The U.S. Food and Drug Administration (FDA) is preparing to authorize use of the Pfizer-BioNTech COVID vaccine in adolescents 12 to 15 years old by early next week, according to federal officials familiar with the agency’s plans. The vaccine is currently authorized in the U.S for emergency use in people 16 and older.

The decision, which is likely to be supported by the Centers for Disease Control and Prevention (CDC), would allow most middle and high school students to get vaccinated before summer camps and the start of the 2021-22 school year, USA TODAY reported.

The FDA will have to amend the Emergency Use Authorization (EUA) for Pfizer’s vaccine, but the process should be straightforward, said a federal official who was not authorized to speak about the process publicly and requested anonymity.

“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and science-based approach,” the FDA said in an email to CNN last week.

The FDA is reviewing data submitted by Pfizer to support the expanded use of its experimental vaccine, including a clinical trial involving 2,260 12 to 15 year-olds. Results showed Pfizer’s vaccine was 100% effective at preventing moderate to severe COVID in an age group which, according to the CDC, experiences mostly asymptomatic infection.

Pfizer said clinical trial volunteers produced strong antibody responses and administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years old.

Before issuing the EUAs for the Pfizer, Moderna and Johnson & Johnson COVID vaccines, the FDA held meetings of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the data and vote on whether to recommend EUA. That will not happen in extending EUA to this younger age group. CNN reported:

“Based on an initial evaluation of the information submitted, at this time, the agency does not plan to hold a meeting of the VRBPAC on this request to amend the EUA for the Pfizer-BioNTech COVID-19 Vaccine, which was discussed and recommended for authorization [for adults over the age of 18] at a VRBPAC meeting in December 2020. As with all FDA-authorized COVID-19 vaccines, we are committed to transparency with this EUA review process.”

Some experts are raising questions about whether COVID vaccines should be targeted to an age group that so far appears to be mostly spared from severe COVID.

“I do think we need to have a national and global conversation about the ethics of our vaccinating kids, who are low risk for serious complications from the virus, when there aren’t enough vaccines in the world to protect high-risk adults from dying,” Jennifer B. Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security, told The New York Times.

Dr. Rupali J. Limaye, a Johns Hopkins University researcher who studies vaccine use and hesitancy, said the U.S should not ethically be prioritizing children over people from other countries like India.

According to the CDC, between March 1 and Dec. 12, 2020, there were a total of 2,871,828 laboratory-confirmed cases of COVID in children, adolescents and young adults aged 0 to 24 years in the U.S. out of a total U.S. population of approximately 330,000 million people.

Here’s a breakdown of COVID cases by age group:

1,648,429 (57.4%) cases occurred in young adults aged 18-24 years
468,108(16.3%) cases occurred in children aged 14-17 years
226,874 (7.9%) cases occurred in children aged 11-13 years
331,029 (10.9%) cases occurred in children aged 5-10 years
212,515 (7.4%) of cases occurred in children aged 0-4 years

According to CDC data, the death rate among adolescents ages 0 to 17 who get COVID and are subsequently hospitalized is 0.7%, with many experiencing either mild or no symptoms at all. The COVID death rate in all adolescent age categories is less than 0.1%.

A study in the European Journal of Pediatrics confirmed hospitalization and in-hospital death are rare in children diagnosed with COVID, with complications occurring mostly in those with serious underlying medical conditions.

Herd immunity and children

As The Defender reported in February, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, admitted to The New York Times that he “nudged” the level required to achieve herd immunity up to 90% from the previously estimated 70% after he saw polls indicating growing public unwillingness to get the vaccine

Educators have been quick to reinforce Fauci’s message that young people should get the shots, stating that vaccinating students is “a crucial step in the return-to-normal for schools.”

Although health officials admit “kids do not generally suffer from severe COVID-19” and are unlikely to directly benefit from the injections, they have no intention of excluding children from their herd immunity calculus. Instead, they claim “inoculating [children] could reduce the spread to people at higher risk.”

In short, public health leaders say, parents must “vaccinate the young to protect the old.”

The federal government estimates that one vaccine injury results from every 39 vaccines administered, and recent VAERS data show 118,902 reports of adverse events following COVID vaccines, including 3,544 deaths and 12,619 serious injuries between Dec. 14, 2020 and April 23.

As The Defender reported last week, the latest VAERS data included three reports of teens under age 18 who died after receiving COVID vaccines, including two 15-year-olds and one 16-year-old who died unexpectedly from a blood clot 11 days after receiving her first Pfizer dose.

A 15-year-old female died of cardiac arrest after receiving the second dose of the Moderna vaccine, and a 15-year-old male died of cardiac failure two days after receiving the Pfizer vaccine.

Pfizer cashing in on COVID vaccine

Pfizer has been vocal over the past year about its desire to create a third dose of its vaccine, market its vaccine to children as young as 12 by the time school starts in the fall and create annual boosters like influenza vaccines to create a consistent demand –– all things that are pleasing to investors.

During a virtual investor conference in March, Pfizer’s CFO, Frank D’Amelio, said the company sees “significant opportunity” for its COVID vaccine once the market shifts from a “pandemic situation to an endemic situation.”

At that point “factors like efficacy, booster ability, clinical utility will basically become very important, and we view that as, quite frankly, a significant opportunity for our vaccine from a demand perspective, from a pricing perspective, given the clinical profile of our vaccine,” D’Amelio told the analyst.

Pfizer’s first quarter revenue report released today showed $3.5 billion in revenue generated during the first three months of this year by the company’s COVID vaccine –– making it the biggest source of Pfizer’s revenue.

The company did not disclose profits, but now anticipates revenue of $26 billion for its COVID vaccine, up from its previous estimate of $15 billion. Pfizer splits its vaccine revenue with BioNTech, which will report its own first-quarter results next week. BioNTech said in March that it had locked in revenue of nearly $11.8 billion, based on vaccine orders at the time.

The vaccine is expected to keep generating significant revenue for Pfizer and BioNTech, as the company anticipates people will need annual booster shots.

The post FDA Set to Authorize Pfizer Vaccine for Adolescents, But Some Experts Question Need, Ethics appeared first on Children’s Health Defense.

 

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