Today, Pfizer and BioNTech announced that they would extend their rolling submission for an Emergency Use Authorization (EUA) to use their mRNA vaccine in children aged six months to four years. Doing so will delay the approval of the EUA. According to the press release, the companies intend to amend it to include a third dose of the for the youngest children:
The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.
In December 2021, Pfizer and BioNTech announced that the ongoing clinical study would evaluate a third 3 µg dose at least two months after the second dose of the two-dose series in this age group. Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group.
The release asserts that a third dose of the mRNA vaccine boosts the levels of neutralizing antibodies. While this may be true, after providing third doses to a high percentage of the population, Israel saw record levels of cases with omicron. The seven-day average of new cases during the peak of the omicron wave was nearly eight times the peak number during delta. The country moved on to a fourth dose for those over 18.
The Pfizer vaccine in the trial is also the same formulation that the CDC acknowledged does not prevent infection or transmission of omicron. The CDC asserts that vaccination prevents severe illness and death from the virus. However, the incidence of severe and deadly COVID-19 in children under five is vanishingly small. Several studies have demonstrated that reporting overstates the number of hospitalizations in children. Even Dr. Anthony Fauci admitted most children get admitted to the hospital with an illness other than COVID and the virus gets detected on incidental testing.
Related: Doctor Says She Was Pressured to Make Omicron Sound More Dangerous
Asking why the Food and Drug Administration (FDA) is even contemplating vaccinations using an outdated spike protein that can’t prevent transmission or illness on children of any age without long-term safety data is perfectly legitimate. Part of the reason is likely the expectations set by the Biden Administration. The FDA had planned to begin formally debating the EUA for the littlest Americans next week. Original reports indicated the vaccines could be available by the end of this month. The administration, the teachers’ unions, and the media have all pushed the narrative that exiting the pandemic requires everyone to get vaccinated. When the expert panels in the FDA and CDC failed to recommend boosters for all eligible Americans, the political appointees who led the agencies overruled them. That a recommendation to vaccinate infants and toddlers will happen is not a question of if. Instead, it is a question of when.
In April, Pfizer expects to have three-dose data on the study population under five years old, putting it in the position to ask for an EUA. NextStrain estimates omicron makes up 98% of the COVID cases in the United States now. Pfizer CEO Albert Bourla said an omicron vaccine would be ready in March, and that the company is already manufacturing doses. Someone should ask him why his company is still pursuing approval to use an outdated vaccine on children given their risk profile and the fact case rates in the U.S. are plummeting?
And while we know the seroprevalence of antibodies to COVID in whitetail deer in Michigan, there is no data on how many of our children have circulating antibodies after the highly contagious omicron variant. Maybe a delay of a few months will bring some sanity to the highly politicized COVID response. Asking the FDA to approve three doses of an outdated vaccine for children who are not at significant risk from the illness in the first place hardly seems like an exercise that will improve public health.
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