Latest news with #Makary
Yahoo
a day ago
- General
- Yahoo
FDA: COVID-19 vaccine choice in pregnancy is personal
Federal health officials have pulled back a key recommendation that pregnant women get the COVID-19 vaccine -- causing sharp criticism from doctors and other experts. The announcement came Tuesday from Health and Human Services Secretary Robert F. Kennedy Jr., who said the government will no longer recommend COVID shots for healthy children or pregnant women. Dr. Marty Makary, head of the U.S. Food and Drug Administration (FDA), said Wednesday that the decision should be made between a pregnant woman and her doctor. "The data on the COVID vaccine booster in pregnant women is a mixed set of data," Makary said in an interview. "Now, I think the decision should be between a doctor and a pregnant woman." The U.S. Centers for Disease Control and Prevention (CDC) usually relies on a panel of vaccine experts to review studies and make public health recommendations. This process was skipped in making the COVID recommendation. The CDC, which currently has no director, still hasn't updated its website to reflect the change. Its advice plays a major role in insurance coverage. If the CDC no longer recommends a vaccine, many patients may be unable to get it for free. The CDC has said pregnant women are more likely to become seriously sick from COVID than people who aren't pregnant. Dr. Beverly Gray, an OB-GYN at Duke Health in Durham, N.C., told NBC News she'll keep recommending the shot to her patients. "The evidence is [overwhelmingly] clear that it reduces the risk of miscarriage, risk of ICU admissions, risk of death," Gray said. "And as an obstetrician-gynecologist who cared for patients through the COVID pandemic and who cared for patients who lost their pregnancies, there are really scary consequences of getting an infection." She said this sudden change may cause more confusion for pregnant people trying to make informed decisions. "It's really heartbreaking to see this movement against science and data," Gray said. Dr. Jesse Goodman, a former FDA chief scientist, said he hasn't seen any "mixed" data about the COVID shot in pregnancy. "I am aware of multiple studies that have shown the benefit of COVID vaccines in protecting pregnant women, who are very clearly at very high risk of more severe outcomes from COVID," he told NBC News. "Several studies have also shown that maternal immunization helps protect against illness and hospitalizations in infants less than 6 months old." Dr. Paul Offit, head of the Vaccine Education Center at Children's Hospital of Philadelphia, agreed. He said pregnant women are 1.5 to 2 times more likely to be hospitalized or die from COVID. "It seems to be that the burden of proof on not recommending for pregnancy is on [the government] to prove that it really isn't a value anymore," Offit said. Tuesday's announcement was made without anyone from the CDC present. Makary said "many scientists" were involved in the discussions but didn't confirm if any were from the CDC. He also wouldn't say whether the government would release any data supporting the recommendation. The American College of Obstetricians and Gynecologists (ACOG) called the move "extremely disappointing," NBC News reported. "We also understand that despite the change in recommendations from HHS, the science has not changed," the group said in a statement. "It is very clear that COVID infection during pregnancy can be catastrophic and lead to major disability." More information The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccination. Copyright © 2025 HealthDay. All rights reserved.
UPI
a day ago
- Health
- UPI
FDA: COVID vaccine choice in pregnancy is personal
Federal health officials have pulled back a key recommendation that pregnant women get the COVID-19 vaccine -- causing sharp criticism from doctors and other experts. The announcement came Tuesday from Health and Human Services Secretary Robert F. Kennedy Jr., who said the government will no longer recommend COVID shots for healthy children or pregnant women. Dr. Marty Makary, head of the U.S. Food and Drug Administration (FDA), said Wednesday that the decision should be made between a pregnant woman and her doctor. "The data on the COVID vaccine booster in pregnant women is a mixed set of data," Makary said in an interview. "Now, I think the decision should be between a doctor and a pregnant woman." The U.S. Centers for Disease Control and Prevention (CDC) usually relies on a panel of vaccine experts to review studies and make public health recommendations. This process was skipped in making the COVID recommendation. The CDC, which currently has no director, still hasn't updated its website to reflect the change. Its advice plays a major role in insurance coverage. If the CDC no longer recommends a vaccine, many patients may be unable to get it for free. The CDC has said pregnant women are more likely to become seriously sick from COVID than people who aren't pregnant. Dr. Beverly Gray, an OB-GYN at Duke Health in Durham, N.C., told NBC News she'll keep recommending the shot to her patients. "The evidence is [overwhelmingly] clear that it reduces the risk of miscarriage, risk of ICU admissions, risk of death," Gray said. "And as an obstetrician-gynecologist who cared for patients through the COVID pandemic and who cared for patients who lost their pregnancies, there are really scary consequences of getting an infection." She said this sudden change may cause more confusion for pregnant people trying to make informed decisions. "It's really heartbreaking to see this movement against science and data," Gray said. Dr. Jesse Goodman, a former FDA chief scientist, said he hasn't seen any "mixed" data about the COVID shot in pregnancy. "I am aware of multiple studies that have shown the benefit of COVID vaccines in protecting pregnant women, who are very clearly at very high risk of more severe outcomes from COVID," he told NBC News. "Several studies have also shown that maternal immunization helps protect against illness and hospitalizations in infants less than 6 months old." Dr. Paul Offit, head of the Vaccine Education Center at Children's Hospital of Philadelphia, agreed. He said pregnant women are 1.5 to 2 times more likely to be hospitalized or die from COVID. "It seems to be that the burden of proof on not recommending for pregnancy is on [the government] to prove that it really isn't a value anymore," Offit said. Tuesday's announcement was made without anyone from the CDC present. Makary said "many scientists" were involved in the discussions but didn't confirm if any were from the CDC. He also wouldn't say whether the government would release any data supporting the recommendation. The American College of Obstetricians and Gynecologists (ACOG) called the move "extremely disappointing," NBC News reported. "We also understand that despite the change in recommendations from HHS, the science has not changed," the group said in a statement. "It is very clear that COVID infection during pregnancy can be catastrophic and lead to major disability." More information The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccination. Copyright © 2025 HealthDay. All rights reserved.
Miami Herald
2 days ago
- Health
- Miami Herald
Silence on an E. Coli outbreak shows how changes under Trump affect food safety
Colton George felt sick. The 9-year-old Indiana boy told his parents his stomach hurt. He kept running to the bathroom and felt too ill to finish a basketball game. Days later, he lay in a hospital bed, fighting for his life. He had eaten tainted salad, according to a lawsuit against the lettuce grower filed by his parents on April 17 in federal court for the Southern District of Indiana. The E. coli bacteria that ravaged Colton's kidneys was a genetic match to the strain that killed one person and sickened nearly 90 people in 15 states last fall. Federal health agencies investigated the cases and linked them to a farm that grew romaine lettuce. But most people have never heard about this outbreak, which a Feb. 11 internal FDA memo linked to a single lettuce processor and ranch as the source of the contamination. In what many experts said was a break with common practice, officials never issued public communications after the investigation or identified the grower who produced the lettuce. From failing to publicize a major outbreak to scaling back safety alert specialists and rules, the Trump administration's anti-regulatory and cost-cutting push risks unraveling a critical system that helps ensure the safety of the U.S. food supply, according to consumer advocates, researchers and former employees at the FDA and U.S. Department of Agriculture. The investigation into the illnesses began near the end of the Biden administration but work on the lettuce outbreak wasn't completed until Feb. 11. At that time, the decision was made by the Trump administration not to release the names of the grower and processor because the FDA said no product remained on the market. The administration also has withdrawn a proposed regulation to reduce the presence of salmonella in raw poultry, according to an April USDA alert. It was projected to save more than $13 million annually by preventing more than 3,000 illnesses, according to the proposal. Officials from the Department of Health and Human Services have said that food safety is a priority, and FDA Commissioner Marty Makary said in an April 29 interview with the newsletter Inside Medicine that the recent job cuts would not affect agency operations. 'The FDA had 9,500 employees in 2007. Last year it was nearly 19,000. Has the 100% increase in employees increased approval times, innovation, AI, food safety, or agency morale?' Makary asked. 'No, it hasn't. In fact, it's increased regulatory creep.' The FDA referred questions to HHS, which declined to comment or make Makary available for an interview. In a statement, the agency said 'protecting public health and insuring food safety remain top priorities for HHS. FDA inspectors were not impacted [by job cuts] and this critical work will continue.' Public health advocates warn companies and growers will face less regulatory oversight and fewer consequences for selling tainted food products as a result of recent FDA actions. The administration is disbanding a Justice Department unit that pursues civil and criminal actions against companies that sell contaminated food and is reassigning its attorneys. Some work will be assumed by other divisions, according to a publicly posted memo from the head of the department's criminal division and a white paper by the law firm Gibson Dunn. The Justice Department did not respond to an email requesting comment. 'They need the DOJ to enforce the law,' said Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest, a nonprofit consumer advocacy group. 'For an executive investing in food safety, the knowledge they could go to jail if they don't is a really strong motivator.' Federal regulators also want states to conduct more inspections, according to two former FDA officials, who spoke on the condition of anonymity out of fear of retaliation. But some Democratic lawmakers say states lack the resources to take over most food safety inspections. 'Handing that duty to state and local agencies is really troubling,' said Rep. Shontel M. Brown, D-Ohio. 'They don't have the resources, and it creates a potentially unsafe situation that puts families in Ohio and America at risk.' The high cost of foodborne illnesses Foodborne illnesses exact a major economic toll in the United States, according to federal data, and cost thousands of lives each year. The U.S. Department of Agriculture estimates the deaths, chronic illness, medical treatment, and lost productivity from food-related illnesses amounted to $75 billion in 2023. Each year, about 48 million people in the U.S. get sick with foodborne illnesses, 128,000 are hospitalized, and 3,000 die, according to the Centers for Disease Control and Prevention. In its first few months, the administration has suspended a program known as the Food Emergency Response Network Proficiency Testing that ensures food-testing labs accurately identify pathogens that can sicken or kill, according to a former FDA official. In March, the agency said it would delay from January 2026 to July 2028 compliance with a Biden-era rule that aims to speed up the identification and removal of potentially contaminated food from the market. However, the FDA is taking aim at foreign food manufacturing, saying in a May 6 notice that it would expand unannounced inspections overseas. 'This expanded approach marks a new era in FDA enforcement — stronger, smarter, and unapologetically in support of the public health and safety of Americans,' the notice said. Some former FDA and USDA officials said that goal isn't realistic, because U.S. inspectors often need to obtain travel visas that can wind up alerting companies to their arrival. 'It's really, really difficult to do surprise inspections,' said Brian Ronholm, director of food policy for Consumer Reports and a former USDA deputy undersecretary for food safety. 'The visa process can alert the local authority.' HHS declined to address Ronholm's concerns. The FDA hasn't met the mandated targets for inspecting food facilities in the U.S. since fiscal year 2018, and the agency has consistently fallen short of meeting its annual targets for foreign inspections, according to a January report by the U.S. Government Accountability Office. Foodborne illness can turn serious. Listeria bacteria in cucumbers sickened dozens of people in April and May and left at least nine people hospitalized, according to the FDA. Salmonella in peanut butter killed nine in 2008 and 2009, resulting in criminal charges against company executives. And E. coli in cookie dough sickened more than 70 people in 2009, including a Nevada mother who died of complications from eating the raw dough. 'Life or death for our son' E. coli, commonly found in feces, can be especially dangerous to children like Colton, the boy from Avon, Indiana, who ate contaminated lettuce. The bacteria can damage blood vessels and cause clots that destroy the kidneys, leading to strokes and comas. Consumers sickened by E. coli can pass it along to others, and, in some cases, the bacteria end up killing victims who never consumed the contaminated food. By the time Colton's mother brought him to the emergency room that November day, the bacteria were releasing toxins and damaging his blood cells and kidneys, according to his father, Chris George. Colton was sent to Riley Hospital for Children in Indianapolis. Chris said doctors told him and his wife, Amber George, that their son was in kidney failure and the next 24 to 72 hours would determine whether he would survive, the father recalled. 'They said it was life or death for our son, and I was like, wait, he was just playing basketball,' said Chris, a firefighter. 'I told them, 'You do what you need to do to save my son.'' Usually, the FDA alerts the public and identifies growers and food manufacturers when there are outbreaks like the one that sickened Colton. The FDA said in its February internal summary that the grower wasn't named because no product remained on the market. But Bill Marler, a Seattle lawyer who specializes in food-safety litigation and represents the George family, said the information is still important because it can prevent more cases, pressure growers to improve sanitation, and identify repeat offenders. It also gives victims an explanation for their illnesses and helps them determine whom they might take legal action against, he said. 'Normally we would see the information on their websites,' Marler said, adding that the agency's investigatory findings on the outbreak were 'all redacted' and he obtained them through a Freedom of Information Act request. The FDA, USDA, and CDC play central roles in overseeing food safety, including inspections and investigations. The FDA and CDC have been rocked by job cuts that are part of a reduction of 20,000 staff at HHS, their parent agency. The Agriculture Department has also shrunk its workforce. Staffing cuts mean delays in publicizing deadly outbreaks, said Susan Mayne, an adjunct professor at Yale School of Public Health who retired from the FDA in 2023. 'Consumers are being notified with delays about important food safety notifications,' she said, referring to a recent outbreak in cucumbers. 'People can die if there are pathogens like listeria, which can have a 30% fatality rate.' Makary has said the cuts wouldn't touch inspectors, reviewers, or scientists at the agency. But the FDA laid off scientists in April who worked at food safety labs in Chicago and San Francisco, where they performed specialized analysis for food inspectors, former FDA officials said. The FDA later restored some positions. 'No scientists were fired? That was incorrect,' Mayne said. Siobhan DeLancey, who worked in the agency's Office of Foods and Veterinary Medicine for more than 20 years before she also was laid off in April, said new requirements for reviewing agency announcements became so arduous that it took weeks to get approval for alerts that should have been going out much sooner. She said some employees who were laid off include communications specialists and web staff who do consumer outreach aimed at preventing illness. The USDA and FDA have been bringing some workers back or are asking some who accepted deferred resignations to take back their decisions. 'It's all about destruction and not about efficiency,' DeLancey said. 'We're going to see the effects for years. It will cost lives.' HHS did not respond to an email seeking a response to DeLancey's comments. For 13 days, Colton stayed on dialysis at the hospital, initially unable to eat or drink. His mother wet a sponge to moisten his lips and tongue. He turned 10 in the hospital. Chris George bought paint markers to make signs on the windows of his son's room. 'I am not happy with the CDC and FDA,' Chris George said. 'Victims have a right to know who made them sick. This is my kid. He's my life.' Colton was able to leave the hospital almost three weeks after first eating the contaminated lettuce but still has nightmares about the ordeal and is seeing a therapist. 'The whole 'Make America Healthy Again,' the focus on taking food color dyes out of cereal?' said Chris George, who objects to the Trump administration's decision to redact information about the grower in the February report. 'How about we take E. coli out of our lettuce, so it doesn't kill our kids?' KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Yahoo
3 days ago
- General
- Yahoo
RFK Jr. says annual COVID-19 shots no longer advised for healthy children and pregnant women – a public health expert explains the new guidance
On May 27, 2025, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Centers for Disease Control and Prevention will no longer include the COVID-19 vaccine on the list of immunizations it recommends for healthy children and pregnant women. The announcement, made in a video posted on the social platform X, comes on the heels of another announcement, made on May 20, in which the Food and Drug Administration revealed that it will approve new versions of the vaccine only for adults 65 years of age and older and for people with one or more risk factors for severe COVID-19 outcomes. The agency will require vaccine manufacturers to conduct clinical trials to demonstrate that the vaccine benefits low-risk groups. The Conversation U.S. asked Libby Richards, a nursing professor from Purdue University involved in public health promotion, to explain what these announcements mean for the general public. Currently, getting a yearly COVID-19 vaccine is recommended for everyone ages 6 months and older, regardless of their health risk. In the video announcing the plan to remove the vaccine from the CDC's recommended immunization schedule for healthy children and healthy pregnant women, Kennedy spoke alongside National Institutes of Health Director Jay Bhattacharya and FDA Commissioner Marty Makary. The trio cited a lack of evidence to support vaccinating healthy children. They did not explain the reason for the change to the vaccine schedule for pregnant people, who have previously been considered at high-risk for severe COVID-19. Similarly, in the FDA announcement made a week prior, Makary and the agency's head of vaccines, Vinay Prasad, said that public health trends now support limiting vaccines to people at high risk of serious illness instead of a universal COVID-19 vaccination strategy. Many public health experts and professional health care associations have raised concerns about Kennedy's latest announcement, saying it contradicts studies showing that COVID-19 vaccination benefits pregnant people and children. The American College of Obstetrics and Gynecology, considered the premier professional organization for that medical specialty, reinforced the importance of COVID-19 vaccination during pregnancy, especially to protect infants after birth. Likewise, the American Academy of Pediatrics pointed to the data on hospitalizations of children with COVID-19 during the 2024-to-2025 respiratory virus season as evidence for the importance of vaccination. Kennedy's announcement on children and pregnant women comes roughly a month ahead of a planned meeting of the Advisory Committee on Immunization Practices, a panel of vaccine experts that offers guidance to the CDC on vaccine policy. The meeting was set to review guidance for the 2025-to-2026 COVID-19 vaccines. It's not typical for the CDC to alter its recommendations without input from the committee. FDA officials Makary and Prasad also strayed from past established vaccine regulatory processes in announcing the FDA's new stance on recommendations for healthy people under age 65. Usually, the FDA broadly approves a vaccine based on whether it is safe and effective, and decisions on who should be eligible to receive it are left to the CDC, which bases its decision on the advisory committee's research-based guidance. The advisory committee was expected to recommend a risk-based approach for the COVID-19 vaccine, but it was also expected to recommend allowing low-risk people to get annual COVID-19 vaccines if they want to. The CDC's and FDA's new policies on the vaccine will likely make it difficult for healthy people to get the vaccine. The CDC lists several medical conditions and other factors that increase peoples' risk for severe COVID-19. These conditions include cancer, diabetes, heart disease, obesity, chronic kidney disease and some lung conditions like COPD and asthma. Pregnancy is also on the list. The article authored by Makary and Prasad describing the FDA's new stance on the vaccine also contain a lengthy list of risk factors and notes that about 100 million to 200 million people will fall into this category and will thus be eligible to get the vaccine. Pregnancy is included. Reversing the recommendation for vaccinating healthy pregnant women thus contradicts the new framework described by the FDA. Studies have documented that COVID-19 vaccines are safe during pregnancy and may reduce the risk of stillbirth. A study published in May 2025 using data from 26,783 pregnancies found a link between COVID-19 infection before and during pregnancy and an increased risk for spontaneous abortions. Importantly, a 2024 analysis of 120 studies including a total of 168,444 pregnant women with COVID-19 infections did not find enough evidence to suggest the infections are a direct cause of early pregnancy loss. Nonetheless, the authors did state that COVID-19 vaccination remains a crucial preventive measure for pregnant women to reduce the overall risk of serious complications in pregnancy due to infection. Immune changes during pregnancy increase the risk of severe illness from respiratory viruses. Vaccination during pregnancy also provides protection to the fetus that lasts into the first few months of life and is associated with a lower risk of COVID-19 related hospitalization among infants. The changes to the CDC's and the FDA's plan for COVID-19 vaccines also leave out an important group – caregivers and household members of people at high risk of severe illness from infection. This omission leaves high-risk people more vulnerable to exposure to COVID-19 from healthy people they regularly interact with. Multiple countries with risk-based vaccination policies do include this group. High-risk children age 6 months and older who have conditions that increase the risk of severe COVID-19 are still eligible for the vaccine. Existing vaccines already on the market will remain available, but it is unclear how long they will stay authorized and how the change in vaccine policy will affect childhood vaccination overall. To date, millions of children have safely received the COVID-19 vaccine. Data on whether children benefit from annual COVD-19 vaccines is less clear. Parents and clinicians make vaccination decisions by weighing potential risks with potential benefits. Not automatically. Kennedy's announcement does not broadly address healthy adults, but under the new FDA framework, healthy adults who wish to receive the fall COVID-19 vaccine will likely face obstacles. Health care providers can administer vaccines 'off-label', but insurance coverage is widely based on FDA recommendations. The new, narrower FDA approval will likely reduce both access to COVID-19 vaccines for the general public and insurance coverage for COVID-19 vaccines. Under the Affordable Care Act, Medicare, Medicaid and private insurance providers are required to fully cover the cost of any vaccine endorsed by the CDC. Kennedy's announcement will likely limit insurance coverage for COVID-19 vaccination. Overall, the move to focus on individual risks and benefits may overlook broader public health benefits. Communities with higher vaccination rates have fewer opportunities to spread the virus. This is an updated version of an article originally published on May 22, 2025. This article is republished from The Conversation, a nonprofit, independent news organization bringing you facts and trustworthy analysis to help you make sense of our complex world. It was written by: Libby Richards, Purdue University Read more: FDA will approve COVID-19 vaccine only for older adults and high-risk groups – a public health expert explains the new rules Vaccines against COVID-19, the seasonal flu and RSV are our best chance of preventing a winter surge Why pregnant people should get vaccinated for COVID-19 – a maternal care expert explains Libby Richards has received funding from the American Nurses Foundation, the National Institutes of Health, and the Indiana Clinical and Translational Sciences Institute.
Yahoo
3 days ago
- General
- Yahoo
FDA chief says pregnant women should decide on Covid vaccine with doctors
SILVER SPRING, Md. — The Food and Drug Administration commissioner, Dr. Marty Makary, said Wednesday that the decision of whether a pregnant woman should get a Covid vaccine should come down to a conversation with her doctor — not a recommendation by the federal government. Makary took part in Health and Human Services Secretary Robert F. Kennedy Jr.'s announcement Tuesday revoking the Centers for Disease Control and Prevention's recommendation that Covid shots should be offered to pregnant women and healthy children. 'The data on the Covid vaccine booster in pregnant women is a mixed set of data,' Makary said in an interview. 'Now, I think the decision should be between a doctor and a pregnant woman, but the idea that the government has to tell you what to do in this in an area where there is mixed data.' That assertion — that the data is mixed — isn't supported by evidence, vaccine experts say. The CDC doesn't mandate vaccination. For decades its panel of independent vaccine experts, called the Advisory Committee on Immunization Practices, has recommended vaccination for certain groups of people based on data. The panel then passes recommendations to the director of the CDC to endorse. (For example, the CDC advises pregnant women to get an inactivated influenza vaccine during flu season.) The U.S. surgeon general established the committee in 1964. Tuesday's decision skipped the usual process of consulting the CDC's vaccine advisory committee and having the CDC director formally sign off. (The CDC currently has no director.) The CDC's recommendation plays a key role in determining which vaccines insurance companies must cover at no cost to patients. OB-GYNs quickly raised alarms over patient access to the vaccine. Pregnant women are at increased risk of serious complications from Covid compared with people who aren't pregnant, according to the CDC. At the height of the Covid pandemic, doctors reported an unprecedented surge in pregnant women hospitalized and in critical condition after Covid infections. Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and a former chief scientist at the FDA, said he's not aware of any 'mixed' data on the Covid vaccine in pregnant women. 'I am aware of multiple studies that have shown the benefit of Covid vaccines in protecting pregnant women, who are very clearly at very high risk of more severe outcomes from Covid,' he said. 'Several studies have also shown that maternal immunization helps protect against illness and hospitalizations in infants less than 6 months old.' Dr. Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Pennsylvania, said pregnant women are 1½ to two times more likely to be hospitalized and die from Covid infections. 'It seems to be that the burden of proof on not recommending for pregnancy is on you to prove that it really isn't a value anymore,' said Offit, adding that federal health officials hadn't provided evidence to end the recommendation. Goodman added that if there are concerns about a specific study, the FDA should review the data and report on it. 'Let's give people accurate information and freedom of choice,' he said. As of Wednesday, the CDC hadn't updated its website to align with the new recommendations. Kennedy's announcement Tuesday — flanked by Makary and the director of the National Institutes of Health, Dr. Jay Bhattacharya — drew attention for what it lacked: CDC officials. Asked about the people involved in revoking the Covid vaccine recommendation, Makary said 'many scientists' were consulted, but he didn't answer whether any were from the CDC. 'I didn't organize that discussion, but there were a lot of individual discussions and group discussions, and I was part of those discussions, and I was certainly asked of my opinion,' he said. 'The FDA has a very clear role of approving products based on the data presented to the FDA. The CDC has a role of issuing recommendations. And so, this really was a CDC announcement in consultation with many scientists.' He also declined to say whether the Department of Health and Human Services will make any data about how it arrived at its decision public. 'Well, look, the tradition, the system that we have, is a system whereby Congress gives us a charge as the nation's top drug regulator, and that is to approve or not approve drugs based on the data presented to the FDA,' Makary said. 'So our job has always been to review data that is submitted and then make a decision about it. Now, that data is sometimes made public, the companies make it public. We encourage total transparency of that data. They often make the data public once the drugs are approved.' The American College of Obstetricians and Gynecologists said it was 'extremely disappointed' by Kennedy's announcement. 'We have seen firsthand how dangerous Covid infection can be during pregnancy and for newborns who depend on maternal antibodies from the vaccine for protection,' it wrote in a statement Tuesday. 'We also understand that despite the change in recommendations from HHS, the science has not changed. It is very clear that Covid infection during pregnancy can be catastrophic and lead to major disability.' This article was originally published on
