The American Academy of Pediatrics (AAP) and the Children’s Hospital Association (CHA) recently reported that over 6.6 million children tested positive for the coronavirus from the onset of the pandemic till November 11th, 2021.

Although the weekly number of cases has decreased compared to the second week of September, there have been an additional 1.6 million child cases in the last two months.

Children have accounted for 16.8% of total accumulated cases in the US since the pandemic. In November, 2021, children constituted 27% of the total US population infected with the virus.

While the hospitalization and death rate of children infected by the virus is not high, parents are concerned and there is an urgent need to take action on the impact of the virus on kids.

Pfizer and BioNTech have acted on this need and developed a vaccine formulation for children in different age groups.

As the FDA tests these formulations and comes up with regulatory guidelines, hospitals, pharmacies, and other healthcare units must adapt to the changing needs for storing and administering the pediatric vaccines.

vaccine-for-kids-requires-new-storage-requirements

Pfizer has been instrumental in manufacturing vaccinations for adults, and now children, across the globe.

When the company received approval to test vaccines for kids, they enrolled over 4,500 children from the ages of 6 months to 11 years in the US, Finland, Spain, and Poland for the three phases of vaccine trials.

These children come from 90 different clinical sites to represent a diverse demographic.

The children enrolled in the trial belonged to both previously SARS-CoV-2 infected groups and non infected groups.

What it means for kids: different doses, dilution, and storage?

The trials were designed to evaluate the Pfizer vaccine’s tolerability, safety, and immunogenicity on a schedule comprising two doses.

Each dose was set 21 days apart and administered to three age groups: 5 to 11 years, 2 to 5 years, and 6 months to 2 years.

Based on the first phase of dose escalation of the trial, children between ages 5 to 11 received two dose schedules of 10 micrograms each.

Those under the age of 5 received a dose lower than 3 micrograms for each injection in phase two of the three phased trial.

The results announced by Pfizer and BioNTech SE for their second phase displayed favorable safety profiles and neutralizing antibody responses in children between 5 to 11 years.

This response was in the two dose regimen group that received 10 micrograms administered 21 days apart. For kids who are 12 years of age or above, the dose was smaller than 30 micrograms.

The antibody response visible in participants with 10 microgram doses was analogous to the reaction recorded in individuals aged 16 to 25 who were previously administered 20 micrograms in a Pfizer and BioNTech trial.

The 10 micrograms dilution was preferred for safety, immunogenicity, and tolerability amongst children from 5 to 11 years of age. The results obtained were a first from the pivotal trial of the vaccine for this age group of children.

According to Pfizer and BioNTech, millions of kids aged 12 and up have been administered their vaccines in the past nine months.

As a result of the positive responses in these trials, the company is preparing to extend its vaccine protection against the virus to a younger population.

Pfizer’s preliminary plan states that each vial of Pfizer’s dose will consist of 10 doses and require a dilution of 1.3 mL. An essential requirement for storing these vials is six months of storage in an ultra cold freezer.

The vaccine cannot come soon enough for the pediatric population: the US witnessed a rise of 240% in pediatric cases of the coronavirus since July 2021. This highlights the need for vaccination for kids and proper measures to store and administer the vaccines.

What does this mean for hospitals and pharmacies?

With more variants coming into the spotlight, it is becoming essential to vaccinate kids.

And that means that pharmacies, hospitals, and healthcare centers responsible for storing and administering the vaccines must establish adequate cold storage settings quickly and efficiently.

Dickson notes that the focus has shifted on gathering advanced equipment to ensure safe and effective storage facilities, equipment like temperature data loggers and more. Hospitals are hiring external services that can assist with transportation and storage.

How does cold storage play an essential role?

As more regions in the US and other parts of the world formulate a full fledged action plan for administering vaccines for kids, the need for cold storage equipment and facilities will dramatically increase.

These vaccines are incredibly temperature sensitive, and even a slight alteration in the temperature can damage an entire batch of vaccines.

Data loggers, used also in manufacturing and food storage, are in extremely high demand, as they can ensure that cold storage facilities for the vaccine remain within the appropriate temperature range to ensure the safety and efficacy of the jab.

Safeguarding children before the Omicron variant rolls through populations is critical, it’s current impact on young children is unknown, but it has been established that vaccines may offer some protection from it.

After experiencing the impact of the coronavirus, adults understand how dangerous it would be for children to get exposed to any variant of the virus.

Pfizer and BioNTech together have created a protection shield for children, preparing for Omicron and potentially new mutations of the virus.

With the coronavirus vaccines for kids coming into the market, the emphasis is on providing a robust mechanism to ensure the best and most efficacious storage for the vaccines.

Even as Pfizer releases the vaccine for children between the ages of 5 and 11 years, the company, along with BioNTech, is working towards a unique formula that does not require dilution.

This formulation is expected to have the exact same storage requirements both for adults and children.

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here