BCHHS Public Health Provider Update: COVID 3rd doses & booster doses; parental consent now required for vaccines with EUA

August 23, 2021

Information from Buncombe County Health & Human Services (BCHHS) on CDC’s Recommendation for a 3rd Dose of mRNA COVID-19 Vaccines (Pfizer-BioNTech or Moderna) for People who are Moderately to Severely Immunocompromised

Additional dose of mRNA COVID-19 vaccines for those who are moderately to severely immunocompromised

  • No changes in the information I shared last week, but I have attached a one-pager on the recommendations and how we are operationalizing it at our COVID-19 Vaccine Clinic at 40 Coxe Ave. (open Monday-Friday, 9am-4pm)

 

Parental consent now required for vaccines under emergency use authorization (EUA)

  • On Friday afternoon, Governor Cooper signed Session Law 2021-110, which included an update to NC General Statute 90-21.5, more commonly known as the minor consent law.
    • Effective immediately, NC’s minor consent law now states that healthcare providers shall obtain written consent from a parent or legal guardian prior to administering any vaccine that has been granted EUA and is not yet fully approved by the FDA – like the Moderna and Pfizer COVID-19 vaccines – to an individual under 18 years of age.
    • Once these vaccines receive full FDA approval, which may be within the next month for Pfizer, minors will no longer need parental/guardian consent for the vaccine.
  • Interestingly, Session Law 2021-110 also expands the ability of immunizing pharmacists to administer vaccines and dispense, deliver, or administer nicotine replacement therapy, oral or transdermal contraceptives, prenatal vitamins, HIV post-exposure prophylactic medications, and glucagon.
    • More to come on these changes, as many details first must be worked out by the State Health Director and representatives from the NC Medical Board and NC Board of Pharmacy, and parts of the law go into effect at later dates.

 

K-12 school guidance

  • As we start the school year, I again encourage you to review the requirements for return to school for students and school staff on pages 17-18 of the StrongSchoolsNC Toolkit, so that you correctly counsel families on when they can return to school.
  • The following updates were made to the toolkit on 8/18/2021:
    • Aligned symptom list with entire CDC symptom list (so that now includes runny nose or congestion, chills, fatigue, muscle or body aches and nausea)
    • Added additional guidance that instruction involving singing, shouting, playing wind instruments, rigorous dance, or exercise, should be held outside if possible. If held indoors, ensure consistent mask use and 6-feet physical distancing between students

 

Booster doses

While the FDA and CDC have not approved a booster dose yet, here are some key messages and talking points from the US DHHS that you can share with your patients, coworkers, friends and family

  • The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant.  
  • Although we continue to see stable and highly effective protection against hospitalizations and severe outcomes for people who are fully vaccinated, we are seeing a decrease in vaccine effectiveness against infection.  
  • It is critical that unvaccinated and partially vaccinated people get their primary series of vaccines to further reduce the risk of COVID-19 and its more severe outcomes. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated at all.  
  • US DHHS has developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence.   
    • Only after a thorough review of the evidence will CDC’s independent advisory committee make recommendations on the use of boosters for the public.   
    • The Advisory Committee on Immunization Practices (ACIP), composed of medical and public health experts, develops recommendations, and provides guidance to the CDC Director on the use of vaccines for the general public.    
  • Among fully vaccinated people in New York state (data includes NYC) from May 3–July 25, 2021, COVID-19 vaccines were more than 90% effective against hospitalizations.  
    • A new study finds that among all adults in New York state, overall effectiveness against new COVID-19 infections declined from about 92% to about 80%.   
    • The decline in effectiveness against new infections coincides with the increase in the Delta variant in the United States, along with relaxation of masking and physical distancing recommendations. 
    • The factors driving the apparent changes in vaccine effectiveness, including variations by age, are uncertain.  The substantially increased infectiousness of the Delta variant might underpin its increased transmissibility and could potentially lead to reduced vaccine-induced protection against infection.  
  • A new CDC study finds the Pfizer and Moderna COVID-19 vaccines were highly effective in providing at least 24 weeks of protection for fully vaccinated adults against severe COVID-19 illness requiring hospitalization.  
    • Vaccine effectiveness against COVID-19 associated hospitalization was 86% during the first 2–12 weeks post-vaccination and 84% effective during the following 12-week period.   
    • The vaccine was found to be 90% effective against COVID-19 associated hospitalizations for people without immunocompromising conditions.  
    • For those with immunocompromising conditions, the vaccine was found to be only 63% effective against hospitalizations associated with COVID-19 (over the 24 week study). CDC now recommends that people whose immune systems are moderately to severely compromised should receive an additional dose of mRNA COVID-19 vaccine at least 4 weeks after their second dose, for a total of three doses.   
    • Widespread vaccination is a critical tool to reduce the risk of hospitalization due to COVID-19.  
  • Nursing home residents were prioritized for COVID-19 vaccination early in the U.S. vaccination program and might be among the first groups to show evidence of potential waning of the immunity provided by vaccines.  
    • Among nursing home residents, in the pre-Delta period two doses of mRNA vaccine were 75% effective against COVID-19 infections; but during the Delta period, mRNA vaccine effectiveness declined to 53%.   
    • Investigators could not determine if the lowered vaccine effectiveness was caused by potential waning immunity, reduced protection against the Delta variant (that became the dominant strain within 6 months after vaccine rollout), or a combination of both factors.   
    • Vaccination of nursing home residents, staff members, and visitors should be prioritized because residents remain at higher risk for COVID-19 despite vaccination.   
    • A potential need for an additional vaccine dose exists among populations at higher risk of severe COVID-19 outcomes.  
  • US DHHS’ top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines.  
    • This virus is constantly changing, and we are following the science. Vaccines remain the most powerful tool we have against COVID-19.  
    • If you haven’t been vaccinated yet, you should get vaccinated right away. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated.