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Vaccine advisers to the US Centers for Disease Control and Prevention argued long and hard Thursday before recommending booster shots for some Americans age 18 and older who got Pfizer’s Covid-19 vaccine.
The CDC’s Advisory Committee on Immunization Practices voted easily to recommend booster doses of Pfizer’s vaccine to people 65 and older who had their first two Pfizer doses six months ago or longer.
They also voted easily to recommend boosters to people 50 and older with underlying medical conditions that might put them at higher risk of severe disease. However, the advisers were divided on the question of recommending such boosters to people under 50. In a separate question, they voted 9-6 to recommend boosters to people 18-49 who have underlying health conditions.
After long arguments, they voted against recommending boosters for people whose occupations put them at high risk of infection – rejecting the US Food and Drug Administration’s emergency use authorization decision that included such people, such as healthcare workers and other first responders.
What could happen next: CDC officials noted that ACIP can come back and vote on such questions again at any time.
CDC Director Dr. Rochelle Walensky will now need to issue her own decision on ACIP’s recommendations.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted against allowing booster Covid-19 vaccines for people whose jobs or situations put them at high risk of breakthrough infections.
ACIP voted 9-6 against the question: “A single Pfizer-BioNTech Covid-19 vaccine booster dose is recommended based on individual benefit and risk for persons aged 18-64 years who are in an occupational or institutional setting where the burden of Covid-19 infection and risk of transmission are high, at least six months after the primary series under the FDA’s Emergency Use Authorization.”
These might have included frontline workers, include healthcare workers, caregivers for frail or immunocompromised people, people in homeless shelters and people in correctional facilities, the CDC said.
ACIP members argued before voting.
“I feel very uncomfortable about this,” said Dr. Wilbur Chen, a professor of medicine at the University of Maryland School of Medicine. “The implementation part of this is going to be fraught with such complexity that the people with the best health literacy will get boosters.”
But ACIP chair Dr. Grace Lee, a Stanford University pediatrician, said her personal experience made her aware of the need to make boosters widely available.
“I have cared for children who have died of Covid,” she said. “Their family members wish that they had extra protection for their kids.”
Earlier Thursday: ACIP voted to recommend boosters to people 65 and older and to people 50-64 with underlying medical conditions.
That was short of the FDA’s emergency use authorization, which OK’d giving boosters to anyone 18 and older at high risk of severe disease from breakthrough infections. ACIP instead limited its recommendation to people over 50 with such conditions after members expressed doubts about recommending boosters too broadly.
So staff added a third question that would allow a younger group to access boosters. Members were less enthusiastic about this option but voted 9-6 to recommend it.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 9 to 6 Thursday to allow younger adults to get a Covid-19 vaccine dose if they have underlying health conditions.
The vote was on this question: “A single Pfizer Covid-19 vaccine booster dose is recommended for persons based on individual benefit and risk who are aged 18-49 years with underlying medical conditions, at least 6 months after the primary series, under the FDA’s Emergency Use Authorization.”
Moments earlier, ACIP voted to recommend boosters to people 65 and older and to people 50 to 64 with underlying medical conditions. That was short of the FDA’s emergency use authorization, which OK’d giving boosters to anyone 18 and older at high risk of severe disease from breakthrough infections. ACIP instead limited its recommendation to people over 50 with such conditions after members expressed doubts about recommending boosters too broadly.
So staff added a third question that would allow a younger group to access boosters. Members were less enthusiastic about this option.
Now they are voting on recommending boosters for people who are at high risk of infection because of occupation.
Vaccine advisers to the US Centers for Disease Control and Prevention voted 13 to 2 Thursday to endorse giving booster doses of Pfizer’s Covid-19 vaccine to people with underlying medical conditions.
The CDC’s Advisory Committee on Immunization Practices voted on the question: “A single Pfizer/BioNtech covid 19 vaccine booster is recommended for persons aged 50-64 years with underlying medical conditions least six months after the primary series under the FDA’s Emergency Use Authorization.”
Moments earlier, ACIP voted to recommend boosters to people 65 and older. One more vote is coming.
Late on Wednesday, the US Food and Drug Administration authorized giving boosters to people 65 and older and those at higher risk of severe disease and death, as well as people such as health care workers at higher risk of breakthrough infections because of their work.
What happens next: After CDC Director Dr. Rochelle Walensky signs off on the ACIP recommendations, booster shots may be given immediately.
Vaccine advisers to the US Centers for Disease Control and Prevention endorsed giving booster doses of Pfizer’s Covid-19 vaccine to people 65 and older, as well as long-term care facility residents.
The CDC’s Advisory Committee on Immunization Practices voted unanimously on the question: “A single Pfizer/BioNtech covid 19 vaccine booster is recommended for persons aged 65 years or older and long term care facility residents, at least six months after the primary series under the FDA’s Emergency Use Authorization.”
They are now voting on a second question.
Late on Wednesday, the US Food and Drug Administration authorized giving boosters to people 65 and older and those at higher risk of severe disease and death, as well as people such as healthcare workers at higher risk of breakthrough infections because of their work.
A CDC analysis showed it was much more beneficial to give a booster dose to people 65 and older than to people in younger age groups.
After CDC Director Dr. Rochelle Walensky signs off on the ACIP recommendations, booster shots may be given immediately.
Additional types of Covid-19 vaccines may be available at some point in the future, National Institutes of Health Director Dr. Francis Collins said on Thursday.
“There are two vaccines that depend upon a purified protein subunit, basically purifying that spike protein, and adding to it an adjuvant to kind of get the immune system to kick in, and one of those is Sanofi GSK, and one of those is Novavax,” he said in a discussion hosted by Bloomberg Philanthropies.
Collins said there’s also interest in a vaccine that’s easier to handle, store, and administer.
“You want something that is not going to be challenging in terms of its cold chain demand, something that requires ultra-low temperatures is not going to be easy to administer in a lot of parts of the world. There is effort also ongoing, although it’s some distance away, to develop vaccines that could be given by basically a nasal spray, instead of requiring a needle and obviously, that makes it even easier, but you got to be sure it’s going to work.”
While vaccines in children aged 5 to 11 may become available by the end of October, vaccination schedules mean children in this age group won’t be fully vaccinated until December, National Institutes of Health Director Dr. Francis Collins said Thursday.
In a discussion hosted by Bloomberg Philanthropies, Collins said data from Pfizer on its vaccine in this age group is “supposedly coming to FDA in the next week or so.”
Collins said this time frame means that other Covid-19 mitigation measures will still be important for preventing spread in schools through the fall.
“Realistically, in schools for the fall semester, we’re going to have to depend on other means of mitigation. Which means the best thing you can do for those kids is actually be sure they’re hanging out with other people who are immunized,” he said, naming parents, older siblings, and teachers.
Collins added: “And as unpopular as it is, wearing masks in schools, indoors, is clearly going to reduce the likelihood of outbreaks which will drive those kids back home again just when we’re trying to keep them in school where they can have the benefits of that kind of learning experience.”
Data available so far indicates an additional dose of a Covid-19 vaccine can substantially reduce infection, National Institutes of Health Director Dr. Francis Collins said Thursday.
“Without dipping my hand too much, I will say the data looks really impressive, that the boosters do in fact provide substantial reduction in infection, like a tenfold reduction just within 12 days after that booster – and also a reduction in severe illness, which is the thing we’re most concerned about,” Collins said in a conversation hosted by Bloomberg Philanthropies.
Currently, the US Centers for Disease Control and Prevention’s Advisory Committee for Immunization Practices is meeting to consider the recommendation of an additional dose of Pfizer’s Covid-19 vaccine in certain groups.
“Now we’ll see whether CDC agrees with that. People may say this is a very strange and contorting process, but it’s our process, and what it does make possible is for everybody who’s interested to see the data and hear the debate in the public meeting and then understand how we came to the conclusion. I think that’s a really good thing.”
The US Food and Drug Administration understands that people who got Moderna or Johnson & Johnson vaccines want to know if and when they can get booster doses, too, a top FDA official said Thursday.
The CDC’s Advisory Committee on Immunization Practices is considering how to recommend use of boosters after the FDA extended emergency use authorization to Pfizer for a third dose six months after certain people are fully immunized, including those over 65.
The EUA only covered Pfizer’s vaccine, with boosters going to those who got their first two doses of Pfizer/BioNtech vaccine at least six months ago. The FDA has not decided on Moderna’s application for booster authorization, and Johnson & Johnson has not yet applied.
Dr. Peter Marks, who heads the FDA’s vaccine branch, jumped into ACIP’s discussion Thursday.
But he said there is no precise timeline yet.
“I can tell you that we will proceed with all due urgency to try to get there as rapidly as possible working with the various vaccine sponsors,” Marks said.
Health officials in California are considering a Covid-19 vaccine requirement for students 12 and older, Gov. Gavin Newsom said Thursday.
The governor said he recognizes that a decision to require vaccines could be turbulent.
“Well we’re used to pushback, we’re the first state to do a stay-at-home order, first state to require all state employees to get vaccinated or tested as well as school employees to do the same,” he told CNN.
“We want to continue to lean in and we still have a lot of work to do,” Newsom said expressing worry about a winter surge.
“It’s back on the table to get our kids vaccinated 12 to 17. The decision will be made over the course of the next few days with a lot of partners, with 1,050 school districts in the state of California,” the governor added.
Dr. Mark Ghaly, California’s Health and Human Services secretary, reiterated that “no definitive action or decision is being made at the moment.”
Ghaly said childhood immunization requirements are part of a long tradition of protection for students and generally, vaccinations are part of ongoing public health discourse.
“Certainly, the Covid vaccine as raised a number of different concerns from a number of people who have their kids fully vaccinated against a number of the other required vaccine-preventable illnesses that we see. So that said, I just want to start by reminding people that this is not something that is a new part of a conversation,” Ghaly said.
Vaccine advisers to the US Centers for Disease Control and Prevention are meeting now to discuss Covid-19 booster shots. Their meeting comes a day after the US Food and Drug Administration granted emergency use authorization for a booster dose of Pfizer’s vaccine for some people.
Currently, members are discussing the questions to vote on. They are considering the following policy questions:
The committee was scheduled to start voting at 3 p.m. ET and adjourn by 3:30 p.m. ET. However, the discussion is running a bit overtime. It is currently unclear when the vote will begin.
The Covid-19 vaccine booster shot is not the answer to ending the pandemic, a member of the vaccine advisory committee to the US Centers for Disease Control and Prevention said Thursday.
The CDC’s Advisory Committee on Immunization Practices is considering how to recommend use of boosters today. Their meeting comes after the US Food and Drug Administration extended emergency use authorization to Pfizer for a third dose six months after certain people are first fully immunized, including those over 65.
Some members expressed concern that focusing on boosters was causing them to miss the bigger issues.
“And I really feel like, yes, we may move the needle a little bit by giving a booster dose,” Talbot said in comments given before ACIP voted on the question.
“But the real fact of the matter is this is a pandemic of the unvaccinated,” she added.
Some of the people at special risk of severe disease from breakthrough Covid-19 cases include cancer patients, people with chronic kidney disease, heart disease, stroke and diabetes, as well as pregnant women and smokers, the US Centers for Disease Control and Prevention said Thursday.
CDC vaccine advisers are considering how to recommend use of boosters after the US Food and Drug Administration extended emergency use authorization to Pfizer for a third dose of its Covid-19 vaccine six months after people are fully immunized.
The CDC’s Dr. Kathleen Dooling told the Advisory Committee on Immunization Practices there’s a wide variety of people who might be included in the groups named by the FDA: people over 65, those at risk of severe disease and those at high risk of infection because of their jobs.
“Fully vaccinated persons may be at increased risk of SARS-CoV-2 infection due to occupation or setting,” Dooling added. These include essential workers and unpaid caregivers of frail or immunocompromised people, she said.
“Fully vaccinated persons with underlying medical conditions may be at risk of severe COVID-19 if they become infected with SARS-CoV-2,” she added. They include cancer stroke, chronic kidney disease, chronic obstructive pulmonary disease or COPD, diabetes, heart conditions, obesity, pregnancy and smoking.
ACIP is scheduled to vote at 3 p.m. ET.
The benefits of giving booster Covid-19 vaccine doses are much higher for people 65 and older than for younger people, according to an analysis from the US Centers for Disease Control and Prevention.
CDC vaccine advisers are considering how to recommend use of boosters after the US Food and Drug Administration extended emergency use authorization to Pfizer for a third dose six months after people are first fully immunized.
One consideration is how benefits might outweigh any risks and if so, who benefits most.
Immunizing 1 million people 65 and older would prevent 8,000 cases of Covid-19 and 2,080 hospitalizations over six months, the CDC’s Megan Wallace told the Advisory Committee on Immunization Practices. The biggest risk from vaccination with Pfizer’s vaccine is a rare heart inflammatory condition called myocarditis and just one case of myocarditis could be expected in a million people vaccinated in that age group, Wallace said.
“Even if myocarditis risk doubles – we still see more hospitalizations prevented that myocarditis cases expected,” Wallace said.
For every 1 million booster doses given, the model projects four cases of myocarditis among females and 48 among males aged 18 to 29.
A booster would prevent 9,500 cases and 114 hospitalizations among people 18-29, Wallace told the meeting. A booster would prevent:
To put it another way, she said, to prevent one hospitalization over six months, doctors would need to vaccinate 8,738 people 18-29; 3,361 people 30-49; 2,051 people 50 to 64 and 481 people 65 and older.
The CDC projection assumes a booster would raise vaccine effectiveness back up to 95%.
ACIP is scheduled to vote at 3 p.m. ET.
The goal with considering booster shots of Covid-19 vaccines is to do what’s best for the most people, US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said Thursday.
The CDC’s Advisory Committee for Immunization Practices (ACIP) is meeting to decide how best to act on the new authorization for booster shots given late Wednesday from the US Food and Drug Administration.
The FDA granted emergency use authorization to give Pfizer booster shots to people already immunized with Pfizer’s vaccine to certain people – those over 65, those at high risk of severe complications from Covid-19 breakthrough infections and those at high risk of infection because of their jobs.
ACIP is being asked to recommend how best to deploy the vaccines under the EUA. Walensky painted a picture of who might be covered under the new EUA.
“Like you, I’m approaching this decision with an interest in doing what’s right for the public health,” Walensky told the ACIP members.
“And like you, I’m also thinking about the 25-year-old man with cystic fibrosis, who may walk into our clinic, nervous about his risk of for one more complication, and also of the 35-year-old pregnant resident, working in a Tennessee emergency room with a one-year-old at home.”
Walensky said many more decisions will need to be made about Covid-19 vaccines. “We all know that the pace is unlikely to let up any time soon,” she said.
Moderna has asked for authorization for boosters for people who got its vaccine, and Johnson & Johnson is preparing to make a case for boosters for its vaccine.
Vaccine advisers to the US Centers for Disease Control and Prevention are meeting now to discuss Covid-19 booster shots a day after the US Food and Drug Administration Wednesday granted emergency use authorization for a booster dose of Pfizer’s vaccine for some people.
The FDA said it would grant emergency use authorization for boosters in people 65 and older, people at high risk of severe disease and people whose jobs put them at risk of infection.
The CDC must give its stamp of approval for any booster doses to be officially given.
They are expected to vote on the measure today.
The CDC’s Advisory Committee on Immunization Practices can further tweak recommendations for how any vaccine booster doses should be given.
New York Health Commissioner Dr. Howard Zucker has submitted his letter of resignation, according to New York Gov. Kathy Hochul.
He will stay on until the position is filled, she said.
When asked if the administration put pressure on the New York Health Commissioner to resign, due to his connection to former Gov. Andrew Cuomo and the scandal surrounding the sharing of Covid-19 information in nursing homes, Hochul said, “I made it very clear on my first day in office that I would be looking to build a new team, and I am building that team.
“I’m just taking time to build that team, but there will be other changes forthcoming,” she said.
“I do respect everyone who has been a public servant, I thank them for their service,” she added.
New Covid-19 cases have been on the decline over the last week — and while that development is hopeful, one expert is warning it’s not time to let down the guard with the Delta variant still spreading and winter on the way.
Over the last week, the seven-day average of new cases has declined by more than 20,000 to about 130,000 cases a day, according to data from Johns Hopkins University. Much of the decline has to do with states that saw huge numbers of Delta variant cases early, such as Florida and Mississippi, coming down off of their peaks, Ranney told CNN on Wednesday.
And for the second consecutive week, an ensemble forecast from the US Centers for Disease Control and Prevention predicts that new daily Covid-19 hospitalizations will likely decrease over the next four weeks.
Last week’s forecast, published Sept. 15, predicted hospitalizations would decrease for the first time since the June 23 forecast. This week’s forecast predicts that there will be 4,600 to 11,800 new Covid-19 hospital admissions likely reported on Oct. 18.
But the South could still see more cases, and the Northeast could be in for a surge as well, Ranney added. And historically, more cases have been followed by increased hospitalizations — a concerning possibility for many hospitals that are already inundated.
West Virginia recently had its highest number of Covid-19 patients in hospitals on a given day – topping 1,000 for the first time – according to Gov. Jim Justice’s office. And across the country, nearly 80% of intensive care unit beds are in use – more than a quarter of those taken up by Covid-19 patients, according to the Department of Health and Human Services.
Despite the call from healthcare professionals for the public to get vaccinated to keep hospitalizations and death rates low, the current pace of people receiving a first dose of a Covid-19 vaccine is the slowest in two months, according to CDC data.
“For the vast majority of us, if you get your vaccines, you are not going to die,” Ranney said. “As this disease spreads, it spreads throughout the entire community. It’s more likely to catch those more vulnerable people.”
The average bill for a Covid-19 hospitalization is about $75,000, and more serious hospitalizations – such as those that require the use of ventilators or days in an ICU – cost more than $300,000 on average, according to a new analysis of insurance claims from FAIR Health.
After price negotiations, the average allowed amount actually paid by patients and in-network insurance providers is about $33,500 for a general Covid-19 hospitalization and about $98,000 for a more complex hospitalization.
For this analysis on Covid-19 hospitalizations, FAIR Health – a non-profit organization focused on bringing transparency to health care costs and insurance – assessed claims for inpatient services such as lab tests, radiology, room and board, treatments and specialty drugs, as well as outpatient and provider services such as follow-up office visits and oxygen and respiratory equipment for previously hospitalized patients.
A separate study published in August found that Covid-19 hospitalizations cost an average of about $22,000 for Medicare fee-for-service enrollees. That’s nearly 150 times more than Medicare pays to reimburse health care providers to fully vaccinate Medicare beneficiaries. Covid-19 vaccines are provided at no direct cost to residents of the United States.
According to the FAIR Health analysis, treatment for Covid-19 that does not result in hospitalization – including lab work, radiology and cardiography procedures – could cost non-insured patients an average of more than $2,500. For insured patients who are treated in-network, the average total cost to insurance and the patient is about $1,000.
The information about the safety of Covid-19 vaccines in pregnant women is “incredibly reassuring,” the chair of a panel of vaccine advisers to the US Centers for Disease Control and Prevention said Wednesday.
Only 30% of pregnant women in the US have been vaccinated against coronavirus – even as Covid-19 is killing more pregnant women than ever before, the advisers heard during the panel.
The CDC’s Advisory Committee on Immunization Practices is meeting Wednesday and Thursday to discuss vaccine safety and the potential need for coronavirus vaccine boosters.
The panel heard the latest data on vaccine safety during pregnancy.
So far, there’s no evidence that getting vaccinated during pregnancy raises the risk of miscarriage or birth defects, several experts said during the meeting.
But pregnant people have a higher risk than most of severe disease if they catch coronavirus, Dr. Dana Meaney-Delman, the CDC’s lead on maternal immunization, said during the meeting.
“We now see increased numbers of pregnant people admitted to the ICU in July and August,” Meaney-Delman said.
The trend has continued into September, she said.
“The deaths reported in August is the highest number of deaths reported in any month since the start of the pandemic,” Meaney-Delman added.
About 97% of the pregnant people treated in the hospital for Covid-19 have been unvaccinated, she said.
