Covid Vaccines

Researcher Blows the Whistle on Data Integrity Issues in Pfizer’s Vaccine Trials

The BMJ has just posted a story that calls into question the reliability of the data generated by Pfizer’s vaccine trials. It’s based on dozens of documents, photos, audio recordings and emails supplied to the BMJ by a researcher at one of Pfizer’s sub-contractors involved in testing the Covid vaccine.

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective COVID-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work. But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Worth reading in full.

Double Jabbed White House Press Secretary Catches Covid

White House Press Secretary Jen Psaki, who has received two doses of the vaccine and is a devout mask wearer, revealed last night she had tested positive for COVID-19 after deciding not to travel with President Biden to the G20 summit in Rome because members of her family had already received positive tests. Will this persuade Joe Biden that vaccine passports are a waste of time? Don’t count on it. MailOnline has more.

Psaki, 42, who has had two doses of vaccine, said she was last in contact with the president on Tuesday, and the two sat more than six feet apart while wearing masks.

It makes her the most visible member of the Biden administration to test positive.

“While I have not had close contact in person with the president or senior members of the White House staff since Wednesday – and tested negative for four days after that last contact – I am disclosing today’s positive test out of an abundance of transparency,” she said in a statement.

“I last saw the president on Tuesday, when we sat outside more than six-feet apart, and wore masks.”

She was a late scratch from Biden’s trip to summit in Rome, replaced on the trip by principal deputy press secretary Karine Jean-Pierre.

Awkward!

Worth reading in full.

Five Members of England Football Squad Refuse Jab

Five English football players who have been selected for the England squad recently are refusing to have a coronavirus vaccine, threatening their places in the World Cup squad in Qatar. MailOnline has more.

Three senior team members are reportedly among the rebels who believe they are too healthy to suffer Covid or have been pressured by their wives.

One is said to have brazenly declared he was too “young and fit” to be negatively affected by the virus, while another reportedly believes the anti-vaxxer ‘conspiracy theories’ about the jab.

The rest of the players are understood to have been ‘pressured’ not to get the jab by their wives or girlfriends who are against the vaccine.

It will come as a huge blow for England boss Gareth Southgate as World Cup organisers plan to ban all unvaccinated players from Qatar next year.

The Premier League is also struggling to clamp down on stars not taking the vaccine, with almost two-thirds of top-flight players yet to be fully jabbed and many refusing altogether.

Club officials are complaining dressing rooms have been ‘polluted’ by senior players spreading conspiracy theories involving Bill Gates, infertility and the power of vitamins.

But on Thursday night the league received reassurances from the Government that unvaccinated players will remain available for selection if Covid passports are made compulsory at mass events.

Former footballers weighed in on the issue and openly argued on social media over whether vaccines should be forced on stars.

Ex-England player Chris Waddle branded it “embarrassing” and called for a “simple no jab no play” policy. But former Tottenham midfielder Jamie O’Hara hit back, saying “it’s a choice and everyone has a choice in life”.

Worth reading in full.

JCVI Recommends Against Jabs For Teens

In a pleasant surprise, the JCVI, the U.K.’s vaccine regulator, has decided not to recommend that healthy 12-15 year-olds get vaccinated due to the risk of side effects. The BBC has more.

The U.K.’s vaccine advisory body has refused to give the green light to vaccinating healthy children aged 12-15 years-old on health grounds alone.

But the JCVI said the Government should consider wider issues including disruption to schools.

Ministers across the U.K. have asked chief medical officers to look at whether that tips the balance.

Meanwhile, an extra 200,000 teens with underlying conditions will now be eligible for two doses.

Doctors identified that children with chronic heart, lung and liver conditions were at much higher risk of Covid than healthy children. A group of 150,000 children with conditions such as severe neurodisabilities, Down’s syndrome and severely weakened immune systems are already eligible.

This is out of a total of three million children in this age group across the U.K.

The decision on healthy children was based on concern over an extremely rare side effect of the Pfizer vaccine which causes heart inflammation.

But as children are at such low risk from the virus, they decided that vaccination would offer only “marginal gain” and, therefore, there was “insufficient” evidence to offer mass vaccination for this age group.

Stop Press: A journalist colleague passed on some information from a source inside the vaccination programme. Sounds grimly plausible. Below is a summary:

  1. An announcement to be made to the public this Sunday confirming that vaccination of healthy 12-15 year-olds WILL go ahead. Likely to be a decision made by Chris Whitty and the other CMOs, given the JCVI’s position and the fact that no senior politician wants to take responsibility for it.
  2. The start date for first jabs in arms has been delayed until September 13th, a week longer that originally planned. The end date by which time we are required to have offered a Pfizer jab to all healthy 12-15 year olds remains November 1st. Uptake of 75% is expected, although I think that’s a little high, particularly in light of today’s JCVI announcement. We have had to complete a planning return setting out numbers of schools and vaccinations planned for the week beginning Sept 13th – there’s going to be a big push to maximise the number of vaccinations given in schools during the first week, consent be damned.
  3. All relevant documents including those relating to consent forms, consent process, national protocols, etc. will only be released to NHS Trusts on Monday Sept 6th, the day after the Whitty announcement is expected. It will be interesting to see how they get around the Green Book consent protocols.
  4. There is some consternation within the programme that NHS trusts only found out from the BBC, not the national team leaders, that the top-up third dose (not the booster) for the immunologically suppressed will go ahead from Sept 6th. The booster programme is still planned to start on Sept 20th with priority for care homes and health and social care staff likely to be first.

Stop Press 2: MailOnline has more on this story – much more.

Are the Vaccines Reducing Hospitalisations?

There follows a guest post by the academic economist who wrote a short post a few days ago about the apparent failure of the vaccine roll-out to reduce the number of over-60s being admitted to hospital with COVID-19 as a percentage of the number of over-60s testing positive rate. It generated a lively discussion in the comments so I asked the author to expand on it.

In the following short essay, I am going to examine whether the vaccines are preventing hospitalisations. We already know that the vaccines are not proving very effective at suppressing cases – which appear to be soaring in many countries, and notably the United Kingdom, in spite of the successful vaccine roll out and even though we are in summer and last summer cases remained suppressed. Some of us expected this to happen. The vaccine trials were rushed, the studies were of dubious quality, and they were released by drug companies who had a vested commercial interest in claiming high efficacy for the vaccines.

In addition to this, it should be obvious to anyone who gives it any thought that vaccines do not suppress highly contagious respiratory illnesses; more than half of Americans get flu shots every year, yet the United States has a flu season that is every bit as bad as Europe – which does not have high rates of annual flu vaccinations. A cynic might say that the flu vaccine business is much like the cosmetic business: a hustle by pharmaceutical companies to sell medicine to people who are not ill thereby massively expanding their market.

Now that it has become obvious that the vaccines are not preventing the spread of the virus, the public health clown show is doing what it does best: moving the goalposts. They are acting as if we knew all along that the vaccines did not prevent transmission. Instead, they tell us, the vaccines are there to prevent serious illness and death. We are supposed to ignore the fact that they are also insisting that groups that are not at-risk take the vaccine, but no matter – water under the bridge and if hundreds of young people die from blood clots or heart inflammation, so be it, better than Whitty and Vallance having to (gasp!) admit they were wrong.

Okay, well let us do what these clods never do: let’s test their hypothesis against the data. We are going to use data from Scotland (see here, here and here). Why? Because Scotland has had an outbreak that rivals previous outbreaks. The U.K. has not. It may appear the U.K. has had a full-on outbreak if you simply look at case data, but this is misleading. Testing has increased due to the proliferation of lateral flow testing. When we control for testing and look at the percent of tests that are positive rather than cases, we see this clearly.

Okay, so Scotland has a verified outbreak. How do we check whether the vaccines are preventing serious illness? Well, we know that serious illness only really occurs in older groups. We also know that older groups are more heavily vaccinated than younger groups. In fact, in Scotland almost 100% of over-60s are fully vaccinated. This provides us with a very nice natural experiment.

What we need to check is whether the correlation between positive cases among the over-60s and hospitalisations has broken down. In the pre-vaccination period we know that a certain percentage of positive cases among the over-60s would go on to become hospital patients. Well, if the public health boffins are correct and the vaccine prevents hospitalisations then fewer people should be being hospitalised relative to the number of cases. Do we see this?

Maybe. Squint and you will miss is. Hospitalisations do not appear to be rising quite as fast as cases in the over-60s. But let us not forget that testing has increased. So, what we really need to do is construct a positive test rate for the over-60s. With a bit of digging and applying a few statistical tricks, we can do this.

No squinting required this time around. The link has not been broken at all. The slight break between hospitalisations and cases in the over-60s is fully explained by the rise in testing. Control for this and the break disappears. Just as many people over the age of 60 are being hospitalised today in Scotland relative to the number of over-60s testing positive as they were before the vaccine roll-out began. The real-world evidence suggests that the vaccines are not, in fact, preventing serious illness. This confirms the impression we get reading the Scottish press. The Herald reports ‘Covid hospital admissions triple in over-60s — and nearly half of patients fully vaccinated’ – in fact, half is probably an understatement.

What about the link between hospitalisations and deaths? Perhaps the vaccines aren’t preventing serious illness, but maybe they’re preventing people with serious illness from dying?

Again, squint and you will miss it. Deaths are rising together with hospitalisations. If there are slightly fewer deaths relative to hospitalisations this could well be due to the better treatments for Covid that we know have been developed. Anyway, the notion that the vaccines will stop our hospitals from being overwhelmed – (were they ever really overwhelmed?) – is nonsense.

As we move into autumn and cases rise, it seems possible that the vaccines may fail spectacularly. What happens next? A rational society would turn on the public health buffoons and the greedy pharmaceutical companies. A rational society would take seriously the grim statistics on vaccine fatalities being reported to the Government’s Yellow Card system.

But we do not live in a rational society. We live in a society gripped by hysteria and fear; a society where control at both a governmental level and in day-to-day interactions has been handed over to the most neurotic and stupid among us. What will likely happen then is that these people double down. Rather than admit they were wrong they will get angry and project that anger on the people who doubted them. Those who have chosen not to get vaccinated will become increasingly vilified. They will be blamed for the hospitals stuffed full of fully vaccinated elderly people. Boosters will be insisted upon – and the dodgy pharmaceutical companies will continue to rake it in as they peddle untested drugs.

Either that, or our leaders grow spines and put a stop to this madness.

Stop Press: Covid hospital admissions among over-65s are a third of the level they would be if Britain didn’t have vaccines, according to PHE. MailOnline has more.

Stop Press 2: The Swiss Doctor has weighed in on this subject with a typically measured and erudite post.