The latest on the Covid-19 pandemic in the US

By Melissa Mahtani, Melissa Macaya and Veronica Rocha, CNN

Updated 8:00 p.m. ET, September 17, 2021
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11:29 a.m. ET, September 17, 2021

The two big questions the FDA will be asking in today's meeting on Covid-19 boosters

From CNN's Maggie Fox

Vials of the Pfizer/BioNTech Covid-19 vaccine are on a table in Providence, Rhode Island, on August 5.
Vials of the Pfizer/BioNTech Covid-19 vaccine are on a table in Providence, Rhode Island, on August 5. (Erin Clark/The Boston Globe/Getty Images)

Vaccine advisers to the US Food and Drug Administration are meeting today to discuss whether Americans need booster shots yet.

It's a topic that has become bogged down in politics and turf battles. It's sometimes seemed to put the FDA's independence at odds with a White House team eager to appear to be out ahead of an unpredictable pandemic.

On the surface, it's a routine consideration of one company's request for permission to start giving people a third, booster shot of its vaccine to help improve protection.

Underneath, it's a decision that will affect all three vaccines authorized for the US market, and more that are in the pipeline. It could affect how people view vaccines, and for many, it taps into fears about disease and unknown risks.

But the questions the FDA's Vaccine and Related Biological Products Advisory Committee will be considering are straightforward: Is immunity waning, and will boosters restore it?

Researchers have been busy answering the second question first. Multiple studies now show that a third dose of Pfizer's or Moderna's vaccines, or a second dose of Johnson & Johnson's vaccine, turbo-charge the production of antibodies.

Levels of these immune system proteins — the first line of defense against infection — spike after people get a booster dose. As with other vaccines that require boosters, a longer interval of time between initial immunization and the booster seems to amplify this response.

Some initial data from Israel also indicates this boost in antibodies does translate into fewer infections among vaccinated people. It's this data that has helped drive the enthusiasm of White House advisers, including National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci.

The second question is a little harder to answer. Is immunity waning? Are fully vaccinated people becoming, with each day, more likely to become infected?

Again, data from Israel indicated that the longer out people were from their first round of immunizations, the more likely they were to suffer breakthrough infections.

But there is much less data about this from the United States. That's in no small part because the US Centers for Disease Control and Prevention has not been tracking all breakthrough cases — only those serious enough to put people into the hospital or to kill them. One question VRBPAC will be asking is how much data there is indicating that immunity is starting to drop off among Americans who were among the first to be vaccinated.

Read more about today's FDA meeting here.

10:30 a.m. ET, September 17, 2021

FDA officials urge vaccine advisers to focus "on the science" and not "stray" in today's booster meeting

From CNN's Jacqueline Howard

US Food and Drug Administration’s Dr. Peter Marks urged the agency's vaccine advisers to stay focused "on the science" in a committee meeting Friday to consider Covid-19 vaccine booster shots.

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to discuss Pfizer/BioNTech's application for the administration of a booster dose of its Covid-19 vaccine.

"We know that there may be differing opinions as to the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex and evolving — and it also requires near real-time analyses," Marks, director of the FDA's Center for Biologics Evaluation and Research, told VRBPAC members in Friday's meeting.

"We're committed to focusing on the science, and we'll drive our decision-making, and we'll carefully consider those data in the context of the clear and obvious public health need to continue slowing the spread of Covid-19, which at this time is leading to the deaths of close to 2,000 Americans each day," Marks said.

"As we proceed, I would ask that we do our best to focus our deliberations on the science related to the application under consideration today, and not on operational issues related to a booster campaign or on issues related to global vaccine equity. If we stray into those latter topics, the chair and I will gently bring us back into the scope of this advisory committee meeting," he continued.

Marion Gruber, director of the FDA's Office of Vaccines Research and Review, said in the meeting that she looks forward to a "robust" and "evidence-based" discussion. Gruber was one of two FDA officials who signed an opinion piece published this week in the Lancet that said current evidence do not appear to support a need for Covid-19 vaccine booster shots in the general public right now.

Gruber acknowledged that Friday's VRBPAC meeting was likely her last, as she plans to retire next month. 

"I want to thank the American public. It has been my privilege to serve you," Gruber said. "All of my actions and decisions over my 32-year FDA career has been grounded in science, with you in mind and in the best interest of your health and safety – and I will continue to hold fast to these principles moving forward."

10:17 a.m. ET, September 17, 2021

Covid-19 booster timeline a "self-inflicted distraction" by the White House, public health expert says

From CNN’s Virginia Langmaid

Dr. Ali Khan
Dr. Ali Khan (CNN)

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.

“I think we need to agree that this was a self-inflicted distraction by the White House, when they announced a date certain – an outcome certain – before the full FDA and CDC process,” Khan told CNN’s Erica Hill

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.

 

9:51 a.m. ET, September 17, 2021

Children of color have faced serious health and academic problems due to the pandemic, report finds

From CNN's Jen Christensen

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.

9:40 a.m. ET, September 17, 2021

CDC official presenting data on Covid-19 infections now to FDA vaccine advisers

From CNN's Jacqueline Howard

(US Food and Drug Administration)
(US Food and Drug Administration)

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.

10:10 a.m. ET, September 17, 2021

Former FDA chief scientist: Initial White House Covid-19 booster announcement "backwards and not helpful" 

From CNN’s Virginia Langmaid

Dr. Jesse Goodman appears on CNN's New Day on September 17.
Dr. Jesse Goodman appears on CNN's New Day on September 17. (CNN)

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.

“What I do think was backwards and not helpful was that the White House made an announcement with a certain date before, really, all the data had come in – before FDA had had a chance to review it, and before there was this public discussion that we're now going to have,” Goodman told CNN’s Brianna Keilar.

“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.

8:41 a.m. ET, September 17, 2021

NOW: FDA's vaccine advisers meeting on Covid-19 boosters has started 

From CNN’s Maggie Fox and Jamie Gumbrecht

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.

9:12 a.m. ET, September 17, 2021

Scientists don't agree on need for Covid-19 boosters

From CNN's Jacqueline Howard

(Hannah Beier/Bloomberg/Getty Images)
(Hannah Beier/Bloomberg/Getty Images)

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.

"Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high," the scientists write in a new opinion piece, published Monday in the medical journal The Lancet.

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 limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine. Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated," the scientists write. "If vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants."

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.

8:27 a.m. ET, September 17, 2021

State and local health departments are preparing for possible Covid-19 booster rollout

From CNN's Jacqueline Howard

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.

"We don't want to be unprepared," Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials, told CNN on Wednesday.

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.