Pfizer has submitted information to U.S. health regulators about a new version of its coronavirus vaccine that could allow it to be stored at refrigerator temperatures for up to 10 weeks.
In an earnings report on Tuesday, the pharmaceutical company said it sent ‘stability data’ to the U.S. 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 at ultra-cold temperatures, between -112F (-80C) and ‑76F (-60C) for up to six months or from 13F (-25C) to 5F (-15C) for two weeks.
Once opened, the vials can be kept in the refrigerator between 36F (2C) and 46F (8C) for up to five days.
However, if approved, the new version could be stored at just above freezing temperatures for 70 days, or 10 weeks.
It comes as Pfizer and its German partner, BioNTech SE, plan to ask for approval of the vaccine for use in children aged 11 and younger by September and as President Joe Biden announced children from ages 12 to 15 might be able to get vaccinated starting next week.
Pfizer says it has developed a new version of its coronavirus vaccine that could be stored between 36F (2C) and and 46F (8C) for up to 10 weeks. Pictured: Vial of the Pfizer vaccine for COVID-19 in Seattle, January 2021
Currently, the vaccine must be kept between -112F (-80C) and ‑76F (-60C) for up to six months or from 13F (-25C) to 5F (-15C) for two weeks. Pictured: Freezers for storing finished Pfizer COVID-19 vaccines, October 2020
Prior to the FDA granting emergency use authorization, engineers at Pfizer developed special boxes to ship the vaccine at extreme temperatures once it is approved and shipped from Kalamazoo, Michigan.
The isothermic boxes with dry ice have a GPS inside each one as well as a meter so, at any point in time, it can be determined where the box is and what the temperature is.
This allows the vials to be shipped via any method 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 would allow the shots to be distributed more efficiently.
In an earnings call on Tuesday, Pfizer said it plans on asking the FDA for full approval this month and to ask for approval for kids ages 2 to 11 in September. Pictured: Caleb Chung receives the first dose of either the vaccine or placebo in a trial, December 2020
‘If successful, we expect to have the data to support this formulation in August,’ Pfizer CEO Albert Bourla said during the earnings call.
In addition, the company said it plans to expand access of its coronavirus vaccine over the next few months.
Firstly, Bourla announced on the earnings call that Pfizer will ask the FDA to give full approval to the vaccine rather than just emergency use authorization of people above age 16.
Getting full approval would allow the vaccine to be marketed directly to the general public, but the process is expected to take months.
‘Full approval is a welcome indicator 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.
Expanding approval could also ‘build further confidence in the importance of vaccination,’ she added.
Additionally, the company said it expects to apply for emergency use of its vaccine in children from ages two to 11 in September.
This comes on the heels of news the the FDA is likely to expand emergency use to youngsters between ages 12 and 15 next week.
Recently, Phase III clinical trial data showed that the vaccine was 100 percent safe and effective in younger teenagers.
On Tuesday, President Biden said if the FDA authorizes Pfizer’s vaccine for the 12-to-15 age group next week, distribution could start ‘immediately.’
‘If that announcement comes, we are ready to move immediately to make about 20,000 pharmacy sites across the country ready to vaccinate those adolescents as soon as the FDA grants its okay,’ he said.
What’s more, Pfizer announced on the call its vaccine brought in $3.5 billion in revenue and made the company some $900 million in profits in the first three months of 2021.
Bourla said that, with the vaccine shipping to more than 90 countries, Pfizer expect revenues of approximately $26 billion from the vaccine by the end of 2021.
‘I couldn’t be prouder of the way Pfizer has started 2021,’ Bourla said on the call.
‘We continued to accelerate production and shipments of our Covid-19 vaccine – in many cases exceeding our contractual obligations for delivery timelines.’