Pfizer-BioNTech's COVID Vaccine Gets Full Approval From The FDA, and regarding boosters...

Posted almost 4 years ago by Meredith Roberts

The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.

The vaccine, developed by Pfizer and its partner BioNTech, is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.

The full approval could make it easier for employers, the military and universities to mandate vaccination and may reassure some people who are hesitant about the vaccine.

"While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," acting FDA Commissioner Janet Woodcock said in a statement.

President Biden seized on the announcement in remarks to the nation on Monday afternoon to press for more people to get vaccinated as soon as possible.

"Let me say this loudly and clearly: If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened," he said. "The moment you've been waiting for is here. It's time for you to go get your vaccination. Get it today."

The president also encouraged businesses to "step up their vaccine requirements."

A June poll from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA.

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,"... More at:

https://www.npr.org/sections/coronavirus-live-updates/2021/08/23/1030251410/pfizer-covid-vaccine-fda-approval

COVID-19 Booster Shots Will Roll Out In September In The U.S.

COVID-19 booster shots of the Pfizer and Moderna vaccines are set to become available for all U.S. adults beginning next month, the country's top health officials announced Wednesday.

"We know that even highly effective vaccines become less effective over time," Dr. Vivek Murthy, the surgeon general, said at a White House briefing. "It is now our clinical judgment that the time to lay out a plan for COVID boosters is now."

He added, "This includes our most vulnerable populations, like our health care providers, nursing home residents and other seniors. We will also begin delivering booster shots directly to residents of long-term care facilities."... More at https://www.npr.org/sections/coronavirus-live-updates/2021/08/18/1028798003/covid-19-booster-shots-roll-out-september-moderna-pfizer

ANA poll: Nurses willing to getting a booster shot

A nationwide poll by the American Nurses Association of more than 4,500 nurses found that 85% would be willing to get a recommended booster shot. "Nurses' knowledge, coupled with their frontline experience caring for those with COVID-19 over the past 16 months, is evident by these survey findings," ANA President Ernest Grant said.

Full Story: Daily Nurse (8/19)

Analysis: Insurers to stop COVID-19 cost-sharing waivers

Seventy-two percent of 102 health plans in the US are ending cost-sharing waivers for COVID-19 treatments as of this month, while an additional 10% of insurers are expected to follow suit by the end of October, according to a Kaiser Family Foundation analysis. A rebound in health care utilization and the availability of vaccines mean health insurers may "no longer face political or public relations pressure to continue waiving costs for COVID-19 treatment," the analysis stated.

Full Story: FierceHealthcare