On July 27, the U.S. reached over 342.2 million total COVID-19 vaccine doses administered with 188.7 million persons (56.8% of the total U.S. population) having received at least one dose and 163.2 million persons (49.1% of the total U.S. population) being fully vaccinated. Among those individuals aged 65 years and older, 89.5% have received at least one dose and 79.8% are fully vaccinated. Twenty 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, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, and Washington).
The CDC’s guidance for fully vaccinated individuals released in May 2021 stated 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. At the time, the Delta variant represented 1% of all new cases. On July 27 and in response to the latest available data regarding the Delta variant, the CDC announced revised guidance that recommends that all individuals, including those who are fully vaccinated, resume indoor masking in public in areas with “substantial” (50 – 100 cases per 100,000) or “high” (>100 cases per 100,000) levels of community transmission. As of July 27, nearly two-thirds of all U.S. counties are considered by the CDC to have substantial or high levels of community transmission. Guidance for unvaccinated individuals remains the same – to continue masking and social distancing until they are vaccinated). Finally, the CDC now recommends universal masking in K – 12 schools, including students, teachers, staff, and visitors. In many settings, there is still no uniform or reliable way to verify who is and who is not vaccinated. This is particularly concerning in regions where mask requirements have been lifted or relaxed, vaccination rates remain lower than average, and the prevalence of the Delta variant is higher or increasing.
Cases, positive tests, hospitalizations, and deaths are all up nationally over the past fourteen days. The Delta variant is believed to be the most contagious variant yet, spreading two to three times faster than the original version of the virus and now representing over 80% of cases in the U.S. Recent studies suggest this is because the variant grows more quickly in people’s respiratory tract and to much higher levels. Persons infected with the variant are also believed to be more infectious sooner as compared to previous versions of the virus. Yet Delta’s impact is not being felt equally across the United States; seven of the ten states or territories with the highest increases in cases are in the South. All states and territories with the highest increases in cases have rates of fully vaccinated below 50% ranging from 34% (Alabama and Mississippi) to 49% (Florida).
Thus far, the Pfizer/BioNTech, Moderna, Johnson & Johnson/Janssen vaccines appear to largely be effective against the Delta variant. Although not yet authorized in the U.S., the AstraZeneca vaccine also reportedly holds up well against the variant. However, in the rare instance in which a fully vaccinated individual experiences a breakthrough infection (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), data suggests they may be able to transmit COVID to others at rates comparable to unvaccinated individuals. Overall, vaccinated individuals appear to play a very small role in transmission and breakthrough infections are still rare.
Progress has been made in Pfizer/BioNTech’s process to obtain FDA approval for a biologics license application (BLA) to distribute and market their vaccine in the U.S. for adults. On July 16, the FDA granted Pfizer/BioNTech an official priority review of their vaccine, committing to a decision being made no later than January 2022. That said, it is widely anticipated that the FDA will decide Pfizer/BioNTech’s BLA within the next two months. Moderna has also submitted their own BLA to the FDA although they have not yet been granted a priority review. 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. Meanwhile, 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 and by extension, vaccine credentials.
As demand for vaccination has stagnated while cases, hospitalizations, and deaths due to the Delta variant climb, governments, schools, employers and other organizations are increasingly requiring proof of COVID-19 vaccination. In June, a federal judge dismissed a lawsuit against the Houston Methodist hospital system over its policy of terminating employees who refuse to be vaccinated. Since then, more than fifty provider groups including the American Medical Association (AMA), the American College of Physicians, and the American Academy of Pediatrics have issued a joint statement supporting healthcare and long-term care employers implementing vaccine requirements for employees. Meanwhile, another federal judge rejected a bid to block an Indiana University vaccine requirement for students and staff. On July 26, California and New York City both announced requirements that all employees must be vaccinated or comply with weekly testing and other prevention measures. California’s policy goes a step further in requiring all workers in healthcare and congregate settings to demonstrate proof of vaccination. The U.S. Veterans Administration, the first federal agency to do so, will also require that all healthcare staff be vaccinated. The Biden Administration issued a vaccine requirement for all federal employees on Thursday, July 29. 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.
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 still 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. In July, the FDA urged both manufacturers to expand these trials to include twice as many children to ensure that rarer potential side effects (e.g., myocarditis) are captured.
- Additional vaccine manufacturers possibly seeking authorization in the U.S., including the two-dose AstraZeneca/Oxford University and Novavax vaccines.
- 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 July 23, 2021, the U.S. announced that another 200 million doses of Pfizer/BioNTech’s vaccine have been purchased for use in the U.S. These doses are expected to be delivered between October 2021 and April 2022 in addition to the 300 million already purchased for use in the U.S. Under the terms, the U.S. government has the option to acquire updated versions of the vaccine for variants as well as new formulations, as needed.
- Additional data gathered and published regarding vaccine efficacy against COVID-19 variants as well as rates of transmission and disease severity for those variants.
- 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.