Immunocompromised individuals (the vast majority of which 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).

COVID-19 Vaccines for Younger Children

On October 26, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened to review Pfizer/BioNTech’s application to expand their EUA to include children 5 – 11 years of age. VRBPAC, a body of medical experts that provides guidance to the FDA as they consider authorizing or fully licensing a vaccine, voted to endorse the Pfizer/BioNTech vaccine for this age group. FDA leadership agreed with VRPBPAC’s guidance and updated the Pfizer/BioNTech EUA to allow for vaccinations of children aged 5- 11. The CDC ACIP met to discuss and vote on recommendations for the Pfizer/BioNTech vaccine for children on Tuesday, November 2. They unanimously voted to recommend use of the vaccine among these children. CDC Director Walensky then issued the final recommendation that allows for the first COVID-19 vaccines to be available to younger children as early as Wednesday, November 3. The pediatric vaccine roll-out will be 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. 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.

The Biden Administration has released a fact sheet detailing their plans to distribute the vaccines to younger children, including leveraging medical providers such as pediatricians, family practitioners, etc. Between vaccinating younger children, managing the booster effort, and vaccinating the estimated 23% of all persons 12 years and older that remain unvaccinated, the overall effort to vaccinate the U.S. population will soon be far more complex and potentially challenging. However, vaccine uptake for younger children may lag initially as compared to adults; the Kaiser Family Foundation (KFF) reported that only 34% of parents of children aged 5 – 11 years of age would get their children vaccinated “right away.”

Private and Public Sector Vaccine Requirements

Governments, schools, employers, and other organizations are continuing to require proof of COVID-19 vaccination. Some deadlines by which individuals must provide proof of vaccination for employment or school attendance have passed while others are still approaching. For example, starting November 9, federal agencies can begin disciplinary processes for employees who have not received one or more doses of any COVID-19 vaccine. For those entities where the deadline to be vaccinated has already passed, most have seen extremely high rates of compliance. Hospitals have reported particularly high rates of vaccine uptake among staff, including Houston Methodist (one of the first U.S. healthcare institutions to institute a vaccine requirement) where 98% of staff have been vaccinated. The number of healthcare settings requiring vaccinations among staff is expected to increase as the Biden Administration’s vaccine requirement for all healthcare workers at Medicare- and Medicaid-participating entities takes effect.

Meanwhile, in accordance with the Biden Administration’s COVID-19 plan, the Occupational Safety and Health Administration (OSHA) has submitted text for review to the Office of Management and Budget (OMB) for a new vaccine rule that would apply to employers of 100 or more individuals. Once OMB finishes reviewing the draft regulation, the emergency temporary standard will be published in the Federal Register and the policy will take effect. OSHA will be responsible for enforcing the policy. For more information regarding the legal and policy implications of the COVID-19 vaccine, please see NAAG’s materials from a related training held in December 2020.

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 data released regarding the safety and efficacy of mixing and matching vaccines for purposes of boosters.
• Further updates from the Biden Administration and state health officials regarding plans for the booster and child vaccine campaigns this fall.
• The potential emergence of additional variants with greater transmissibility, disease severity, and/or ability to evade currently available vaccines.
• 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.