Pfizer

Republic of Ireland to Begin Vaccinating Children as Soon as Possible

Paul Reid, the head of the Republic of Ireland’s Health Service Executive (HSE), has said that the Government has already begun planning a child vaccination campaign which he hopes begins “as quickly as possible”. Yesterday, the the European Medicines Agency (EMA) approved use of the Pfizer jab for five to 11 year-olds, with the vaccine now waiting approval from the country’s National Immunisation Advisory Committee, which will most likely follow the EMA’s original decision. The Times has the story.

Reid said delivery of the children’s vaccine across Europe was scheduled towards the end of December. “What we would be doing in the meantime is mobilising a plan and the channels in which we would prepare the vaccination of those younger age groups,” he said at a HSE weekly briefing.

The EMA said that a lower dose of the vaccine would be administered to primary school children (10 µg compared with 30 µg), with research showing that younger children produced a comparable immune response with the lower dose to that seen in people who received the higher dose.

The agency said the most common side effects in children aged five to 11 year-olds were mild or moderate, and similar to those recorded in older age groups. It said the benefits of vaccinating younger children outweighed the risks, particularly among those with conditions that increase the risk of severe forms of the disease.

Reid told yesterday’s briefing that there was a “really serious and continued escalation” of Covid transmission in the community. He noted that the public had responded to calls to work from home and curb social activities, but said this needed to be sustained because transmission levels were “still far too high” and putting severe pressure on the health system.

“We are still in a very volatile position overall in terms of where the virus is at,” he said.

There were 4,764 new Covid cases reported yesterday, with 598 people in hospital (down 13 from Wednesday) including 126 in intensive care (up six). The briefing was told that in the past week 395 Covid patients were admitted to hospital, an increase of 29% on the previous week. The five-day moving average of daily cases is at 4,665 compared with a peak of 6,867 in January.

Reid acknowledged the recent delays in accessing PCR tests during a week in which there has been no availability for testing in many counties across the country. The briefing was told that the HSE had increased its testing capacity and that 210,000 tests were completed in the past week. Three more PCR test centres are expected to open over the next week, including one in the Midlands and two on the east coast.

Reid said the healthcare system was “not elastic” and “not infinite” in terms of the demands it could meet. He said it would be misleading to suggest it could keep “surging up” and that there would be some testing delays.

“We put in the capacity but there are limits as to what capacity we can keep pumping into a system at these levels,” he said. “There does come a point where we have to be up-front, and we have been up-front, to set out that there will be people who experience some delays in terms of getting their test.

“Those who have been clinically prioritised are receiving tests in a very timely manner on either the same day or next day. But we do acknowledge some people are waiting with the significant numbers that we have coming through in terms of self referrals.”

Worth reading in full.

Can Anything About the Pfizer Vaccine Trial be Trusted?

In a recent article in the BMJ, a whistle-blower exposed serious problems she had observed first-hand in the Pfizer vaccine trial in Texas.

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.

Another Ventavia employee said of the data the company generated for the Pfizer trial: “I don’t think it was good clean data. It’s a crazy mess.”

The six-month trial results for the Pfizer vaccine have now been published in the New England Journal of Medicine. These findings, the researchers note, “contributed to the full approval of BNT162b2 [the Pfizer vaccine] in the United States”. A close inspection of the study, however, reveals a number of problems that raise serious questions about the reliability of its findings, as well as about the safety of the vaccine.

Here is the graph of cumulative incidence for the two trial arms, vaccine and placebo, over the six months of the study period, showing how the symptomatic Covid PCR-positives added up following receipt of the first dose.

CDC Approves the Pfizer Vaccine for Five Year-Olds

28 million U.S. children between five and 11 years-old have just become eligible for the Pfizer vaccine today after the Centres for Disease Control and Prevention (CDC) gave the green-light to the jab. The decision was rubber-stamped by the CDC Director Dr. Rochelle Walensky, who spoke of the vital importance of vaccinating young children. Sky News has the story.

The Food and Drug Administration (FDA) had already approved the shots for the age group, but the Centers for Disease Control and Prevention (CDC) formally recommends who should receive FDA-cleared vaccines – which it has now done.

CDC director Dr. Rochelle Walensky made the announcement just hours after an advisory panel unanimously decided Pfizer’s vaccine should be opened to the 28 million youngsters in that age category.

“As a mum, I encourage parents with questions to talk to their paediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” she said in a statement.

U.S. President Joe Biden marked the decision, describing it as a “turning point”.

He said: “It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others.

“It is a major step forward for our nation in our fight to defeat the virus.”

Worth reading in full.

Stop Press: Yesterday, we highlighted a concerning article published by the BMJ where a whistleblower calls into question the integrity, legitimacy, and safety of Pfizer’s vaccine trials in Texas, which can be found here.

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.

U.S. Vaccine Panels Approve The Pfizer Vaccine For Five-to-Eleven Year-Olds.

Advisory boards working in the Food and Drug Administration (FDA) as well as for the Centers for Disease Control and Prevention (CDC) have approved the use of the Pfizer jab for five to 11-year olds, outlining that the benefits outweigh the potential risks posed to this age demographic. Although the decision now awaits formal approval from the FDA and CDC as a whole, it is expected that both organisations will confirm the original verdict, meaning that 28 million U.S. schoolchildren will soon be eligible for the vaccine. BBC NEWS has the story.

Following the FDA independent advisory committee’s green light on Tuesday, the CDC is expected to follow suit on November 2nd, meaning jabs for five-year olds could begin as soon as a day later.

The Pfizer vaccine is already approved for American adults and adolescents, but it has not yet been fully approved for most school-aged children.

Among those between five and 11 years-old, there have been about 1.8 million Covid cases confirmed in the US, according to the CDC. Fewer than 200 have died, and most of those had underlying medical conditions.

Some medical experts say that, given the persistence of the Delta variant and the return to in-person schooling, vaccinating children is a crucial next step in fighting the pandemic.

“Parents need to understand the urgency of vaccination because the pandemic is not over”, said Dr. James Versalovic, pathologist in chief at Texas Children’s Hospital (TCH)…

Vaccine hesitancy remains a challenge for US medical authorities. Uptake in the adult population has stalled below 60% over the past several months.

Only a third of parents in a poll last month by the Kaiser Family Foundation said they would get their children vaccinated ‘right away’. Another third said they would like to ‘wait and see’.

Some parents have expressed concern about hundreds of cases of myocarditis, an inflammation of the heart muscle, that have been reported predominantly in young adults who took the vaccine, mostly after the second jab.

Worth reading in full.

Study Links Pfizer and Astrazeneca Vaccines to Life Threatening Side Effects

The most comprehensive study into vaccine side effects so far has uncovered that the Pfizer and AstraZeneca vaccines are linked to serious and potentially life threatening side effects. Although rare, the Pfizer vaccine has been connected to the neurological condition Guillain-Barré syndrome, which carries symptoms of numbness and muscle weakness, while the AstraZeneca vaccine has been associated with bleeding on the brain and hemorrhagic stroke. The Times has the story.

Professor Aziz Sheikh, from the University of Edinburgh, said that it was possible to identify the adverse events only because they were able to look at so much data. The study, published in the journal Nature Medicine, looked at 20 million first doses of the Oxford-AstraZeneca vaccine, 12 million of Pfizer and two million infections.

“These are very rare adverse events. They’re so rare that we’re having to report them per million of the population,” Sheikh said. “It’s not what you’d normally see, where it’s per 1,000 people exposed.”

The work is the largest investigation into potential side effects so far, using data from the UK vaccine programme. It involved comparing occurrences of the conditions in the same people prior to vaccination with occurrences after. In this way it attempted to correct for the possibility that those getting the vaccines were different in other ways from those who did not.

To check the findings, the scientists looked first at English data then checked it with that from Scotland. In doing so, they could not find strong enough evidence to be certain the strokes really were associated with the Pfizer vaccine, but they again found the link between the AstraZeneca jab and Guillan-Barré [sic] syndrome. Eighty per cent of people recover completely from Guillain-Barré syndrome, but some can experience long-term ill health.

Sheikh said that it was up to individuals to weigh up the risks, but that in his view the benefits of the vaccines still easily outweighed any potential side effects.

Worth reading in full.

Pfizer Accused of Bullying Developing Countries Provisions in Covid Vaccine Contracts

Unredacted copies of Pfizer’s purchasing agreements with a range of countries show that the pharmaceutical giant is bullying the governments of developing countries, making them waive sovereign immunity, preventing them from penalising Pfizer over late shipments and allowing the company to restrict vaccine donations – all this according to a new report by the non-profit organisation Public Citizen. MailOnline has the story.

The bombshell report, published by Public Citizen on Tuesday, alleges the New York City-based company worked to silence governments, restricted nations’ access to vaccine donations, forced governments to pay out lawsuits they may face for breaking intellectual property laws (IP), and to seize public assets in case of missed payments such as foreign bank accounts.

Countries including Albania, Brazil, Colombia, Chile, the Dominican Republic and Peru were subject to these terms in order to acquire the vaccine.

Public Citizen reports that high income countries, such as the U.S., have assisted Pfizer in these bullying tactics by staunchly protecting their IP and allowing the company to form a ‘monopoly’.

Public Citizen obtained nine unredacted copies of Pfizer purchasing agreement with eight countries and the European Union.

The documents revealed previously unknown clauses within contracts that could potentially damage developing nations.

One provision in the contract with Brazil, for example, made the South American country waive sovereign immunity – which protects the nation from lawsuits – in order to access the vaccines, according to Public Citizen.

The contract also prevents Pfizer from being penalized for late shipments.

Little information about these contracts is allowed to be made public, though.

Countries, including the U.S., are not allowed to make any public announcement regarding the details of the contract and any potential dispute must be resolved by private arbitration.

Pfizer is also allowed to control and restrict vaccine donations as part of the contract, Public Citizen reveals.

Nations that sign purchasing agreements with Pfizer could be prevented from receiving donations from other nations, with the company instead wanting doses to be purchased directly from them.

If Brazil, for example, were to receive a donation of Covid vaccine doses from another nation, Pfizer would terminate the contract and the nation would have to pay out the remainder of the contract without receiving any of the remaining doses.

Worth reading in full.

More Evidence that Natural Immunity Beats Vaccine-Induced Immunity

I previously wrote about the Israeli study which found that natural immunity provides much better protection against infection than the Pfizer vaccine.

Sivan Gazit and colleagues tracked two groups of people over time: fully vaccinated people who’d never tested positive; and unvaccinated people who had tested positive. Of the 257 cases that were detected at follow-up, 93% occurred in the vaccinated group, and only 7% occurred in the previously infected group.

And indeed, a recent systematic review (which has not yet been peer-reviewed) confirms that natural immunity confers a very high degree of protection against infection. The researchers analysed 10 studies, and found that the “weighted average risk reduction against reinfection was 90.4%”.

Compare this to studies of the vaccines’ efficacy against infection. In July, the Israeli Ministry of Health reported that the Pfizer vaccine’s effectiveness had dropped to just 39%. And a pre-print study by Qatari researchers found that it fell to zero after six months. (Though the vaccines’ efficacy against severe diseases appears to hold up well.)

Adding to the evidence outlined above, there are now studies comparing natural and vaccine-induced immunity at the cellular level.

I should mention that I am not qualified to evaluate the methods used by these studies, so I will have to assume the authors have done things properly. With that qualification in mind, it’s worth briefly discussing what they found.

In a recent paper published in Cell Reports, researchers from Minneapolis compared the memory B cells generated after natural infection versus mRNA vaccination. Memory B cells (MBCs) are part of the adaptive immune system; they are responsible for recognising antigens, and triggering a secondary immune response.

The researchers found that “infection-induced primary MBCs have better antigen-binding capacity and generate more plasmablasts and secondary MBCs of the classical and atypical subsets than vaccine-induced primary MBCs”. As a result, infection-induced MBCs “produce more robust secondary responses”.

In a second study, published as a preprint, researchers from Boston compared the durability and breadth of antibodies after natural infection versus mRNA vaccination. They found that infection-induced antibodies “exhibited superior stability and cross-variant neutralisation breadth than antibodies induced by a two-dose mRNA regimen”.

In other words, individuals who’d already been infected had better immunity against the then-novel Delta variant, as compared to ‘naïve’ individuals who’d received an mRNA vaccine.

Taken together, the statistical and immunological evidence suggests that natural immunity provides better protection against infection than the mRNA vaccines. This does not mean that nobody stands to benefit from vaccination. The vaccines are still an important way of achieving focused protection for high-risk groups.

But it does undermine the case for vaccine passports, and for vaccinating 12-15 year-olds. As Jay Bhattacharya wrote back in July: “Any infection-blocking effects are probably short-term unless the vaccine does very much better than natural immunity, which is rare in medicine.”

Pfizer Will Ask U.S. FDA for Approval of Its Vaccines in 5-11 Year-Olds “In Days”

We’ve not yet finished debating the vaccination of 12-15 year-olds. But Pfizer’s CEO, who hinted at “annual re-vaccinations” against Covid over the weekend, is already looking to go one step further by asking the U.S. Food and Drug Administration (FDA) “in days” to authorise the use of its vaccine in even younger children. MailOnline has the story.

On Sunday, in an appearance on ABC’s This Week, Albert Bourla was asked when the country should expect the shots to be approved in kids between ages five and 11.

The New York-based firm, along with its German partner BioNTech, recently released data that it said showed the vaccine was safe and effective in a [sic] smaller doses in elementary schoolers.

“I think we are going to submit this data pretty soon,” Bourla told host George Stephanopoulos.

“It’s a question of days, not weeks, and then it is up to FDA to be able to review the data and come to their conclusions and approve it or not.”

According to clinicaltrials.gov, Pfizer’s study in younger children worked similarly to the way it did in older children and adults.

A total of 4,500 younger kids from ages six months to 11 years were enrolled at nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain

About half of the ages five-to-11 group were given two doses 21 days apart and the other half were given placebo shots.

The team then tested the safety, tolerability and immune response generated by the vaccine by measuring antibody levels in the young subjects.

Pfizer said it had selected lower doses for Covid vaccine trials in children than are given to teenagers and adults. …

Bourla assured that Pfizer would be ready to ship these smaller doses across the country if the FDA authorises the shot in younger children. …

Unlike the larger clinical trial conducted in adults, the pediatric trial did not measure efficacy by comparing the number of Covid cases among the vaccine group to the number in the placebo group.

Instead, scientists looked at levels of neutralizing antibodies in young vaccine recipients and compared the levels to those seen in adults.

The companies expect data on how well the vaccine works in children between ages two and five and between six months and two years of age by the end of the year.

Worth reading in full.

Pfizer CEO Hints at Annual Covid Vaccine Booster Roll-Outs

The CEO of the pharmaceutical giant Pfizer says he believes life will return to normal “within a year” – but his vision of ‘normal’ involves “annual re-vaccinations” against Covid. MailOnline has the story.

“Finally, Moderna’s CEO said this week that the pandemic is on course to be over in about a year. Do you agree with that?” ABC This Week host George Stephanapoulos asked [Albert] Bourla on Sunday.

“I agree that, within a year, I think we will be able to come back to normal life,” he concurred.

“I don’t think that this means that variants will not be continuing coming,” Bourla countered. “And I don’t think that this means that we should be able to live our lives without having vaccinations, basically. But that’s – again, remains to be seen.”

He said that the most likely outcome is that people will need to continue to get Covid booster vaccines annually, similar to how people get the flu shot each year to protect against the most likely variant of the influenza virus that year.

“The most likely scenario for me, it is that, because the virus is spread all over the world, that we will continue seeing new variants that are coming out,” he said. “And, also, we will have vaccines that – they will last at least a year.”

“And I think the most likely scenario – it is annual re-vaccinations. But we don’t know, really. We need to wait and see the data,” the pharmaceutical company chief added.

Pfizer is the only company of the three who were approved by the Food and Drug Administration (FDA) for Covid vaccines in the U.S. that has also been approved for a booster.

The booster shot, however, was only permitted by the FDA to be distributed to elderly people – those 65 and older – and high-risk individuals, like those with autoimmune disorders.

The Centers for Disease Control overruled on Friday the advisory panel’s decision, allowing the booster to be distributed for other high-risk individuals, including those who live or work in high contact areas. …

Morningstar analyst Karen Andersen expects boosters alone to bring in about $26 billion in global sales next year for Pfizer and BioNTech and around $14 billion for Moderna if they’re endorsed for nearly all Americans.

Pfizer’s stock price shot up from $30.99 on March 8th, 2020 – days before the World Health Organisation declared Covid a global pandemic – to $43.94 today.

Worth reading in full.