FDA approves updated COVID vaccines with restrictions on who can receive them
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(WASHINGTON) — The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines for some Americans.
The vaccines were approved for use in adults aged 65 and older and for those between ages 5 and 64 with at least one underlying condition that puts them at high risk for severe COVID.
This is a developing story. Please check back for updates.
Additionally, for the week ending Aug. 23, 11.2% of weekly tests came back positive for COVID, up from 3.3% the prior two months, CDC data shows.
Despite the increases, metrics remain much lower than in previous years.
Hospitalization rates are about three times lower than at the same time last year and the percentage of weekly tests coming pack positive is about two times lower compared to the same period last year.
Additionally, over the past two months, roughly 200 Americans have been dying from COVID every week, according to CDC data.
There has been confusion over who may be able to receive a COVID vaccine after the Food and Drug Administration approved updated versions of those shots for those over age 65 and younger Americans who are at high risk for severe disease. Federal health officials have insisted that anyone who wants the shot can receive it.
CDC data shows test positivity has increased above 10% in much of the southwest and western U.S. as kids head to class.
“When the dust settles, I expect it to not be as bad as last year … but that still means that some people are getting sick,” Dr. Peter Chin-Hong, a professor of medicine and an infectious diseases specialist at the University of California, San Francisco, told ABC News. “Fewer people are getting hospitalized, proportionately speaking, but some people are still being hospitalized.”
“The reason why we’re seeing the increase is because of the usual factors of more than six months since a lot of people got COVID [and] new variants,” he continued.
As of the week ending August 30, XFG, an offshoot of the omicron variant, is the dominant variant in the U.S., accounting for an estimated 78% of new COVID cases.
Meanwhile, NB.1.8.1 and LP.8.1, also omicron variant offshoots, make up 14% and 3% of estimated new COVID cases in the U.S., CDC data shows.
Dr. William Schaffner, a professor of preventive medicine and of medicine at Vanderbilt University School of Medicine, told ABC News that because the currently circulating variants are all members of this omicron family, there are no major mutations that make the virus more transmissible or more infectious.
“You can think of them all as cousins,” he said. “Now these cousins do share a couple of characteristics, one is that they appear to be fairly contagious and are quite capable of producing a great deal of mild disease. By mild, I mean not serious enough to get you into the hospital.”
Schaffner continued, “Fortunately, the vaccines that will become available this fall … should provide reasonable protection against serious disease caused by these variants.”
In a press release, Pfizer-BioNTech said its 2025-2026 COVID vaccine will target the LP.8.1 sublineage in line with FDA guidance to more closely match circulating strains.
It remains unclear how COVID vaccinations will be rolled out in the U.S. Recently, CVS said how it offers the shots will vary by state due to “the current regulatory environment.”
In 34 states, Americans can receive the COVID vaccine at a CVS pharmacy. In 13 states and in Washington, D.C., Americans can be vaccinated, depending on age, with a prescription. In three states – Massachusetts, Nevada and New Mexico – the COVID vaccine isn’t being offered.
Chin-Hong said he is worried about low vaccination rates as the country heads into respiratory virus season during the fall and winter months.
“As vaccination rates decline, from both people’s desire as well as structural barriers that are being put up by the federal government, it means that fewer people are going to get vaccines, even if people wanted to,” he said. “I’m worried that … it may mean that we would have some hospitalizations and deaths that we wouldn’t have seen normally if there was a simpler rule around vaccines.”
Schaffner said those who can receive the COVID vaccine should do so, along with the annual influenza vaccine, and advised those with risk factors for severe disease to be more cautious.
“You can get out your mask and put that on when you’re going indoors in crowded environments,” he said. “And if you’re really concerned, as I like to say, do some social distancing. Stream the movie rather than going to the movie.”
ABC News’ Youri Benadjaoud and Cheyenne Haslett contributed to this report.
(Ukraine) — About 70% of children in Ukraine — roughly 3.5 million — do not have access to basic goods and services, such as adequate food or shelter, more than three years into the country’s ongoing war with Russia, according to new data published Thursday from UNICEF.
This is a four-fold increase from the 18% who were experiencing the same level of “material deprivation” in 2021, before Russia invaded Ukraine.
UNICEF said “continued and relentless attacks” from Russia on Ukrainian infrastructure as well as on homes, schools and health care facilities have led to a rise in material deprivation.
“Seven out of 10 children are experiencing a severe deprivation in one of these areas that we have looked at whether that’s nutritious food, warm clothing, eating, spaces to play all of the things that any person would want for that child,” Joe English, a communications specialist with UNICEF, told ABC News. “And this is the result when you have more than three years of grinding war with little end in sight.”
English added, “It’s 70% who have this material deprivation, but there is not a child in Ukraine who has not been affected by this war today.”
UNICEF also found that one-third of children in Ukraine live in homes without a functioning water supply and sewage, and nearly half of children in the country do not have access to an area to play at home or outside.
English said it’s likely that these shares of children will only increase unless a ceasefire occurs.
Children in Ukraine have been among the casualties of the war. More than 2,700 children have been killed or maimed since February 2022, according to UNICEF.
Due to the destruction of health care infrastructure, English said many children have not been able to get the care they need for injuries and cannot be medically evacuated either.
English said when he was in Ukraine, he met a 15-year-old boy named Andre whose leg was badly injured when a car he was traveling in hit a landmine. Andre was eventually medically evacuated for treatment.
“No parent, no child wants to leave their homeland if they have any kind of choice,” English said. “When I spoke to Andre, he was adamant he would have preferred to stay in Ukraine, been able to have the support there. And so, investing in health facilities, health structures so that families can continue their lives is critical.”
He added that building infrastructure for psychosocial support is also critical due to children who currently need mental health support and will need it years from now.
“Providing that psychosocial support, that starts with a safe space and then professional, dedicated support to help children process the experiences they’ve been through,” he said. “It’s critical because … it really can help children recover.”
The UNICEF report comes as Russia hit Kyiv with another massive air attack overnight, sending missiles and drones over the span of almost 10 hours, according to Ukrainian President Volodymyr Zelenskyy. At least two were killed and 22 others were injured, Ukrainian officials said.
Russia’s Defense Ministry said the July 10 strikes targeted “military-industrial complex facilities” and an airfield.
The first 10 days of July have already seen Russia launch 2,464 drones and 58 missiles into Ukraine, according to Ukrainian air force data.
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(WASHINGTON) — The Advisory Committee on Immunization Practices (ACIP), made up of members recently hand-selected by Health and Human Services Secretary Robert F. Kennedy Jr., voted 5-1 on Thursday to recommend against flu vaccines containing the preservative thimerosal.
A few moments before, the Centers for Disease Control and Prevention’s vaccine advisory committee voted 6-0 to recommend all Americans aged 6 months and older receive an annual influenza vaccine.
One committee member, Vicky Pebsworth, abstained on each vote.
Thimerosal is a mercury-based preservative, which is used to prevent microbial contamination of vaccines. Most flu vaccines currently used in the United States contain little to no thimerosal, but both the Food and Drug Administration and the CDC say there is no evidence low doses of thimerosal in vaccines cause harm other than minor reactions at the injection site, such as redness or swelling.
Additionally, a 2010 CDC study found exposure to vaccines and immunoglobulins that contain thimerosal, in prenatal or infant stages, does not increase risk for autism spectrum disorder.
This preservative was previously used in some common childhood immunizations, However, in the late 1990s, federal health agencies, the American Academy of Pediatrics and vaccine manufacturers agreed to reduce or eliminate thimerosal in vaccines as a precautionary measure, which public health experts previously told ABC News gave rise to anti-vaccine groups alleging thimerosal is not safe and fueled speculation that mercury causes autism.
Kennedy, who has promoted vaccine-skeptic views that experts and decades of robust research have refuted, wrote a book in 2014 falsely claiming thimerosal is “toxic to brain tissue” and may cause autism, calling for its removal from all vaccines.
During the ACIP meeting, Lyn Redwood, a former president of Children’s Health Defense, a group that used to be chaired by Kennedy, gave a highly charged presentation as a private citizen. She claimed the preservative was toxic to the brain and refuted evidence-based claims that there has been no proven harm from thimerosal in vaccines.
Her presentation received pushback from ACIP member Dr. Cody Meissner, who was the only member to vote against the recommendation. He said there “is no scientific evidence that thimerosal has caused problems.”
“The risk for influenza is so much greater than the non-existing risk from thimerosal,” he added.
Meissner said vaccines with thimerosal are metabolized as ethylmercury, not methylmercury, which is the form of mercury found in fish and shellfish, and is known to be a neurotoxin.
“I’m not quite sure how to respond to this presentation,” he said. “This is an old issue that has been addressed in the past. Ethylmercury is excreted much more quickly from the body. It is not associated with the high neurotoxicity that methylmercury [is].”
Meissner also added that thimerosal is included in most multi-dose vaccines administered around the world because single-dose vials are more expensive, and removing thimerosal could increase the costs of vaccines.
“Thimerosal is included in most vaccines that are administered around the globe, and that is because single-dose vials are more expensive, and many countries cannot afford a single-dose vial,” Meissner said.
He went on, “I realize ACIP is focused on the United States, but the recommendations that the ACIP makes are followed among many countries around the world and removing thimerosal from all vaccines that are used in other countries, for example, is going to reduce access to these vaccines, it will increase cost.”
Multiple liaisons of medical groups in the committee also questioned in the meeting why Redwood was permitted to present given her limited scientific background and pushed back on the lack of peer-reviewed studies in her presentation.
“This committee has always prided itself on openness, transparency and data and evidence. So I am wondering if we will have an actual scientific presentation with peer-reviewed literature, strong evidence to actually discuss this issue, as many statements have been made here today, without support of science or evidence, but merely opinion,” Dr. Jason Goldman, a liaison for the American College of Physicians (ACP), said in the meeting.
A CDC review of evidence on thimerosal was previously published on the agency’s website — showing no safety risks from the ingredient — but was later taken down. A former CDC official posted a copy of the article online.
“A scientifically rigorous CDC report reviewing the safety of thimerosal was posted for public access and then abruptly removed at the direction of the Office of the Secretary. The removal of this document, which contextualized decades of evidence showing no link between thimerosal and neurotoxicity or autism, raises serious concerns about transparency and the integrity of the decision-making process,” Sean O’Leary, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said in a statement to ABC News.
Doctors have voiced concern that no longer recommending thimerosal in some flu shots could lead to less people getting vaccinated and fuel further distrust of vaccines.
“Any decrease in the number of flu vaccines available will likely result in fewer people being vaccinated and subsequently more hospitalizations and deaths. Its removal could also signal to the general public unwarranted safety concerns,” O’Leary said.
Another heated exchange in the meeting came during the discussion of flu vaccines when ACIP member Dr. Robert Malone described the 250 flu deaths among children during the most recent flu season as a “modest number.”
“The 250 pediatric deaths, which is, let’s acknowledge, is a modest number fortunately,” Malone said.
This past season saw the highest number of flu deaths among children for a non-pandemic season, and the highest number seen since the 2009 H1N1 global flu pandemic, CDC data shows.
Malone received immediate push back during the meeting. Goldman from ACP said the number of deaths “is not a small number, especially if it’s your own child dying from the vaccine preventable illness.”