Full FDA Approval Of Pfizer Vaccine Imminent

The Food and Drug Administration is pushing to approve Pfizer-BioNTech's two-dose COVID-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency's planning.

Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company. The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time.

An FDA spokesperson declined to comment.

The agency had recently set an unofficial deadline for approval of around Labor Day.

The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting firmer regulatory backing before implementing mandates. Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.

Some universities and hospitals are expected to mandate inoculation once a vaccine is fully approved. The Pentagon earlier this month said it plans to make COVID-19 vaccinations mandatory for the country's 1.3 million active-duty troops "no later" than the middle of next month, or sooner if the FDA acts earlier.

The timing of the approval could result in an uncomfortable messaging problem for the Biden administration, which on Wednesday announced that fully vaccinated people should prepare to get booster shots eight months after they received second doses. Approving the vaccine and encouraging boosters at the same time may suggest to some that the vaccine as licensed is inadequate without an extra shot.

The FDA last week updated its authorizations of Pfizer-BioNTech's and Moderna's vaccine to allow third doses for some immunocompromised people, a decision backed by the Centers for Disease Control and Prevention.

Regulators are still reviewing Moderna's application for full approval for its coronavirus vaccine, and a decision could come at least several weeks after the one for Pfizer-BioNTech.

Antibody drugs

People infected with COVID-19 were captured in a photo this week lying on the floor in pain while waiting for antibody infusions at a treatment site set up inside the library in Jacksonville, Florida.

The image has become a vivid illustration of the huge demand for the once-neglected COVID-19 drugs in the states hit hardest by a summer surge of infections being driven by the highly contagious delta variant.

"They were moaning and obviously in a lot of pain. They were miserable," said Louie Lopez, who shot the photograph as he waited for more than two hours to receive the treatment.

Antibody treatments remain one of a handful of therapies that can blunt the worst effects of COVID-19, and they are the only option available to people with mild-to-moderate cases who aren't yet in the hospital.

They have risen in demand in states seeing a spike in infections, including Florida, Louisiana and Texas, where hospitalizations among the unvaccinated are overwhelming the health care system.

White House officials reported recently that federal shipments of the drugs increased fivefold last month to nearly 110,000 doses, with the vast majority going to states with low vaccination rates.

"They are safe, they are free, they keep people out of the hospital and help keep them alive," said Dr. Marcella Nunez-Smith, a senior adviser to the White House's COVID-19 response team.

The main drug in use is Regeneron's dual-antibody cocktail, which has been purchased in mass quantities by the U.S. government. It's the same drug former President Donald Trump received when he was hospitalized with COVID-19 last October.

The drugs are laboratory-made versions of virus-blocking antibodies that help fight off infections. The treatments help the patient by supplying concentrated doses of one or two antibodies.

The drugs are only recommended for people at the highest risk of progressing to severe COVID-19, but regulators have slowly broadened who can qualify. The list of conditions now includes older age, obesity, diabetes, heart disease, pregnancy and more than a half-dozen other issues.

Pandemic anxiety

Anxiety in the United States over COVID-19 is at its highest level since winter, a new poll shows, as the delta variant rages, more states and school districts adopt mask and vaccination requirements and the nation's hospitals once again fill to capacity.

The poll from The Associated Press-NORC Center for Public Affairs Research also finds that majorities of American adults want vaccination mandates for those attending movies, sports, concerts and other crowded events; those traveling by airplane; and workers in hospitals, restaurants, stores and government offices.

The poll shows that 41% are "extremely" or "very" worried about themselves or their family becoming infected with the virus. That is up from 21% in June, and about the same as in January, during the country's last major surge, when 43% were extremely or very worried.

"I wouldn't have said this a couple of years ago, but I'm not as confident as I was in America's ability to take care of itself," said David Bowers, a 42-year-old business analyst in the Phoenix suburb of Peoria.

Bowers, a Democrat, and his wife, a public school teacher, got vaccinated early. But they fret once again about their daughters, ages 7 and 9, attending school in a state whose Republican governor, Doug Ducey, signed a law to block school districts from mandating masks, let alone vaccines.

Close to 6 in 10 Americans say they favor requiring people to be fully vaccinated against COVID-19 to travel on an airplane or attend crowded public events. Only about a quarter of Americans oppose such measures.

Roughly 6 in 10 also support vaccine mandates for hospital or other health care workers, along with government employees, members of the military and workers who interact with the public, such as in restaurants and stores. Support is slightly lower for requiring vaccinations to go out to a bar or restaurant, though more are in favor than opposed, 51% to 28%.

Nearly 200 million people, or just over 60% of the U.S. population, had received at least one vaccine dose as of Thursday, according to the Centers for Disease Control and Prevention. Just over half of the population was fully vaccinated.

The New York Times and The Associated Press contributed to this report