As was expected, the FDA granted full approval for the Pfizer vaccine on Monday. Here’s a gushy article that talks of hundreds of thousands of pages of data being submitted – perhaps they were, but I’ll wager not one in every thousand pages were studied, with most of the pages being nothing other than supplementary meaningless data to allow the application to pass the “thickness” test – how thick is a printed out copy of the application.
The article also anticipates that changing the vaccine from a limited emergency use approval to a fully approved vaccine will encourage lots of the unvaccinated people to now be vaccinated. I don’t believe that for a second, particularly because the full approval process was as superficial as the EUA approval was before it – for example, this article observes that the FDA didn’t hold a meeting of its Vaccination Advisory Committee to consider the application. The last time this committee met was back in December 2020 – and, yes, a huge amount has changed since then, including an enormous database of side effects, much greater knowledge of vaccine effectiveness, new virus variants, and also new vaccine competitors.
To suggest that the Pfizer vaccine can now get formal approval without allowing the Advisory Committee to review the extraordinary changes in the last nine months is a stark indicator of how “the fix was in” and far from reassuring the undecided about now getting vaccinated, it would seem to give them still more reasons to be concerned.
Now that the Pfizer vaccination has been fully approved, there’s an interesting consequence. Keeping in mind that EUAs can be granted only in cases where there is no approved alternative, does that mean the Moderna and Johnson & Johnson vaccines will now lose their EUAs?
There’s a second interesting issue as well. Now the vaccine has been fully approved, does that mean Pfizer will no longer be indemnified from any liability and can now be sued as people may choose to?
The rush of peoople demanding booster shots – and the eagerness of the government to allow them – strangely seems to be something that doesn’t need either a formal EUA or full approval.
In this article, the CDC director is now saying that perhaps the third shot might be enough and we’ll not need annual booster shots. But she doesn’t cite any studies at all, and I’m left with the unmistakable feeling she’s simply telling us what we want to hear rather than the reality of what is in front of her.
For those of us who chose the J&J vaccine as being the lesser of two evils, you’ll be interested to learn that J&J is now suggesting we should get another shot too. J&J says that doing so causes antibody levels to soar to a count nine times higher than 28 days after the first shot.
But that isn’t really the appropriate measure – the key measure surely is understanding how antibody levels have dropped subsequent to the first shot, and matching that to the level needed for a good level of protection. If the level after 28 days was deemed more than sufficient back then, who cares if a second shot raises them nine times higher. That’s a bit like buying a 1,000 hp super-car in the hope it will make the morning commute in jammed traffic faster.
In evaluating the statements of all the pharmaceutical companies, it is essential to keep in mind that they are in the business of selling drugs for profit. Of course they’ll advocate for more shots of their vaccines, whether we need them or not. We should not be making decisions about multiple vaccinations based on drug company data.
The immediate issues of course are whether we need a booster shot at all, and if so, when. Here’s an article citing assorted scientists who say the need for a booster shot has not yet been appropriately confirmed.
Question – how can we just “follow the science” when the scientists themselves are heading in opposite directions?
Talking about following the science, where are the scientists racing to follow behind this very powerful article showing the enormous impact ivermectin use had on the Covid outbreak in the Indian state of Uttar Pradesh? Ivermectin critics facetiously claim that there haven’t been large enough studies to justify the positive results appearing – so how about a study of 240 million people (the population of Uttar Pradesh)?
Here is some “science” best considered with a grain of salt – a claim that the Covid threat is beginning to fade and the next pandemic will appear in 59 years time. The claim is nonsense in both its parts, not just for describing the last two months of steady increases as “beginning to fade” but particularly because the 59 year prediction ignores the most enormous element of risk/threat, a risk that surely should have been apparent because of the nature of the Covid appearance. Our biggest threat is not from natural animal viruses magically transitioning to humans. Our risk is demonstrably from manmade viruses escaping from laboratories (or being deliberately released). The next pandemic might be only 59 months, or 59 weeks, or 59 days from appearance, depending on how lucky/unlucky we are and how headlong and uncontrolled our rush is into further dangerous virus and “gain of function” research.
Talking about gain of function, where scientists deliberately make viruses more dangerous, here’s an excellent article about such activity. One of the biggest supporters of gain of research is none other than “the patron saint of viruses” himself, Tony Fauci. That would be the same Tony Fauci who says, about himself, “everybody thinks I’m doing more than an outstanding job” (a great article at the link).
French Polynesia rose up one place in the minor country list, with an enormous increase in cases in the last week. Georgia displaced Aruba at the bottom of the list.
The UK rose two places in the major country list. In the death rate list, the US dropped a place, with Mexico rising.
The activity for last week table has both the US and UK rising two places, and North Macedonia debuting.
In Europe there was a 3% rise in cases overall. Norway had a high 68% rise in new cases, Germany continues to experience strong growth, with another 48% increase in the last week, while Austria enjoys a more mild 27% rise. Spain reported a 20% drop in cases, and both Sweden and France had a 14% drop.
Canada continues to see its case numbers rise, with a 28% increase over the last week. Mexico had a 10% drop, and the world as a whole had a minor 0.8% drop.
Top Case Rates Minor Countries (cases per million)
|Rank||One Week Ago||Today|
|1||Seychelles (195,787)||Seychelles (199,671)|
|2||Andorra (193,540)||Andorra (193,988)|
|4||Gibraltar (156,205)||Gibraltar (157,784)|
|5||San Marino||San Marino|
|7||St Barth||St Barth|
|9||Aruba||French Polynesia (142,084)|
|10||French Polynesia (126,414)||Georgia (133,700)|
Top Case Rates Major Countries (cases per million)
|Rank||One Week Ago||Today|
|1||Czech Republic (156,272)||Czech Republic (156,388)|
|2||USA (114,742)||USA (118,061)|
|12||UK (93,604)||Colombia (95,116)|
Top Death Rate Major Countries (deaths per million)
|Rank||One Week Ago||Today|
|1||Peru (5,902)||Peru (5,911)|
|2||Czech Rep (2,831)||Czech Rep (2,832)|
|9||USA (1,930)||Mexico (1,964)|
|10||Mexico (1,926)||USA (1,956)|
Top Rates in New Cases Reported in the Last Week (new cases per million) for Countries over one million population
|Rank||One Week Ago||Today|
|1||Georgia 8,786||Georgia 7,757|
|2||Cuba 5,508||Israel 5,894|
|3||Israel 4,827||Cuba 5,780|
|8||UK 3,124||USA 3,229|
|12||Ireland 2,454||Costa Rica 2,799|
I Am Not a Doctor, But….
As we learn more about the virus, it is becoming apparent the virus first establishes itself in the nasal cavities where it quietly replicates and grows in numbers before then moving down to the lungs. The significance of this is the vaccines are generally focused on the “spike proteins” and preventing growth in our lungs, so the virus gets “a free ride” in our nose. A nasal spray that kills the virus before it goes to our lungs is obviously helpful.
The other key point of understanding is that the severity of an infection and its ability to break through vaccine protections is directly related to the size of the “dose” of virus a person gets to start with. A nasal spray that kills the virus is again obviously helpful.
Anti-Trumpers of course, who love to pretend that President Trump suggested we should all drink bleach (he didn’t) will be ideologically opposed to this, but the rest of us should be able to see this as a possibly valuable way of reducing risk and the severity of an infection. This “Enovid” spray could be a great thing to use, but apparently is not available here, but might be available mail order from Israel. This other article lists various nasal sprays being developed.
WHO has announced it will be coordinating the testing of three more off-the-shelf drugs that might possibly be repurposed to fight Covid. But after their unenthusiastic approach to HCQ and IVM, I’m far from optimistic their findings on these three more obscure drugs will be positive.
Disappointing news out of Israel, which often is at the leading edge of Covid research, this time noting that 4,811 Israelis who had previously had a Covid infection have been reinfected.
There seem to be a varying mix of stories as to which is better – immunity from prior infection or from vaccination. The only thing I can conclude is that neither is perfect.
So, how long before we “need” a third shot? Eight months, as is apparently becoming US policy? Six months, as is rumored might become new policy? Or five months, as is the case now in Israel?
The article also notes that to qualify for the Israeli version of a “vaccination passport” people will now have to show they have been triple jabbed. I don’t even want to start to think about the added level of argument this will cause, particularly here in the US – we’re still arguing about “regular” vaccination passports, can you guess as to the level of further argument about whether or not it is necessary to have a third (and possibly subsequent) shots to keep the passport current?
Here’s a fascinating “side-bar” to the main Covid vax story – the first vaccine made for animals.
Timings And Numbers
Here’s the entirety of the US pandemic experience in a single chart, showing daily new cases from mid-March last year through until today. It speaks for itself.
It is frustrating, in my attempt to understand and track the rate of new infections in the US, that there are really only three days each week when reasonable data is available (Tuesday, Wednesday, and Thursday). It seems many public health reporting agencies close early on Fridays, don’t report at all over the weekend, and don’t catch up with the backlog of reporting until Tuesday.
Dr Fauci loves his publicity, doesn’t he, even when he has nothing new to say. Here’s a great example of a Fauci feature full of platitudes and empty of hard facts and new developments – his announcement that the pandemic won’t end before Spring of next year, at the earliest.
Fauci’s very quotidian prediction, almost certainly not wrong, does raise an interesting issue. Looking at the above chart, comparing new Covid case numbers this year to the same time last year, there is a school of thought that the virus is somewhat seasonal. This belief is of course supported by the rise in the winter months for 2020-2021. If we are to anticipate a similar rise for this winter, how high might it go? Today we’re at 352% of the new case numbers for the same time last year. What might the winter be like, this year? Perhaps Dr Fauci could tell us about that?
Talking about numbers, and experts, a USA Today article claimed that nearly half of the people in a town in TX had been “hit by Covid”, causing the town to close. The reality is that 42 out of the 1150 people in the town had been infected. The original article has now been rewritten……
People missing an exotic Asian sea, sun and sand type tropical getaway had been heartened at Thailand opening up its Phuket resort area for international visitors. To visit, you had to be fully vaccinated and also have a negative PCR test within 72 hours of traveling. That’s a fairly normal “belt and braces” requirement that other countries have adopted too.
What makes the Thai/Phuket situation interesting is that you also had to get a rapid test upon arrival to show your continued free-of-Covid status, and reconfirm again on the sixth and – if still there – twelfth day of your stay with full-on PCR tests. The Thai authorities have kept statistics.
For 24,190 visitors (and remember, these are people who have both been fully vaccinated and also tested negative prior to travel), 32 of them tested positive upon arrival, another 23 when they had their second test six days later, and another 2 of the people who stayed long enough for a third test on the twelfth day.
While the numbers are low, they are also not zero, which shows again the necessity, if you want to 100% keep the virus out of a region, to not just test, and to not just require vaccination, but also to have a two week quarantine as a third level of defense. Nothing else will suffice, and even that is far from guaranteed, due to assorted possible mistakes in protocol and biological breaches through the quarantine.
This was the case in New Zealand, where a person in quarantine somehow had an infection leak out of the quarantine, ten days ago. Despite an instant national lockdown, strictly enforced, as soon as the infection was noticed, that one case has now grown to 347 infections in the country, with every chance of the number continuing to increase further. This shows, more than anything else, the extraordinary infectiousness of the Delta variant, especially in a country that had no social distancing and a low vaccination rate, as was the case in NZ, which had not had a single case of Covid for over six months and was starting to feel complacent.
New Zealand is now vaccinating at over twice the rate of before.
Closings and Openings
The Covid situation in China continues to be quite different to anywhere else. At present, in total, China is admitting to have had 66 Covid cases per million population, which makes it 215th out of a list of 221 countries in the world. The world average is 27,000 cases per million, and in the US, we have 118,000 cases per million.
When you consider that there was perhaps a month or more for the virus to spread uncontrolled in China before the country acknowledged its existence and placed its strong controls in place, and when you further keep in mind that China was slow to start vaccinating its people, and its vaccines are generally considered to be the least effective in the world, it would seem there are at least two zeroes missing from the “66” number of cases, and more credibly three.
Or maybe not. Here’s an interesting article that shows how China was so successful in creating social distancing that caused an effective barrier to virus transmission. This is of course New Zealand’s strategy now, and while other countries have paid lip-service to the concept of lockdowns, they have rarely been implemented successfully or completely.
Why don’t we simply create a two week lockdown to stop the spread of the virus in the US, and allow us to reset down from 175,000+ new infections every day down to zero?
Who Should Pay
Delta Air Lines has come up with an interesting concept. It will charge unvaccinated employees an extra $200/month for their healthcare. The airline claims it is costing $50,000 per Covid related health stay. I’m not arguing that number, but I am surprised – I thought the US government was reimbursing for Covid related hospitalizations.
One interesting point. The airline avoids calling the current virus variant by its official name. It refers to it as the B.1.617.2 variant. For some reason, it doesn’t like referring to it as the “Delta variant”.
We know the last 18 months have been extremely stressful for many healthcare professionals. So perhaps a hospital in Oregon has come up with a great concept to allow the most suffering of its doctors and nurses to “let off steam”.
Will particularly difficult patients now find a new line item on their hospital bill? For broken plates?
Please stay happy and healthy; all going well, I’ll be back again on Sunday.