After a two-dose regimen failed to induce an adequate immunological response in children of ages 2, 3 and 4, Pfizer and BioNTech stated on Friday that they will modify the vaccine and adjust the clinical study for their coronavirus vaccine in young children.
The firms stated that the trial found no safety issues and that participants aged 2-4 will receive a third vaccine dose two months following the second. The vaccine produced an adequate immune response in participants aged six months to 24 months.
The vaccine dose was 3 micrograms or one-tenth of the dose given to individuals over the age of 18. According to Pfizer spokeswoman Jerica Pitts, the company is not planning to increase the dosage for young children, but instead will see if a third 3-microgram dose is sufficient.
Pitts told the New York Times, ‘The purpose here is to determine the potential of protection of the third dose.’
Pfizer still expects to pursue emergency authorisation for the vaccine in children under 5 before summer 2022.
‘It’s important to note that this adjustment is not expected to materially alter our expectations that we will file for emergency use authorization and conditional approvals in the second quarter of 2022,’ Kathrin Jansen, Pfizer’s head of vaccine development, said in a conference call with investors.
The Pfizer vaccine for the Covid-19, developed in collaboration with BioNTech, is the only coronavirus vaccination approved for children aged 5 and up in the United States. For Americans aged 18 and up, the Moderna and Johnson & Johnson Covid vaccinations are approved.
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