Current Status of COVID-19 Vaccines Rollout Nationwide: May 2022 Update for the Attorney General Community

On May 16, the U.S. reached nearly 220.6 million persons (66.4% 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 102 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 46.3% of those who are fully vaccinated, including 48.2% of those aged 12 years and older, 49.9% of those aged 18 years and older, and 69.2% of those 65 years and older.

Jurisdictions with the highest percentages of their total population having received their primary series include Rhode Island (87.3%), Puerto Rico (86.4%), Vermont (81.4%), Maine (79.8%), Connecticut (79.5%), and Massachusetts (79.3%). Meanwhile states with the lowest include Wyoming (51%), Alabama (51.2%), Mississippi (51.9%), Louisiana (53.6%), and Idaho (54.7%). Vermont leads all states with 60.7% of those who have received their primary series having also received one or more booster. Minnesota (57.9%), Wisconsin (56.4%), Maine (56.2%), and Michigan (54.5%) follow. States with the lowest rates of booster doses include North Carolina (26.7%), Alabama (35.8%), Mississippi (37.5%), Oklahoma (37.7%), and Georgia (37.9%).

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 BA.2 variant. 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. This led the Food & Drug Administration (FDA) and Centers for Disease Control & Prevention (CDC) to authorize second mRNA boosters for all persons 50 years of age and older and expand booster recommendations among other key groups.

The Impact of Variants

Data indicates that BA.2, a “sister variant” to BA.1, is roughly 30% more transmissible than BA.1 and is the most common COVID-19 strain in the U.S., representing 56.4% of all infections as of May 7. Meanwhile, a sub-lineage of BA.2 first identified in New York State (i.e., BA.2.12.1) is estimated to be 23-27% more transmissible than even BA.2 and already represents 42.6% of cases in the U.S. This is a significant increase from the 19% of all cases in the U.S. attributable to BA.2.12.1 as of April 16.

Reported COVID cases have continued to rise in the United States after mostly trending downward since January 2022 when BA.1 first peaked. Over 600,000 cases were reported the week of May 6 – 13. Pediatric cases are also rising with 93,000 reported as of May 12, a 78% increase from the prior two weeks. These are likely significant underestimates as many cities and states are closing community and/or health department-run COVID testing sites and at-home COVID antigen tests have increasingly been used. At-home testing results are typically not reported to and captured by public health surveillance systems. Hospitalizations and deaths have also ticked up in recent days. The seven-day average of hospitalizations reached 21,626 on May 13 while average deaths have risen to 366.

Meanwhile, there is another wave in cases in Africa driven by a combination of BA.2 and the emerging BA.4 and BA.5 variants. In each of the past three weeks, cases have risen in Africa with 87% of these cases reported from South Africa. First identified in South Africa in January and February 2022, BA.4 and BA.5 also appear to be more transmissible than BA.2 with enhanced ability to escape immunity from prior infections and/or vaccinations. As of May 12, the European Union Centers for Disease Control and Prevention have classified BA.4 and BA.5 as variants of concern, the highest level.

Boosters

The following table summarizes when and what kind of booster different individuals are now eligible for:

** Adolescents aged 12 – 17 years of age can only receive a third dose of the Pfizer/BioNTech vaccine as a booster. To date, the Pfizer/BioNTech vaccine is the only one to be authorized for this age group as either a primary series or booster.* 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 18 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 April 14, Pfizer/BioNTech released updated data from their trial among children ages 5 – 11 years of age detailing the safety and efficacy of a third 10 microgram dose of their COVID vaccine for this age group. Booster doses were administered six months after the second shot and showed a 36-fold increase in neutralizing antibody response to the Omicron variant as compared to after the first two doses. Pfizer/BioNTech submitted their application to the FDA to allow for a booster dose for immunocompetent children 5 – 11 years of age (i.e., those with a normal immune response) six months after receiving their second dose. On May 17, the FDA authorized Pfizer/BioNTech booster shots for children 5 – 11 years of age. The CDC’s Advisory Committee on Immunization Practice (ACIP) will meet on Thursday, May 19, to vote on its recommendations for boosters for this age group. Moderately or severely immunocompromised children 5 – 11 years of age are already eligible to receive a third Pfizer/BioNTech shot at least four weeks (i.e., 28 days) after their second dose.

The FDA and CDC will continue to issue updated guidance regarding the U.S. booster strategy including the need to revamp existing vaccines. 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 Delta and Omicron variants although it was not designed to specifically target them. The study has not yet been reviewed by the FDA. Moderna will continue to study updated monovalent and bivalent vaccine candidates in the months ahead to see which is best suited for 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. Should the FDA and CDC recommend additional boosters for all Americans, the Biden Administration and state/local health officials have reported that funding available to support the purchase and distribution of boosters will soon run out. 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. As officials continue to push for additional funding, they also are considering contingency plans including shifting the vaccine distribution to the private sector similar to the process for other vaccines.

COVID-19 Vaccines for Youngest Children

For the youngest children (i.e., those aged 6 months to 4 years), vaccines will not be authorized and available until early summer. Just before the FDA vaccine advisory body was scheduled to meet in mid-February to consider authorizing two 10 microgram doses of the Pfizer/BioNTech vaccine for this age group, the manufacturer announced that it would delay its application until data on the safety and efficacy of a third dose was available. In initial trial data, the two doses generated comparable antibody responses among children 6 months to 2 years but not among those aged 2 to 4 years. Pfizer/BioNTech has not yet released updated trial data regarding the efficacy of a third dose in this age group.

On April 28, Moderna asked the FDA to authorize its own two-dose COVID vaccine for children 6 months to 6 years. On March 23, the manufacturer released data detailing how its vaccine generated antibody responses in younger children comparable to those seen in adults. The shots, at one quarter the size of adult doses, were less effective in preventing symptomatic infections than were shots in previous trials in older groups. In children 6 months to 23 months, cases of COVID were decreased by 43.7%. Among those 2 – 6 years of age, the decrease was 37.5%. Moderna has said that this lower efficacy against symptomatic disease is to be expected against the Omicron variant. The company has also submitted a separate EUA for children ages 6 -11 and updated its EUA application for teens aged 12 – 17 years of age. The vaccine is still only authorized for those 18 years of age and older.

The FDA VRBPAC is scheduled to meet June 8, 21, and 22 to discuss and vote on its recommendations for Moderna and Pfizer/BioNTech’s EUAs for younger populations. Should the FDA authorize one or both vaccines for the youngest children, the CDC’s ACIP would then convene to vote on its own recommendations to be submitted to CDC leadership. Assuming ACIP and the CDC Director were to recommend the vaccine(s) for these age groups, they would likely be available to the public by the end of June at the earliest.

Potential End to Public Health Emergency (PHE) Declaration and Vaccine Distribution

On April 16, Secretary of Health and Human Services Xavier Becerra renewed the public health emergency (PHE) declaration for COVID-19 through July 15, 2022. The PHE has allowed the federal government to implement numerous flexibilities on policies and requirements that impact payers such as Medicare, Medicaid, and private insurance.

In February 2020, and separately from the PHE, the then Secretary of HHS signed a separate emergency declaration per Section 564 of the Federal Food, Drug, and Cosmetic Act that allows the FDA to issue EUAs for medical countermeasures to combat COVID-19 including, but not limited to, tests, treatments, and vaccines. To date, only the primary Moderna and Pfizer/BioNTech vaccine series for adults 18 years of age and older have received full licensures from the FDA. Once an EUA for a countermeasure officially ends, the countermeasure will no longer be available in the U.S. The Johnson & Johnson/Janssen vaccine, the primary vaccine series for children under 18 years of age for Moderna and 16 years of age for Pfizer/BioNTech, and all booster doses are still authorized under an EUA only. There is no publicly stated end-date to any of the current COVID-related EUAs. The Secretary of HHS may terminate the EUA declaration at any time. If the Secretary should do so, current EUAs would no longer be in effect and the FDA would be unable to issue new EUAs for products covered by the original declaration.

Finally, a declaration under the Public Readiness and Emergency Preparedness (PREP) Act was also issued by the former Secretary of HHS in March 2020 that provides liability immunity for activities related to medical countermeasures for COVID, including for vaccines. This declaration is scheduled to end October 1, 2024.

For a detailed overview of how ending the COVID-related public health emergency declarations would impact the distribution of and access to vaccines and other flexibilities, please review the following resource by the Kaiser Family Foundation. Of note, without additional funding for the federal government to respond to COVID, some of these flexibilities will effectively be unavailable (e.g., the Health Resources and Services Administration (HRSA) program to cover testing, treatment, and vaccines for uninsured individuals has stopped accepting claims from providers).

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 PHE 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.
• 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.
• 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 The FDA VRBPAC will meet to discuss Novavax’s application for their vaccine on June 7.

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.