Pfizer

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.

New Zealand Woman Dies After Receiving Pfizer Covid Vaccine

The whole of New Zealand was plunged into lockdown following the reporting of a single Covid ‘case’ earlier this month. But the main response to today’s reporting of a death in the country linked to the Pfizer vaccine appears to be highlighting just how safe the jab really is. Sky News has the story.

The Covid Independent Safety Monitoring Board (CV-ISMB) did note that there were other medical issues occurring simultaneously, which may have influenced [the woman’s] death following her vaccination.

“This is the first case in New Zealand where a death in the days following vaccination has been linked to the Pfizer Covid vaccine,” the Ministry said in a statement, without giving the woman’s age.

The Ministry added the vaccine monitoring panel attributed the death to myocarditis, a rare but known side effect of the vaccination.

Myocarditis is an inflammation of the heart muscle that can limit the organ’s ability to pump blood and can cause changes in heartbeat rhythms.

Last month, New Zealand Medicines and Medical Devices Safety Authority (Medsafe) issued a safety alert on myocarditis to raise awareness of the side effect.

All cases of deaths following vaccinations are referred to the CV-ISMB for review.

The board’s Chairman, Dr. John Tait, said: “We want to ensure that the outcomes from this investigation are widely available for others to learn from.

“The Pfizer vaccine is highly effective in protecting against serious illness and death from Covid and we remain confident about using it in New Zealand.”

The Health Ministry has reassured people that the benefits of the jab continue to “greatly outweigh” the risk of Covid and vaccine side effects.

In response, Pfizer said it recognised there could be incidences of myocarditis after vaccinations but such side effects were extremely rare.

Worth reading in full.

FDA Approval of Pfizer Covid Vaccine Will Lead To More Vaccine Mandates, Says Dr. Fauci

Rather than allow the full approval of the Pfizer Covid vaccine by the U.S. Food and Drug Administration (FDA) to simply persuade otherwise sceptical Americans that the jab is safe for use, businesses and universities are likely to use it as an excuse to introduce vaccine mandates, according to Dr. Anthony Fauci. The Chief Medical Advisor to Joe Biden says “you’re gonna see a lot more mandates because there will be institutions and organisations which previously were reluctant to require vaccinations, which will now feel much more empowered to do that”. MailOnline has the story.

In an interview on MSNBC’s Morning Joe on Tuesday, Dr. Anthony Fauci said he thinks approval will help push more Americans to get the Covid vaccine because it might reduce their fears about the safety of the shot.  

But he added that businesses and schools may feel more comfortable requiring workers or students to get a jab that has full authorisation.

“You’re gonna see a lot more mandates [from a range of] institutions…

“That could be organisations, businesses, colleges, universities. We’re even seeing it with the military already.”

However, mandates are a contentious topic with many states outright banning laws that would require workers to be vaccinated. …

Fauci referenced a recent report from the Kaiser Family Foundation that found three in ten unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines were fully approved.

“I think that’s gonna be an important group because if you talk about 30% of the unvaccinated, that’s a lot of people,” he told Morning Joe.

About 90 million Americans who are eligible to get the Covid vaccine have not yet done so, according to the Centers for Disease Control and Prevention. …

At a news conference on Monday morning, Pentagon Press Secretary John Kirby confirmed that the full approval will lead to COVID-19 vaccines being mandated for the U.S. military. 

“Now that the Pfizer vaccine has been approved, the Department is prepared to issue updated guidance requiring all service members to be vaccinated. A timeline for vaccinated completion will be provided in the coming days,” he said. 

And Louisiana State University President William Tate announced two weeks ago that the school will mandate that students receive the vaccine following full FDA authorisation. 

Worth reading in full.

Stop Press: President Joe Biden has called on U.S. companies to introduce Covid vaccine mandates, saying: “Require it. Do what I did last month. Require your employees to get vaccinated or face strict requirements.”

Tens of Millions of Brits Will Be Offered Pfizer Booster Vaccine This Autumn

Millions of Brits, including the over-50s, people who are vulnerable, and NHS staff, will be offered a Pfizer booster vaccine this Autumn, even if their first two doses were from a different provider. MailOnline has the story.

Extra vaccines would be rolled out in two stages – prioritising those most at risk of Covid, before the programme is extended.

While patients were initially expected to be offered the jab they were originally inoculated with, it is understood all patients will be offered the Pfizer jab as it has proven to be the most effective against the Delta variant.

The Department of Health has yet to confirm the official details of the booster scheme, plans of which were first shared by the Joint Committee on Vaccination and Immunisation (JCVI) in June.

The JCVI is expected to issue its final advice in regards to the booster scheme in the coming months. 

A senior Government source also told the Times that those who received the AstraZeneca vaccine would “be getting an mRNA booster”. …

A U.K. Government-backed study published earlier this year found that mixing and matching Covid vaccines may result in higher protection against the virus.

People who had been vaccinated with AstraZeneca’s jab initially and then received a top-up with Pfizer’s had nine times more antibodies than those who stuck to the U.K. vaccine. …

The Government said analysis has shown that the Pfizer vaccine is 96% effective against the Delta variant while the AstraZeneca vaccine is 92% effective against hospitalisation after two doses.

A study published this week also showed that a third dose of the Pfizer vaccine could offer strong protection against the Delta variant.

Worth reading in full.

All U.K. Children Could Be Offered Covid Vaccines by the End of the Year

The Government will announce its plans for the vaccination of children against Covid later today and is expected to say that only clinically vulnerable children and those living with vulnerable adults will be included in the national roll-out – for now. It hasn’t taken long for reports to emerge suggesting that all children could be offered a vaccine by the end of the year. The argument is that it will be difficult to reach herd immunity if children remain unvaccinated. The Telegraph has the story.

The Joint Committee on Vaccination and Immunisation (JCVI) is expected to announce that only vulnerable youngsters between the ages of 12 and 15, and 17 year-olds within three months of their 18th birthday, will be offered a jab amid concerns there is too little data on safety and efficacy in young people.

But the JCVI is expected to leave the door open for more children to be vaccinated once trials conclude later this year, the Telegraph understands.

In June, the Medicines and Healthcare products Regulatory Agency approved the Pfizer jab for 12 to 15 year-olds in Britain following early trial results in teenagers, but there is still no data for younger children. 

Pfizer is expected to release results on trials for five to 11 year-olds in September and two to five year-olds by November, with the company expecting regulator approval within a month of releasing positive data. AstraZeneca is also conducting trials in children aged six to 17, with the British team likely to release results before the end of the year.

On Sunday, experts warned that it may be difficult to reach herd immunity in Britain if children are not vaccinated. Nearly one in five people in the U.K. are under 16 and, despite everyone being offered a vaccine, around 12% of adults have not had a first jab.

Professor Neil Ferguson, of Imperial College, a member of SAGE, told the BBC: “In the absence of vaccinating it’s inevitable that we’re going to have very high numbers of cases in teenagers, and we will not be able to reach herd immunity without significant immunity in people under 18.”

The JCVI is expected to keep the situation under review and will be watching the results from trials closely. 

Scientists are particularly concerned that vaccination may damage the developing immune system of younger children. Different age groups may require different doses, further complicating the roll-out, and companies must show it will not make children who get Covid more ill – which has happened with other vaccines in the past. 

Experts are also worried that the benefits to children may not outweigh the risks, making vaccination ethically dubious and leaving the Government vulnerable to legal challenges.

A Department of Health spokesman said: “The Government will continue to be guided by the advice of the JCVI, and no decisions have been made by ministers on whether people aged 12 to 17 should be routinely offered Covid vaccines.”

Worth reading in full.

U.S. Medicines Regulator Will Decide Whether to Fully Approve the Pfizer Covid Vaccine by January 2022

The Food and Drug Administration (FDA) will decide on whether to fully approve the use of the Pfizer Covid vaccine in the U.S. for those aged 16 and over no later than January 2022, it has been announced. The vaccine is currently only authorised for emergency use in Americans aged 12 and over and has been given to millions of people across the world. The MailOnline has the story.

According to a press release from the [Pfizer and BioNTech] on Friday, the federal health agency’s goal date for a decision is by January 2022.

If approved, the vaccine will be the first fully approved Covid shot and could help ease vaccine hesitancy among some Americans due to the longer-term data required for full FDA approval. 

As of Friday, more than 186.5 million shots of the vaccine have been administered in the U.S., according to data from the Centers for Disease Control and Prevention (CDC). 

Because Pfizer’s vaccine is currently approved for use on an emergency basis, it is still considered somewhat experimental despite data showing it is safe and effective.

Additionally, emergency use authorisation requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older in December 2020.

The designation is also intended to be temporary.

If and when the shot is fully approved, companies and schools may feel more comfortable requiring employees and students to get it. 

The decision would also allow the vaccine makers to market their shots directly to the general public.

According to the press release, Pfizer and BioNTech completed the rolling submission of data to the FDA in May 2021.

It includes data from the Phase III trial completed last year and six months of follow-up data rather than two months.

Although the shot is currently approved for use in teenagers and adults, the full approval would only be for those aged 16 and older because emergency authorization for Americans aged 12 to 15 only occurred in May.

The companies plan to apply for full approval in teens as well, but only after six months of follow-up data is available, the press release states. …

Moderna Inc has also filed for full approval from FDA for its Covid vaccine, announcing the news on June 1st. …

The decision to fully approve Moderna’s vaccine will likely come after the Pfizer decision due to Moderna submitting its application later.   

Worth reading in full.

Pfizer Vaccine Effectiveness Drops to 64% in Israel

As infections have surged in Israel in the last few weeks, the Israeli Government reports that the effectiveness of the Pfizer vaccine against infection has dropped to 64% from 94% the previous month. However, its effectiveness against serious disease is holding up. The Telegraph has more.

The vaccine had a 64% efficacy rate from early June until early July, the latest figures show, down from 94% a month earlier. The decrease coincides with a period in which the government reversed coronavirus restrictions and the delta variant spread through the country.

But the vaccine is still conferring strong protection against severe symptoms of the virus, with hospitalisation rates remaining low. The ministry’s data shows the vaccine’s efficacy in preventing hospitalisation was 93% from June 6th to July 3rd, compared to a 98% rate in the previous period.

On Monday, Israel reported the highest rate of new infections since the start of its most recent outbreaks, with the ministry recording 343 new cases over the past 24 hours.

Over half (55%) of the new infections are in fully vaccinated people, according to recent data. Since the country has fully vaccinated about 60% of the population, this suggests the vaccine is not protecting from infection very much at all (less even than the new stated efficacy figure of 64%). This is particularly so given that most of the infections are likely to be in socially and economically active younger people (like they are in the U.K.) who have lower vaccination rates, so that the vaccinated may even be suffering disproportionately more infections than the unvaccinated (the data is currently unavailable to confirm this).

The pattern of outbreaks in highly vaccinated countries such as Bahrain, Seychelles, Maldives and Chile and the fact that the vaccines don’t produce mucosal IgA antibodies has suggested for a while that their effectiveness against infection may have been exaggerated in studies. The idea that the IgG antibodies they produce in the blood should protect against progression to serious illness makes more sense and it is reassuring to see this data holding up.

The Israeli Government is now discussing the need for a third booster shot, and Pfizer CEO Albert Bourla has said people will “likely” need a third dose within 12 months of getting “fully vaccinated”. The Government may also consider limiting gathering sizes and reintroducing the controversial “Green Pass” vaccine apartheid system.

However, if a highly vaccinated country like Israel cannot return to normal without constant threat of new restrictions you have to wonder if anyone can. At some point leaders will need to accept that they have done all they can to guard the vulnerable against serious illness and death and remember that there is more to life than avoiding COVID-19.

Stop Press: The Centers for Disease Control and Prevention (CDC) is now investigating the death of a 13 year-old American boy who died a few days after receiving his second dose of the Pfizer Covid vaccine.