Pfizer COVID pediatric vaccine will require a third dose during clinical trials

pexels-photo-5863389.jpeg

On 17 December 2021, Pfizer stated that trials for its pediatric COVID-19 vaccine for children ages 2 to 5 show that it did not provide the expected immunity. Therefore, it is adding a third dose to the clinical trial, and it will probably mean a significant delay in getting Emergency Use Authorization (EUA) for the COVID-19 vaccine for that age group.

Pfizer, after its independentData and Safety Monitoring Board examined the data, decided to add the third dose for all children and babes, ages 6 months to 5 years, that were included in the clinical trial. Apparently, the data showed that the two pediatric-sized doses of the Pfizer COVID-19 vaccine were not producing the expected immunity in the 2- to 5-year-old group. Although they did not have the data for babies up to two years old, they decided to add the booster to them.

person getting vaccinated Pfizer COVID pediatric vaccine
Photo by Gustavo Fring on Pexels.com

The Pfizer pediatric vaccine includes a 3 microgram (µg) dose as opposed to the 10 µg dose for individuals 5-12 years old, and a 30 µg dose for those older than 12-years-old. Pfizer said that the third 3 µg dose will be given at least two months after the second dose in the two-dose series that was included in the original clinical trial protocol.

The independent Data and Safety Monitoring Board, which can see clinical trial data without giving details to the company or investigators, also indicated that there were “no safety concerns were identified and the 3 microgram dose demonstrated a favorable safety profile in children 6 months to under 5 years of age.” This should assure anyone that a third dose will not bring up any safety issues.

person holding test tubes
Photo by Polina Tankilevitch on Pexels.com

Pfizer stated:

The decision to evaluate a third dose of 3 micrograms for children 6 months to under 5 years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile. If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022.

Pfizer is also planning to test third doses in older children, who do not yet have authorization for booster doses of vaccine. Kids ages 5 to 11 and 12 to 15 will get full-dose third shots in the trials.

It’s clear that Pfizer is taking extreme care with its lower-dose pediatric COVID-19 vaccine. They want to make certain that they are providing effective doses without any serious safety signals.

One final point — whenever someone makes a claim that companies somehow cheat during vaccine clinical trials, nothing could be further from the truth. Companies, such as Pfizer, institute a number of protocols and independent advisors to make certain that these clinical trials provide unbiased and quality data that support the safety and effectiveness of these vaccines.

mRNA cancer vaccine – immunotherapy for colorectal cancer

mRNA cancer vaccine

Germany-based BioNTech, the company that developed the COVID-19 mRNA vaccine with Pfizer, has announced an mRNA cancer vaccine for colorectal cancer. I hate to get excited about new technologies, but it’s clear that mRNA vaccines could lead to a lot of advances in medicine.

Let’s take a look at this new therapy for colorectal cancer, one of the deadliest cancers.

Continue reading “mRNA cancer vaccine – immunotherapy for colorectal cancer”

Pfizer COVID-19 vaccine facts – scientific evidence to deal with misinformation

Pfizer COVID-19 vaccine facts

Because the Pfizer COVID-19 vaccine is ready to launch in many countries, it is time that we provide the facts about the vaccine. This will be different than my myth debunking article (which will be constantly updated as the anti-vaxxers get going with their lies and disinformation), as this article will try to make sure that everyone is on the same page with what this vaccine is. 

Almost all of the information will come from the Pfizer/BioNTech COVID-19 mRNA vaccine documents that were submitted for review by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA) that was issued by the FDA on the evening of 11 December 2020. I read through most of the material to save you all time during this holiday season (so please like this article and share it across the planet).

I’m going to just hit what I think will be the most important points about the vaccine’s safety, effectiveness, ingredients, and other related information. Because these Pfizer COVID-19 vaccine facts will be most useful in debunking wild claims that you might read on the internet. I am planning to do the same with the Moderna vaccine, so stay tuned once VRBPAC reviews their data and the FDA issues an EUA.

Continue reading “Pfizer COVID-19 vaccine facts – scientific evidence to deal with misinformation”

Pfizer COVID-19 mRNA vaccine – FDA approves emergency use authorization

pfizer COVID-19 mRNA vaccine

On 10 December 2020, the Pfizer/BioNTech COVID-19 mRNA vaccine was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). Unless you were avoiding the internet (and hence, you wouldn’t be reading this), you would know that the review went well, and VRBPAC “approved” the vaccine. On the evening of 11 December, the FDA gave approval for the EUA, the first COVID-19 vaccine available in the USA.

This article will quickly review the major points about the VRBPAC discussion, a review of some of the data, and finally a summary of what we know and don’t know about the Pfizer COVID-19 mRNA vaccine. 

Continue reading “Pfizer COVID-19 mRNA vaccine – FDA approves emergency use authorization”

Pfizer COVID-19 vaccine news – should we pump the brakes just a bit?

pfizer COVID-19 vaccine

Recently, we saw a lot of news about the Pfizer COVID-19 vaccine –  it seemed to show about a 90% effectiveness in preventing the disease. This is potentially good news in preventing the spread of this disease because alternatives like herd immunity is a disastrous form of genocide.

But, what does this news actually mean? Does it imply that the world is saved, and soon we can eschew masks and social distancing? Does that mean the pandemic will come to an end?

We need to know if the COVID-19 vaccine actually does what Pfizer claims. We need to know if it is safe. And we need to know when the vast majority of people can receive the vaccine. When we know all of that, we can then see the light at the end of the tunnel for this deadly pandemic.

Let’s take a skeptical look at the Pfizer COVID-19 vaccine along with what it may mean to the world. I’m writing this in the form of several questions that I have with the answers as I know them.

Continue reading “Pfizer COVID-19 vaccine news – should we pump the brakes just a bit?”