facebook linkedin twitter

FDA Relaxes Vaccine Storage Rules to Speed Up Rollout

February 26, 2021 by Daniel Mollenkamp
Empty vials of the Pfizer-BioNTech COVID-19 vaccine are seen at a vaccination center at the University of Nevada, Las Vegas in Las Vegas. (AP Photo/John Locher)

WASHINGTON – The Food and Drug Administration has relaxed the rules around storage and transportation for some coronavirus vaccines in order to speed up the vaccine rollout.

Frozen vials of Pfizer-BioNTech’s coronavirus vaccine will be allowed to be kept at “conventional temperatures” found in pharmaceutical freezers for up to two weeks, following data provided to the agency by the company. Typically, the FDA demands that undiluted vials be stored in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF), a written statement from the agency said. 

This will allow for more flexibility, according to the FDA. Health care providers will receive new fact sheets to reflect this update.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that the data Pfizer provided to the agency proves that the vaccines will remain stable at these less extreme temperatures for the two-week time period.

“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 vaccines to more sites,” Marks said in a written comment.

In the U.S., 68.27 million doses of the vaccine were administered as of Thursday, Feb. 25, according to data estimates affiliated with Oxford University. An estimated 13.8% of the country, or 46.07 million people, have received at least one dose of a coronavirus vaccine. 

The Pfizer vaccine got an emergency authorization from the FDA in December. An estimate provided by the Department of Health and Human Services reported that the U.S. had purchased about $6 billion worth of Pfizer’s coronavirus vaccine as of Feb. 11.

The FDA has relaxed restrictions and oversights during the coronavirus, which has caused researchers to warn that the situation will need to be revisited after the coronavirus crisis is over to avoid the risk of weakening patient safety in the country. At the moment, however, vaccine rollout is a top priority for the agency.

Health

FDA Panel Takes Up Tough Questions on J&J COVID-19 Boosters

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine... Read More

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when — and whether using a competing brand for the second dose might provide better protection. The push for boosters kicked off last month after... Read More

FDA Panel Endorses Lower-Dose Moderna COVID Shot for Booster

U.S. health advisers said Thursday that some Americans who received Moderna's COVID-19 vaccine should get a half-dose booster to bolster... Read More

U.S. health advisers said Thursday that some Americans who received Moderna's COVID-19 vaccine should get a half-dose booster to bolster protection against the virus. The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, adults with other... Read More

Nursing Schools See Applications Rise, Despite COVID Burnout

STORRS, Conn. (AP) — Nurses around the U.S. are getting burned out by the COVID-19 crisis and quitting, yet applications... Read More

STORRS, Conn. (AP) — Nurses around the U.S. are getting burned out by the COVID-19 crisis and quitting, yet applications to nursing schools are rising, driven by what educators say are young people who see the global emergency as an opportunity and a challenge. Among them... Read More

FDA Spells Out Lower Sodium Goals for Food Industry

NEW YORK (AP) — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out... Read More

NEW YORK (AP) — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, cereals, french fries and potato chips. The voluntary goals finalized Wednesday for 163... Read More

October 13, 2021
by Alexa Hornbeck
Gene Editing Treatment Used in Human Subjects With Rare Genetic Blindness

WASHINGTON — New data presented by researchers from Editas Medicine, a leading genome editing company, reveals that gene editing treatments... Read More

WASHINGTON — New data presented by researchers from Editas Medicine, a leading genome editing company, reveals that gene editing treatments are not only safe in humans, but may hold promise of treating a rare retinal disease that leads to blindness. “We believe these findings validate the... Read More

October 13, 2021
by Alexa Hornbeck
How Telehealth is Helping Address Veteran Food Insecurity

WASHINGTON -- The COVID-19 pandemic has impacted veterans' access to food, leading to greater food insecurity, and according to officials... Read More

WASHINGTON -- The COVID-19 pandemic has impacted veterans' access to food, leading to greater food insecurity, and according to officials from the United States Department of Veterans Affairs, telehealth is now helping to combat the issue.  “The COVID-19 pandemic certainly has been impactful for many Americans,... Read More

News From The Well
scroll top