The latest on the Covid-19 pandemic in the US

Setting a timeline for Covid-19 booster doses before a full review of data was an avoidable distraction on the part of the White House, and the focus right now needs to be on people who are not yet vaccinated, University of Nebraska Medical Center College of Public Health Dean Dr. Ali Khan told CNN on Friday.

The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting Friday to review data on a potential third dose of Pfizer/BioNTech’s Covid-19 vaccine.

“We have 2,000 people dying a day currently, still about 100,000 people hospitalized. So the focus should be on the 67 million people who have not been vaccinated. They are the ones driving this pandemic, not those who have already been fully vaccinated," he said.

Data from the US Centers for Disease Control and Prevention show just over 25% of Americans eligible to be vaccinated have not gotten a single dose yet, and more than 1.9 million Americans have received an additional dose – or booster – of a Covid-19 vaccine.

Compared to White children, kids of color in the US have borne the brunt of the Covid-19 pandemic.

These children had more cases, deaths, and have had more mental health and academic problems related to the pandemic. While the most vulnerable, they’re also less likely to be vaccinated, according to a new analysis.

The analysis published Thursday by the Kaiser Family Foundation found that the race-based disparities among children mirrored those among adults.

Compared to White children, Black, Hispanic, and Asian children were less likely to be tested for Covid-19, but were much more likely to be sick with it.

Infection rates were highest – at more than 500 cases per 10,000 children – among American Indian and Alaska Native children, Native Hawaiian and Other Pacific Islander children and Hispanic children. White and Black children had similar number of infections with about 300 cases per 10,000 people. Asian children had the lowest infection rate at a little over 200 cases per 10,000.

While Covid-19 hospitalization and death are rare among children compared to adults, those kids who were hospitalized were more likely to be Black and Hispanic. Black and Hispanic kids were also more likely to have a Covid-19 related condition called MIS-C – multisystem inflammatory syndrome in children – and Black children were more likely to be admitted to intensive care for it.

Black, Hispanic, American Indian and Alaska Native children were more likely to die from Covid-19 than White children.

More data: When it comes to school, half of the parents of Hispanic children said their children fell behind academically during the pandemic, compared to a third of White parents who said the same.

Half of Hispanic parents said their children had difficulty concentrating on their school work and also had problems eating, sleeping and had frequent stomach aches and headaches during the pandemic. About 40% of White parents said their children had the same complaints.

Researchers say there is a “dearth of data” to understand vaccination rates by race among children. From the seven states that reported this information, the vaccination rate for White children was higher than for Black children. In Connecticut and Wisconsin it was higher for White children than for Hispanic children. Vaccines are authorized for kids 12 and older in the US.

“Because children make up a significant share of the population and are more racially diverse than the rest of the population, equitable vaccination among this group is key for achieving an overall high rate of vaccine coverage among the population and may help to reduce disparities in vaccination rates more broadly,” the report said.

Dr. Sara Oliver with the US Centers for Disease Control and Prevention is presenting data on Covid-19 infections and the impact of the Delta variant right now in the meeting of the FDA's Vaccines and Related Biological Products Advisory Committee.

The committee is made up of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts.

The all-day meeting will be packed with presentations. They'll include Pfizer/BioNTech, which is arguing that there's enough evidence of waning immunity to justify giving booster doses to people.

The FDA will present its own take on the data that's been sent to the agency so far — although written briefing materials published before the meeting suggest the agency is remaining neutral for the time being.

The meeting is scheduled to adjourn at 4:45 p.m. ET.

While it’s not surprising there is discussion around a booster dose of Covid-19 vaccine, it was unhelpful for the White House to announce an intention to go forward with boosters before the US Food and Drug Administration had fully reviewed available data, former FDA Chief Scientist Dr. Jesse Goodman said Friday.

“We need to have the best public discussion. And I think any number of decisions could be reasonable here, and it's just going to be really important to explain the evidence and the decisions to the American people,” he said.

The FDA’s Vaccines and Related Biological Products Advisory Committee is meeting today to review data on a potential third dose of Pfizer/BioNTech’s Covid-19 vaccine.

Goodman said there is some data from “short term” studies showing a third dose elicits a positive antibody response, and that additional doses in a vaccination regimen is not uncommon.

“It's not surprising that we're talking about boosters, because virtually every vaccine we have needs and uses a shot several months after the initial shot or shots, to sort of cement and strengthen immunity,” Goodman said.

“I just hope, because people have put some pretty strong positions out there, that everybody listens to the evidence, because we see new studies emerging every day, and makes the best possible decision,” he said.

Vaccine advisers to the US Food and Drug Administration are meeting this morning to discuss whether most Americans need to start getting booster doses of coronavirus vaccine.

The all-day meeting will be packed with presentations. They'll include Pfizer/BioNTech, which is arguing that there's enough evidence of waning immunity to justify giving booster doses to people.

The FDA will present its own take on the data that's been sent to the agency so far — although written briefing materials published before the meeting suggest the agency is remaining neutral for the time being.

The Vaccines and Related Biological Products Advisory Committee is made up of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts. The group advises the FDA on vaccines, and the agency usually follows its advice.

How today's meeting will unfold: The meeting, which will be streamed online, is expected to last until 4:45 p.m. ET or later, with a discussion and vote scheduled to start at 2:25 p.m. and to last at least two hours.

The question will be whether it's time to start approving boosters now and if so, who should get them and when.

They'll hear first from Dr. Peter Marks, who heads the FDA's vaccine arm, the Center for Biologics Evaluation and Research. Another CBER official, Marion Gruber, will lay out the question at hand. It's a routine presentation, but Gruber announced her retirement only a few weeks ago amid speculation that she was stepping down to protest White House involvement in the booster decision.

Gruber also, very unusually, signed a Lancet paper published earlier this week that argued it's too soon to start giving people boosters.

Experts at the US Centers for Disease Control and Prevention will detail what's known about how the Delta variant affects the rate of breakthrough infections. Researchers from the UK and Israel will present some real-world data about how many fully vaccinated people have become infected anyway, and whether giving boosters has lowered that rate of breakthroughs.

The White House has said it’s planning to be ready to start giving booster doses of vaccines Sept. 20, pending sign-off from the FDA and CDC. 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.

Third doses are already approved for certain immunocompromised people, but not for the general public.

The current evidence on Covid-19 vaccines does not appear to support a need for booster shots in the general public right now, according to an international group of vaccine scientists, including some from the US Food and Drug Administration and the World Health Organization.

The authors of the paper include two senior FDA vaccine leaders, Dr. Philip Krause and Marion Gruber, who will be stepping down in October and November, the FDA announced late last month. No further details were released about their retirements, although they sparked questions about whether the departures would affect the agency's work.

The FDA and other public health agencies around the world continue to examine evidence on Covid-19 vaccine efficacy and the role booster doses of vaccine might play in improving immunity against the disease.

For the new paper in The Lancet, the scientists note that they reviewed randomized trials and observational studies on Covid-19 vaccines and consistently find that "vaccine efficacy is substantially greater against severe disease than against any infection; in addition, vaccination appears to be substantially protective against severe disease from all the main viral variants. Although the efficacy of most vaccines against symptomatic disease is somewhat less for the delta variant than for the alpha variant, there is still high vaccine efficacy against both symptomatic and severe disease due to the delta variant."

The scientists note that there is an opportunity right now to study variant-based boosters before there could be a widespread need for them. But they also argue in their paper that the current Covid-19 vaccine supply could "save more lives" if used in people who are not yet vaccinated than if used as boosters. In early August, the World Health Organization called for a moratorium on booster shots until at least the end of September.

"To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease," the scientists write in their paper.

The paper published just shy of a month after US federal health officials announced plans for booster doses of Covid-19 vaccine to be offered this fall, starting Sept. 20, subject to authorization from the FDA and sign off from the US Centers for Disease Control and Prevention.

It's not clear if or when boosters doses of Covid-19 vaccines will be OK'd for fully vaccinated people in the United States, but state and local health departments across the United States are moving ahead with plans for a potential rollout next week.

Last month, US health officials announced plans for booster doses of Covid-19 vaccine to be offered starting the week of Sept. 20, subject to sign-off from the US Food and Drug Administration and the US Centers for Disease Control and Prevention.

Those conversations are getting underway this week, including a key meeting of FDA vaccine advisers on Friday, but the decision isn't a slam dunk, experts have said.

Still, those tasked with administering boosters can't wait for the details to be finalized.

She said that local health departments are planning now to be ready after the FDA review's Pfizer data — especially, as they already are "really overwhelmed" right now with responding to surges of Covid-19 cases, working to get the unvaccinated vaccinated, and preparing for the flu season.

The last thing local health officials need at the moment is more chaos or confusion, but many of their questions around boosters still have not been answered: "What is the interval for boosters? Is it any shorter than eight months at this point? What is the age cut-off? Will there be priority groupings?" Freeman said. "We don't want to appear uncoordinated on boosters."

Read more here.

Dr. Paul Offit, a member of the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, told CNN he thinks the decision on whether to offer Covid-19 vaccine boosters to the general public is being rushed because of a target date set by the Biden administration.

“Why did we see the New England Journal of Medicine study essentially the day before (the) meeting? I think the rush is that the date was set by the Biden administration – the Biden administration gave a date and now we’re scrambling to meet that date. I think it should have taken more time.” 

On Wednesday evening, the New England Journal of Medicine published three reports that support the argument that people may need a booster dose of Pfizer/BioNTech’s Covid-19 vaccine over time, and suggest such boosters would be safe.

Biden administration officials last month announced a plan to provide booster shots for people vaccinated against Covid-19 starting the week of Sept. 20, pending sign-off from the FDA and the US Centers for Disease Control and Prevention.

The FDA’s advisory committee meets today, and the CDC’s Advisory Committee on Immunization Practices is scheduled to meet next week. 

Three reports published Wednesday support the argument that people may need a booster dose of Pfizer's Covid-19 vaccine over time, and suggest such boosters would be safe.

The reports are part of a batch of data that will be discussed Friday by vaccine advisers to the US Food and Drug Administration. The FDA is considering a request by Pfizer to approve a third, booster dose of its vaccine for most people six months after they get their first two doses of vaccine.

But while the FDA clearly signaled it would grant emergency use authorization to Pfizer's and Moderna's vaccines last December, that it would grant EUA to Johnson & Johnson's vaccine in February and that it would fully approve Pfizer's vaccine last month, it was notably neutral about the question of booster doses for the general public.

There are "many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions," it said in a briefing document released Wednesday ahead of the meeting of its Vaccines and Related Biological Products Advisory Committee.

One of the reports is the formal presentation of data from Israel released earlier this month that showed booster doses of vaccine not only raised immunity as measured in the blood, but also showed a real-world reduction in infection.

Two others, sponsored by Pfizer, support the argument that immunity, as measured in the blood, does begin to wane over time after people get both initial doses. One shows a booster restores that immunity.

The reports, all published in the New England Journal of Medicine, are being used by Pfizer and by some federal officials to support the argument that most people will need booster doses starting around six months after they are initially vaccinated.

Read more here.