Posts tagged with "Johnson & Johnson"

FDA moves closer to clearing Moderna and J&J COVID booster shots this week

October 12, 2021

Millions of Americans will be one step closer to receiving a COVID-19 booster shot this week when a key Food and Drug Administration advisory panel meets Thursday and Friday, October  14 and 15, to debate extra doses of the Moderna and Johnson & Johnson vaccines, reports CNBC.

The FDA’s Vaccines and Related Biological Products Advisory Committee meetings come less than a month after U.S. regulators authorized COVID booster shots of Pfizer and BioNTech’s vaccine to a wide array of Americans, including the elderly, adults with underlying medical conditions; and those who work or live in high-risk settings, like health and grocery workers.

More than 7 million Americans have received a booster dose in the United States as of Saturday, October 9, according to the latest data available from the Centers for Disease Control (CDC).

Members on independent committees by the FDA and CDC and Prevention said at the time they were frustrated that only Pfizer recipients would be eligible to get the extra shots, leaving out millions of Americans who got Moderna or J&J’s shots.

The FDA advisory group is scheduled Thursday to discuss data on the safety and effectiveness of a Moderna booster shot in adults. On Friday, the committee is expected to debate J&J booster shots for adults. The FDA could make a final decision within days of the meetings, handing it off to the CDC and its vaccine advisory committee to make their own decision.

The CDC’s next vaccine advisory meeting is scheduled to take place from October 20 to October 21, when it’s expected to discuss the boosters.

Research contact: @CNBC

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