Pfizer’s Covid Vaccine Doesn’t Need Ultra-Cold Storage, FDA Says - Forbes

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Topline

U.S. regulators on Thursday cleared the way for Pfizer’s coronavirus vaccine to be stored in normal freezers for two weeks, instead of holding them at ultra-cold temperatures, making the vaccine easier to handle for smaller medical clinics with fewer resources.

Key Facts

The Food and Drug Administration said frozen, undiluted vaccine vials can be held at standard pharmacy freezer temperatures — between -13 and 5 degrees Fahrenheit — for up to two weeks after they arrive at a vaccination site.

If the drugs are held for more than two weeks, they need to stay in much colder freezers with temperatures below -78 degrees Fahrenheit.

Pfizer first discovered last week that its vaccine stays effective at normal freezer temperatures, citing research from Israel, the world’s most heavily vaccinated country.

A Pfizer spokesperson told Forbes the company is “pleased” with the FDA’s decision, which it hopes will give pharmacies and clinics more flexibility.

Tangent

This change doesn’t apply to other coronavirus vaccines. Moderna’s vaccine can already be stored in standard freezers, and vaccine candidates made by Johnson & Johnson and AstraZeneca remain stable at refrigerator temperatures.

Key Background

It’s not uncommon for vaccines to need refrigeration, but Pfizer initially thought its drug needed especially frigid storage to stay potent, posing a challenge for distributors and local health officials. Ultra-cold freezers are pricey, making them out of reach for many rural hospitals and resource-strapped medical clinics, and the sudden demand for those specialized freezers sparked a worldwide rush to buy them.

Crucial Quote

“The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, wrote in a statement Thursday.

Surprising Fact

Pfizer allows its vaccine doses to be stored in dry ice containers, a temporary and labor-intensive workaround for clinics that lack ultra-cold freezers. Late last year, this system led to a surge in demand for dry ice in parts of the United States.

Big Number

34.2 million. That’s how many doses of Pfizer’s coronavirus vaccine have been administered in the United States as of Wednesday, according to figures from the Centers for Disease Control and Prevention. By comparison, just under 32.2 million shots of Moderna’s vaccine have entered U.S. patients’ arms so far.