On June 17, the U.S. reached nearly 221.9 million persons (66.8% 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). Over 104.7 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 47.2% of those who have had their primary series, including 48.9% of those aged 12 years and older, 50.6% of those aged 18 years and older, and 69.9% of those 65 years and older. In terms of second boosters, 25.3% of eligible people (i.e., those aged 50 years and older) have received one while 31.8% 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 (83.6%), Puerto Rico (83.5%), Vermont (81.8%), Maine (80.3%), Connecticut (80%), and Massachusetts (79.8%). Meanwhile states with the lowest include Wyoming (51.3%), Alabama (51.5%), Mississippi (52.2%), Louisiana (53.8%), Arkansas (54.9%), and Tennessee (54.9%). Vermont leads all states with 61.8% of those who have received their primary series having also received one or more booster. Puerto Rico (59.4%), Minnesota (58.7%), Wisconsin (57.2%), and Maine (57%) follow. States with the lowest rates of booster doses include North Carolina (27.2%), Alabama (36.4%), Mississippi (38.1%), Oklahoma (38.1%), and Georgia (38.9%).
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. However, there is evidence to suggest that this wanes over time.
A sub-lineage of variant BA.2 first identified in New York State (i.e., BA.2.12.1) represents 64.2% of cases in the U.S. as of June 11. Yet the BA.4 and BA.5 variants first identified in South Africa are quickly gaining ground here. More than one in five COVID infections in the U.S. were caused by BA.4 or BA.5 during the week of June 4, up from 13% the week prior. Regions with the highest BA.4. and BA.5 prevalence include Texas, New Mexico, Arkansas, Oklahoma, and Louisiana. 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.
In South Africa, BA.4 and BA.5 caused increases in cases though not the same extent seen with the earlier Omicron variant, BA.1. By contrast, in Portugal where BA.5 is dominant, deaths are now on par with its initial Omicron wave. It is unclear how the U.S. will continue to fare in the weeks ahead as the proportion of cases attributable to BA.4 and BA.5 grow.
Overall reported COVID cases in the U.S. have plateaued in recent weeks. Daily mortality has held steady since late April as new hospital admissions and current hospitalizations both have increased (+6.5% and +1.8%, respectively).
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 May 19, the Centers for Disease Control and Prevention (CDC) expanded eligibility for first COVID-19 vaccine boosters to everyone aged 5 years and older. For children aged 5 – 11 years of age, the updated guidance stated that they should receive a third shot five months after their initial Pfizer/BioNTech series. For all children aged 12 – 16 years of age who received Pfizer/BioNTech initially, they too are recommended to receive a first booster dose. Second Pfizer/BioNTech booster doses are recommended for individuals aged 5 years and older who are moderately or severely immunocompromised. As of June 21, the CDC has not yet authorized the Moderna vaccine primary series or boosters for children aged 6 – 18 though the FDA has amended the emergency use authorization (EUA) to allow for teens 12 – 18 years of age to receive the primary series. On June 24, the CDC accepted the recommendations from the Advisory Committee on Immunization Practice (ACIP) for the Moderna primary series for this age group.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet 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. Moderna has released early study data of a new, bivalent COVID-19 vaccine (i.e., a vaccine that includes two different strains of mRNA to train the immune system to respond to a wider range of variants). The vaccine reportedly generated higher antibody responses than the previous Moderna booster including against the Omicron variants. Moderna stated that it plans to submit this interim analysis to the FDA for review ahead of a probable fall booster campaign. Pfizer/BioNTech announced in January 2022 that they would be testing their own Omicron-specific vaccine although they have not yet released any data.
The Administration continues to advocate for an additional $10 billion in COVID-related spending to maintain minimum activities across testing, vaccination, and treatment. The Administration has stressed that if no new funding is allocated soon, the U.S. may fall behind other countries in securing purchase orders from vaccine manufacturers for a booster campaign this fall. On June 8, the Administration announced that it had diverted $10 billion in COVID relief from test procurement and other activities to fund future vaccine doses and treatments. As a result, test manufacturers are reportedly considering potential layoffs and other measures in response to this reduction in funding for testing efforts.
COVID-19 Vaccines for Youngest Children
On June 17, the FDA authorized the emergency use of Pfizer/BioNTech and Moderna COVID-19 vaccines for children down to six months of age. For the Moderna vaccine, the EUA was expanded to include children six months to 17 years old; previously, the vaccine was only authorized for adults 18 years of age and older. For Pfizer/BioNTech, the EUA was amended to include children six months to four years of age; previously, the vaccine was authorized for individuals five years and older. On June 18, the CDC also authorized the Moderna vaccine for children 6 months to 5 years of age and the Pfizer/BioNTech vaccine for children aged 6 months to 4 years.
The following table summarizes the recommendations for the Moderna and Pfizer/BioNTech vaccines by age for immunocompetent individuals:
| 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 |
There are differences between the Moderna and Pfizer/BioNTech vaccines for the youngest children. While the Moderna vaccine provides protection comparable to adults with only two doses, the doses are larger and appear to cause more severe and frequent side effects than Pfizer/BioNTech’s. On the other hand, the three-dose vaccine schedule for Pfizer/BioNTech may pose challenges for parents or caregivers who would like maximum protection for their children sooner or who would have a harder time squeezing in another vaccine appointment.
Following the CDC Director’s endorsement of both vaccines for younger children, doses started to ship the weekend of June 20. Providers began administering vaccines in children under five years of age on Tuesday, June 22. Around 17 million more children are now eligible to be vaccinated. Uptake and interest in the vaccines for younger children may be tepid in the first weeks of the roll-out. Polling by the Kaiser Family Foundation (KFF) in April 2022 indicate that just one in five parents of children under five years of age plan to get their child vaccinated right away. About four in ten parents are reluctant to get their child vaccinated with 27% saying they “definitely will not” do so.
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.
- Either an extension of or end to the current Public Health Emergency and other declarations related to COVID-19.
- Additional information on the (1) transmissibility, (2) disease severity, and (3) potential for immune escape of the Omicron variant and its multiple sub-lineages. The possible emergence of other variants or sub-lineages with increased transmissibility, virulence, and/or immune escape.
- Guidance and decisions reached by the FDA and CDC regarding modified vaccines for a fall booster campaign.
- Release of additional data regarding the long-term efficacy of second booster doses in preventing symptomatic infection, hospitalization, and death.
- Release of additional data regarding the safety and efficacy of mixing and matching vaccines for purposes of boosters.
- 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.
- Additional vaccine manufacturers possibly seeking authorization in the U.S., including the two-dose AstraZeneca/Oxford University and Novavax On June 7, the FDA VRBPAC recommended granting an EUA for the Novavax two-dose protein subunit vaccine for people 18 years and older. The FDA has not officially granted the EUA as they finalize review of Novavax’s manufacturing practices.
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.
