In the U.S., the average daily rate of COVID-19 vaccines administered has decreased from a peak of 3.3 million on April 11 to around 1 million in June. On June 27, the U.S. reached over 323.3 million total doses administered with 179.3 million persons (54% of the total U.S. population) having received at least one dose and 153.0 million persons (46.1% of the total U.S. population) being fully vaccinated. Among those individuals aged 65 years and older, 87.6% have received at least one dose and 77.7% are fully vaccinated. Fourteen states and the District of Columbia have met the Biden Administration’s stated goal of achieving 70% or more of adults having received one or more doses by July 4 (those states are California, Connecticut, Hawaii, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, Rhode Island, Vermont, and Washington).
On June 22, the Biden Administration announced that they anticipate missing their stated goal of reaching 70% of all adults having received at least one dose of the vaccine by July 4. Instead, the Administration has shifted the goal to achieving 70% vaccination (i.e., at least one shot) among all individuals aged 27 years and older by that date. Currently, 70% of all persons 30 and older are already at least partially vaccinated.
There continue to be notable differences among states, regions, and demographic groups in terms of their pace in meeting the Biden Administration’s 70% goal. As of the end of May 2021, poorer counties with the highest social vulnerability are estimated to have a 32% lower vaccination rate. Southern U.S. states had the most high-vulnerability/low-vaccination counties, using the COVID-19 Community Vulnerability Index (CCVI). The Surgo Foundation developed the CCVI as a tool to identify communities which may need the most support during a pandemic such as COVID-19 or a similar public health emergency. According to the Centers for Disease Control & Prevention (CDC), counties with more households with children, more households with a single-parent, more people living with disabilities, higher rates of poverty, and lower education rates reported lower vaccination rates. These issues are particularly pronounced in rural regions; except for Alaska, all states report higher rates of vaccination in urban vs. rural areas. Finally, there are differences observed by race and ethnicity. Based on current trends, it is estimated that Hispanic persons will not reach 70% at least partially vaccinated until July 27 whereas White and Black persons will reach that goal until August 2 and early September, respectively. While early data demonstrated disparities in vaccination rates among Hispanic vs. non-Hispanic/White communities, in recent weeks the pace of vaccination among Hispanic persons has exceeded that among White individuals. To learn more about effective communication strategies that can be used to address COVID-19 vaccine-related concerns and access challenges, please see this related AG Journal article.
As part of a national push to achieve high rates of vaccination by the end of this summer, state governments, employers, schools, and private businesses have offered incentives or perks to those who choose to be vaccinated. The federal government now maintains a list of companies offering support or rewards for getting vaccinated. Beginning with Ohio, multiple states have created “vaccine lotteries,” where individuals who are vaccinated are entered to win cash, other prizes, or, for teens, scholarships to college. After announcing its $5.6 million lottery (i.e., five individual $1 million winners and $600,000 in scholarships to students), Ohio saw a spike in its daily shots administered with steady increases persisting over time. These actions, as well as concerted efforts at all levels of government and within the private sector to make vaccinations easier to secure and attend, are aimed at helping the U.S. achieve a high level of vaccination as quickly as possible.
The CDC’s guidance for fully vaccinated individuals states that they may resume most activities without wearing a mask or social distancing, regardless of whether those activities are indoors or outdoors, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations. Of note, the CDC continues to recommend that individuals who are not vaccinated take COVID-19-related precautions and that fully vaccinated individuals should still do so in certain settings (e.g., airports). Given the CDC’s guidance, as well as their vaccination and/or incidence rates, many state and local governments have already lifted COVID-19-related restrictions or announced plans to do so. Yet, in many settings, there is still no uniform or reliable way to verify who is and who is not vaccinated.
For employers, the Equal Employment Opportunity Commission (EEOC) announced that U.S. businesses could require employees be vaccinated for COVID-19 as long as they comply with the reasonable accommodation provisions under the Americans with Disabilities Act for those individuals with a medical contraindication or a sincere religious objection. The guidance does not address whether mandates could be upheld for vaccines available under an emergency use authorization (EUA) as opposed to a biologics license application (BLA), perhaps because it is anticipated that one or more of the currently authorized COVID-19 vaccines will soon be fully approved by the FDA as part of a BLA. The EEOC guidance also states that employers may offer incentives to their staff to encourage vaccine uptake so long as those incentives are not coercive. This EEOC resource provides further details. Beyond vaccine requirements, employers may choose to follow additional guidance and maintain continued COVID-related precautions even as their staff increasingly are vaccinated. For example, on June 21, 2021, the Occupational Safety and Health Administration (OSHA) adopted its COVID-19 Healthcare Emergency Temporary Standard (ETS), which applies to staff in many healthcare settings.
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.
- Updates to the FDA/CDC guidance allowing for COVID-19 vaccinations among younger individuals. As of June 8, Pfizer/BioNTech have announced that they are recruiting for a study testing their vaccine among children under 12 years of age. It is anticipated that they will request an update to their original authorization to include younger children as early as September 2021. Meanwhile Moderna has filed for an update to its authorization to extend to children 12 to 18 years of age and has its own trial ongoing for children younger than 12 years old.
- Additional vaccine manufacturers possibly seeking authorization in the U.S., including the two-dose AstraZeneca/Oxford University and Novavax vaccines. Novavax released preliminary data on June 14, 2021 that its protein-based vaccine demonstrated overall 90% efficacy in its Phase III trial and 100% protection against moderate or severe illness. Novavax intends to apply for authorization for adults in the U.S. within the next few months. While AstraZeneca is widely expected to be distributed by the U.S. to other nations’ vaccination efforts, Novavax may also play a role in the U.S. as a booster shot for those who have already received one of the three other authorized vaccines.
- Progress in Pfizer/BioNTech and Moderna’s process to obtain FDA approval for a BLA to distribute and market their respective vaccines in the U.S. for adults. Both companies will then submit BLAs for their vaccines for younger age groups as they gather the requisite six months or more of follow-up data from their trial participants. Both manufacturers have requested a “priority review” in which the FDA would decide within six months instead of the usual ten-month review period. Lastly, AstraZeneca may skip the EUA process altogether and instead move to seek a BLA from the FDA. These possible BLA approvals may have implications for the adoption or durability of vaccine requirements.
- Further increased vaccine supply secured by the U.S. government via new or amended contracts with manufacturers in preparation for younger children’s vaccinations and/or possible boosters. On June 16, 2021, the U.S. announced that another 200 million doses of Moderna’s vaccine have been purchased for use in the U.S. Also in June 2021, the Biden Administration announced the purchase of 500 million more doses of the Pfizer/BioNTech vaccine to be donated to the World Health Organization (WHO)-led COVID-19 Vaccines Global Access (COVAX). COVAX is a worldwide initiative to ensure equitable access to vaccines for COVID-19 globally. The 500 million Pfizer/BioNTech doses are in addition to the 80 million doses the U.S. had already committed to COVAX, which include Pfizer/BioNTech, Johnson & Johnson/Janssen, and Moderna.
- Additional data gathered and published regarding vaccine efficacy against COVID-19 variants as well as rates of transmission and disease severity for those variants, particularly the Delta variant originally identified in India. The Delta variant is believed to be the most contagious variant yet and is estimated to become the dominant strain here in the U.S. in the next several weeks. Thus far, both the Pfizer/BioNTech and Moderna vaccines appear effective against the Delta variant.
- Possible increases in the number of schools, employers, etc., requiring proof of COVID-19 vaccination for individuals returning to in-person activities. 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.
- Additional data gathered and published regarding the long-term effectiveness of existing COVID-19 vaccines (i.e., when or if individuals will need to be revaccinated).
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.