On August 25, the U.S. reached over 363.9 million total COVID-19 vaccine doses administered with 202 million persons (60.9% of the total U.S. population) having received at least one dose and 171.2 million persons (51.6% of the total U.S. population) being fully vaccinated. Among those individuals aged 65 years and older, 91.5% have received at least one dose and 81.2% are fully vaccinated. Twenty-three states and the District of Columbia have met the Biden Administration’s stated goal of having 70% or more of adults with one or more doses (those states are California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Minnesota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Utah, Vermont, Virginia, and Washington). Guam and Puerto Rico have also met this milestone.

New COVID-19 cases (up 14.0%), hospitalizations (up 14.2%), and deaths (up 10.8%) were all up nationally between August 13 and 20. 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 90% 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. Delta’s impact is not being felt equally across the United States; nine of the ten states or territories with the highest numbers of cases per 100,000 persons are in the South. Their rates of fully vaccinated range from 37% (Alabama and Mississippi) to 52% (Florida). That said, some data suggests that some of these states may be approaching their peak in Delta-related cases with Arkansas and Louisiana each reporting decreases over the course of the previous fourteen days.

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. It is unclear why the numbers of breakthrough cases are increasing – it could be a result of waning vaccine efficacy over time, an indication of Delta’s increased infectiousness, a result of relaxing non-medical interventions such as masking or social distancing, or a combination of these factors.

While breakthrough cases are expected for any vaccine that is not 100% effective in preventing disease, including the three COVID vaccines available in the U.S., the exact extent to which they are occurring is difficult to assess at this time. The Centers for Disease Control & Prevention (CDC) currently monitors hospitalizations and deaths for any cause among those who are fully vaccinated. However, the CDC decided in May that it would only monitor a small portion of all breakthrough infections (i.e., only those that resulted in disease severe enough to cause hospitalization or death). . As a result, tracking breakthrough infection rates varies state-by-state and locality-by-locality with some limiting their tracking to just the most severe cases as CDC requires and others going a step further and tracking asymptomatic or mild breakthrough cases. A Kaiser Family Foundation (KFF) analysis from the end of July 2021 estimated that less than 1% of all new COVID cases were among vaccinated individuals across the twenty-four states that reported such data.  The percentage of cases resulting in hospitalization or death were even lower for vaccinated persons. More than nine in ten cases, hospitalizations, and deaths occurred in unvaccinated individuals. Yet this data does carry a significant caveat: vaccinated individuals, particularly those with asymptomatic or mild cases, are less likely to seek testing and therefore total breakthrough case rates may be underestimated.

Vaccine Approval Status

On August 23, the FDA granted Pfizer/BioNTech a full approval for their vaccine’s biologics license application (BLA) for persons sixteen years and older. The vaccine, under its brand name of Comirnaty, can now be sold and marketed in the U.S. including after the current COVID public health emergency ends. A BLA is “FDA’s standard ‘full approval’ mechanism” for biologics including vaccines, whereas an emergency use authorization (EUA) allows a manufacturer to “distribute an otherwise unapproved product (or an approved product for an unapproved use) during an emergency formally declared by the Secretary of Health & Human Services.” Moderna’s BLA to the FDA has not yet been granted a priority review.

For persons 12 – 15 years of age, an EUA still prevails for the Pfizer/BioNTech vaccine. Their BLA also has no bearing on Moderna’s or Johnson & Johnson/Janssen’s respective EUAs for persons 18 years and younger. For children younger than 12 years of age, all three manufacturers are still completing their respective trials. An update to their EUAs for these children is not anticipated until either the end of 2021 or early 2022.

Beginning with the approval of Pfizer/BioNTech, BLA approvals are anticipated to have implications for the adoption or durability of vaccine requirements and, by extension, vaccine credentials. BLA approvals could also help to boost confidence in the vaccines and increase the numbers of people willing to be vaccinated. That is far from certain, however; another KFF poll suggests that although three in ten unvaccinated adults say that they would be more likely to be vaccinated if one or more of the vaccines receive full authorization, the majority (two-thirds) either believe the available vaccines were already fully approved or are unsure of the difference between an EUA and a BLA. This suggests that at least some portion of these individuals cite the EUA status as a “proxy for general safety concerns” and therefore will be unlikely to change their minds now that Pfizer/BioNTech have received their full authorization from the FDA.

Private and Public Sector Vaccine Requirements

Governments, schools, employers, and other organizations are increasingly requiring proof of COVID-19 vaccination. For example, on August 18, the Centers for Medicare & Medicaid Services (CMS), in collaboration with the CDC, announced that they would be developing emergency regulations requiring staff vaccinations within nursing homes that participate in Medicare and/or Medicaid. More entities have explicitly done so in response to the full FDA approval for the Pfizer/BioNTech vaccine. The Secretary of Defense has announced that the U.S. military will mandate COVID vaccines for all service members, citing the full authorization of the Pfizer/BioNTech vaccine. COVID vaccines will join the seventeen other inoculations service members are already required to get before enlisting or deploying overseas. Prior to the FDA’s announcement regarding the full authorization, the Biden Administration had announced requirements for all federal workers and contractors to either be vaccinated or submit to regular testing and strict mask-wearing. Following the announcement, the Administration stated that some agencies may adopt even more stringent vaccine requirements for at least some subsets of their staff.

The full approval has also influenced private businesses, schools and universities, as well as state and local governments to require proof of vaccinations. Chevron and CVS Health instituted vaccine requirements in the days following the authorization. Other businesses that have not yet explicitly required vaccines have announced other strategies to encourage vaccine uptake. For example, Delta Airlines has announced that it will charge unvaccinated employees $200 more per month for their health insurance premiums starting November 1. 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.

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 August 18, the Biden Administration announced that, pending formal authorization from the FDA and CDC, the U.S. will begin delivering booster shots to adults that received either the Pfizer/BioNTech or Moderna vaccines eight to nine months following their last shot. The booster program will officially begin on September 20 with a focus on residents and staff of long-term care facilities and nursing homes, as well as other healthcare staff. At least initially, individuals will be advised to receive a third shot of the same vaccine they had for their first two doses. The booster program does not yet include individuals who initially received a Johnson & Johnson/Janssen vaccine as there is not sufficient data available to justify doing so. Surgeon General Vivek Murthy and others anticipate that that data will be available in the coming weeks and a booster for these individuals will likely be necessary.

The Administration’s decision to begin providing boosters was made based on the results of three studies featured in Morbidity and Mortality Weekly Report (MMWR), the CDC’s journal. The first study suggests that mRNA vaccines’ efficacy in preventing infection among nursing home residents has declined from 74.7% in March – May 2021 to 53.1% during June – July 2021 (i.e., during the rise of the Delta variant). The second study evaluated the efficacy of the mRNA vaccines in preventing hospitalization, with only a slight reported drop in efficacy observed before and after the Delta variant’s emergence (87% to 84%). Finally, the third study, conducted in New York State, reports a similarly modest drop in vaccine efficacy against hospitalization but a much larger decrease (91.7% to 79.8%) in protection against infection between May 3 and June 25, 2021.

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, as well as more booster-related guidance specifically for persons who received the Johnson & Johnson/Janssen vaccine.
• Further updates from the Biden Administration and state health officials regarding plans for the anticipated booster campaign this fall.
• The potential emergence of additional variants with greater transmissibility, disease severity, and/or ability to evade currently available vaccines.
• Updates to the FDA/CDC guidance allowing for COVID-19 vaccinations among younger individuals. It is still anticipated that Pfizer/BioNTech 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.

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.