Pfizer has provided information to health regulators in the United States about a new version of itCoronavirus vaccine that can be stored in refrigerators for up to 10 weeks.
In its earnings report on Tuesday, the pharmaceutical company said it sent “stability data” to the US Food and Drug Administration (FDA) on Friday and expects the formulation to be approved for emergency use “soon”.
Currently, the two-dose vaccine can be stored in extremely cold temperatures, between -112 F (-80 ° C) and -76 F (-60 ° C) for up to six months, or from 13 F (-25 ° C). To 5 F (-15 C) for two weeks.
Once opened, the flasks can be refrigerated between 36 F (2 C) and 46 F (8 C) for up to five days.
However, if approved, the new version can be stored at temperatures just above freezing for a period of 70 days or 10 weeks.
It comes as Pfizer and its German partner BioNTech SE plan to have the vaccine approved for children aged 11 years and under by September, and as President Joe Biden announced, children between the ages of 12 and 15 may be able to get the vaccine. Starting next week.
Pfizer says it has developed a new version of the coronavirus vaccine that can be stored between 36 degrees Fahrenheit (2 degrees Celsius) and 46 degrees Fahrenheit (8 degrees Celsius) for up to 10 weeks. Pictured: A vial of a Pfizer vaccine for COVID-19 in Seattle, January 2021
Currently, the vaccine must be kept between -112 F (-80 ° C) and -76 F (-60 ° C) for up to six months or from 13 F (-25 ° C) to 5 F (-15 ° C) for a period of time. Two weeks. Pictured: Freezers for storing final Pfizer COVID-19 vaccines, October 2020
Before the FDA granted a license for emergency use, engineers at Pfizer developed special boxes to ship the vaccine at extreme temperatures once it was approved and shipped from Kalamazoo, Michigan.
The isothermal boxes with dry ice inside each contain a Global Positioning System (GPS) plus a meter, so, at any time, the location and temperature of the box can be determined.
This allows bottles to be shipped by any means of transportation, including trucks, airplanes and boats.
Reformulating the vaccine to allow vials to be stored in refrigerators is faster, cheaper, and easier than the current model, and will allow shots to be distributed more efficiently.
In a earnings call on Tuesday, Pfizer said it plans to seek full approval from the Food and Drug Administration this month and seek approval for children ages 2 to 11 in September. Pictured: Caleb Chung receives the first dose of vaccine or placebo in a trial, December 2020
“If successful, we expect to have data to support this formula in August,” said Albert Burla, CEO of Pfizer, during the earnings call.
In addition, the company said it plans to expand access to the Coronavirus vaccine over the next few months.
First, Burla announced on the earnings call that Pfizer would ask the Food and Drug Administration to grant full approval for the vaccine rather than just an emergency use permit for people over 16.
Getting full approval will allow the vaccine to be marketed directly to the general public, but the process is expected to take months.
“Full approval is a welcome indication of the continued safety and efficacy of the Pfizer vaccine,” Dr. Saskia Popescu, an infectious disease epidemiologist at George Mason University, told the New York Times in an email.
She added that expanding approval could “build more confidence in the importance of vaccination.”
In addition, the company said it expects to apply for the emergency use of the vaccine for children ages 2 to 11 in September.
This comes on the heels of news that the Food and Drug Administration will likely expand emergency use for teens 12 to 15 years old next week.
Recently, data from Phase 3 clinical trials showed that the vaccine was 100 percent safe and effective in younger adolescents.
On Tuesday, President Biden said that if the US Food and Drug Administration approves a Pfizer vaccine for the age group of 12 to 15 next week, distribution may begin “immediately”.
He said, “If this announcement comes, we are ready to move immediately to have about 20 thousand pharmacy sites across the country ready to vaccinate these adolescents as soon as the Food and Drug Administration gives its approval.”
Furthermore, Pfizer announced during the call that its vaccine had generated $ 3.5 billion in revenue and the company had earned $ 900 million in the first three months of 2021.
With the vaccine shipped to more than 90 countries, Burla said, Pfizer expects nearly $ 26 billion in revenue from the vaccine by the end of 2021.
“I couldn’t be more proud of the way Pfizer started in 2021,” Burla said on the call.
We have continued to accelerate production and shipment of Covid-19 vaccine – in many cases we have exceeded our contractual commitments to delivery schedules.