Pfizer

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.

Pfizer Set to Seek Approval for Its Covid Vaccine in U.S. Babies This Winter

It’s been less than a week since reports suggested Pfizer was preparing to seek approval from U.S. and European medicines agencies for its vaccine in 5-11 year-olds. The pharmaceutical is now seeking authorisation for the vaccination of American babies as young as six months this winter. MailOnline has the story.

In a move likely to cause international controversy, the company intends to apply for authorisation to immunise American infants within the next two months.

The timeline will depend on the findings of in-house trials looking into whether the vaccines are safe and effective in youngsters aged six months to five years.

Frank D’Amelio, Chief Financial Officer at Pfizer, told an industry conference yesterday that the firm plans to “go file” by November, the Financial Times reports.

“We would expect to have… data for children between the ages of six months and five years old that we would file with the FDA,” D’Amelio said at the Morgan Stanley Global Healthcare Conference. “I’ll call it in the weeks shortly thereafter the filing of the data for the five to 11 year-olds.”

Pfizer was already planning to seek approval from the Food and Drug Administration (FDA) for the jabs to be given in children aged five to 11 by October.

But the latest comments confirm the firm’s intention to work its way down much younger age groups. They will be given a lower dose than adults. …

Scott Gottlieb, who headed the FDA under former President Donald Trump and now sits on the board of directors at Pfizer, says that the emergency use approval process for vaccinating young children could be done in a matter of weeks.

Gottlieb says the pharmaceutical giant is expected to file the paperwork with the federal government requesting authorisation to vaccinate kids as early as September.

Worth reading in full.

Pfizer Initially Turned Down Offer to Develop Covid Vaccine, Believing Virus Would Be “Controlled”

Millions of doses have been administered across the world, but it has been revealed today that Pfizer initially turned down the offer to develop its Covid vaccine because executives believed the virus could be “controlled” and that mRNA technology was too experimental. The Telegraph has the story.

Dr. Ugur Sahin and his wife, Dr. Özlem Türeci, the founders of BioNTech, were told “guys, this is not going to work” by the pharmaceutical giant as the virus was starting to sweep the globe in January 2020.

The mRNA technology, which has proved so crucial to the vaccine breakthroughs, was, at the time, also considered too experimental by Dr. Phil Dormitzer, Pfizer’s Vice-President and Chief Scientific Officer for Viral Vaccines.

“My working assumption was that it [Covid] would be controlled” like the SARS and MERS outbreaks, Dr. Dormitzer admits.

The initial rejection, revealed in a new book, came just days after the Turkish-born couple decided to dedicate BionNTech to creating an mRNA based Covid jab, effectively gambling the business on something that had never been done before. Their company is now worth $85 billion.

Yet Drs. Sahin and Türeci remain close to Pfizer and Dr. Dormitzer, or “Phil” as they know him.

Dr Sahin had a detailed image in his mind of how the pandemic would unfold but also thought the Pfizer man’s assessment “completely rational”.

“After the phone call with Phil, I just thought for a second and said ‘we will call him again in a few weeks,’” Dr. Sahin told the Telegraph.

The couple thought it only a “matter of time” before the drugs giant changed its mind – and they were right. A deal was announced between the two companies a month later.

Worth reading in full.

Pfizer Preparing to Seek Approval for Its Covid Vaccine in 5-11 Year-Olds

Not content with the ‘jabbing’ of children over the age of 12 with their Covid vaccine, Pfizer and BioNTech are now preparing to seek approval from U.S. and European medicines agencies for their vaccine in 5-11 year-olds. MailOnline has the story.

Dr. Özlem Türeci, Chief Physician for BioNTech, told German news site Der Spiegel that the companies are set to shortly release results from their study in kids under age 12 and will ask for the shot to be approved for emergency use authorization by the U.S. Food and Drug Administration (FDA) and other agencies.

“In the coming weeks, we will present the results of our study on the 5-11 year-olds worldwide to the authorities and apply for approval of the vaccine for this age group,'”Türeci said.

She added that the vaccine formula is the same as that approved for adolescents and adults, but that the dose size is smaller. 

Currently, the Pfizer vaccine is only approved for children aged 12 and older in both the U.S. and the European Union.

Parents and doctors have been debating about whether or not to inoculate children because they make up 0.1% of all Covid deaths in the U.S. 

A few hours after the new from Pfizer and BioNTech, the FDA said that clinical trial data submitted by vaccine manufacturers must include a monitoring period of at least two months after the final dose to ensure safety. …

Around 4,500 younger kids have been enrolled at nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain. …

If the vaccine is proven to be safe and effective, the trial will be unblinded at the six-month follow-up, meaning those who received [a] placebo will be allowed to get the inoculation. 

Trials for kids as young as six months to four years old are still in early stages and will expand once the researchers can determine safety.

Worth reading in full.

Teenage Boys Six Times More Likely to Suffer Heart Problems from Vaccine Than to Be Hospitalised from Covid, According to New Study

As the Government tries to push on with the vaccination of healthy children against Covid, despite warnings from the Joint Committee on Vaccination and Immunisation (JCVI), a major new U.S. study has found that teenage boys are six times more likely to suffer from heart problems due to the vaccine than to be hospitalised from Covid. This should force ministers to think twice. The Telegraph has the story.

Children who face the highest risk of a “cardiac adverse event” are boys aged between 12 and 15 following two doses of a vaccine, according to new research from the U.S. 

The findings come as Professor Chris Whitty, England’s Chief Medical Officer, prepares to advise ministers on whether there is a wider benefit to society from vaccinating children.

Last week, the JCVI delivered its long-awaited verdict, saying the “margin of benefit” of jabbing 12 to 15 year-olds was “considered too small” and citing the low risk to healthy children from the virus.

However, Sajid Javid, the Health Secretary, said he wanted Prof Whitty and the Chief Medical Officers from Scotland, Wales and Northern Ireland to “consider the vaccination of 12 to 15 year-olds from a broader perspective”. …

Research published on Thursday will prompt fresh concerns about whether the risk of the vaccine outweighs the benefits for otherwise healthy children.

A team led by Dr. Tracy Hoeg at the University of California investigated the rate of cardiac myocarditis – heart inflammation – and chest pain in children aged 12-17 following their second dose of the vaccine.

They then compared this with the likelihood of children needing hospital treatment owing to Covid, at times of low, moderate and high rates of hospitalisation.

Researchers found that the risk of heart complications for boys aged 12-15 following the vaccine was 162.2 per million, which was the highest out of all the groups they looked at.

Evidence from studies show it is unlikely for boys to suffer either heart problems from the vaccine or be hospitalised by Covid.

The second highest rate was among boys aged 16-17 (94.0 per million) followed by girls aged 16-17 (13.4 per million) and girls aged 12-15 (13.0 per million).

Meanwhile, the risk of a healthy boy needing hospital treatment owing to Covid in the next 120 days is 26.7 per million. This means the risk they face from heart complications is 6.1 times higher than that of hospitalisation.

This is based on current rates of hospitalisations from Covid-19, which are judged to be “moderate”. During a period of low risk of hospitalisation, such as June 2021, the likelihood of heart complications rises to 22.8 times higher, and during a period of high risk, such as January 2021, the likelihood of heart complications is still 4.3 times higher.

The study, which has not yet been peer reviewed, analysed reports of adverse effects children have suffered from the vaccine between January and June of this year.

The study looked at MRNA vaccines – such as Pfizer and Moderna – which will be particularly relevant for Britain because youngsters will not be given the AstraZeneca jab because of the increased risk of dangerous blood clots.

Worth reading in full.

Stop Press: Ross Clark has written about the risk mRNA vaccines pose to young boys in the Spectator.

Stop Press 2: Dame Sarah Gilbert, the driving force behind the AstraZeneca vaccine, has told the Telegraph there’s no need to vaccinate healthy 12-15 year-olds and we’d be better off exporting any spare vaccines we have to low income countries.