The latest on the Covid-19 pandemic in the US

Vaccine advisers to the US Food and Drug Administration voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine six months after full vaccination in people 65 and older and those at high risk of severe Covid-19. They rejected Pfizer’s application for boosters for a wider group of people, age 16 and older.

Here's how some of the advisers reacted:

“I am really glad that we authorized this vaccine for a third dose and I plan to go out and get my third vaccine this afternoon,” said Dr. Jay Portnoy, a professor of pediatrics at Children’s Mercy Hospital in Kansas City.

Dr. Steven Pergram, medical director for infection prevention at Seattle Cancer Care Alliance, expressed concern that the recommendation did not cover health care workers, who are at high risk of exposure to coronavirus even if they are not necessarily at high risk of severe disease.

Dr. Peter Marks, who heads FDA’s vaccine arm, said the agency can make its own decision and asked the committee members to weigh on possible changes in wording on the EUA. “We are not bound at FDA by your vote,” Marks said. “We can tweak it.”

So the committee members voted unanimously to informally advise the FDA to include health care workers or others at high risk in the EUA.

What happens next: The Advisory Committee for Immunization Practices meets next week to advise the US Centers for Disease Control and Prevention on how to apply the FDA’s eventual decision and can fine-tune the recommendation.

The CDC has scheduled a meeting of its vaccine advisers for Sept. 22 and 23 — and CDC must give its stamp of approval for any booster doses to be officially given.

Vaccine advisers to the US Food and Drug Administration voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer’s vaccine six months after full vaccination in people 65 and older and those at high risk of severe Covid-19.

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee had rejected a broader application – to approve the use of booster doses of Pfizer’s vaccines in everyone 16 and older six months after they are fully vaccinated.

So the FDA offered a revised question to vote on.

Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long term efficacy of a booster dose.

Remember: The meeting and vote is just the start of the process. It's the US Centers for Disease Control and Prevention who will decide whether or not they should be used. After the FDA advisory committee makes its recommendation, the FDA makes the decision about whether to approve the booster dose.

The CDC has scheduled a meeting of its vaccine advisers for Sept. 22 and 23 — and CDC must give its stamp of approval for any booster doses to be officially given.

In a letter sent Thursday and obtained by CNN, the CDC urged local and state health officials to wait to administer boosters until both agencies had signed off.

Biden administration officials have previously announced a plan to begin administering booster doses to the general population during the week of Sept. 20, pending signoff from the FDA and CDC.

Where things stand now on vaccines and boosters: Third doses are already approved for certain immunocompromised people, but not for the general public.

Pfizer received full approval for its vaccine from the FDA, so the request to add a booster dose is a supplement to that approval. Pfizer — and other researchers — say their studies show people develop strong immunity after two doses of vaccine, but that levels of antibodies start to drop after a few months

The FDA noted in its briefing documents that Pfizer's vaccine — as well as vaccines made by Moderna and Johnson & Johnson — still provide strong protection against severe disease, hospitalization and death, even if antibodies do wane over time.

CNN's Jamie Gumbrecht and Jacqueline Howard contributed reporting to this post. 

Orange County, Florida, Mayor Jerry Demings opened a news conference this afternoon by acknowledging a "fairly grim milestone" in the state as Florida marks over 50,000 Covid-19 deaths.  

They have "seen the same trends in Orange County as well," Demings said, with at least 372 resident deaths in August. There have been at least 85 additional Covid-19 deaths since the last briefing this Monday alone. 

However, Orange County is also "seeing some very promising news," said the mayor, such as the number of daily infections declining. For the 13th straight day, the number of daily cases has been under 1,000. 

In addition, Demings pointed to Advent Health transitioning to "green status" for their facilities in Central Florida, meaning they have now returned to normal operations. This is a direct result of the steady decrease in infections in the area since the peak in August. 

There is also a continued increase in the number of eligible county residents getting their vaccinations for Covid-19, the mayor said.

"As of today, 72% of eligible residents ages 12 and up have received one or more doses of the vaccine," he said.

What the latest data shows: According to data from John Hopkins University, the five states reporting the highest numbers of total Covid-19 deaths are:

As of 3:30 p.m. ET Friday, the total US death toll from Covid-19 was 671,098.

Vaccine advisers to the US Food and Drug Administration have received a new question to consider about boosters.

The FDA has rewritten the question it is asking its advisers. Although the Pfizer vaccine has full approval, the committee will be asked to vote on an emergency use authorization or EUA for a booster.

They are being asked to vote on whether boosters should get emergency use authorization for a booster dose six months after full vaccination in people 65 and older and those at high risk of severe Covid-19.

Members of the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee have returned from their break to revise their vote on Pfizer’s application to add a booster dose of its coronavirus vaccine.

They are readying to vote on a rewritten question they will vote on after rejecting approval of a booster dose for everyone 16 and older six months after full vaccination.

After vaccine advisers to the US Food and Drug Administration rejected Pfizer's application to add a booster dose of its Covid-19 vaccine, several members of the committee voiced doubts that it is a good idea to start giving boosters to the entire population.

They especially expressed concern about younger adults and older teens, who may have a higher risk of a rare complication called myocarditis – an inflammation of the heart.

“Recommending a third dose for younger people is not something I would be comfortable with at this point,” said Dr. Melinda Wharton, director of immunization services at the US Centers for Disease Control and Prevention.

The committee is now discussing voting on another question limiting the approval of a booster dose to a more limited group.

Vaccine data published Friday by the US Centers for Disease Control and Prevention shows more than two million Americans have already taken a Covid-19 booster shot and just over half the population is fully vaccinated, 54.4%.

The data shows:

You can see more of the CDC's data here.

The committee is taking a 10-minute break and will reconvene to discuss voting on another question limiting the approval of a booster dose to a more limited group – possibly people 60 or 65 and older, and those at high risk of occupational exposure.

Vaccine advisers to the US Food and Drug Administration rejected Pfizer’s application to add a third, booster dose of its coronavirus vaccine to the two-dose regimen. 

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee rejected the application by a vote of 16 to 2. But they reserved the right to amend the question being asked in a second round of voting.

The voting question: Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least six months after completion of the primary series for use in individuals 16 years of age and older?

Committee members were preparing to vote on a narrower approval – perhaps one that allowed booster doses for people 60 or 65 or older, or for people at high risk of exposure at work.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine.

Dr. Sanjay Gupta: No, this is not what we were expecting