Pharmaceutical firm, Pfizer seeks US Food and Drug Administration's complete approval for its COVID-19 vaccine for children whose ages range from two to 11 years old.
According to a CNN report, this month, Pfizer has also sought approval of its COVID-19 vaccine for individuals from 16 to 85 years of age.
The Pfizer's vaccine safety and efficacy trial in children aged six months to 11 years old is still ongoing. Albert Bourla, company's CEO said, they are expecting to have definitive readouts and submit for an emergency use authorization or EUA for two cohorts, which include children aged two to five years old, as well as five to 11 years of age later, in September.
The company executive also said, the readout and submission for children whose ages are between six months and two years, are expected in the last quarter of this year.
EUA for COVID-19 Vaccine for Teens and Children
To date, the vaccine manufacturer has already sought application for EUA for its COVID-19 Vaccine for teenagers and kids aged 12 to 15 years old.
A federal government official told the news agency, the FDA is posed to authorize the COVID-19 vaccine of Pfizer in that particular age group by early next week.
Earlier today, Bourla also explained, Phase 2 safety data from the ongoing research of Pfizer in pregnant women, "is expected by late July or early August."
From Authorized to Approve COVID-19 Vaccine
With the status of being "approved" from the current "authorized" status, enables vaccine manufacturers to sell and deliver their COVID-19 jabs directly.
It could have an effect on vaccine mandates as well, and probably help sway skeptics hesitating to get vaccinated at present.
Some companies have said they are anticipating to necessitate the COVID-19 vaccine. However, they decided not to, while all vaccines available are still in their "authorized" and not "approved" status.
According to Health expert Dr. Anthony Fauci, when people hear it is still emergency use, they still have a concern about how far one can go with it.
To date, according to the Centers for Disease Control and Prevention data, the Pfizer-BioNTech, other vaccine manufacturers, Johnson & Johnson, and Moderna, which all distribute COVID-19 vaccines in the US, currently hold the "authorized" status.
EUA, according to this report, a medical product like a vaccine for one, that's getting special FDA authorization to be used during an emergency.
There is high demand for the Pfizer COVID-19 vaccine. Bourla said early today, the company has been contracted to deliver 1.6 billion of the doses of its vaccine worldwide this year, and Pfizer is expecting to produce at least three billion of the vaccine next year.
Temperature Requirement
At present, the Pfizer COVID-19 vaccine is authorized to be stored at ultra-cold temperatures from 80 to -60 degrees Celsius, or in cold storage from -25 to -15 degrees Celsius, for up to two weeks, which can complicate the vaccine's distribution.
Bourla said a new data could enable the vaccine to be stored at standard temperatures from two to eight degrees Celsius, for a maximum of four weeks.
The company executive added Pfizer is currently working on additional formulations that could further extend the vaccine' storage time in both ultra-cold and standard refrigerators.
The related report shown on ABC News's YouTube video below:
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