“All Hands on Deck”: The New Bivalent COVID Boosters Are Here
The FDA, CDC, & Western States Scientific Safety Review Workgroup have approved the EAU for the new Pfizer and Moderna mRNA bivalent vaccines. These vaccines target the COVID-19 spike protein, which has rapidly mutated over the course of the pandemic. These vaccines target the original Wuhan spike protein (monovalent vaccines) and the Omicron BA.4 & BA.5 subvariants. BA .5 has proved very contagious and still accounts for over 88% of the infections in California. Though the numbers of COVID cases, hospitalizations, and deaths have slowly improved since the end of July, the rates are still substantial. On 9/8/22, a large 250-hospital network study of COVID-19 hospitalizations in the USA from January 2021-April 2022 was published in JAMA IM (https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2796235). They found the rate of hospitalization was 10.5 times greater for unvaccinated and 2.5 times higher for vaccinated, but not boosted. We anticipate an even greater benefit of the new bivalent vaccines which better target BA .5. This vaccine roll-out is well timed to combine with our efforts to provide the usual Flu vaccines before winter arrives. As of 9/10, over 50 million doses have been delivered to states for distribution.
Your local public health officials have already completed much background work to make these vaccines available. In Sonoma County we have a team procuring the vaccine and an advance planning lead that has developed powerful analytic tools that coordinate the scheduled work of matching facility vaccination providers with senior living facilities, homebound, and homeless persons. Though CVS, Walgreens, and Safeway pharmacies are no longer funded to do this, in my area, some of these pharmacies have continued to provide this service to their prior facilities. We also have partnered for in-facility vaccination services with a local pharmacy, a home health agency, and the state wide Optum Health test and treat LHI program. These vaccines are free to residents and the public.
The CDC recommended high-dose and adjuvant Flu vaccines for seniors, which are free to the uninsured in our state. However, this has added a wrinkle to our efforts to combine influenza vaccine with the bivalent COVID boosters (CDC recommends this), since our procuring team needs to procure flu vaccine for those with billable insurance and set up a billing system with our vaccinating teams to recover the cost of that service.
As a reminder, our state requires both vaccines for all health care workers (HCWs), except those with vaccine waivers. Going forward, the original monovalent COVID vaccines will only be used for the primary vaccination series. This bivalent vaccine is recommended for those who are fully vaccinated and are at least 2 months since their last COVID vaccine. They are recommended for those 12 y/o or older (Pfizer) or 18 y/o or older (Moderna). For those with recent COVID infections, the CDC continues to recommend holding off on the booster until the infection becomes asymptomatic. Some experts have also recommended waiting until 2-3 months post onset of the infection. These boosters are approved for use in pregnant and lactating women as well as persons with moderate to severe immunodeficiency.
If you have HCWs with a religious waiver, you may encourage use of the Novavax vaccine, which was developed without any relationship to human fetal cells and is a traditional protein-based vaccine similar to other commonly used vaccines like the Prevnar pneumococcal vaccines and Shingrix for shingles. As of this time, the approved monovalent targeted COVID vaccines will only be used for the primary vaccination series. The FDA anticipates the Bivalent Boosters will be approved for those 5-11 y/o by early October. In the interim, the emphasis in this age group should be on completing the primary vaccination series. CDC has changed their definition of “Up to Date” for COVID vaccines to: completion of primary series + the bivalent booster, if booster eligible.
Some of your staff and residents may prefer to schedule an appointment for the vaccine at community pharmacies or vaccination sites in their communities. This can be done through the MyTurn.CA.gov website or by texting your Zip Code on your smartphone to GETVAX or VACUNA.
You should be aware that your public health’s COVID mitigation resources were dramatically slashed June 30, 2022 due to reduced federal government funding for COVID mitigation. In my county with 500,000 residents, we now have only two nurses dedicated to COVID mitigation and no longer have strike teams. We are helping facilities to use the statewide Spot Portal for COVID case reporting (https://spot.cdph.ca.gov/s/?language=en_US). We are now recommending that facilities first screen or test for possible COVID with POC antigen tests rather than PCR tests and then have confirming PCR tests done through community labs, since our public health lab has reduced PCR processing capacity. In addition, rather than calling public health for assistance with COVID outbreaks, we are encouraging use of [email protected] to more efficiently utilize our COVID mitigation expertise.
This fall it's time for “All Hands on Deck '' to ensure our residents and staff are well protected.
Tim Gieseke MD, CMDCo-Lead for Sonoma County Senior Living Facility Learning Collaborative