Items of recent pandemic news: Moderna announces preliminary results for their vaccine in children; the White House rolls out the one-stop information site covid.gov; FDA authorizes a fourth shot for older adults; and much more. Plus a frippery.
Apologies to those of you who looked for a Pandemic Update in the last week or two. My wife Katharyn and I set out on a road trip for the first time in nearly four years, and were away from home for ten days. However, the pandemic news kept coming thick and fast, so this issue is on the hefty side (the third-longest post of the pandemic). Let’s get to it.
Quote of the week
- Vincent Raciniello — “Here are the data in the Israel paper. If you think they mean anything you’ve lost your mind.”
Fourth shot (second booster) authorized for 50+
This week the FDA authorized and the CDC ratified allowing a second booster shot — a fourth dose — of mRNA vaccine to those aged 50 and above, four months or more after the first booster. People of any age who got a J&J vaccination and booster can now also get an additional mRNA boost with Pfizer or Moderna. Also authorized was an extra boost (a fifth shot) for immunocompromised people older than 12 years. Both agencies acted without requesting input from their advisory committees. Note that this booster is not “recommended,” merely allowed.
A couple of weeks ago both Pfizer and Moderna had applied to the FDA for a second booster. Pfizer’s application called for an age cutoff of 65 years and Moderna’s suggested all adults, leaving any cutoff up to the regulators.
Both applications relied on somewhat preliminary data out of Israel on the efficacy of fourth doses, as well as the companies’ own research. The FDA cited the Israeli data in their announcement. Some experts were harshly critical of the FDA for its decision. Here is Vincent Raciniello, host of This Week in Virology, as quoted by Zvi Mowshowitz:
So if you are eligible, should you roll up your sleeve a fourth time? Here are analysis and advice from Eric Topol; Katelyn Jetelina (Your Local Epidemiologist); Zvi Mowshowitz; the NY Times; NPR; and The Atlantic. I read them all so that you don’t have to. Their advice clusters fairly closely for those more than 4 months past the first booster, to wit:
- Over 75? Get the boost.
- Over 65 with co-morbidities? Get the boost.
- 50-65 with co-morbidities? Consider getting the boost.
- 50-65 and healthy? You can afford to wait.
Individual circumstances need to be considered. For example, if you experienced strong side-effects from an earlier shot, you’ll want to factor that in.
One theoretical downside to taking a fourth shot involves a possible sub-optimal immune response or “immune exhaustion.” Zvi, Katelyn, and the experts consulted by The Atlantic agree that the chances of this being a problem are small to none.
Another objection that some have raised: What if the coming BA.2 bump fizzles but a real surge begins in the fall? Another boost, possibly with a reformulated vaccine, could be expected in that case.
Zvi emerges as the most cautious among the advice-givers linked above. Here is his bottom line:
1. Cost of second booster is small.
2. Benefit of second booster is small and temporary.
3. If you’re at very high risk, maybe it makes sense.
4. Either decision is at worst a small mistake.
Katharyn and I are six months out from the third shot and we are signed up to get the second boost early next week. We have taken Pfizer to date and will go with Moderna this time, based on hints (no solid evidence) that mixing it up might confer broader protection.
White House rolls out covid.gov
This is the resource we wish we had had for the last two years. It collects in one place up-to-date statistics on the pandemic and localized guidance on where to find testing, treatment, vaccination, boosters, masks, etc. The site is well designed, simply worded, and accessible from computers / tablets / phones.
This site, linked from covid.gov, lets you find “Test-to-Treat” locations near you — for people at high risk, immediate access to Paxlovid or Molnupiravir after an on-the-spot positive rapid antigen test. Over 1,000 Test-to-Treat sites are now live. President Biden had promised to roll out this program in his state of the union address in January.
Treatment options in priority order
The original posting under this heading contained out-of-date information. You can find it here. Rather than edit it for accuracy, I have replaced it entirely below.
I recently had occasion to look up the recommended treatments in priority order, for non-hospitalized, high-risk people with mild to moderate Covid-19. Here they are from the National Institutes of Health. I have excerpted the core of of the advice in the figure below; follow the link for footnotes, qualifiers, and confidence levels for these clinical recommendations.
Paxlovid and Molnupiravir are oral antivirals, taken by mouth over five days. Remdesivir is far less convenient to administer: it requires three intravenous (IV) infusions over a period of three days. Bebtelovimab is given in a single injection in a doctor’s office or clinic. Sotrovimab requires a single IV infusion.
Moderna announces solid results in kids 6 mo. – 6 yr.
After Pfizer / BioNTech’s stumble while testing their vaccine in young children, Moderna may have pulled ahead in the race to vaccinate the youngest. Low doses of its Spikevax vaccine generated strong antibody levels in children.
Moderna chose to trial shots with 1/4 of the adult dose — 25 μg — in all children 6 months to less than 6 years of age. 4,200 children 0.5-2 years were enrolled, and 2,500 2-6 years. The children generated levels of neutralizing antibodies at or above those seen in 18-to-25-year-olds, meeting the clinical trial’s primary objective.
While the study was designed as an “immunobridging” trial, using antibody levels as a proxy for protection, the Omicron wave gave the researchers access to preliminary efficacy data against disease. Given Omicron’s immune-evasiveness, the bottom-line efficacy numbers did not reach the unanticipated heights of the first vaccines. Spikevax was about 44% effective at preventing Omicron infection in the 0.5-2-year-olds, and 37.5% in the older children. Moderna did not publish the full data but hinted that the error bounds may be wide.
In another strike against the immunobridging technique for studies on this disease, a new paper published in Nature points to mysteriously low overall antibody levels in children. Kids seem to be able to clear the virus quickly, perhaps via an innate immune response, so an antibody-generating adaptive response may not get off the ground.
Moderna said it will apply to the FDA “within the coming weeks” for the youngest children. The company also announced that it had completed the application for an EUA for a two-dose regime in kids 6 to 11 years old.
- Do you remember almost two years ago when we wrote about ultraviolet light, “far-UVC,” disabling the coronavirus? Very little real-world adoption of that solution has taken place. Now researchers led by the group behind the earlier research have published the results of taking far-UVC out of the laboratory and into a real-world setting. They found that 5 to 10 minute of exposure to far-UVC light cleared 98.4% of common cold coronavirus from a room, and maintained that level as new virus was continuously pumped in. The researchers say that if they tried to get a similar level of clearance by ventilation alone, it would require an impossible 184 air changes per hour. Here is a summary from Columbia, home of the lead researcher.
- The White House has put out a paper expanding on its push for better ventilation in public places. The paper emphasizes the aerosol characteristic of the coronavirus’s spread; in fact the word “droplet” does not appear at all. In this the administration has gotten out ahead of the CDC, which still talks about 6-foot distancing as if droplet spread were the primary concern. Here is CIDRAP’s coverage.
- Pfizer has begun what they are calling a Phase II / III trial of their oral antiviral Paxlovid in children aged 6 to 17. The study will enroll only 140 subjects with mild to moderate Covid-19 (normally a Phase III study involves thousands). They will receive either the full dose currently authorized for people 12 and older (if they weigh at least 88 lbs.), or half that dose (if 44 to 88 lbs.). Readout should happen this summer.
- A new study of worldwide excess deaths indicates that the pandemic’s total impact may exceed 18 million, more than three times the official fatality figure.
Frippery: Depths of Wikipedia
Everyone needs a pandemic hobby. The one developed by Annie Rauwerda (that’s her at upper left), in 2020 a sophomore at the University of Michigan, was unearthing the weirdest and most peculiar and intriguing articles in Wikipedia. She surfaces the collection on her Instagram account, @depthsofwikipedia. Here is a NY Times profile of Rauwerda.
Below are a few of my favorites from the collection. Metafilter user storybored links a number of others.
[ Note added 2022-04-03: ] The article “Treatment options in priority order” contained obsolete information and has been replaced above in its entirety. You can access the obsolete article as originally published here.