COVID and Vaccine: It takes two to Tango

This post follows on from last weeks Vaccine Rag or Vaccine Tango.

In the photo above, appropriately in the centre, we have Nicolás Vaquer, the plenipotentiary to Argentina of a Big American Power (Pfizer).  On the left of the photo, to the right of the Boss of Bosses, is Dr. Fernando Polack, the head of a company about to take something like $50 million for running a forthcoming vaccine trial.  On the right of the photo is Alberto Fernandez, the head of an executive that tries to facilitate the operations of major corporations – please do your trial here, we will pay for all the staff  and put the army at your disposal so the trial will cost you almost nothing. 

In the material presented to the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) Full Approval meeting, Pfizer said there were 3410 cases of Suspected COVID in the trial cohort – 1816 cases of Covid like illnesses on placebo and 1594 on vaccine.  This is not 95% efficacy.

In the submission to FDA for an EUA, there were 409 suspected COVID-19 cases that occurred within 7 days after any vaccination in the vaccine group versus 287 in the placebo group.  This is not 95% efficacy.

In the later submission to FDA for full approval:

4,931 participants (2,285 in the BNT162b2 group and 2,636 in the placebo group) … developed protocol-defined symptoms after 7 days post Dose 2 during the blinded follow-up period but were not counted as a confirmed case.  Of these 4,331 had negative PCR tests and 699 had missing or unavailable tests.

In the submissions to FDA claiming efficacy, these case numbers dropped to 162 confirmed Covid cases on placebo and 8 on vaccine, the figures that give us a claimed 95% efficacy.

How did 4,931, 3410, or 696 cases shrink by 95% in the case of 3410 to 170 – one twentieth the number of cases?

Some Explanations

Clinicians and researchers have talked about flu-like illnesses for several decades.  In a flu season, people can have what looks like flu but tests don’t confirm this. There are lots of viruses that give clinical pictures like flu and COVID.  Even the alterations of taste and smell that were made so much of with the initial outbreak of COVID are not distinctive to it.

In the 7 day period after the vaccination, either active or placebo, what the submissions to FDA term ‘vaccine reactogenicity’ can give rise to symptoms consistent with a diagnosis of COVID.

The trial, however, managed to show slightly more symptoms among this group who had received placebo than received the vaccine.  It would be interesting to see the App that invited/prompted people to record these symptoms – to see whether the placebo group had milder symptoms than the vaccinated group or whether they were even offered the opportunity to record mild, moderate or severe.

In the trial, becoming a confirmed case of COVID hinges on the PCR tests done or not done.  There were 699 cases where the tests were either not done or were not available.  As noted in The Fog of a Special Military Operation, a lot of people ended up in hospital with respiratory or cardiac problems without tests being done or at least results being recorded.  Pfizer told FDA that their analysis of these cases showed that they would not have made any difference.

There is another option – false negative PCR results.  The clinicians or sponsor may know the person has COVID – even though the tests say no.  Augusto features in these approval documents, where these issues are discussed:

In one case, a 36-year-old male with no medical comorbidities experienced fever, malaise, nausea, headache and myalgias beginning on the day of Dose 2 and was hospitalized 3 days later for further evaluation of apparent infiltrates on chest radiograph and treatment of dehydration. A nasopharyngeal PCR test for SARS-CoV-2 was negative on the day of admission, and a chest CT was reported as normal. The participant was discharged from the hospital 2 days after admission. With chest imaging findings that are difficult to reconcile, it is possible that this event represented reactogenicity following the second vaccination, a COVID-19 case with false negative test that occurred less than 7 days after completion of the vaccination series, or an unrelated infectious process.

Far from being clearcut, a lot comes down to discretion.  The system was inordinately keen to make Augusto a case of Covid, even though he had been vaccinated.  Why?  Well a case of COVID happening in the week after Dose 2 disappears through a trapdoor built into the protocol – you are not defined as vaccinated until 7 days after Dose 2.

If he is a Suspected Covid, he also disappears as an Adverse Event caused by the vaccine.   This is Win-Win for Pfizer.  Had Augusto not been so persistent in challenging what had gone on, what odds on his vanishing through the trapdoor?

NAB and PCR

Of the 170 positive cases which formed the EUA case for efficacy, Buenos Aires recruited 36 – 35 placebo and 1 on BNT165b2 in site 1231 and 1231/4444.

Of the 36,

• 12 were PCR and NAB positive
• 16 were PCR positive and NAB negative
• 8 were PCR positive and NAB not done.

For an explanation of PCR and NAB tests see mRNA Boosterism.

From these figures it looks like a lot of cases could end up being down to discretion.

Argentina  EUA Cases

The first positive Buenos Aires case listed in the Table below – 1043 – is interesting.  The Nab test suggests this 46 year old man was never infected.  He only had one clinical symptom (cough) for one day, although a separate document says cough and chills.  Everything hinges on the PCR test done in Pfizer’s laboratory in New York.

Several other cases – 1556, 1764, and 4112 – had only one symptom, which lasted very few days with negative NAB tests or tests not done.

Case 3895 has a protocol deviation – this woman appears to have had immunoglobulins or other blood products prior to the end of the study.  She was hospitalized after Dose 2 and it may have been then she received treatment that might have affected testing.

The man who was volunteer 2914 has a very interesting protocol deviation.  The protocol states that people needed to receive Dose 2 between days 19 to 23 after Dose 1.  But there were 8 people included among the 170 cases whose Dose 2 happened outside this window.  If you are a purist, this man would not be included.

The woman who was volunteer 1204, right at the end of recruitment to this trial in Buenos Aires, was the only COVID case who was vaccinated . Remove her and Buenos Aires would have had 100% efficacy and there would have been an infinite contrast between Buenos Aires and the rest of the trial.

The man who was case 1224 withdrew from the study before the closing date, but was still included as a placebo COVID case.

Finally to become a case, you had to be a clear 7 days after Dose 2.  What does this mean.  It seems clear that if you were vaccinated on September 1 and had your first symptoms of COVID on September 8, you would qualify.

What if you were vaccinated at 5 PM on September 1 and woke up with symptoms on September 8?  This is less than seven 24 hour periods.  There were 4 people who had first symptoms on Day 8 some of whom seem to fit this template – and 3 more with first symptoms on Day 9.

Many of the other sites have discrepancies in the PCR results reported from New York compared to the local test.  Not so Buenos Aires whose local and central results appear almost completely consistent as might be expected, perhaps, of a military operation.

There are a number of other interesting cases that will be picked over in the next post.  For instance, there is a mention of August 31 in the Table below.  Something as of yet unexplained happened in Buenos Aires on August 23 that had consequences on August 31, and that is pertinent to Augusto Roux’s case.  This will be discussed in the next post.

Table of Buenos Aires EUA Cases

In the Table below, PCR Pos stands for a positive PCR test done at the point of apparent illness – see mRNA Boosterism post for an explanation of this.

NAB stands for the N Antibody Test done 5 weeks after dose 2 which indicates an infection but doesn’t locate it to the weeks after the week after Dose 2.

There was/is an Internal Review Panel within Pfizer, comprised of Pfizer employees who made a judgement call as to whether a case was a case or not.  The cases here hinge on their judgement.  There are up to 10 placebo cases here than can be questioned.

The apparent efficacy of the Pfizer vaccine in these Buenos Aires cases as decided by Pfizer is over 97%.

Cases After First Dose Placebo

Pfizer claimed 85% efficacy after the first dose of vaccine.  This was not the case in Buenos Aires where there was 30 cases after the Dose 1 of placebo and 14 cases after Dose 1 of vaccine.  This is 68% relative efficacy.

It is a much much lower absolute efficacy.  Of the placebo cases in the trial 1% got COVID while 0.5% of the vaccinated cases caught COVID.  The main message is that vaccinated or unvaccinated, people were unlikey to catch COVID at the height of the epidemic, with 1 in 200 people taking placebo perhaps less likely to catch it if they had been vaccinated.

There is a play on the word vaccinated here.  For Pfizer you are only vaccinated two weeks after Dose 2.  But you can’t get to this blessed state without being vaccinated – taking a risky step for what benefit?

If we add both COVID cases after first and second doses we have 65 cases on placebo and 15 on vaccine – roughly 80% efficacy.

These figures do not take into account protocol deviations or cases with one symptom lasting one day and with a negative NAB test.

They also do not take into account the waning efficacy after Dose 2 that has led to repeated boosters and repeated boosterism, with little evidence for benefit.

COVID Cases After First Dose of Vaccine

Puzzles

There are many puzzles remaining to resolve in the Pfizer trial and in its Buenos Aires arm  There are also others surrounding this trial.

Why is there no long table between Fernandez and Putin in this picture, taken just before the Ukraine invasion?

What’s up with several Argentines taking Sputnik vaccines in the midst of the Pfizer trial?

Why did Pfizer want complete and utter and total indemnity for any possible harm in all possible universes linked to its vaccine?

Where did Alberto F get the courage from to tell them No?

Footnote

With the pandemic, Blogs have been replaced by Substacks, which often note a subscription would help keep things going.

Published by Samizdat, Shipwreck of the Singular. Healthcare’s Castaways rolled out with the Vaccines.  Its descriptions of a dystopian medical future seem all too present now.

It is priced at $18.95, and $8.99 in kindle from each of which Samizdat gets $5, and even less as El Naufragio de lo Singular.

Samizdat aims at the middle ground in health, enabling conversations to happen. A copy of any of its books for you or a friend, in lieu of an hypnotic, might help us all find a way to wake up.