|The latest proposal for COVID-19 testing|
Regeneron: An intravenous infusion of this monoclonal antibody cocktail is good at keeping high-risk outpatients from going downhill. Now it seems a simple subcutaneous injection at half the dose can ward off COVID-19 symptoms in household contacts of infected individuals. But maybe that much easier treatment, which you could get in your doctor’s office or even at home, might also work for people who are already sick. I hope somebody’s testing it, and fast!
Lilly: Lilly’s antibody treatment is now available in Italy, but hasn’t exactly taken off. As of April 16th, only 2140 doses had been administered, out of 150,000 shipped in March. Admittedly things are not much better in the United States, where physicians are so unlikely to refer people for monoclonal antibody therapy that the federal government has set up a webpage to help patients who think they are eligible to find infusion centers themselves.
|A poster child with polio|
Antivirals in a pill: They may be new frontier for COVID-19 outpatients. I’ve mentioned a candidate from Merck, and now Pfizer is at it too. But the problem is that antivirals (remdesivir included) don’t usually work very well. When a major article claims that what we need is "a Tamiflu for SARS-CoV-2,” they’re picking a lousy poster child. Tamiflu is not very effective, and rather toxic.
Sputnik V: The Russians scored a major publicity coup when the tiny Republic of San Marino, perched on an Italian hilltop, decided to snub Western products and go for Sputnik. They’ve already vaccinated 75% of their adult population and plan on scrapping virtually all restrictions on April 26th. I sure hope the Russian vaccine works as billed.
Curevac: Looks like she’ll be comin’ round the mountain! European Union plans feature 400 million doses of this German mRNA vaccine, which can be stored in a fridge. Now the company hopes to have its product approved in May. This could be a game-changer, letting Europe vaccinate its population without resorting to AstraZeneca.
Reithera: Hot off the presses. The adenovirus-based Italian vaccine candidate never seemed very promising. Now it may be on its way to the scrap heap, with the company’s factories retooled to produce Curevac.
|À la Game of Thrones|
Johnson & Johnson: First the Johnson & Johnson doses-in-the-trash story got even worse. Things only went downhill when this convenient one-dose vaccine turned out to give the same cerebral venous sinus thrombosis complication as the similar AstraZeneca product. Administration has been halted in the USA and Europe while 8 cases, all but one in women between 18 and 48, are investigated. Bad news especially for Europe with its scanty dose supply. Can Curevac ride in in time to save the day? I have a feeling, with Anthony Fauci, that everybody will wind up bringing the J&J vaccine back but only for people over a certain age. Fortunately J&J seems to work somewhat better than AZ in the healthy elderly.
Why mostly women in their fertile years? Whatever the reason, it’s not the birth control pill. I don't know about the American women, but only one of the 14 British women with clots from the AstraZeneca vaccine was using hormonal contraception. The Pill increases the risk of run-of-the-mill blood clots, including in the brain, but vaccine-related clotting is entirely different: anti-platelet antibodies decrease the number of platelets but, paradoxically, increase clotting. Heparin is the only other drug known to cause this strange phenomenon. (The risk of a serious clotting complication from the J&J vaccine is almost surely less than the risk of a serious clotting complication from taking the Pill.)
AstraZeneca: It’s every country for itself. A report from Norway suggests a considerably higher risk of severe clotting complications than previously thought: not one in a million vaccinees but at best one in 26,000. Researchers have at least now proposed a protocol for treating them. The UK has now declared it will give its proudly home-grown product only to people over 30. Germany is offering RNA vaccines as the second dose to younger people who already had a dose of AstraZeneca. Iceland is foolishly giving it only to 70s and Italy only to healthy people ages 60-79, while Denmark, Latvia, the Netherlands, and Norway have scrapped it entirely. But Europe seems to be coming around to what I suggested in my last post, saying nuts to AstraZeneca and putting all its eggs in the mRNA basket.
Pfizer: Pfizer remains, as a friend put it, the Mercedes-Benz of vaccines. We already knew that it protects against COVID-19, severe COVID-19, and asymptomatic SARS-CoV-2 infection by 95% or more in clinical trials, and by at least 92% in real-world settings. Now we also know that in cases of breakthrough infection the amount of virus carried in the nose is extremely low, further preventing the pandemic from spreading. Also, when given to 6 Israeli health care workers who had previously had COVID-19, a single dose raised their levels of neutralizing antibodies into the stratosphere – not only against the strain that had originally infected them, but also against the English B.1.1.7, Brazilian P1, and South African B.1.351 variants. Would that there were enough doses, cheap, to blanket the world. Europe may be getting more soon, from French assembly lines. But watch for phony Pfizer! There’s so much around in Mexico that the FDA has had to warn off American citizens who may be considering vaccine tourism.
Moderna: As with Pfizer, we now have evidence of long-lasting efficacy, at least in the test tube. Thirty-three healthy adults all still had neutralizing antibodies 6 months after participating in a Phase 1 trial, though older volunteers had somewhat fewer.
|The Turkish third wave|
The bad idea of putting off the second dose of vaccine for months is unfortunately gaining adherents. And sloppiness on the part of reporters – understandable given the complexity of the data – makes it likely to spread further. A perfect example is the April 10th New York Times article headlined To Speed Vaccination, Some Call for Delaying Second Shots. Its key sentence reads: “And researchers in Britain have found that first-dose protection is persistent for at least 12 weeks.” If you follow the link and read the manuscript carefully you see that the longest period of followup following the Pfizer vaccine was 8 weeks, not 12. And efficacy was a relatively low 72%. Finally, the study subjects were health care workers, a relatively young and healthy group likely to respond better to any vaccine than the elderly main victims of the pandemic.
An Op-Ed by Dr. Ezekial Emanuel, is still worse: “A single dose of an mRNA vaccine is 80% effective and durable for 12 weeks.” But the “80%” link is to an MMWR report about the week preceding a second dose. And the key sentence of the "12-week" article reads: “The JCVI [English FDA] adds that: ‘Protective immunity from the first dose likely lasts for a duration of 12 weeks.’ But it has not published evidence to support this.” I find this misreporting by a prominent physician exasperating.
France and Italy may start giving the second dose of Pfizer and Moderna after 6 weeks rather than 3 or 4 – I’ve always thought this was OK, and now we do have a little supportive evidence. None for the 12-week gap, though.
Here’s another bad idea: governments sending more vaccines to regions or states that are experiencing pandemic surges. I see it as a reward for bad behavior. Biden is absolutely right to resist Gretchen Whitmer’s pleas. Her state of Michigan is having a terrible surge but she’s avoiding severe restrictions, having been attacked by Donald Trump and company for doing so earlier in the pandemic. But only lockdowns and masks, not vaccinations, can stop an outbreak fast.
Start by forgetting the loaded term “passport”: they’re just certificates proving you’re vaccinated. After scammersjumped in to counterfeit the paper certificates, helped along by people who invited identify theft with their selfies, digital versions are being preferred, with New York State’s Excelsior Pass already up and running. The idea was pioneered in Israel, where you can’t enter a hotel or theater without a “Green Pass” certifying vaccination or recent infection. Europe hopes to follow soon, with the added option of a negative swab. Note that the infection really does need to be recent: immunity after infections is proving much less robust and shorter-lasting than immunity after vaccination (unlike having, say, measles, which gives life-long immunity).
|Israeli Green Pass|
Marjorie Taylor Greene, Ron DeSantis, etc. have lambasted them as everything from a mere “ethical minefield” to “the end of civil society.”
Frankly, I don’t get it. I already have one vaccine certificate, the Yellow Card some countries require to prove vaccination against yellow fever. Kids generally have to be vaccinated to start school, college kids can’t set foot on most campuses without measles and meningitis shots, and I had to demonstrate my immunity to rubella and measles before I could start my internship.
So far nobody’s suggesting vaccination be mandatory except perhaps (as in Italy) for health care workers. But why shouldn’t it make your life easier? I don’t see what’s wrong with letting someone who’s been vaccinated skip quarantine requirements after travelling or being exposed to COVID-19, as recommended by the CDC. And it would be great to bar people from theaters, restaurants, and ball games without vaccination, recent infection, or a negative PCR swab. That would safely get the world turning again, while nudging holdouts toward getting their shots.
In the US, opposition to “vaccine passports” comes largely from no-mask and no-vax segments of the political right. But there is also a legitimate inequity issue in the American context, because of the poor access of minority communities to vaccines.
Is Italy screwing up?
|Waiting for vaccination outside Naples's Capodimonte museum (the paintings are reproductions)|
A recent Washington Post article asked, “Has Italy been vaccinating the wrong people? Its daily coronavirus death tolls suggest so,” with The New York Times later following suit. That Post title had me putting my dukes up, since Italy’s is doing well at playing the lousy hand it’s been dealt, but the piece was better than I expected.
Yes, vaccines don’t always get into the right arms (ummm… they don’t in the US either). In small part it’s mafiosi pushing their pals to the head of the line. But Mob-infested southern regions are not where the worst inequities have been. Virtuous Tuscany hit the news for prioritizing university professors, judges, and lawyers, all of whom work remotely. Arrogant Lombardy was shamed early on for vaccinating so few of its elderly, though they’ve since caught up.
And The Post has it right that the death toll was awful in March and much of April. I mainly blame the government, though, for failing to act swiftly when it was clear around the end of January that disaster was looming. While the authorities putzed around, Italian ICUs filled with COVID-19 patients and deaths rose steadily.
The Post article is a bit misleading when it says people 70-79 are being short-changed, many more of them than any younger age group have gotten a first dose. More scandalous is that 19% of people over 80 still haven’t had one.
Eight months after a large sample of Swedish health care professionals were diagnosed with mild COVID-19, 15% still had at least one moderate-to-severe symptom – most often fatigue, lack of smell or taste, and/or shortness of breath. A disturbing Italian study looked at patients who were surveyed when they had mild-to-moderate COVID-19 and again a year later: 53% still had symptoms similar to the Swedes’, plus muscle pain, insomnia, dizziness, and a broad range of miscellany. And many long-haulers still sadly find themselves treated as whiners, not sufferers.
Most reports suggest younger people are more likely to become long-haulers. But in reality the symptoms may be just as common in the elderly, though they’re less likely to mention them. Non-hospitalized elderly patients are even at risk for strokes, dementia, psychosis, and Parkinsonism during the months after their acute illness.
The predominance of women has suggested that an estrogen-related autoimmune process may be responsible; all autoimmune diseases are more common in women. I do think some kind of immune system dysfunction is likely. Other hypotheses have been proposed, though, and all of them may turn out to be wrong.
|Belgian Shepherd Malinois, star COVID-19 sniffer|
After drug-sniffers and cancer-sniffers we have COVID-19 sniffers. Dogs’ super noses can detect SARS-CoV-2-infected cells, even in many asymptomatic people. They’re already being used at some airports and sporting events with, supposedly, a 94% accuracy.
Various do-it-yourself antigen swab kits have come out, but apparently they’re prone to false positives. And the false negative rate is major, despite assurances from the manufacturers. One device ran a whopping 60% when users took their own swabs, even under video supervision. EU authorities estimate that self-tests are 57% sensitive for SARS-CoV-2 as compared with PCR tests, which are in themselves imperfect. So home tests miss half of genuine cases, especially if asymptomatic, and label many healthy people as sick. Salivary tests may be even worse, detecting as few as 24% or even 13% of asymptomatic cases.
Then there’s the scream test (photo at top). Go into an airtight space and yell, and a Dutch gadget will scoop up the air and find any coronavirus particles in 3 minutes. It’s been proposed for mass screening at sites such as airports and concerts but seems unlikely to catch on – when infected people leave virus particles behind, the space will become a factory for false-positives.
The Not-So-Great Outdoors: Alabama
|Crammed into Tuscaloosa's Strip January 11th, 2021|
It’s hard to hard to catch COVID-19 outdoors, but if any event can do it I’d say this one – maskless college students celebrating their football championship – would fit the bill.
The Tuscaloosa mob scene did lead to a modest surge in local cases 10 days later, for me the first convincing evidence of an outdoor superspreader event (the Amy Coney Barrett Rose Garden party is dubious, and people at the Sturgis motorcycle rally crammed unmasked into bars and concerts).
The Not-So-Great Outdoors: India
|The Kumbh Mela festival on the Ganges in Haridwar, March 2021|
India had a mysterious fall in cases last fall, an apparent exception to the rule that if you let up on lockdowns, distancing, and masking, cases will rise. Now, though, they’re into a scary second wave, fed in part by religious gatherings and political rallies.
|The pandemic in India|
The herds are back, the herds are back
The phantom of herd immunity has raised its unlikely head again…
In Russia, conjured up in February by the mayor of Moscow. He claimed that 50% of the city population was already immune months earlier, and that with mass vaccination it should be approaching herd immunity. The 50% is questionable, though, and vaccine skepticism is so high that Russia has only managed to get a dose into 7% of its population (it’s 18% in Italy, 40% in the United States, 62% in Israel).
In Alabama, by students enjoying wishful thinking. But they’re not alone. Requirements for University of Alabama Tuscaloosa students will change this fall: unlike in 2020 students will not be tested, classroom instruction will have no occupancy limits, there will be no mask requirements, and the football stadium will be full. From the official university info page, I gather this folly is based on the conviction that the campus community has already reached herd immunity. And here I was calling students silly!
In the United States – as an explanation of why hospitalizations and deaths have been falling so precipitously. But even if I’m wrong in thinking Americans have started catching on to masking and distancing, by now 81% of Americans over 65, the most vulnerable, have received a dose of vaccine. So I don’t think the improvements demand other explanations.
In the UK: “Britain will pass the threshold required for herd immunity against Covid on Monday [April 12th], according to University College London researchers. The institution’s data shows the number of people who have protection against the virus either through vaccination or previous infection will hit 73.4% on 12 April, enough to tip the country into herd immunity.” Hmmmm… I’m skeptical, and I’m not the only one. First, the level for herd immunity is more likely to be 80-90%; second, protection from previous infection probably only lasts 6-8 months; and third – propaganda to the contrary notwithstanding – the 12-week gap between doses used in the UK probably makes vaccines less effective.
Israel: With 82% of the adult population having received at least one dose of vaccine, they may actually have gotten there! (Though the Israelis themselves are urging caution.)
One thing most people don’t grasp about herd immunity is how local it is. Even if 95% of Americans are vaccinated by the time kids head back to college in the fall, that won’t protect the University of Alabama from an outbreak if its students aren’t. More than 90% of American toddlers are vaccinated against measles, but 1282 cases occurred in 2019, in tight-knit communities where no-vax sentiment was strong.
|Bourla, Fauci, Trump|
The CEO of Pfizer, Albert Bourla, says people will “likely” need a third dose of his vaccine 6-12 months later, and another one every year thereafter. Total speculation. Everything depends on 1) whether vaccine-escaping variants become widespread (they’re still rare in Europe and the US); and 2) how long protection lasts against current strains (nobody’s even one year out from their vaccination, so who knows?). Don’t forget Mr. Bourla has skin in the game – the more shots are given, the richer he and his company get. On April 5th Anthony Fauci pointed out optimistically that protection from the vaccines may last several years. Here’s some of the thanks he got:
Talk about delusional…
This fellow, Abdul Alim Muhammad, claims Moderna and Pfizer “are not vaccines” but “operating systems” that will turn your body into a virus-making factory and you into a zombie.
As with every post, this was insightful, entertaining and great reading. I appreciate your synthesizing the latest news.ReplyDelete
Thanks a lot, Midge, you've made my day!Delete
Thank you for the informative articles. I do have a question though regarding efficacy.ReplyDelete
How is it that the efficacy of a vaccine varies from one country to another? For example, in the UAE and in Bahrain, they found the efficacy for Sinopharm to be around 86%. Yet the Chinese are now stating it is much lower.
I know that in Bahrain they tested Sinopharm on more than 6000 volunteers over a 3 month period. I can only assume that the results are related to the number of people tested.
I myself have had the Sinopharm vaccine back in January. I am now considering having a serology test to see if I have sufficient antibodies against COVID.
On another matter, one that I have mentioned before.
If Italy wants to get serious about kick starting the economy again, they need to make it compulsory that all premises or venues take down the customers name, phone number and temperature before allowing them to enter. In doing so, it will easily allow authorities to contact people who may have been exposed by someone that has COVID. This is normal practice in countries outside the EU. Countries such as Australia and New Zealand have had success in employing the above. As such, the economy is faring far better than countries that have little to no contact tracing programs.
Relying solely on an app is ridiculous. You could probably count on your hands how many people use the Immuni app in each city.
Whoops, sorry this went by without my publishing or answering it. The efficacy of vaccines is likely to vary less from one country to another than from one population/setting to another (e.g. a study done only on people under 60, or where there are or aren't variants, or whatever). The original Sinopharm press release said 79%, in the same ballpark, while I see a Bahrain site says 86%. It does seem to work better than Sinovac, the other Chinese vaccine. But no proper data have been published for either of them as far as I know. The Bahrain site doesn't mention a specific trial in that country but refers to a 42,000-volunteer trial, never published. 6000 would not likely be enough for any conclusions. In Italy museums etc. do record names and phone numbers because you need to reserve ahead of time. Then they check your temperature at the door. ...But you're making the important point that real contact tracing fell by the wayside in Italy long ago, with the second wave. The number of new cases have to be under a certain level before you can track the contacts of each. (And, yes, the Immuni app is a total flop.)Delete
Thank you for mentioning La Serenissma Repubblica di San Marino's experience with Sputnik vaccinations. One small error however. Il Monte Titano and the Republic of San Marino are NOT located on an Italian hill. San Marino was never part of Italy. Has been an independent Republic since the year 301 AD. Predates the Italian Republic by 1500+ years. Would never have been able to avail itself of the Sputnik vaccine if it were part Italy.ReplyDelete
OK, OK, be picky!!! It's on a hill inside Italy but yes it's not part of Italy - just as the Vatican is a separate state, and the Knights of Malta on the Aventine Hill too.Delete