Coronavirus COVID-19 (2019-nCoV) Thread - 2021 Breaking News

That’s today, eh.

Over-hydration is a concern?

Ha! Guess I should’ve added one word:

  • Drink too much alcohol?

243,298,750 total cases
4,945,940 dead
220,490,808 recovered

In the US:

46,174,547 total cases
753,747 dead
35,898,041 recovered

Yesterday’s numbers for comparison:

This is odd – I wonder if it’s related to the story Bonum_Legatum reports about COVID rates rising with decreasing temperatures forcing people indoors.

It’s not just Michigan where the seven-day average new COVID case numbers are rising. Several northern states (and no southern states) are in deep red on the Johns Hopkins Coronavirus map:

Alaska

Montana

Wyoming

South Dakota

Idaho

New Hampshire

Maine

Utah

Colorado

Iowa

Most of these states are nowhere near their record highs yet, but Alaska and Montana and New Hampshire are, and might yet set new records. Maine has been flirting with high values and almost set a new record at the end of last month.

It hasn’t really gotten cold even in northern New England yet, certainly not to the point we’re spending a lot more time indoors. It was 70 yesterday and until today daytime temps have ranged from the high 70s half of last week through the 60s and high 50s this week in New Hampshire, and looking at central Maine the only big differences are they’re had a day as low as 51 (vs 55 here today) and a few more 60s vs 70s.

Oregon is going to show a spike in fatalities for a while. They missed 550 deaths from May through August this year due to counting errors, so those deaths will be added to current numbers over the next month as they are reconciled.

I live in new England, too, and agree that it’s been generally unseasonably warm. But i also know there have been a few nights and even days that compelled me to wear a jacket. In Lebanon New Hampshire the average temperature has been in the 50s on average and going into the 40s and lower at night. Portland Maine charts show pretty much the same thing.

Pfizer-BioNTech Covid-19 Vaccine for Young Kids Satisfied FDA Criteria, Agency Says Pfizer-BioNTech Covid-19 Vaccine for Young Kids Satisfied FDA Criteria, Agency Says - WSJ

243,745,106 total cases
4,953,505 dead
220,869,669 recovered

In the US:

46,264,596 total cases
755,721 dead
36,000,821 recovered

Yesterday’s numbers for comparison:

Nice animation of COVID cases in NYT. Should be accessible.

244,142,304 total cases
4,959,716 dead
221,205,019 recovered

In the US:

46,294,210 total cases
756,205 dead
36,033,886 recovered

Yesterday’s numbers for comparison:

A new COVID treatment for infected people on the near horizon.

What is molnupiravir?

Molnupiravir is an antiviral pill by pharmaceutical giant Merck that aims to prevent mild to moderate cases of covid-19 from becoming severe cases that result in hospitalization or death. People who have covid-19 take the drug twice a day for five days, starting within five days of the onset of symptoms.

It was shown in an international clinical trial of 775 high-risk, unvaccinated people to cut the risk of hospitalization and death in half (the participants had at least one risk factor for severe covid-19, such as obesity or advanced age). The treatment was also shown in a separate trial to accelerate the clearance of infectious virus from the nose and throat, indicating that it may also help reduce the spread of the virus.

Still, medical experts warn that vaccines remain the primary tool against the coronavirus, as it is better to prevent people from getting the virus than to treat it after infection.

When will molnupiravir become available?

Merck has submitted data to the Food and Drug Administration following the success of its trial — which was ended early because of its positive results — seeking emergency use authorization for molnupiravir.

Merck and its partner Ridgeback Biotherapeutics said in a news release that, in addition to submitting their FDA application, they plan to apply for emergency use or marketing authorization in other countries “in the coming months.” Ahead of a decision by U.S. regulators, the companies have already started producing the pill, and have agreed to sell courses of the treatment to the United States and other countries if they get the green light.

An FDA advisory committee will meet Nov. 30 to discuss the emergency use authorization request, setting a timeline that could have the drug available by the end of the year.

244,427,834 total cases
4,963,752 dead
221,459,802 recovered

In the US:

46,312,782 total cases
756,362 dead
36,052,614 recovered

Yesterday’s numbers for comparison:

Moderna says its COVID-19 vaccine protective, safe in young children | Reuters

A little odd, since it hasn’t been approved for those 12-17, and its use in young adults has been paused in parts of Scandinavia. But this trial of a dose half the size of the adult dose (same as the booster) reported good immunity and acceptable side effects in kids 5-11.

(Also a little odd that the adult dose for Pfizer is 30mcg, and for kids is 10mcg, whereas Moderna is recommending 100mcg for adults, and 50mcg for kids. I thought the two were more similar, and I’m surprised by the difference in dose. Maybe that belongs in its own thread.)

Dose ranging anything isn’t a particularly precise process*. Bear in mind that the clinical programs for the vaccines were extremely compressed. You evaluate probable efficacy of a range of doses as best you can, based on immunogenic response**; you make your best estimate of an appropriate dose; and then you’re into clinical studies and, to all intents and purposes, from that point onwards the dose is effectively set.

They may be very similar, and the difference may be explained by how dose ranging was performed/evaluated.

j

* - Ever see a 135 mg tablet? Nope, 100 or 200. There’s a fondness for tidy numbers, and intersubject variability (and for that matter, intrasubject) is sufficiently high that in practice narrowing the optimal dose down (to 135 mg, say) may not even be doable. (There are rare cases where a real narrow therapeutic window makes precision more important. But you won’t solve that in a headlong rush).

** - FWIW, so far as I can tell, immunogenic response was only accepted as a validated surrogate endpoint for efficacy long after the trials of Pfizer, Moderna, Astrazeneca…(Surrogate endpoint = something which is supposed to indicate the outcome you would see with the real endpoint. In this case immunogenic response to indicate prevention of disease etc).

In the initial animal studies, Moderna looked at a wide range of doses, differing by orders of magnitude. In the early (phase 1) clinical studies Moderna looked at 25mcg, 100mcg, and 250 mcg, and settled on 100mcg because the results looked better than for 25mcg, and about the same as for 250mcg.

Fall 2020: 7.00 (“COVID-19, SARS-CoV-2 and the Pandemic”) - MIT Department of Biology

lecture 10, starting about 39 minutes in, through around 42 minutes.

So the dosing wasn’t completely random, although of course they didn’t look at 50mcg, or 75mcg, or 93mcg.

I didn’t look back at the development history (so props to you!) but that kinda was my point.

You can’t look at every dose; and if Moderna couldn’t see much of a difference between 100 mcg and 250 mcg, then there isn’t much to be gained by trying to.

j

I get that. But Moderna DID see a difference between 25mcg and 100mcg, and yet Pfizer went to market with a rather similar thing at a dose of 30mcg. Okay, at least they are in the same ballpark.

Pfizer looked at 10, 20, and 30 mcg for kids

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults - Full Text View - ClinicalTrials.gov

I’m really surprised they picked 10mcg, when Moderna went to market with 50mcg.

The Moderna study just says they will look at “up to three doses” (unless I’m missing something) but it just strikes me as odd that the selected doses differ by a factor of 5, when as I said before, I thought the active ingredient was rather similar.

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age - Full Text View - ClinicalTrials.gov

I guess we’ll have to wait to see the study reports to understand what happened (or rather, what’s happening).

I don’t see any stratification for age in the Moderna protocol. I assume they’re doing it - it would be very strange not to.

j