fda booster shot :: Article CreatorSecond Dose Of This Year's COVID Vaccine Recommended For People Age 65 And Up
Immunocompromised people and those who are age 65 or older should get a second dose of the 2024-2025 COVID-19 vaccine, according to the latest recommendations from the Centers for Disease Control and Prevention.
In a statement released Wednesday, the CDC said the second dose should be received six months after the first dose.
The CDC also said its recommendations allow for flexibility for those who are moderately or severely immunocompromised to consider additional doses (three or more). In consultation with their health care provider.
In August, the Food and Drug Administration greenlit updated COVID-19 vaccines from Pfizer and Moderna for the 2024 fall season. The updated shots were revised to target the KP.2 variant of SARS-CoV-2, the virus that causes COVID-19, and medical experts say it will also provide protection against other recent strains.
This was part of a now-annual process undertaken by the FDA and health authorities around the world to update the vaccines to protect against newer strains of the virus.
Similar to previous seasons, the Centers for Disease Control and Prevention recommends that all Americans ages 6 months and older get a shot of the updated 2024-2025 COVID-19 vaccine to protect against another expected surge of the virus this fall and winter.
Still, as another fall virus season approaches, not everyone is following the CDC's advice. According to a survey from Ohio State Wexner Medical Center last month, less than half of Americans were planning to get their COVID or flu shots this season.
"Data continues to confirm the importance of vaccination to protect those most at risk for severe outcomes of COVID-19," the CDC noted in the latest release. "Receiving recommended 2024-2025 COVID-19 vaccines can restore and enhance protection against the virus variants currently responsible for most infections and hospitalizations in the United States."
The CDC also reminded the public that the COVID-19 vaccine can help reduce the chances of suffering the effects of long COVID.
Editor's note: This story has been updated to clarify that the second dose is recommended for everyone age 65 or over, as well as people who are immunocompromised.
Alexander Tin contributed to this report.
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Sara Moniuszko is a health and lifestyle reporter at CBSNews.Com. Previously, she wrote for USA Today, where she was selected to help launch the newspaper's wellness vertical. She now covers breaking and trending news for CBS News' HealthWatch.
HHS Spent $911M On COVID Vaccine Messaging, 'consistently Overstated' Virus Risk To Kids, Damning House Report Finds
The Department of Health and Human Services (HHS) spent $911 million of taxpayer money on a massive COVID-19 vaccination promotion campaign that lied about masking, vaccines and boosters — and "consistently overstated" the risk of the virus to children, according to a shocking House committee report.
The GOP-led House Energy and Commerce panel released a scathing, 113-page document Wednesday about the most significant public health missteps, fibs and cover-ups from HHS and its subagency, the Centers for Disease Control and Prevention (CDC), during the COVID-19 pandemic.
"CDC's guidance, which the Campaign relied on, went beyond the terms of FDA's Emergency Use Authorization (EUA) to state, without evidence, that COVID vaccines were highly effective against transmission," the report states. "This ultimately had a negative impact on vaccine confidence and the CDC's credibility when proven untrue."
HHS shelled out $911,174,285 from taxpayer funding to the behavior change research and strategy firm Fors Marsh for the multimedia advertising campaign between August 2020 and June 2023. Bloomberg via Getty Images
It also states that the CDC "had inconsistent and flawed messaging about the effectiveness of masks," "consistently overstated the risk of COVID-19 to children" and still "continues to recommend COVID-19 vaccines for all Americans ages six months and older, which has made the United States a global outlier in COVID-19 policy."
HHS shelled out $911,174,285 to the behavior change research and strategy firm Fors Marsh for the multimedia advertising campaign between August 2020 and June 2023.
That's 20 times more than the $45 million spent on an ad campaign by the National Institutes of Health to promote its National Cancer Institute in 2012 — and roughly 40 times the whole communications budget that same year for the Food and Drug Administration (FDA).
The "We Can Do This" campaign kicked off as the final stages of Operation Warp Speed vaccine trials wound down — and then-Democratic vice presidential nominee and California Sen. Kamala Harris sowed doubt about their efficacy.
"I will say that I would not trust Donald Trump, and it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he's talking about," she told CNN of Operation Warp Speed in September 2020. "I will not take his word for it."
The "We Can Do This" campaign kicked off as the final stages of Operation Warp Speed vaccine trials wound down — and even prominent politicians like Kamala Harris began to sow doubt about its efficacy. US Congress
Nevertheless, Harris and President Biden's administration went on to spread unreliable information about "vaccine uptake, masking, social distancing and booster vaccine uptake," much of which was based on CDC guidance.
As the House panel probed the campaign, the CDC began to "edit and erase" many of the video ads from its YouTube channel, the report noted.
None remain available to the public — and most used scaremongering to browbeat the unvaccinated into believing that taking the shot was the only way to return to pre-pandemic norms.
"Say yes. Say yes to seeing friends. Yes to hanging out. Yes to vacations. Yes to sleepovers. After a year of saying no, imagine how good yes is going to feel. Everyone 12 and older is now eligible for COVID vaccines," a June 16, 2021, ad script read.
Charts from the report show vaccine uptake remained relatively flat despite the ad campaign. US Congress
"Get a COVID vaccine. Party like it's 2019," a June 22, 2021, ad also promised while showing footage of a nightclub.
"The Delta wave that we're seeing now, people are younger and sicker, and we're intubating and losing people that are my age and younger," said a visibly rattled nurse in another October 2021 ad. "People with kids that are my kids' age that are never gonna see their kids graduate. They're never gonna meet their grandkids and then to know that they could have gotten vaccinated, and it could have made a difference."
The campaign also tapped social media influencers, whose videos remain up, and made use of health professionals who toed the party line in an effort to reach the so-called "movable middle" of vaccine-hesitant Americans.
"I will continue to listen to the health professionals in my life and I will continue … believing in science because it's brought us so many good things," one of many vlogs boosted by the campaign declared.
Even after a majority of the US population had gotten vaccinated by June 2022, the campaign was pushing for children as young as 6 months old to be given the jab. MediaNews Group via Getty Images
Fors Marsh's internal surveys, however, found that by March 2022, between 60% and 76% of parents with unvaccinated kids younger than 18 had concerns about side effects that were not sufficiently answered.
Through several "Ask a Doctor" sessions, the campaign also parroted CDC recommendations — that did not align with published scientific studies — to urge vaccination and continued booster shots.
Even after a majority of the US population had gotten vaccinated by June 2022, the campaign was pushing for children as young as 6 months old to be given the jab.
"It doesn't really matter if your child's completely healthy, because some children will have the sniffles, maybe signs like the flu; fever, runny nose, or body aches. But others will end up in the hospital and end up there for a long time," another ad from the campaign threatened.
CDC Director Rochelle Walensky had overruled her agency's Advisory Committee on Immunization Practices in September 2021 and unilaterally approved booster shots without their input. Getty Images
Then-CDC Director Rochelle Walensky overruled her agency's Advisory Committee on Immunization Practices in September 2021 and unilaterally approved booster shots without their input. Two senior advisers on the committee resigned the same month.
Walensky would also later cave to pressure from powerful unions like the American Federation of Teachers to keep schools closed to in-person learning in early 2021.
The US was an outlier in pushing for child vaccinations, as other industrialized nations like the UK, France, Germany, Australia and Japan did not recommend COVID shots except for those with pre-existing conditions.
The FDA had also issued emergency use authorizations for the Pfizer-BioNTech and Moderna COVID vaccines back in December 2020 despite no clinical data showing the length of their efficacy or whether they blocked viral transmission from person to person.
Walensky would also later cave to pressure from powerful unions like the American Federation of Teachers to keep schools closed to in-person learning in early 2021. REUTERS
At the time of Walensky's booster decision, studies were already showing that COVID posed virtually no risk to children and the virus was not spreading at higher rates in classrooms.
The then-CDC chief had already made erroneous assertions about the vaccines in high-profile media interviews and congressional testimony, going beyond even the manufacturers and the FDA's assessment to claim COVID-19 transmissibility was reduced after vaccination.
"Data have emerged again, that have demonstrated, even if you were to get infected during post-vaccination, that you cannot give it to anyone else," Walensky told members of the Senate Appropriations Committee in a May 2021 hearing.
"CDC personnel should — and must — have known that, historically, vaccines inoculating against respiratory viruses are seldom 100[%] effective at stopping transmission, largely due to viral mutation," the House report notes.
To counter the growing consensus that breakthrough infections were occurring, the campaign rolled out ads that called for double masking. Getty Images
To counter the growing consensus that breakthrough infections were occurring, the campaign rolled out ads that called for double masking.
"My son and I were headed down to the store when he asked me why I always get an extra bag of nuts and an extra water. 'Well, it's a backup,' I tell him. It's doubling up, so you are covered for later," an ad titled "Double-Up Dad" from July 2021 stated.
"He then asks me why I am still avoiding crowded places and wearing my mask since I already got the vaccine. I say, 'Son, it's the double-up effect.' It's doing our part and doing what is right, so we are protected. There are new forms of the virus, so we need to double up to beat them," it adds.
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The ad ran alongside one featuring a "Double-Up Mom," with both spots targeting Native American parents.
"I know many people are getting the vaccine, but there are new forms of the virus, and I don't want to take the chance. Wearing a well-fitted mask, keeping 6 feet apart, and avoiding crowds are my way of doubling up against the virus," the mother says.
Children and young people under 18 years of age who had a positive COVID-19 infection in the first year before vaccines were approved had a survival rate of 99.995%, according to a July 2021 study in the UK of all COVID-related deaths in that cohort conducted by Nature Medicine.
Children and young people under 18 years old who had a positive SARS-CoV-2 infection in the first year of infection before vaccines had a survival rate of 99.995%, a Nature Medicine study found. UCG/Universal Images Group via Getty Images
"The risk of removal of [children and young people] from their normal activities across education and social events might prove a greater risk than that of [COVID-19] itself," the authors also warned.
HHS' masking crusade was also a crucial part of the ad campaign and continued even after the rollout of vaccines in 2021.
"I know we need to keep up everything we're already doing — masking up, keeping that 6-foot distance, and avoiding crowds," intoned a radio ad that aired in March 2021.
The all-out masking effort by the most prominent public health figure of the pandemic — Dr. Anthony Fauci — had the worst effect on schoolchildren, according to the committee report. Bloomberg via Getty Images
Another radio ad that same month featured two women discussing how they had become "experts at things like social distancing in the park" and that others "won't see us hanging out indoors with our friends."
All state governors had terminated stay-at-home orders by the end of May 2020, and the CDC published a study four months later that only found the restrictions were able to "help reduce activities associated with the spread of COVID-19" — not the actual viral spread.
The all-out masking effort by the most prominent public health figure of the pandemic — Dr. Anthony Fauci — had the worst effect on schoolchildren, according to the committee report.
Fauci urged leaders "to be as forceful as possible in getting your citizenry to wear masks" during a July 2020 event with the US Chamber of Commerce — though studies and the doctor himself later confirmed they made little to no difference. CQ-Roll Call, Inc via Getty Images
The Education Department later released statistics in September 2022 showing reading scores among 9-year-olds had plummeted over the course of the outbreak to their lowest point in 30 years, while math scores fell for the first time ever in a half-century of tracking.
US officials like Fauci, then director of the National Institute of Allergy and Infectious Diseases (NIAID), and Surgeon General Jerome Adams infamously advocated against the use of masks early in the pandemic, before reversing course.
"Masks are really for infected people to prevent them from spreading infection to people who are not infected rather than protecting uninfected people from acquiring infection," Fauci even wrote in a private February 2020 email.
The ex-NIAID head testified to another House committee in January that he was worried about causing a shortage of masks for frontline health care workers and they were not aware how prevalent asymptomatic spread was at the time.
A page from the House committee report on the unvaccinated population. US Congress
Fauci later urged leaders "to be as forceful as possible in getting your citizenry to wear masks" during a July 2020 event with the US Chamber of Commerce — though studies and the doctor himself later confirmed they made little to no difference.
The White House chief medical adviser still called for a federal mask mandate on planes, trains and other public transportation that was struck down by the courts in 2022, after pressuring schools in the preceding years into adopting a 6-foot social distancing rule that had no scientific basis.
The Energy and Commerce panel closed its report with several recommendations calling for further transparency, as well as a system to report vaccine injuries and further study of the risks of myocarditis and blood clots after taking the shots.
"While parts of CDC's former COVID-19 health guidance have been preserved on its COVID-19 Museum Timeline — albeit the more favorable parts of such guidance — the CDC has also entirely erased and replaced unscientific guidance, blatant errors, and unfavorable press releases," the report notes.
Chairwoman Cathy McMorris Rodgers (R-Wash.) added in a statement that the agencies spent nearly $1 billion "trying to manipulate Americans with advertisements — sometimes containing erroneous or unproven information." CQ-Roll Call, Inc via Getty Images
"Such editing and erasing of guidance and web content on its government-controlled website, and making taxpayer funded Campaign videos inaccessible is unacceptable," it concludes, "particularly considering the historic and life-altering nature of the COVID-19 pandemic."
Committee Chairwoman Cathy McMorris Rodgers (R-Wash.) added in a statement that federal agencies spent nearly $1 billion "trying to manipulate Americans with advertisements — sometimes containing erroneous or unproven information."
"By overpromising what the COVID-19 vaccines could do — in direct contradiction of the FDA's authorizations — and over emphasizing the virus's risk to children and young adults," she added, "the Biden-Harris administration caused Americans to lose trust in the public health system."
Reps for HHS did not immediately respond to a request for comment.
FDA Places Hold On Novavax's COVID-influenza Combo Vaccine
The FDA has placed a hold on the investigational new drug (IND) application for Novavax's COVID-19 and influenza combination vaccine candidate, as well as a standalone influenza vaccine candidate. The hold does not affect the standalone COVID-19 vaccine.
The FDA's decision follows a report of a serious adverse event from a patient outside the US who took part in a phase 2 trial with the combination vaccine that had been completed in July 2023.
The participant, who received the vaccine in January 2023, reported developing a case of motor neuropathy in September this year. This report led the FDA to halt the development of the vaccine to investigate whether the adverse event could be related to the vaccine candidate.
Robert Walker, Chief Scientific Officer of Novavax, stated that the company has no reason to believe this adverse event was caused by the vaccine. No other cases of motor neuropathy have been reported in previous clinical trials evaluating the combination COVID-19 and influenza vaccine.
"We are working closely with the FDA to provide the necessary information that will allow them to better understand this observation and resolve the clinical hold," said Walker. "It is important to note that safety is our top priority, and while we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA. Our goal is to successfully resolve this matter and to start our phase 3 trial as soon as possible."
The results of the completed phase 2 trial with both the combination and standalone influenza vaccine were positive. For the influenza vaccine candidate, the response was significantly higher than that of Novartis' Fluad and Sanofi's Fluzone, two commercially available influenza vaccines
Novavax had plans to launch a phase 3 trial of both the combination and standalone influenza vaccine later this year, which may be affected by the clinical hold placed by the FDA.
The news comes as the company executes a strategy to reduce annual expenses and R&D costs by more than 50% — including two layoffs that reduced its workforce by approximately 30% at the beginning of this year.
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