Posts tagged with "BioNTech"

Pfizer asks FDA to approve ‘not-so-cold storage’ for its vaccine

February 22, 2021

Pfizer announced on February 19 that  it is seeking permission from the Food and Drug Administration to store its COVID-19 vaccine for two weeks at temperatures that still are extremely cold, but that are commonly found in pharmaceutical freezers and refrigerators, CNBC reports.

The vaccine, which was developed with German drugmaker BioNTech, currently needs to be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, according to the FDA.

Pfizer said it submitted new data to the U.S. agency that demonstrates that the vaccine is stable at between minus 13 and minus 5 degrees Fahrenheit, according to CNBC.

If the FDA grants the request, it could simplify logistics for distribution of the vaccine. U.S. federal and state officials are trying to pick up the pace of vaccinations as the virus spreads.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the [nation] and around the world,” Pfizer CEO Albert Bourla said in a release. “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”

Medical experts had warned that Pfizer’s vaccine would present logistical challenges because of the need for ultracold temperatures. In December, U.S. officials said they quarantined several thousand doses in California and Alabama after an “anomaly” in the transportation process caused the storage temperature to get too cold, CNBC notes.

The vaccine is shipped in a special thermal container that can be used as temporary storage for up to 30 days , if it is refilled with dry ice every five days. Before mixing with a saline diluent, the vaccine also may be refrigerated for up to five days at standard refrigerator temperature, between 36 degrees and 46 degrees Fahrenheit, according to the company.

By comparison, Moderna’s vaccine needs to be shipped at between minus 13 and minus 5 degrees Fahrenheit. It has said its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for six months at minus 4 degrees Fahrenheit.

Johnson & Johnson’s vaccine, which is expected to be authorized for emergency use by the FDA as early as this month, has said it plans to ship its vaccine at 36 to 46 degrees Fahrenheit.

As additional stability data is obtained, Pfizer said it anticipates the shelf life could be extended, and alternate short-term temperature storage may be considered.

Research contact: @CNBC

 

Shot to be ‘heard’ around the world: Pfizer says its coronavirus vaccine is more than 90% effective

November 9, 2020

A coronavirus vaccine developed by New York City-based pharmaceutical firm Pfizer is more than 90% effective, according to the first look at data from a late-stage U.S. trial involving nearly 44,000 participants, Politico rerports.

An analysis of 94 trial participants who contracted COVID-19 showed that the vaccine was 94% effective, the company and its partner BioNTech of Germany said in a press release on November 9.

The pair added that they expect to apply to the U.S. Food & Drug Administration (FDA) for an emergency-use authorization before the end of the month, after they have collected sufficient data on the vaccine’s safety.

The better-than-expected result is the first Phase III data from any of the four candidates now in the final stage of testing in the United States.

“I can’t imagine better news on the vaccine front,” Walid Gellad, director for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told Politico.  Not only is it highly effective based on the press release, but there were 90 cases so we don’t have to deal with the skeptics about interim analyses, and there appeared to be no safety signals.”

Others noted that the information Pfizer had released was promising but still incomplete. “We should remain a little cautious, said Michael Head, a senior research fellow in Global Health at the University of Southampton in the U.K. “The provisional findings are made available in a press release, and the study is ongoing.”

President Donald Trump, who pushed unsuccessfully for a vaccine by Election Day, cheered the Pfizer result. “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he wrote on Twitter.

Although Ivanka Trump tried to link the new vaccine to the Administration’s Operation Warp Speed, a top scientist for Pfizer told the New York Times that her company had not partnered with the Trump administration’s program meant to speed vaccine development.

President-elect Joe Biden issued a statement congratulating “the brilliant women and men who helped produce this breakthrough,” but he cautioned that “the end of the battle against COVID-19 is still months away.”

Even if a shot is authorized by late November, it will take many months before vaccination is widespread, Biden noted. “Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” he said.

Research contact: @politico