On July 13, the U.S. reached over 222.6 million persons (67.1% of the total U.S. population) having received their primary COVID-19 vaccine series (i.e., having received either one shot of the Johnson & Johnson/Janssen vaccine or two shots of either the mRNA Pfizer/BioNTech or Moderna vaccines). Nearly 400,000 children under five years of age have received one or more doses of the newly authorized Pfizer/BioNTech or Moderna vaccines for this age group. Over 107 million persons in the U.S. have received a first booster (i.e., a third dose following an mRNA primary series or a second dose following a Johnson & Johnson/Janssen primary series). This represents 48.1% of those who have had their primary series, including 49.7% of those aged 12 years and older, 51.3% of those aged 18 years and older, and 70.4% of those 65 years and older. In terms of second boosters, 28.5% of eligible people (i.e., those aged 50 years and older) have received one while 35.2% of those aged 65 years and older have done so.
Jurisdictions with the highest percentages of their total population having received their primary series include Rhode Island (84%), Puerto Rico (83.7%), Vermont (82.1%), Maine (80.7%), Connecticut (80.2%), and Massachusetts (80.1%). Meanwhile states with the lowest include Wyoming (51.5%), Alabama (51.7%), Mississippi (52.5%), Louisiana (54%), Arkansas (55.1%), and Tennessee (55%). Vermont leads all states with 62.5% of those who have received their primary series having also received a first booster. Puerto Rico (60%), Minnesota (59.4%), Wisconsin (57.7%), and Maine (57.7%) follow. States with the lowest rates of booster doses include North Carolina (28.1%), Alabama (37.1%), Mississippi (39%), Oklahoma (38.8%), and Georgia (39.8%).
Since June 18, nearly 400,000 children aged six months to five years of age have received at least one dose of either the Moderna or Pfizer/BioNTech vaccines series. There are estimated to be around 18 million children in the U.S. in this age group. The following table summarizes the differences between the two manufacturers’ vaccines available for different ages.
| Moderna | Pfizer/BioNTech | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Age Group | 6 months to 5 years | 6 to 11 years | 12 – 17 years | 18 – 50 years | 50 years + | 6 months to 4 years | 5 to 11 years | 12 – 16 years | 16 – 50 years | 50 years + |
| Number of Doses | Two (primary series) | Two (primary series) | Three (two primary series, one booster) | Three (two primary series, one booster) | Four (two primary series, two boosters) | Three (primary series) | Three (two primary series, one booster) | Three (two primary series, one booster) | Three (two primary series, one booster) | Four (two primary series, two boosters) |
| Dose Size(s) | 25 micrograms (µg) | 50 µg | 100 µg (primary series), 50 µg (booster) | 100 µg (primary series), 50 µg (booster) | 100 µg (primary series), 50 µg (booster) | 3 µg | 10 µg | 30 µg | 30 µg | 30 µg |
| Time Between Doses | 28 days | 28 days | 28 days between dose 1 and 2, 5 months between dose 2 and 3 | 28 days between dose 1 and 2, 5 months between dose 2 and 3 | 28 days between dose 1 and 2, 5 months between dose 2 and 3, 4 months between dose 3 and 4 | 21 days between dose 1 and 2, 8 weeks + between dose 2 and 3 | 21 days between dose 1 and 2, 5 months between dose 2 and 3 | 21 days between dose 1 and 2, 5 months between dose 2 and 3 | 21 days between dose 1 and 2, 5 months between dose 2 and 3 | 21 days between dose 1 and 2, 5 months between dose 2 and 3, 4 months between dose 3 and 4 |
Thus far, children under five have been vaccinated at slower rates than other age groups, including older children. Polling released by Kaiser Family Foundation in April 2022 found that one in five parents of children under five years were eager to get their child vaccinated right away whereas 27% said they would “definitely not” get their child vaccinated. In the first few weeks following the FDA’s and CDC’s authorization of the vaccines for younger children, only 2% of these children received their first dose. In comparison, 15% of children ages 5 to 11 years of age received the vaccine in the first few weeks of authorization.
U.S. officials have long predicted that vaccine uptake in the youngest children would be slower. Unlike other groups where shots were readily available at mass vaccination sites and pharmacies, children under five are expected to largely receive COVID shots at their pediatrician’s or family physician’s office. Many parents may feel more comfortable having their children vaccinated at their regular doctor’s office. It may also be logistically easier to integrate it into a regular check-up or other doctor’s visit. Also, unlike with school-aged kids, those under five are unlikely to be included in any school-based vaccine clinics. Finally, pharmacies are often limited in their ability to vaccinate very young children. Many states bar pharmacies from vaccinated children under three years of age or require a prescription to do so. In some cases, pharmacists and other pharmacy staff have inadequate training, staffing, or space to give shots to the youngest children.
Yet doctors’ offices may take time to ramp up availability of one or both vaccines. Some may choose to carry one but not the other to minimize any potential confusion or mix-ups between the two different formulas. Others may feel as though they would waste too many of the 10-dose vials the vaccines come in for younger children. Some providers may also feel as though they do not have the space or equipment to meet the cold storage requirements for the shots.
In other vaccine-related news, the Novavax two-dose, adjuvanted protein-subunit vaccine received an EUA from the FDA on July 13. On July 19, the CDC’s Advisory Committee on Immunization Practice (ACIP) voted to recommend the vaccine for adults 18 years and older as a primary series. With CDC Director Rochelle Walensky’s approval, the vaccine will soon be shipped and available to the general public. Thus far, the U.S. government has secured 3.2 million doses of the vaccine. As well, Pfizer/BioNTech’s vaccine has received a full biologics license from the FDA for adolescents aged 12 to 17 years of age.
The Impact of Variants
Studies demonstrate that current COVID-19 vaccines remain effective against the Omicron variant including against severe disease, hospitalization, and death. Yet protection against severe disease for those who have only received their primary series is significantly lower against the various Omicron-related variants. First boosters strengthen antibody responses and provide greater protection against infection and severe disease from Omicron variants. Second boosters provide additional protection to eligible adults aged 50 years of age and older.
As of July 16, the BA.4 and BA.5 variants first identified in South Africa make up 90.7% of all COVID infects in the U.S. with BA.5 alone making up 77.9% of cases. Both variants are better able to evade the body’s immune system’s antibody response from prior infections and/or vaccination. Importantly, persons who have recovered from a prior Omicron infection (e.g., from BA.2) could be susceptible to a BA.4 or BA.5 infection not long after. As of now, BA.4 and BA.5 do not appear to cause more severe disease than other Omicron strains.
Overall reported COVID cases in the U.S. have started to increase in recent weeks. Daily mortality has also begun to creep up during the week of July 20 as new hospital admissions and current hospitalizations both have continued to increase (+7.8% and +6.9%, respectively). In response, Secretary of Health and Human Services (HHS), Xavier Becerra, renewed the federal public health emergency on July 15 for another ninety days.
Boosters
The following table summarizes when and what kind of booster different individuals are now eligible for:
| First Booster | Second Booster | |||||
|---|---|---|---|---|---|---|
| Primary Vaccine Series | Groups Eligible to Receive Booster | When to Receive Booster | Booster Doses Can Receive | Groups Eligible to Receive Booster | When to Receive Booster | Booster Doses Can Receive |
| Johnson & Johnson / Janssen | Those 18 years and older | At least two months after first dose | •1 dose Johnson & Johnson/Janssen •1 full dose of Pfizer / BioNTech •1 half dose of Moderna | •Those age 18 years and older who received Johnson & Johnson / Janssen as first booster dose •Those age 50 years and older | At least four months after first booster | •1 full dose of Pfizer / BioNTech •1 half dose of Moderna |
| Moderna | Those 12 years and older | At least five months after second dose * | •1 dose Johnson & Johnson/Janssen •1 full dose of Pfizer/BioNTech •1 half dose of Moderna * | •Those 50 years and older | At least four months after first booster | •1 full dose of Pfizer / BioNTech •1 half dose of Moderna * |
| Pfizer / BioNTech | Those 5 years and older | At least five months after second dose * | •1 dose Johnson & Johnson/Janssen •1 full dose of Pfizer/BioNTech ** •1 half dose of Moderna * | •Those 50 years and older | At least four months after first booster | •1 full dose of Pfizer / BioNTech •1 half dose of Moderna * |
* Immunocompromised individuals aged 5 years of age and older (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 12 years and older and receiving a third Moderna shot, it should be a full-sized dose. Moderately or severely immunocompromised individuals may receive a fourth mRNA dose at least three months after their third shot and a fifth dose at least four months after their fourth shot.
** On May 5, the FDA announced updates to the emergency use authorization (EUA) for the Johnson & Johnson/Janssen vaccine due to increased risk of thrombosis with thrombocytopenia syndrome (TTS) (a syndrome that causes rare and potentially life-threatening blood clotting with low blood platelet levels). The FDA now only authorizes the vaccine to be administered to individuals 18 years of age and older in one of the two situations: (1) other authorized vaccines (i.e., Moderna, Pfizer/BioNTech) are not available or clinically appropriate for them (e.g., they are severely allergic to the other vaccines), or (2) they would otherwise refuse to be vaccinated if only offered one of the other authorized vaccines.
On June 18, the CDC recommended use of the Moderna vaccine in children six months to five years of age. On June 24 they did so for children aged 6 to 17 years of age. Currently, children under 17 years of age who have received the Moderna vaccine are not yet recommended to receive a booster though that will likely change following a subsequent review by the FDA and CDC.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 28 to discuss whether COVID-19 vaccines should be modified to account for new and different variant strains ahead of a potential fall/winter surge in the U.S. Both Moderna and Pfizer/BioNTech developed and tested new, bivalent COVID-19 vaccine boosters (i.e., a vaccine that includes two different strains of mRNA to train the immune system to respond to a wider range of variants) that included the original strain as well as the BA.1 strain. Following the VRBPAC meeting, the FDA officially recommended that vaccine manufacturers develop and test vaccine boosters that include the original COVID strain as well as the BA.4 and BA.5 strains for a booster campaign this fall. Of note, the FDA has not recommended any changes to the primary series. Meanwhile, Pfizer/BioNTech will begin testing a universal COVID vaccine later this year.
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, boosted, and unvaccinated individuals generally and within specific settings.
- Additional information on the (1) transmissibility, (2) disease severity, and (3) potential for immune escape of the Omicron variant and its multiple sub-lineages as well as the possible emergence of other variants or sub-lineages with increased transmissibility, virulence, and/or immune escape.
- Potential updates to the guidance and decisions reached by the FDA and CDC regarding modified vaccines for a fall booster campaign.
- Release of additional data regarding the safety and efficacy of first booster doses among children under five years of age.
- Additional changes to the vaccine distribution, testing, and treatment landscape for COVID in the U.S. in the absence of additional funding appropriated by Congress.
In 2022, 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.
