Today was supposed to be the day that everyone could start getting boosters. As usual, the devil was in the details. An advisory committee met Friday and came up with some well publicized recommendations which are summarized in the following edition of tomorrow’s ACP Internist, a publication of the American College of Physicians. The panel’s recommendation is taken under advisement by the FDA along with the recommendation of their vaccine practices advisory committee, the ACIP which meets this week. Then the FDA comes up with a recommendation and those eligible can get boosters. They still will have to come up with recommendations for those who have received Moderna and J+J vaccines. Those should be coming within the next few weeks. Until then, the only patients eligible for third injections (not boosters) are immunocompromised individuals.
Research, regulators consider booster dose of COVID-19 vaccine
FDA advisors recommended boosters for older and high-risk patients. The latest COVID-19 research looked at vaccine effectiveness, remdesivir’s effects, an early indicator of vaccine-induced immune thrombotic thrombocytopenia, and rates of follow-up after hospitalization.
Booster vaccine doses were the focus of COVID-19 news and research last week. On Sept. 17, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously recommended a third booster shot of the Pfizer-BioNTech vaccine for patients 65 years and older or at risk of serious disease from SARS-CoV-2. The committee voted against booster shots for the general population, but in an unofficial poll, unanimously supported a booster dose for health care workers or others at high risk of occupational exposure, according to NPR. Its advice is not binding but will be considered by the FDA.
A retrospective study in Israel, published by the New England Journal of Medicine (NEJM) on Sept. 15, reported the effects of a booster dose of the Pfizer-BioNTech vaccine in patients age 60 years or older. The month-long study compared more than 10 million patient-days after receipt of a booster to more than 5 million days in patients who had gotten only two doses, finding 934 confirmed infections, 29 of them severe, in those who received a booster versus 4,439 confirmed infections, 294 of them severe, in those who had not. The authors calculated that the booster decreased the rate of COVID-19 infection by a factor of 11.3 (95% CI, 10.4 to 12.3) and the rate of severe illness by a factor of 19.5 (95% CI, 12.9 to 29.5). “Our findings give clear indications of the effectiveness of a booster dose even against the currently dominant delta variant,” the authors said.
Similarly, a letter published by NEJM the same day reported SARS-CoV-2 neutralization geometric mean titers in 23 people who received a third dose of Pfizer-BioNTech vaccine as part of a U.S. trial. “The safety and immunogenicity of a booster dose of BNT162b2 administered 7 to 9 months after the primary two-dose series suggest that a third dose could prolong protection and further increase the breadth of protection,” the authors observed.
However, a group of experts expressed concerns about providing boosters to anyone other than immunocompromised patients in a Viewpoint published by The Lancet on Sept. 13. They reviewed the latest literature on the effectiveness of two doses and a third booster shot and said, “Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.” The relative effectiveness of the three authorized vaccines was compared in a study published by MMWR on Sept. 17. It looked at 3,689 adults from 18 states without immunocompromising conditions who were hospitalized during the period from March 11 to Aug. 15 and calculated that vaccine effectiveness against COVID-19 hospitalization was 93% for the Moderna vaccine, 88% for the Pfizer-BioNTech vaccine, and 71% for the J&J/Janssen vaccine.
A curious phenomenon is being observed. Patients with Covid who were unwilling to get vaccinated are willing to take monoclonal antibodies to treat it. The science of monoclonal antibodies is more trustworthy than the science of vaccines?
Unvaccinated Americans Turn To Antibody Treatment, Causing Demand To Surge
The New York Times (9/18, A1, Mueller) reported, “Vaccine-resistant Americans are turning to” monoclonal antibody treatment “with a zeal that has, at times, mystified their doctors, chasing down lengthy infusions after rejecting vaccines that cost one-hundredth as much.” Orders for the treatment “have exploded so quickly this summer – to 168,000 doses per week in late August, up from 27,000 in July – that the Biden administration warned states this week of a dwindling national supply.” The federal government “has told states to expect scaled-back shipments because of the looming shortages.”
Here is what I was sent by the Texas Department of State Health Services today. I don’t know what effect this will have on the availability of the treatments. I am told by sources at Methodist Healthcare System that they do not expect any delays.
Update from DSHS Regarding COVID-19 Therapeutics Order Requests
The following email is being sent on behalf of the Texas Department of State Health Services.
Sept. 17, 2021
This email is to inform you of the new process to request certain COVID-19 monoclonal antibody (mAb) therapeutics, including REGEN-COV (casirivimab/imdevimab; manufactured by Regeneron) and bamlanivimab/etesevimab (manufactured by Eli Lilly).
Late September 13, 2021, federal US Health and Human Services (US HHS) notified states that, due to supply constraints, providers may no longer order mAb products direct from AmerisourceBergen Corporation (ABC). Instead, US HHS will provide weekly allocations to the states. The states, in turn, will make allocations to their providers.
Following the federal announcement, the Texas Department of State Health Services (DSHS) has been working to put in place a system by which providers can make requests for mAb products. Thank you for your patience as the state makes this unexpected transition.
Below, please find some information on what we know at this point. Please bear in mind that DSHS will be evolving this system as helpful in the coming weeks. For the time being, DSHS has had to implement a rudimentary system to ensure Texas can put in full orders for mAb timely in these first weeks of the new approach.
US HHS has indicated that allocations to the states will decline in coming weeks due to supply limitations. Our understanding is that allocations to the state will be determined by the following factors:
- State population
- State COVID-19 cases and hospitalizations
- State provider adherence to reporting requirements
Of note, this federal shift has made it all the more vital that all mAb providers report daily into the Texas Division of Emergency Management (TDEM) portal or the HHS provider portal, depending on provider type. The federal government has indicated that utilization and reporting will impact future Texas allocations.
Weekly Ordering Cadence
Texas is working to gather more information from HHS and ABC on weekly cadences. The current known weekly schedule is as follows:
- Mondays: DSHS will pull provider requests at end of day to begin the allocation process. Providers may enter requests at any time.
- Tuesdays: The states will receive their allocated amounts for the following week.
- Wednesdays: US HHS will take its snapshot of provider mAb use, which will feed into Texas’s future allocations from HHS.
- Fridays: The state must enter all orders for the state by end of day.
- Shipments will arrive throughout the week. Shipments will only arrive on weekdays.
Provider Requests for MAb
Thousands of Texas providers are now familiar with the Vaccine Allocation and Ordering System (VAOS) that Texas uses for COVID-19 vaccines. DSHS is adding a module to allow providers to put in their mAb requests through VAOS. A first version of this module is now available and will be built out in the coming days for added functionality.
- For Providers Already Registered in VAOS: You will be able to see the new module effective tomorrow, September 18, 2021. If you are a current VAOS user AND you are registered with ABC as a therapeutics provider, you can begin using the VAOS system to document your requests. VAOS users without an ABC account may not place an order.
- For Providers Not Yet Registered in VAOS: DSHS is working to build out the ability for new VAOS users to enter the system specific to therapeutics. This functionality should be available in about a week. In the meantime, please send requests to firstname.lastname@example.org.
Providers who do not have an (established) account with AmerisourceBergen should email email@example.com to start the ABC account process. Once your facility has an ABC account, you may place order requests in VAOS for therapeutics.
Due to the high demand and limited supply of COVID-19 therapeutics, not all requests may be fulfilled at this time. Please continue to submit requests based on your patient needs and administration rate and we will work to fulfill them as soon as possible.
For questions about ordering therapeutics, reach out to firstname.lastname@example.org.
More information may be found below related to provider trainings on the new system.
DSHS Allocation Strategy
DSHS is working to implement a fair allocation strategy that ensures Texas is well positioned to receive its maximum allocation each week.
DSHS will consider the following factors when evaluating provider requests:
- Provider use and reporting
- Geographic coverage
- Rural and urban coverage
- Proportionality to eligible population estimates
Again, provider reporting will be a key and deciding factor for whether a provider may receive mAb allocations. Providers that do not report will not receive allocations.
DSHS will sponsor trainings early next week to provide more details on the process and answer your questions. Your participation in trainings will also help ensure that DSHS training guides and reference materials adequately address common provider questions.
- Existing ABC Providers with VAOS Accounts:will receive an invitation for a webinar scheduled for Monday, September 20th to review the steps to submit therapeutic order requests and reporting requirements. A recording will be made available for providers who cannot attend.
- Existing ABC Providers without VAOS Accounts:will be added to VAOS by Friday, September 24th. You will receive an invitation for a New VAOS User webinar on Monday, September 27th or Wednesday, September 29th. During this webinar, you will receive an orientation to VAOS and learn how to submit order requests and reporting requirements for therapeutics. A recording will be made available for providers who cannot attend.
Thank you again for your understanding while DSHS stands up this complex system. We know that this federal switch has caused shipment delays and cancellation, causing confusion and frustration for everyone. We also know that supply constraints will become increasingly problematic in the coming weeks. Thank you for doing your part to administer and report mAb doses timely to help ensure Texas receives its maximum share of mAb allocations.
Texas Department of State Health Services
As Benjamin Franklin wrote in Poor Richard’s Almanac, “An ounce of prevention is worth a pound of cure.”