Parents who hope to get their children who are vaccinated with Covid-19 now find themselves facing waiting again, with Pfizer announced that it will postpone seeking authorization to be used in children under the age of 5 years. This is a blow to efforts to continue to reopen the US when Pandemi continues, a period that has made parents of smaller children left in the limbo due to the absence of prevention vaccination.
At present, the Pfizer-Biontech Covid-19-vaccine which is marketed as a Comirnaty-has the approval of the US Food and Drug Administration (FDA) for individuals aged 12 years or more. This is also given under the process of authorization of the Emergency Use of FDA (EUA) during Pandemic for children aged between 5 and 11 years.
However, the hope is that the FDA will provide an extension of the EUA, which will include younger children. At present, there is no official or approved vaccination for those under the age of 5, which makes parents and caregivers forced to balance the requirements of their daily lives – including work – while simultaneously keeping children isolated from potential infections. Covid-19 vaccination has been shown in clinical testing to significantly reduce the possibility of severe or life-threatening disease cases.
Vaccine trials for younger children do not go according to plan
The ongoing trial has seen the potential impact of expanding the use of vaccines for these babies and small children. However, the process is not simple. Back in December 2021, for example, preliminary data shows that the age of 6 months to 4 years will likely require a third dose in the vaccine regimen, given a response that is less strong than the series of two initial doses.
“Experiments in children 6 months to 4 years are ongoing and data based on the first two doses of 3 μg in this age group is distributed with the FDA on an ongoing basis,” Pfizer said. “The case continues to accumulate in accordance with the research protocol and more data produced because the level of infection and disease remains high in children at this age, mainly because of the new omicron surge.”
This is the third dose that adds delays. “Considering that this research advances quickly, the company will wait for three doses of data because Pfizer and Biontech continue to believe it can provide a higher level of protection in this age group,” Pfizer explained. “This is also supported by recent observations of three dose amplifier data in several other age groups that seem meaningful to increase the level of antibodies and protection of real world vaccines for Omicron compared to the two dosage regimens.”
This means that, instead of having authorization for expansion to younger people in a matter of days or weeks, will now later in 2022 before that happens. Pfizer said they expect data on the protection of three doses available around early April. After that, the FDA and CDC will give their decision on the placement.
Without a vaccine, some familiar preventive measures
At present, around 8,300 children take part in the trial of phase 1/2/3, with participants in the US, Finland, Poland and Spain. The youngest children are given a lower dose of drugs, with two initial doses separated by about 21 days. The third dose is given at least two months later.Responding to the request, the FDA said today that they will postpone the vaccine and meeting of the related biological product advisory committee which was originally scheduled on February 1522. The new meeting will be scheduled after the third dose data has been sent.
The hope of the FDA, said the agency today, has explored whether two doses will be sufficient, especially considering that more Covid-19 types in evidence in the US and abroad. “Considering this new omicron surge and an important improvement in hospitalization in the youngest children to their highest levels during Pandemi so far, we feel that it is our responsibility as public health agents to act with urgency and consider all the options available , including asking for that the company gave us preliminary data about two doses from the ongoing study, “Acting FDA Commissioner Janet Woodcock, M.D., and Peter Marks, M.D., Ph.D., Director of the FDA Biology Evaluation and Research Center said in the statement Together r with the biologist of the FDA. “The aim is to understand whether two doses will provide sufficient protection to move forward by ratifying the use of vaccines in this age group.”
However, now, parents and caregivers are advised to continue with the same precautions they have taken. That includes social distance and closure, along with the vaccination of each family member or caregiver who qualify.
