Pfizer COVID-19 Vaccine For Kids : What You Need To Know!

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The US FDA is set to approve the new Pfizer COVID-19 vaccine for kids!

Here is what you need to know about this new paediatric vaccine!

 

Pfizer Vaccine For 5-11 Yo Kids : What You Need To Know!

On 22 October 2021, the US FDA publicly released the Pfizer briefing document on their clinical trial of the COMIRNATY vaccine in 5-11 year-old children.

Let me summarise what the Pfizer briefing document revealed…

Lower Paediatric Dose

The paediatric dose of the Pfizer vaccine is only 10 micrograms – 1/3 of the dose used for adults and adolescents.

It will be supplied in a new 10-dose vial, which will be diluted with 1.3 ml of sodium chloride, before being given as a 0.2 ml intramuscular injection.

Pfizer COVID-19 Vaccine For Kids : What You Need To Know!

More Stable Formulation

In addition to the lower dose, Pfizer’s paediatric vaccine has an improved formulation that is more stable. For those who want to know what changed, Pfizer :

  • replaced the phosphate-buffered saline (PBS) with a Tris buffer
  • removed sodium chloride and potassium chloride from the buffer formulation

This new formulation will allow the vaccine to be kept in a normal refrigerator for up to 10 weeks.

90% Efficacious

The study showed that the lower paediatric dose of the Pfizer-BioNTech vaccine was 90.7% efficacious in preventing symptomatic COVID-19 infection.

Efficacious Against Delta Variant

The study also showed that the Pfizer paediatric vaccine produced high neutralising antibody titres against the Delta (B.1.617.2) variant at 1 month after Dose 2.

One Month
After Dose 2
Geometric Mean Titres
(GMT)
Difference
USA-WA1/2020 (Reference) 365.3 +36.5X
B.1.617.2 (Delta) 294.9 +29.5X
Unvaccinated 10 Baseline

Same Interval

Pfizer, however, maintained the same 21-day dose interval. This may mean that the high antibody levels the new paediatric vaccine produces will similarly wane over time, perhaps requiring a booster dose after six months.

As the UK has shown with their AstraZeneca vaccine, increasing the dose interval results in longer-lasting protection.

That said, antibody levels are not an accurate assessment of an individual’s immunity against COVID-19.

Read more : Why delaying AstraZeneca Dose 2 INCREASES efficacy?

Did WHO Say Children Should NOT Get COVID-19 Vaccine?

Fewer Side Effects

The lower paediatric dose of the Pfizer-BioNTech vaccine naturally produced fewer side effects, with no severe side effects noted. They were mostly :

  • pain at injection site : 71-74%
  • headache : 54-61%
  • fatigue : 60-66%
  • muscle pain : 27-41%
  • chills : 25-40%
  • joint pain : 13-22%
  • fever : 7-17%

Side note : It is interesting to note that even the placebo causes common symptoms like fatigue, headache and muscle pain. This shows just how important it is to conduct a randomised controlled trial.

Pfizer COVID-19 Vaccine For Kids : What You Need To Know!

Likely Safer

The much lower dose should ameliorate, if not eliminate, the risk of myocarditis / pericarditis that was highest in adolescents and young adults.

There were no cases of pericarditis or myocarditis in the Pfizer study that involved over 2,260 children, through approximately 3 months of follow-up after Dose 2.

However, the risk of myocarditis in adolescents is only about 1 in 50,000, so we will only know for sure once mass vaccinations have begun.

For a better perspective of the risk of developing myocarditis, I created this comparison table for you :

Myocarditis Risk Per Million People Difference
COVID-19 Patient 450 +2208%
Pfizer Vaccine
(Adult Dose)
20 +2.6%
Normal Population 19.5 Baseline

As you can see, the risk of developing myocarditis is MUCH higher if your child gets infected with COVID-19, compared with getting a full dose of the Pfizer vaccine.

I have no idea if the myocarditis risk is truly lower with the paediatric dose, but it surely cannot be more than the full dose that is currently being administered to adolescents.

 

FDA Panel Recommends Pfizer Vaccine For 5-11 Yo Kids!

On 26 October 2021, the FDA advisory panel met to discuss the data, and voted 17 in favour (with one abstention) of recommending an emergency use authorisation for the new Pfizer paediatric vaccine.

Although the FDA isn’t bound by the advice of its expert panel, it is expected to accept their advice and issue an EUA for the new paediatric dose of the Pfizer COVID-19 vaccine.

Children in this age group currently accounts for 9% of reported COVID-19 cases in the US, and approximately 40% of all paediatric COVID-19 cases, with 1/3 of hospitalised children requiring ICU care.

While the risk of hospitalisation and death is relatively low for children, they still suffer from serious complications like :

  • myocarditis
  • multisystem inflammatory syndrome (MIS-C)
  • long COVID

One UK study, for example, found that 7% to 8% of children continue to have symptoms more than 12 weeks after they were diagnosed with COVID-19.

Read more : What’s The Difference Between Full FDA Approval vs EUA for Vaccines?

 

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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