No More Pfizer’s Early Covid Vaccine for Age 6 Months – 4 Years Trial Data Hints at Bad News for Some Parents

The COVID Pandemic took the world by storm. Caused lockdowns, made companies file for bankruptcy, governments shut down and a lot of people got sick and millions died. According to current online reports, at the time of this report, there is a record of 275,764 Million cases and 5,366,876 million deaths.

Lots of companies are at the forefront of getting a remedy to the Covid-19 Virus. Pfizer and BioNTech is American-German based and according to World Health Organization, the Pfizer-BioNTech vaccine, or BNT162b2 is said to be 95% effective in protecting against the virus in clinical trials.

6 Months – 4 Years Trials

In trials, the vaccine has been declared to be used by children in most age brackets except those ages 6 months to 4 years. Children can also catch the virus and spread the virus too, hence the need for vaccines maker to come up with a remedy for those in that age bracket as soon as possible.

Among the best vaccines recommended by the World Health Organization is Pfizer and BioNTech made the vaccine. And they have been able to capture most age brackets. Expectations are high on them to be able to include children ages 6 months to 4 years in their vaccine usage. Despite the urgency, they have announced plans to expand their ongoing trial involving kids in the youngest age groups.

Third Dose For Babies

Going forward, the clinical study will add a third dose to the vaccine regimen for babies and young kids ages 6 months to 4 years of age. The company noted that there were less than robust responses in participants given the two-dose series after previous clinical trials.

NBC originally reported that the vaccine for children ages 6months – 4 years is expected to be ready before the end of 2021 in order to get approval by FDA for EUA in early 2022. This might not be possible anymore based on their announcement on Friday that expansion involving the clinical trial with kids under the age of 5 may delay the entire process by several months.

The ongoing Pfizer and BioNTech clinical trial to evaluate how well vaccine is tolerated, its safety and the immune response it produces in recipients. The evaluation includes a “pre-specified immunogenicity analysis” that was scheduled to take place a month after the participants received their second vaccine dose.

Data Monitoring Committee

An external independent group of experts called Data Monitoring Committee (DMC) is in charge of the routine review. They found out that two-dose of the COVID-19 regimens didn’t result in robust immune responses in kids ages 2 to 4.

3µg doses of the vaccine were used for the trial and there were no safety issues recorded by Pfizer. Because of issues recorded as regards robust immune responses, there will be a need to administer the 3rd dose of 3µg doses. All things being equal, it will be submitted fit to use by the first half of next year for children ages 6 months – 4 years.

Other Age Brackets.

Another test will be conducted on children ages 5 to 11 and ages 12 to 17. To examine the immune responses that will be triggered if those in those age brackets were given a third dose. Children ages 5 – 11 will receive a 3rd dose at 10µg and those ages 12 – 17 will receive at 10µg or 30µg.

The decision to conduct the 3rd test is because data is showing high efficacy in people ages 16 and older. Pfizer believes that 3 doses of mRNA COVID-19 vaccine may protect against delta and omicron SARS-CoV-2 variants.

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