US FDA Puts All Hands on Deck to Review Pfizer-BioNTech Covid Shot

12:43  01 august  2021
12:43  01 august  2021 Source:   bloomberg.com

Governors pin hopes on full vaccine approval as cases climb

  Governors pin hopes on full vaccine approval as cases climb LITTLE ROCK, Ark. (AP) — As U.S. regulators weigh giving the final stamp of approval for certain COVID-19 vaccines, governors in states hard hit by the pandemic hope the move will help persuade the many holdouts in their states to finally get the shot. The governors of Arkansas and Ohio — where cases and hospitalizations are climbing — have appealed publicly in recent days for full approval, saying it would help combat vaccine hesitancy and could also clear the way for more businesses to require their employees to be inoculated. It's a topic that Republican Gov.

(Bloomberg) -- U.S. drug regulators are taking an “all-hands-on-deck approach” to reviewing Pfizer Inc. and BioNTech SE’s Covid-19 shot for full approval in an effort to persuade as many as possible to get immunized.

a hand holding a cellphone: Henderson And Las Vegas Residents Receive Covid-19 Vaccination © Bloomberg Henderson And Las Vegas Residents Receive Covid-19 Vaccination

The Food and Drug Adminstration is “identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge,” agency spokesperson Abby Capobianco said. Acting Director Janet Woodcock has “offered all agency resources to the team to make this happen,” she said.

Pfizer-BioNTech vaccine effectiveness drops to 84 percent after six months: data

  Pfizer-BioNTech vaccine effectiveness drops to 84 percent after six months: data The effectiveness of the Pfizer-BioNTech COVID-19 vaccine fell from 96 percent to 84 percent over six months, according to data released on Wednesday.The preprint study funded by the companies determined that the vaccine's effectiveness reached a high point of 96.2 percent within two months after the second dose. But the efficacy "declined gradually" to 83.7 percent within six months, with an average decrease of about 6 percent every two months. But even with the slip in efficacy, the data indicates the vaccine offers protection six months later.

Pfizer and BioNTech’s vaccine gained emergency use authorization in December, but many people are waiting for the vaccine to undergo a full review before getting it. The Biden administration is working to vaccinate as many as possible as the highly transmissible delta variant spreads across the U.S., threatening Americans’ return to normal activities.

“We recognize that for some, the FDA approval of Covid-19 vaccines may bring additional confidence and encourage them to get vaccinated,” Capobianco said in the statement. “FDA staff will conduct a thorough review process, while balancing the incredible sense of urgency necessary, both of which are needed to ensure that any vaccine that is authorized or approved meets our rigorous standards for safety, effectiveness, and quality.”

Pfizer submitted the application for full approval in early May. The FDA’s plan to expedite review of the Pfizer-BioNTech vaccine was reported earlier by STAT.

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FDA approval of the Covid-19 vaccine could mean more people will get vaccinated for an unexpected reason .
Pfizer's Covid-19 vaccine is currently only authorized for emergency use in the United States, but its full approval by the US Food and Drug Administration could happen within weeks. © Samuel Corum/Pool/Getty Images Wesley Wheeler, President of Global Healthcare at United Parcel Service (UPS), holds up a sample of the vial that will be used to transport the Pfizer COVID-19 vaccine as he testifies during a Senate Commerce, Science, and Transportation Subcommittee hearing on the logistics of transporting a COVID-19 vaccine on December 10, 2020 in Washington, DC.

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This is interesting!