Updated CDC Guidance for Pfizer-BioNTech COVID-19 vaccination

On Tuesday, January 4, the Centers for Disease Control and Prevention (CDC) issued two new recommendations on guidance on the administration of the COVID-19 vaccine technology from Pfizer-BioNTech. This guidance follows after the Food and Drug Administration (FDA) gave similar recommendations. The updated recommendations include the following: recommendations include the following:

  • Those who received the Pfizer-BioNTech COVID-19 vaccine as their primary series are not recommended to get a booster after 5 months.
  • Children 5-11-years-old who are moderately or severely immunocompromised should received an additional primary dose of the Pfizer-BioNTech vaccine 28 days after their second shot.

Additionally, following a recent Advisory Committee on Immunization Practices (ACIP) meeting, CDC is endorsing ACIP’s recommendation that people 12-17 years old should receive a booster shot 5-months after their initial Pfizer-BioNTech vaccination series. Currently, this vaccine is the only COVID-19 vaccine authorized for adolescents aged 12-17.

UIO Highlight: Bakersfield American Indian Health Project Vehicle Transportation Services – Cleaning and Disinfection

CMS and OSHA Issue New Rules and Standards Around COVID-19 Vaccination Requirements

On November 5, 2021, the Occupational Safety and Health Administration (OSHA) under the U.S. Department of Labor announced new emergency temporary standards to protect nearly 85 million workers from the spread of COVID-19. These standards come in alignment with the Administration’s previous policies requiring federal employees and contractors to be fully vaccinated, as well as the recent Centers for Medicare and Medicaid Services (CMS) rule that health care workers at facilities participating in Medicare and Medicaid be fully vaccinated. 

OSHA’s COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS) will follow the same time frame as both the CMS rule and the Administration’s previously implemented policies – by January 4, 2022 all contractors and employees covered under these vaccination rules must have completed a full series of vaccinations or have received a single dose vaccination. These rules take precedent over any state or local ordinances, and OSHA further clarifies that their standard does not preempt the CMS rule. 

The OHSA COVID-19 Vaccination and Testing (ETS) for employers with 100 or more employees is as follows: 

  • Require full vaccination of employees by Jan 4, 2022. If an employee is not fully vaccinated by then, employees must provide a negative COVID test on at least a weekly basis. The ETS does not require an employer to cover the cost of the tests but they may be required to do so through other agreements or laws. 
  • Pay employees for the time taken to get vaccinated. If needed, employers must also give sick leave to those who need to recover from side effects. Compliance for this must be met by December 5, 2021. 

The CMS COVID-19 Omnibus Vaccine Rule (IFC-6) is as follows: 

  • By December 5, 2021, all facilities must have processes and plans in place for vaccinating staff, providing exemptions and accommodations and tracking and documenting staff vaccinations. All eligible staff must also have received at least one dose of a multi-dose vaccination, or the single dose vaccination by this date. 
  • By January 4, 2022, all covered staff at eligible facilities must have completed a multi-dose series of vaccination or be fully vaccinated. For this rule, CMS considers fully vaccinated to be 2 weeks post completion of either the single or multi-dose inoculations. 

  

For more information, please see:  

Fact Sheet: Biden Administration Announces Details of Two Major Vaccination Policies 

OSHA Publication 4162: Summary of COVID-19 Emergency Temporary Standard 

FAQ: CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule 

FEMA Public Assistance Funds Available to UIOs for COVID-19 Vaccine Administration Activities

On November 5, 2021, in response to the Centers for Disease Control and Prevention (CDC) recommendation that children ages 5-11 receive the Pfizer COVID-19 vaccine, the Federal Emergency Management Agency (FEMA) announced that its Public Assistance program will reimburse 100% of eligible costs associated with administering vaccines to children and adults until December 31, 2021. The funding will continue after December 31, but the reimbursement percentage may change. Urban Indian Organizations (UIOs) operating medical facilities are eligible for this FEMA funding that will be provided on a reimbursement basis for eligible vaccination activities, including:

 

  • Vaccination facilities including community vaccination centers, mass vaccination sites and mobile vaccinations including necessary security and other services for sites.
  • Medical and support staff including contracted and temporary hires to administer vaccinations.
  • Training and technical assistance specific for individuals storing, handling, distributing, and administering of COVID-19 vaccinations.
  • Personal protective equipment, other equipment, supplies, and materials required for storing, handling, distributing, and administering COVID-19 vaccinations.
  • Transportation support such as refrigerated trucks and transport security, for vaccine distribution as well as reasonable transportation to and from the vaccination sites for children and families with limited or no mobility to get to a vaccine site.
  • Onsite infection control measures and emergency medical care for children and families at vaccination sites.
  • Communication efforts that keep the public informed including public messaging campaigns, public service announcements, flyers, newspaper advertisements, websites, translation services, in-person community engagement, and call centers or websites to assist with scheduling appointments or answering questions for children and their families.

 

 

NCUIH worked with FEMA’s Public Assistance Division early in the pandemic to get questions answered about the agency’s available resources for UIOs and open the lines of communication with FEMA officials.

RETURNING TO SCHOOL: WHAT HEALTH LEADERS NEED TO KNOW

With the start of the 2021-22 school year around the corner and some schools starting this week, the entire country is again facing thousands of local decisions about under what conditions schools will reopen, in view of the major upheaval caused by the delta variant of coronavirus.  This strain is highly contagious, on the same level as measles and chickenpox, therefore public health officials are urging strict enforcement for mask wearing, physical distancing and vaccination.  To increase support for vaccines we must double down on containment and mitigation measures, including extensive testing, isolation, use of masks and social distancing of 3 feet at school campuses, under CDC guidelines.  To quote Dr. Rachel Levine, Assistant Secretary for Health at HHS, “We must cocoon a child surrounded by vaccinated adults.” This means that all teachers must be vaccinated, and children must wear masks while in school.  We all play a role and what the pandemic has taught us is that we are all interconnected.

Other Vulnerable Groups

Amidst these decisions weighing heavily on the minds of elected officials and public health officers, one piece of good news is that Pfizer will be seeking another Emergency Order Authorization in the fall for its new COVID-19 vaccine for children ages 5 to 11 years old.  (Younger than 5-yrs-old groups will take longer, because of the size of clinical trials and the cautious approach to de-escalate dosage when treating toddlers and infants).

Dr. Anne Edwards with the American Academy of Pediatrics reported on a national call with HHS and the CDC that pediatricians are seeing a lot of respiratory illness in medical offices, the ICU and regular hospital beds.  She and all medical staff strongly encourage everyone in the 12-and-older age group who are eligible to get vaccinated.  Studies show that no one is more trusted than Pediatricians, therefore the physician should take the time during medical visits to clear up any questions for the family.  We all need your help as trusted leaders in your community.  Dr. Amy Mullins, from the American Academy of Family Physicians, added that when confronting vaccine hesitancy, data shows that there is no single public message that will always overcome.

In addition, evidence about the safety of COVID-19 vaccination during pregnancy has been growing, including in the early months of pregnancy.  There is a trove of surveillance data, according to Dr. Peter Marks from the Federal Drug Administration (FDA).  Pregnant and recently pregnant women are more likely to get severely ill compared with non-pregnant people.  These data strongly point to the conclusion that the benefits of receiving a COVID-19 vaccine outweigh any known or potential risks of vaccination during pregnancy.  During the week of August 11, the Centers for Disease Control advanced this information and posted recommendations on their website.  Learn More.

Vaccine Boost

The FDA recently authorized a third dose or boost of the MRNI-type vaccine for those people who are immune-compromised, ages 15 and over.  Further, the evidence and rationale for taking this next step tells us that if a patient is only taking two medications for the underlying health condition, there is very little risk when taking a third dose.  The Advisory Committee on Immunization Practices (ACIP) will have to issue final guidance on this matter.

When administering immunizations, providers may wish to separate the administration of shots, especially when dealing with live viral vaccines and fever is present).  Soon the CDC will disclose real world evidence.

We ALL need your Help and the enlistment of public and private employers to take extra steps, such as time off from work to get vaccinated and providing free rides to vaccination sites.

NCUIH FACILITATES FIRST FEMA UIO LEADERS CALL

MAY 29, 2020

On May 29, for the first time, the Federal Emergency Management Agency (FEMA) met exclusively with a group of Urban Indian Organization (UIO) leaders. The call took place via Zoom video conference. The purpose of the call was to provide UIOs an opportunity to learn about programs open to nonprofits, get questions answered, and open the lines of communication with FEMA officials. FEMA is one of the major operational components that make up the Department of Homeland Security, which is facilitating a whole-of-government response in confronting COVID-19, keeping Americans safe, and helping detect and slow the spread of the virus.

The following officials from FEMA participated in the call: Acting Director Public Assistance Division Tod Wells; Attorney-Advisor, Federal Indian Law Subject Matter Expert Dorn Lawin; Tribal Affairs Specialist Margeau Valteau; and Tribal Integration Advisor Jessica Specht. Dr. Rose Weahkee, Director of the Office of Urban Indian Health Programs at the Indian Health Service, was also in attendance. FEMA sent NCUIH responses to the questions UIO leaders asked in a document that can be found here.