Pfizer asks FDA to authorize its COVID vaccine for children from six months to four years 

Pfizer-BioNTech announced on Wednesday it has asked the Food and Drug Administration to authorize the use of its COVID-19 vaccine for young children between the ages of just six months and four years.

That age group is the only one not yet eligible for the COVID vaccines, and Pfizer is recommending two doses, given three weeks apart for children in that age group. Those shots would be just three micrograms each – one-tenth the dose given to adults.

Pfizer’s move comes as COVID cases are once again on the rise and follows a similar one from its rival, Moderna, submitted in late April for COVID vaccines for children under the age of six – though COVID cases remain mild in young children.

The FDA will now consider both requests, NBC News reports, and will review the applicable data. It could grant the emergency authorization later this month.

Its advisory group, the Vaccines and Related Biological Products Advisory Committee, is already scheduled to meet on June 15 to offer guidance on pediatric doses – and if the group recommends the use of the vaccine on the young children, the FDA could clear the way for doses within a few days.

But the Centers for Disease Control and Prevention would still need to sign off on the doses before they could be administered.

In a statement to ABC News, FDA officials confirmed they have received Pfizer’s request for an Emergency Use Authorization for children under four.

‘We recognize parents are anxious to have their young children vaccinated against COVID-19, and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible, using a science-based approach,’ they said. 

Pfizer-BioNTech announced on Wednesday it is seeking approval from the Food and Drug Administration to administer its COVID-19 vaccine to children between six months and four years old. Jack Wasserman, 6, is seen receiving his Pfizer booster vaccine on May 19

Moderna has also requested authorization for the use of its vaccine for children under the age of six. A girl from Kentucky is seen here getting her COVID jab in November

As part of its application, Pfizer submitted clinical trial data that found that three doses of its vaccine (pictured) was safe for young children and generated a strong immune response 

As part of its application, NBC reports, Pfizer submitted clinical trial data of 1,678 children found last month that three doses of the vaccine for the youngest of children was safe and generated a strong immune response.

It showed that antibody levels tested one month after the third dose showed the vaccine produced a similar immune response as the two-dose regimen for those ages 16 to 25. 

It also found that the vaccine was 80 percent effective against the omicron variant – but the efficacy rate won’t be finalized until at least 21 symptomatic cases are found in the vaccine group and then compared to the number of symptomatic cases in the placebo group, CNN reports.

The data was released on May 23, but has not been peer-reviewed or published in a medical journal.

‘Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well-tolerated and produced a strong immune response,’ Pfizer CEO Albert Bourla said at the time. 

This is not the first time Pfizer asked the FDA to authorize a vaccine for the youngest of children, however.

In February, the company asked the FDA to authorize a two-dose vaccine, but an advisory committee meeting to review the regimen was postponed after Pfizer admitted that the two doses did not generate enough of an immune response in a trial of children ages two to five.

It said at the time it would wait on data for its three-dose regimen before again seeking authorization.

The company’s main rival, Moderna, meanwhile, submitted its application for a two-dose vaccine regimen for children under 6 at the end of April – though the company said it also expects to seek authorization for a booster dose.

Moderna’s vaccine would be administered as two 25-microgram doses, four weeks apart.

Data from the company showed that its vaccine regimen was 51 percent effective against infection – including asymptomatic and mild infection – among those six months old to under 2 years old, and 37 percent effective for those ages 2 to 5.

The advisory committee will now review both applications at its meeting on June 15.

Pfizer had previously asked the FDA to authorize a two-dose vaccine for young children, but pulled back after revealing it was not effective

Pfizer’s vaccine would be given as two doses, administered three weeks apart for children six months to four years. A three-year-old boy, Hudson, is seen participating in a Moderna COVID-19 vaccine trial last year

Moderna’s vaccine would be administered as two 25-microgram doses, four weeks apart. Ahmed Ali is seen administering a Pfizer dose to 9-year-old Loic Schlagel, while his father Kyle and brother Remi, 6, watched him in November

The move to vaccinate young children comes as case figures are increasing around the country – as hospitalizations and deaths remain at the same rates they were in previous periods of the pandemic.

According to the most recent figures, the nation is averaging 99,748 COVID cases every day, an 8 percent drop over the past week. Deaths have not occurred at the same levels, though, with America recording 611 per day.

And at the same time, interest in the vaccines has waned among the public. 

A recent Gallup poll finds that a third of Americans are no longer worried about the pandemic, one of the lowest figures recorded yet, and national data shows the country’s booster fallout fell flat, with demand for the additional shots being much lower than many officials expected. 

A Kaiser Family Foundation survey from April also found that only 18 percent of parents of children younger than five plan to vaccinate them.

Many remain hesitant, with 27 percent saying they will ‘definitely not’ get their young children vaccinated, and 11 percent reporting that they would only do so if it was required for school.

The remaining 38 percent said they want to ‘wait and see’ before getting their children vaccinated.

In Florida, health officials have already recommended against using the COVID vaccine on ‘healthy’ children, as they face little risk from the virus, with hospitalizations or deaths being especially rare. 

‘The Florida Department of Health is going to be the first state to officially recommend against the COVID-19 vaccines for healthy children,’ Florida Surgeon General Dr. Joseph Ladapo announced last month.

‘We´re kind of scraping at the bottom of the barrel, particularly with healthy kids, in terms of actually being able to quantify with any accuracy and any confidence the even potential of benefit.’

He, nor Republican Gov Ron DeSantis, specified what would classify as a ‘healthy’ child or when the guidance would officially go into effect. 

A survey from the Kaiser Family Foundation found that only 18 percent of parents of children under the age of 5 will get them vaccinated, while 27 percent said they will ‘definitely not,’ and 38 percent said they would ‘wait and see’

But the announcement came as some health experts expressed their concerns about vaccinating children, and doubting whether they were necessary.

Children face little risk from COVID-19, with a ever-growing trove of data showing that they are not nearly as affected by it as adults are.

The CDC reports that children only account less than 0.1 percent of COVID deaths in the U.S. since the pandemic first began.

And a study from the University of Utah last year found that 50 percent of pediatric Covid cases are asymptomatic. The study was performed before the more-mild Omicron variant emerged, meaning the risk for children to even feel symptoms is likely lower now.

Children may also be less likely to spread the virus when infected, with a German study finding that they release as little as only 25 percent of virus particles as adults do.

Dr Joseph Ladapo (pictured) said last month that Florida will formally recommend against COVID-19 vaccinations for healthy children

Data revealed by New York state officials in April also found that Pfizer’s shot was only 12 percent effective at preventing COVID infection for children aged five to 11.

New York researchers gathered data 852,384 children aged 12 to 17 and 365,502 aged five to 11 for the study. 

The study, which is pre-print and pending peer-review, gathered data from the Omicron period of the pandemic, from December 2021 and January 2022.

As part of the study, participants were followed up with and compared to general figures from unvaccinated populations.

One major difference between the study groups is the dosage of the vaccine. While children aged 12 and older receive a 30 microgram shot, it is only ten micrograms for the five to 11 age group. 

Researchers found that 28 to 34 days after receiving the second dose – about one month – vaccine effectiveness in the younger age group had waned from 67 percent to 11 percent against the variant.

This is compared to a much smaller drop from 66 percent to 51 percent in the older age group.

There was also a stark difference found between 11 and 12 year olds – the cut off of where the vaccine dosage changes – implying the smaller doses are not as effective.

Pfizer has run into a similar issue with its dosage in children aged six months to four years old.

For that age group, the jab has been shrunk to three micrograms, though initial trials showed that three and four year olds had little immune response to the smaller jab.

Pfizer CEO Albert Bourla (pictured) has been paid $45 million in compensation over the past two years, banking on the successful rollout of the COVID-19 vaccines

Meanwhile, it was revealed on Tuesday that Pfizer’s vaccine was the best selling pharmaceutical drug in the world in 2021 – nearly doubling the revenue figures of all products across the entire market.

A report published by Fierce Pharma finds that the Pfizer vaccine, a joint project with the German company BioNTech that is officially branded under the name Comirnaty, made $36.8 billion worth of sales last year, topping the entire global drug market by a large margin.

Albert Bourla, CEO of Pfizer, meanwhile, has been paid over $45 million in compensation over the past two years as well, according to multiple reports. His ‘golden parachute’, money he will be paid out should he be forced from the company if it is acquired, is believed to be upwards of $100 million as well.

When asked for comment, a Pfizer spokesperson explained the company’s financial arrangement with BioNTech.

‘The Pfizer-BioNTech vaccine collaboration is a 50/50 gross profit split; development costs are shared equally. Pfizer and BioNTech each book revenues in the markets where each company controls commercialization,’ they said.

‘Pfizer books the vast majority of the global collaboration revenue, except for Germany and Turkey where we receive a profit share (50/50 gross split) from BioNTech. We do not participate in the China region.’ 

Cashing out on Covid! Pfizer’s vaccine raked in $37 billion in 2021 – nearly doubling the revenue of every other available drug across ALL markets: US Covid cases approach 100k per day and daily deaths jump above 600 

ByMansur Shaheen U.S. Deputy Health Editor For Dailymail.Com 

Big pharma company Pfizer is one of the biggest winners of the COVID-19 pandemic, with a recent report finding that its vaccine was the best selling pharmaceutical drug in the world in 2021 – nearly doubling the revenue figures of all products across the entire market.

A report published Tuesday by Fierce Pharma finds that the Pfizer vaccine, a joint project with the German company BioNTech that is officially branded under the name Comirnaty, made $36.8 billion worth of sales last year, topping the entire global drug market by a large margin.

Humira, an arthritis drug manufactured by AbbVie, comes in at a far second, bringing in $20.7 billion in sales last year. Moderna’s vaccine, branded under the title Spikevax, was the third largest pharmaceutical product, earning $17.7 billion in sales – half of its top competitor.

Covid vaccine manufacturers have been under criticism in recent months for prioritization of profits over protection, raking in billions of dollars on selling the drugs to large purchasers like the U.S. and western European nations while leaving others in the developing world behind.

Regulators in the U.S. and elsewhere have been under fire for repeated approval for booster shots – which create more revenue for Pfizer and Moderna – despite limited evidence that more shots are needed to slow the virus’s path.

Pfizer’s vaccine is most popular in the U.S., just as it is in much of the rest of the world, having been administered 346 million times since it first became available in late 2020

Pfizer’s stock price has jumped 40% since the end of 2020, from $36.81 per share to $52 per share Wednesday morning

The United States has become one of Pfizer’s largest and most reliable customers during the COVID-19 pandemic.

The New York City-based company’s Covid shot is most frequently used in the U.S., according to data from the Centers for Disease Control and Prevention, having been administered well over 300 million times since it first became available in late-2020.

Pfizer’s vaccine has launched the firm, which was already one of biggest players in the lucrative pharmaceutical industry, to one of the most recognizable brands in the world, and proved to be a financial boon for executives and shareholders.

The company’s stock price has jumped 40 percent since the end of 2020, from $36.81 on December 31, 2020 to $52 per share on Wednesday morning.

Pfizer CEO Albert Bourla (pictured) has been paid $45 million in compensation over the past two years, banking on the successful rollout of the COVID-19 vaccines

Albert Bourla, CEO of the firm, has been paid over $45 million in compensation over the past two years as well, according to multiple reports. His ‘golden parachute’, money he will be paid out should he be forced from the company if it is acquired, is believed to be upwards of $100 million as well.

When asked for comment, a Pfizer spokesperson explained the company’s financial arrangement with BioNTech.

‘The Pfizer-BioNTech vaccine collaboration is a 50/50 gross profit split; development costs are shared equally. Pfizer and BioNTech each book revenues in the markets where each company controls commercialization,’ they said.

‘Pfizer books the vast majority of the global collaboration revenue, except for Germany and Turkey where we receive a profit share (50/50 gross split) from BioNTech. We do not participate in the China region.’ 

More purchases are likely on the way for the U.S. as well, with the Food and Drug Administration (FDA) and CDC approving the Pfizer booster shots for children aged five to 11 years old in mod-May, a move met with criticism from many health experts.

Dr Marty Makary, a public health expert at Johns Hopkins University, told DailyMail.com last month that the decision was the ‘the biggest slap in the face of science we’ve seen during the pandemic,’ and referred to the CDC advisory panel that approved the decision as a ‘kangaroo court.’

Bourla has been a proponent of more-and-more shots, though. He said earlier this year that all Americans will likely need vaccine doses every year for the long-term future, shots that would be purchased from his firm.

Pfizer is also applying to have its Covid vaccine approved for American children aged six months to five years old, a controversial proposal that would likely lead to the U.S. making another large purchase of the jabs.

Many have also criticized Pfizer’s business practices related to the jabs over the past year. While major nations like the U.S., UK and others in Western Europe have east access to the shots – some nations even sitting on large stockpiles – many in the developing world have been left behind.

In Africa, for example, only 23 percent of residents have received at least one shot of the vaccine, and 17 percent are fully vaccinated – figures dwarfed by their peers in the west.

‘Big pharma companies have grown their businesses through shameless pandemic profiteering,’ Maaza Seyoum, the global south convenor of the People’s Vaccine Alliance told DailyMail.com last month.

‘At the height of the crisis, they sold these lifesaving tools to the highest bidder while people were left to die in the global south.

‘And they locked the technology behind a wall of intellectual property rules, refusing to share the recipes with the world.’

Pfizer projects over $30 billion in revenue from the shots this year, nearly reaching last year’s leading total. The company’s golden goose may soon stop laying eggs, though.

It is also the manufacturer of Paxlovid, a White House-touted Covid antiviral pill that is believed to be able to reduce hospitalizations and deaths caused by the virus 90 percent. 

Interest in the vaccines, and the Covid pandemic overall, has waned among the public. A recent Gallup poll finds that a third of Americans are no longer worried about the pandemic, one of the lowest figures recorded yet.

Case figures are also increasing around the country without translating in hospitalizations and deaths as the same rates they were in previous periods of the pandemic.

According to most recent figures, the nation is averaging 99,748 Covid cases every day, an eight percent drop over the past week. Deaths have not occurred at the same levels, though, with America recording 611 per day.

The nation’s booster rollout famously fell flat, with demand for the additional shots being much lower than many officials expected. Now, the White House is having trouble acquiring funding for future pandemic initiatives, which could lead to the country no longer being able to acquire the jabs.