IN THIS ISSUE
Next round of federal COVID test purchases
National site for reporting COVID home tests
Data on bivalent booster effectiveness
Monkeypox becomes mpox
New and Noteworthy
2022-2023 Round of Federal COVID Test Purchases Announced
HHS has tapped four test manufacturers to provide the federal government with a total of 200 million OTC COVID tests over the next year. The requirements this time: immediate test availability and US manufacturing. The budget: $800 million overall. The winners:
AccessBio and iHealth - 72 million tests each
OraSure and Quidel - 18 million tests each
Note: Mara is on the board of OraSure.
National Site for Reporting COVID Home Tests Launched
As of last week, all Americans can (finally) report the results of their COVID home tests, using the NIH’s MakeMyTestCount.org website. The process takes about one minute, whether you’re positive or negative - and the only personal information you need to provide is your age and your zip code.
Commentary: We and many others have been banging this drum for a long time: the US needs a privacy-protected, manufacturer-agnostic, national database to estimate the number and results of COVID home tests. While it’s wonderful to see the site launch, our expectations as far as adoption rate for COVID tests are low. In reality, this is a huge step forward not for the current pandemic, but for the next one.
Note: Liz is on the NIH / RADx team that developed the site.
Food for Thought
For COVID Winter #3, we’re immunologically better prepared, but not impervious
As we head into December, we hear cautiously optimistic predictions about what COVID has in store for us this winter. (Although not so optimistic about flu and RSV.) Attempts to predict the course of an epidemic are generally based on two types of insights: 1) data on viral evolution and what it portends regarding virulence and immune escape; and 2) current epidemiology, including the population’s immunity profile. We’ve discussed part of #1 before. As of this moment, Omicron (which is now more a group than a single variant) remains objectively less virulent but more transmissible than its predecessors, primarily due to changes in how and where it enters cells. (See the relatively flat death rate after the initial BA.1 surge in our updated chart shown here, as well as Eric Topol’s assessment of the latest entries into the Omicron pantheon, BQ.1 and BQ.1.1.)
For #2, a preprint from the public health schools of Yale and Harvard assesses US population immunity based on data-driven assumptions and detailed modeling calculated down to the state level. The key conclusion: 80% of the US population had an Omicron infection in 2022, allowing us to enter winter 2022 - 23 with some immunity in the face of evolving Omicron variants, but that immunity is incomplete - and it’s waning.
The incompleteness of our past immunity is strikingly demonstrated by the graphic below (from the paper, annotated by us). What it says: No source of prior immunity, whether vaccination, infection, or both, prevented Omicron infections this year.
That being said, hybrid immunity (having been both vaxxed and infected) does provide marginally more protection against reinfection than either vaccination or infection alone, and nearly 90% of the US now falls into that category. As a result, the authors estimate that the US population’s protection against their next Omicron infection rose from 22% to 63% over the course of the Omicron Era. Not perfect, but not terrible. (More comfortingly, the authors estimate that protection against severe disease increased from 61% to 89% during this time.)
So what does this tell us about the upcoming winter?
You can’t rely on vaccination or prior infection to protect you from infection. Want to avoid infection? Wear a high-quality mask that fits well, and avoid crowds, especially indoors.
There are a lot of caveats, but: If you do get infected the odds are good that you won’t get severely ill (for most people under 65).
A final thought: As the paper also stresses, immunity to SARS-CoV-2 wanes over time. Plus, the specter of Long COVID hangs over every case of the disease. As we move through the third COVID Winter, we’ll cross our fingers and hope that current optimism is - finally - justified.
Are bivalent boosters actually better? Signs point to yes.
So in all this talk of immunologic preparedness, where do boosters come in?
Today, all available boosters are bivalent, meaning that they are designed to protect against both the original strain of the virus and Omicron BA.4/BA.5. Moderna has announced highly positive data for their version, showing that it generates up to 6.3x more BA.4/BA.5 spike-neutralizing antibodies (NAb) than their earlier, monovalent, ancestral-strain booster, raising BA.4/BA.5 NAb titers 15.1x from pre- to post-boost. (Pfizer has reported positive results for their own bivalent booster, too.)
In addition, the CDC recently published real-world data indicating that the bivalent boosters do in fact provide additional protection - at least against symptomatic infection, and at least for a few months.
Commentary: We’re just starting to learn exactly how these higher neutralizing antibody (NAb) levels will translate into real-world infection and mortality reduction. In theory, higher levels of antibodies are better, especially since those levels tend to drop within 2 - 4 months, but no one knows where the effectiveness threshold lies.
As if to illustrate this, Moderna last week stated, “Bivalent vaccines demonstrated robust neutralizing activity against BQ.1.1, despite an approximately 5-fold drop in titers compared to BA.4/BA.5.” If a 5-fold drop remains “robust,” how and why is a 5-fold increase better?
EUA Update
The FDA issued 7 new EUAs, 19 amendments to existing EUAs, and no new safety communications in the last four weeks (since the October Newsletter).
New EUAs (7):
COVID Molecular (2): Nanobiosym Precision Testing Services | Premier Medical Laboratory Services
COVID Antigen (4): Azure Biotech Inc. | CorDx, Inc. | Beijing Hotgen Biotech Co., Ltd. | ANP Technologies, Inc
Respiratory multiplex (Flu and COVID) (1): Lucira
Amendments to Existing EUA’s (19):
Molecular (11)
Antigen (6)
Flu/RSV Panels (1)
Collection Kits (1)
Monthly Capacity: Current EUAs
June July Aug Sept Oct Nov
614 518 443 429 429 436
Capacity is essentially flat. Factors that are pushing capacity up: #1 - HHS procurement of 200 million tests (see above). #2 - Four new EUAs for home OTC tests. #3 - Flu and COVID cases are up: The New York Times reports a 6% increase in reported cases in the last two weeks, and we expect the bolus of Thanksgiving COVID “gifts” are soon to come. Factors that are pushing capacity down: #1 - Testing per case or suspected case is down. A year ago, people were learning how to test and getting COVID for the first time. Now, they know how it works and test less frequently at the start and end of an infection period. #2 - With the decrease in demand in the last six months, there was excess capacity in the system.
Quick Hits
The WHO has changed the official name of monkeypox to mpox in an effort to reduce “racist and stigmatizing language.” The full transition is expected to take a year.
The FDA has issued guidelines for the creation of mpox antigen tests.