Pfizer Inc. (PFE) - Get Report launched a trial of its coronavirus vaccine on children under the age of 12 Thursday, just hours ahead of a press conference in which President Joe Biden is set to double his administration's target for vaccinations over his first 100 days in office.
The drugmaker, which won approval from the U.S. Food & Drug Administration late December for the adult use of its messenger-RNA-based vaccine developed with Germany's BioNtech (BNTX) - Get Report, said the trials will begin in the second half of this year, with the aim of administering doses in early 2022.
Pfizer and BioNTech said the trial will involve 144 participants who will receive different dosage levels of the two-shot vaccine over a four-week period. The trial will then be expanded to around 4,500 participants once safety and tolerance data is confirmed.
Pfizer shares were marked 0.8% lower in mid-dat trading Thursday to change hands at $35.31 each, a move that leaves the stock in moderately negative territory for the year.
The Pfizer vaccine, which uses messenger RNA technology, must currently be stored in ultra-cold freezers at temperatures of between -80 and -60 degrees Celsius, and then thawed for three hours in a refrigerator and then diluted within the next two hours.
Last month, the drugmaker submitted new data to the FDA that it hopes will change its Emergency Use Authorization (EUA) approval order from December and allow for the BNT162b2 vaccine to be stored at between -25 and -15 degrees Celsius for up to two weeks, "temperatures more commonly found in pharmaceutical freezers and refrigerators."
Data from the Centers for Disease control shows that more than 130 million doses of the two FDA-approved COVID vaccines -- including a similar mRNA-based treatment developed by Moderna (MRNA) - Get Report, have been administered as of Wednesday, compared to a confirmed case basis of 29.77 million.
President Joe Biden is expected to say Thursday that he plans to increase his administration's vaccine target to 200 million over its first 100 days, more than double his original ambition from his first days in office.