FDA authorizes first Covid vaccine for kids ages 5-11

The Food and Drug Administration on Friday authorized the Pfizer-BioNTech Covid-19 vaccine for children ages 5 to 11.

The hotly anticipated decision will allow roughly 28 million American children to be vaccinated against the coronavirus, with shots rolling out just as flu season starts and with major holidays looming.

The FDA’s action comes days after its independent vaccine advisory committee voted 17-0, with one abstention, to recommend use of the Pfizer-BioNTech shot in younger children. Panel members were swayed in part by data from the Centers for Disease Control and Prevention that showed children ages 5-11 are “at least as likely” as adults to contract the virus, and that hospitalization rates are three times higher among children of color than among while children.

The CDC’s vaccine advisers are scheduled to meet Tuesday to evaluate the shot, and are expected to vote in favor of its use in 5- to 11-year-olds. The final step before the vaccine rolls out will be formal endorsement by CDC Director Rochelle Walensky.

Source: https://www.politico.com/news/2021/10/29/fda-authorizes-first-covid-vaccine-for-kids-ages-5-11-517679
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Fauci says FDA data shows J&J vaccine should have been two shots

President Biden’s chief medical adviser Anthony Fauci said on Sunday that the Johnson & Johnson COVID-19 vaccine likely should have been a two-dose shot instead of a single inoculation. ABC’s Marth…

Source: https://thehill.com/homenews/administration/577108-fauci-says-jj-vaccine-should-have-likely-been-two-dose-shot
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FDA advisers endorse Moderna booster shot: Three takeaways

The Food and Drug Administration’s vaccine advisory panel on Thursday unanimously endorsed use of Moderna’s Covid-19 booster shot for the elderly and younger people whose jobs, underlying health or other factors elevate their risk.

The panel recommended giving the shots at least six months after initial immunization. Its vote is not binding, but the FDA normally follows the recommendations of its advisory committees.

The Moderna plan endorsed by the panel would apply to largely the same groups currently eligible for the Pfizer-BioNTech booster shot. For now, federal regulators only are planning to endorse giving people boosters from the same manufacturer as their initial shots, though the independent advisers will review preliminary data on Friday on so-called “mix-and-match” boosting.

The FDA panel’s Friday meeting will also take up of Johnson & Johnson’s proposed booster.

Here are three takeaways from the first day of the FDA panel’s two-day meeting:

Regulators are grappling with incomplete data

Despite the unanimous vote, some panel members lamented the skimpy data they had to rely upon to make their decision — and that the Pfizer precedent made it difficult for them to go in a different direction with Moderna.

Panel member Patrick Moore, a professor at the University of Pittsburgh Cancer Institute, said he had some “real issues” with the vote result, based on questions about the quality of Moderna’s data.

“I just want to explain why I voted yes; it is more gut feeling rather than based on really truly serious data,” he said, adding: “The data itself is not strong, but it is certainly going in a direction that is supportive of this.”

Moderna, like other vaccine manufacturers, continues to reference antibody response as a sign that people have built a level of immunity against the coronavirus. But FDA regulators at the meeting admitted they still are not entirely sure what is the best yardstick, or “correlate of protection,” by which to measure how well — and how long — the shots work.

University of Pennsylvania vaccine expert Paul Offit, an advisory committee member, lamented using antibody response as a measuring stick when data seemed to indicate that immunity grew over time after two doses. He also criticized thinking of mild and asymptomatic breakthrough infections as a sign of failure or a weak vaccine.

“If the goal is to try and protect against the unfortunately-named breakthrough infections of asymptomatic infection… then we’re going to be talking about getting frequent boosters, which I don’t think is a reasonable strategy for this,” Offit said.

Another panel member, Cody Meissner of Tufts University School of Medicine, expressed concern over the wording of the recommendation for people whose jobs or living situations put them at high risk. He argued that while those people have a greater chance of exposure to the virus, they may not necessarily be more susceptible to severe disease.

“If we can’t defend these recommendations based on evidence, I think it’s going to further complicate getting this vaccine into every single adult American, and that’s really what we want to do,” he said.

Not all vaccines are created equal

Moderna’s presentation to the committee outlined the company’s rationale for proposing a half-dose booster shot, unlike the full doses authorized or proposed for Pfizer and Johnson & Johnson.

“We believe we should vaccinate with the lowest amount of antigen needed to induce an immune response,” said Jacqueline Miller, Moderna’s senior vice president for infectious diseases.

A lower dose is enough to reactivate the body’s immune memory to initial vaccination, she said — and it could help stretch the world’s supply of the Moderna shot.

Moderna’s half-dose booster did not produce the fourfold increase in antibodies that FDA has set as a bar for authorizing boosters, but Miller said that was because participants in the company’s booster studies had high antibody levels to begin with.

“Subjects who did not meet the fourfold rise definition are still deriving substantial benefit from the 50 micrograms booster dose,” she said.

But some panel members questioned whether the smaller dose would provide as long-lasting protection as a full-dose booster.

Moderna’s presented data on the immune response from a full booster dose that suggest immune cells were able to ward off the virus even after antibody levels dropped significantly.

“I don’t know if FDA has a sense of how that will change going from 100 [micrograms] to 50 [micrograms],” said Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translation Sciences. “That may have a tremendous impact on durability.”

Global vaccine equity concerns are coloring the booster debate

FDA staff have tried to keep the agency’s vaccine advisers from veering into broader discussions about equity during booster meetings, but the issue surfaced multiple times Thursday.

Miller began her morning presentation by arguing that the company’s proposed half-dose booster would help stretch the world’s vaccine supply.

Just under half of the world’s population has received at least one dose of a Covid-19 vaccine, but most of those shots have been administered in the richest countries. African countries in particular have struggled to vaccinate their populations.

Miller faced more pointed questions later in the day about Moderna’s role in closing the global vaccine gap from panel member Randy Hawkins, a physician specializing in pulmonary and internal medicine at Charles Drew University and in private practice.

He pressed Miller about criticism that Moderna has lagged in producing doses for low-income countries, either directly or through the global vaccine aid program known as COVAX.

“What is Moderna’s commitment to COVAX and other steps it will take to control the pandemic in countries suffering disproportionately?” he asked Miller.

She noted that the company has said it will not enforce its intellectual property protections against generic versions of vaccine during the pandemic and has delivered 50 million doses to COVAX as of September. Moderna has also committed to build a manufacturing plant in Africa — although she could not say when or where that would open.

“We also have plans to distribute 1 billion doses to low-income countries in 2022, and even though it includes greater complexity, we are reducing the [booster] dose to 50 micrograms in order to make more vaccine available for the world,” Miller said.

Source: https://www.politico.com/news/2021/10/14/fda-moderna-booster-takeaways-516031
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FDA says more than 5 million electronic cigarettes must be taken off the market

FDA has ordered 5 million e-cigarette products off the market, it said Thursday — an announcement timed to a court-ordered deadline that will determine the future of the vaping industry.

But the agency surprised many observers by delaying its verdict on the industry’s largest players, after saying for months that its review process would give priority to firms by market share.

The last-minute verdicts drastically narrow the e-cig market in the United States. Lawmakers and public health organizations groups have lobbied for years to limit the e-cig market, arguing that the risks of vaping exceed its benefits. Much of the concern has focused on flavored e-cigarettes’ appeal to minors. A 2020 study from the CDC and FDA found that among current adolescent smokers, more than 80 percent of high school students and 70 percent of middle school students use flavored vape products.

In its announcement Thursday, FDA said the makers of the banned products “failed to provide sufficient evidence” that the benefits to adult smokers, for whom vapes are a less-damaging alternative to traditional tobacco, outweigh the “documented risks to youth.”

“We are committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review,” acting FDA Commissioner Janet Woodcock and the director of the agency’s Center for Tobacco Products, Mitch Zeller, said in a statement. “Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency’s highest priorities.”

Woodcock and Zeller also noted that the banned products included flavors such as “Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.”

By the numbers: FDA received approximately 6.5 million applications from e-cig makers, who were required by Sept. 9, 2020, to demonstrate that their products were “appropriate for the protection of public health” and would be safe for current smokers and unappealing for non-smokers. The agency said they could continue selling those products for one year while FDA reviewed their submissions.

FDA said Thursday that it had acted on roughly 93 percent of those applications, but it has not yet issued decisions on products from Juul, Reynolds American’s Vuse and NJoy, which control the largest shares of the market.

Applications still pending with FDA are in the “final stages of review,” the agency said.

Background: E-cigarettes have grown in popularity in recent years, but have operated in a gray area without many of the rules and restrictions FDA applies to traditional tobacco products like cigarettes.

The agency finalized a rule in 2016 that gives it full regulatory control over tobacco products, including e-cigarettes, but it has taken years to implement. The rule mandates that all companies with products introduced by Feb. 15, 2007, or later — including e-cigarettes, cigars, hookah, pipe tobacco, dissolves and nicotine gels — apply to stay on the market.

FDA began issuing decisions on e-cigarette applications this summer ahead of its deadline Thursday. In August, the agency issued a “refused to file” notice to a company whose application covered 4.5 million products but was missing key information. As of the Sept. 9 deadline, it issued 132 marketing denial orders that covered roughly 946,000 flavored e-cigarette products.

The last product to receive FDA clearance through its premarket review pathway before the deadline Thursday was Philip Morris International’s IQOS heated tobacco system in 2020.

What’s next: FDA is working to complete its review of the remaining e-cig applications. It is also rounding out reviews of applications filed under the “substantial equivalence” standard for products like cigars, pipes and hookah tobacco. In total, the agency has granted marketing orders to 350 of these products.

Source: https://www.politico.com/news/2021/09/09/fda-electronic-cigarettes-off-market-510967
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USDA says 862,000lbs of sausage, salami and other meats recalled

The US Department of Agriculture has announced a massive meat recall that covers around 862,000 pounds of Italian meats, including sausage, salami, coppa, prosciutto, and soppressata. The recalled units have Best-By dates that span all the way from August of this year to February of next year; they were shipped to stores across the US. The recall was published on … Continue reading

Source: https://www.slashgear.com/usda-says-862000lbs-of-sausage-salami-and-other-meats-recalled-28688771/
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Pfizer Comirnaty COVID-19 vaccine and the FDA: 6 key facts

The FDA has fully approved Comirnaty, the Pfizer-BioNTech COVID-19 vaccine, in a move that’s likely to put greater attention on the wisdom of being immunized and whether employers can legally require it of their employees. While Comirnaty may be approved now, though, that doesn’t mean it’s the end of the emergency use authorization, or indeed of monitoring those vaccinated for … Continue reading

Source: https://www.slashgear.com/pfizer-comirnaty-covid-19-vaccine-and-the-fda-6-key-facts-23688091/
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FDA approves Pfizer’s covid vaccine

The Food and Drug Administration today approved Pfizer’s covid vaccine, paving the way for broader adoption and, experts hope, more acceptance among the vaccine-hesitant.

“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said acting FDA Commissioner Janet Woodcock.

— Read the rest

Source: https://boingboing.net/2021/08/23/fda-approves-pfizers-covid-vaccine.html?utm_source=rss&utm_medium=rss&utm_campaign=fda-approves-pfizers-covid-vaccine
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Full FDA approval of Pfizer Covid shot will enable vaccine requirements

• FDA is trying to finish licensing process as soon as Monday

• Radio host who criticised vaccine efforts dies of Covid-19

Full federal approval of Pfizer’s Covid-19 vaccine will empower businesses and universities to require vaccinations and tip hesitant Americans toward getting the jab, the surgeon general, Vivek Murthy, said on Sunday.

Related: Breakthrough infections and booster shots: what you need to know

Continue reading…

Source: https://www.theguardian.com/us-news/2021/aug/22/pfizer-covid-vaccine-full-fda-approval-monday
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More than 130 dog deaths may be linked to Midwestern Pet Foods, FDA warns

Inspections “revealed evidence of significant violations” of regulations to keep pet food safe, officials said.

Source: https://www.nbcnews.com/news/us-news/more-130-dog-deaths-220-illnesses-may-be-linked-midwestern-n1277084
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FDA authorizes third COVID vaccine dose for certain immunocompromised people

The Food and Drug Administration late Thursday expanded the emergency use authorization for Pfizer and Moderna’s COVID-19 vaccine to allow a third dose for certain immunocompromised people.

Why it matters: Data suggest that people with weakened immune systems don’t generate strong enough levels of protection against the virus with just two doses, but a third dose could significantly help.

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Details: The booster shot will be authorized for “solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise,” according to the FDA.

• The third dose should be administered at least 28 days after the standard two-dose regimen of either Pfizer or Moderna is completed.

The big picture: Scientists have debated who should receive booster shots and when, as the highly contagious Delta variant drives up the number of new cases across the country.

• About 2.7% of U.S. adults are immunocompromised, a group that encompasses people that are undergoing cancer treatment, living with HIV, or are organ transplant recipients, among others, according to the Centers for Disease Control and Prevention (CDC).
• More than 1 million people in the U.S. have received unauthorized booster shots of the Moderna or Pfizer vaccines, according to an internal CDC briefing document obtained by ABC News.

Go deeper … Biden’s big COVID challenge: Fading vaccines may demand boosters

Source: https://www.axios.com/fda-third-vaccine-dose-booster-immunocompromised-17ec0c50-445d-4439-acad-ae55abbf89bb.html
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FDA to add warning about rare heart inflammation to Moderna, Pfizer vaccine fact sheets

FDA plans to “move rapidly” to add a warning to fact sheets for Pfizer and Moderna’s Covid-19 vaccines about the rare risk of developing inflammatory heart conditions, an agency official said Wednesday.

“Based on the available data, a warning statement in the fact sheets for both health care providers and vaccine recipients and caregivers would be warranted in this situation,” Doran Fink, deputy director of FDA’s vaccines division, said during a CDC advisory committee meeting on Covid vaccines.

A CDC safety panel has determined there is a “likely association” between the Pfizer and Moderna shots, which both use mRNA technology, and cases of myocarditis and pericarditis in vaccine recipients, according to an analysis presented at the meeting Wednesday. Myocarditis is marked by inflammation of the heart muscle, while pericarditis involves inflammation of the membrane surrounding the heart.

The CDC meeting follows an FDA advisory committee discussion earlier this month about cases of myocarditis and pericarditis seen in a small number of patients who received either of the two available mRNA shots. Health officials are particularly focused on cases seen in people 30 and younger.

FDA wanted to hear from the CDC committee before finalizing the language, Fink said. The FDA warning likely will note that there may be a risk of developing myocarditis or pericarditis within a week after receiving a second dose of either the Pfizer or Moderna shots, and that most cases appear to resolve themselves, he said. Long-term effects, however, are still unclear.

The scope of the problem: The conditions are rare, with more than 1,200 cases under investigation as of June 11 among more than 150 million people who have received either the Pfizer or Moderna vaccine. CDC has found more cases occurring after the second shot of an mRNA vaccine. More cases have been reported among Pfizer vaccine recipients, which may be due to the fact that the shot is authorized for people age 12 and up, while Moderna’s shot is only authorized for adults.

The “mRNA vaccines may be a new trigger for myocarditis,” said Matthew Oster of the CDC. The condition can also occur after viral infection, including Covid-19.

Despite the potential risk, the benefit of Covid-19 immunization is overwhelming, a group of federal and private sector public health officials said in a statement issued during the CDC meeting. They urged Americans 12 and older to get vaccinated because the risks of declining the shot “are far greater than any rare side effects from the vaccines,” especially as the highly transmissible Delta variant continues to spread widely and make young people sick.

“The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination,” officials including CDC Director Rochelle Walensky and Assistant Secretary for Health Rachel Levine said in the statement. “Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

Keeping watch: If a link is established between the mRNA vaccines and the heart conditions, particularly among youths, the number of cases reported is likely to rise. Nearly every shot administered in the U.S. is either Pfizer or Moderna, and 12- to 15-year-olds only became eligible for Pfizer vaccines as of May 10, when FDA expanded its emergency use authorization to the age group.

The CDC plans to recommend that patients who develop myocarditis after their first mRNA Covid shot delay their second dose until more data is collected on the condition’s link to Covid-19 vaccines, said Sara Oliver of the agency’s National Center for Immunization and Respiratory Diseases. However, she added, the person could receive their second dose after consultation with their doctor if their heart has recovered.

What’s next: Despite lingering questions about myocarditis cases post-vaccination, federal health officials and advisory committee members agreed that the benefits of immunizing teens and young adults exceed the risks. With Covid-19 vaccine makers now studying their shots in children as young as six months, regulators will be watching for any signs of increased risk of heart inflammantion.

Health officials are considering the physiological differences between adolescents and younger children, as well as the severity of disease in those populations, with respect to the benefits of administering shots to various pediatric age groups. Kids are less likely than adults to develop severe Covid, but federal data show that children under 5 and teens have higher rates of hospitalization than 5- to 11-year-olds. Children are also at risk of developing a serious inflammatory syndrome known as MIS-C.

Source: https://www.politico.com/news/2021/06/23/fda-warning-moderna-pfizer-495717
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Moderna seeks full FDA approval of its Covid-19 vaccine

Moderna has asked the Food and Drug Administration for full approval of its coronavirus vaccine in people 18 and older.

The company is the second vaccine maker to seek full approval from U.S. regulators, which would allow it to market the shot directly to consumers. Full approval also makes it easier for schools, employers and the military to require inoculation against Covid-19.

The company said it is providing data to FDA on a rolling basis and is seeking priority review from the agency.

“We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission,” said Stéphane Bancel, chief executive officer of Moderna.

Background: Moderna’s vaccine is currently available for people 18 and over under an emergency authorization from FDA, after a late-stage clinical trial in the U.S. found the shot to be 94 percent effective in adults. The company is the second vaccine maker, after Pfizer and its partner BioNTech, to seek full FDA approval.

Moderna has since expanded its research to test the vaccine in younger people. Moderna said last month that its shot proved 100 percent effective in teens ages 12 to 17 enrolled in a late-stage clinical trial. The company is also studying the vaccine in children from 6 months to 11 years old.

The shot, which is the company’s first product to reach market, uses the same messenger RNA technology as the Covid-19 vaccine from Pfizer and its partner BioNTech. The United States has purchased 300 million doses of the Moderna vaccine, enough to inoculate 150 million people.

What’s next: In addition to studying the safety and efficacy of its vaccine in people younger than 18, Moderna is also conducting trials to determine whether a third dose of its shot or a dose of a modified vaccine can protect against key Covid-19 variants.

The company said in early May that that both a third dose of its original vaccine and a booster aimed specifically at the B.1.351 variant were both effective against B.1.351 and a related variant, P. 1, in preliminary data. Health experts are concerned that B.1.351 — first spotted in South Africa — and the P.1 variant first seen in Brazil are less susceptible to current vaccines.

Source: https://www.politico.com/news/2021/06/01/moderna-seeks-full-fda-approval-of-its-covid-19-vaccine-491481
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FDA approves new imaging tool to find advanced prostate cancer

The approach won’t replace traditional blood screening tests, but it could help guide doctors when cancer spreads.

Source: https://www.nbcnews.com/health/health-news/fda-approves-new-imaging-tool-find-advanced-prostate-cancer-drugmaker-n1268621
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FDA authorizes Pfizer-BioNTech COVID vaccine for 12- to 15-year-olds

The Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech coronavirus vaccine for 12- to 15-year-old adolescents, the agency announced on Monday.

Why it matters: The emergency authorization marks a critical milestone in the push to get more Americans vaccinated and fully reopen schools for in-person learning this fall.

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• Pfizer has said its vaccine was 100% effective at protecting against COVID-19 in a trial of more than 2,200 children between the ages of 12 and 15.

What they’re saying: “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data,” said Acting FDA Commissioner Janet Woodcock.

The big picture: Children are at a low risk for serious illness from COVID-19, but experts say allowing the virus to circulate among unvaccinated kids could lead to new, more dangerous variants and slow down the protection of adults.

• Still, about 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention, since the beginning of the pandemic.
• The FDA has already authorized Pfizer’s vaccine for people 16 and older. Moderna and Johnson & Johnson also have trials for teens underway.

Yes, but: Parents’ enthusiasm for the incoming emergency use has so far been mixed, even among those who themselves have been vaccinated.

• Only 52% of parents of a child under 18 said they’re likely to vaccinate their kids as soon as they’re able, according to an Axios/Ipsos survey from April.
• In a separate survey from KFF, 32% of parents said they’ll wait to see how the vaccine works before getting their child vaccinated, and 19% said they definitely wouldn’t get their child vaccinated. 

What’s next: Moderna is expected to announce trial results for adolescents ages 12 to 17 in the second half of 2021, the New York Times reports.

Source: https://www.axios.com/covid-vaccine-pfizer-adolescents-fda-4420a00e-0a76-42da-83c0-263b79ecbc17.html
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Pfizer seeks full FDA approval of its Covid-19 vaccine

Pfizer and its partner BioNTech have asked the Food and Drug Administration for full approval of their coronavirus vaccine for people ages 16 and over.

The vaccine and two others are currently available in the United States under an emergency authorization from FDA. Pfizer and BioNTech are the first Covid-19 vaccine makers to seek full approval from U.S. regulators, which would allow the companies to market the shot directly to consumers. It could also make it easier for schools, employers and the military to require vaccination against Covid-19.

Pfizer and BioNTech also asked the regulatory agency to allow an expansion of emergency use of the vaccine to people ages 12 to 15.

The U.S. has purchased 400 million doses of Pfizer’s vaccine, enough for 200 million people — making it a pillar of the country’s vaccination push. The shot is currently available for people ages 16 and older, and Pfizer and BioNTech are now studying the vaccine in children as young as 6 months. The companies have said they expect more results from the child study by September.

FDA authorized the vaccine in December 2020 after reviewing data from a clinical trial that enrolled more than 37,000 people 16 and older in the U.S., Europe, South Africa and South America. Now that Pfizer and BioNTech have applied for full approval in adults, the agency will more closely evaluate the shot’s overall safety and efficacy, a higher bar than emergency use authorization — which FDA grants when there is evidence that a vaccine may confer a benefit.

Pfizer has shared data with FDA about its vaccine’s long-term efficacy, as well as potential changes in handling requirements, such as evidence that the vaccine can be refrigerated for longer periods, rather than requiring ultra-cold storage temperatures.

While FDA approval reviews typically take six months or more, the agency could act quickly on the vaccine since it had already received authorization. There is precedent: FDA approved Gilead’s coronavirus treatment Veklury — also known as remdesivir — roughly two months after Gilead filed.

“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” Pfizer CEO Albert Bourla said in a statement.

David Lim contributed to this report.

Source: https://www.politico.com/news/2021/05/07/pfizer-seeks-full-fda-approval-of-its-covid-19-vaccine-485640
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FDA readies plan to bar menthol cigarettes nationwide

The Food and Drug Administration is preparing to bar menthol cigarettes nationwide in a plan to be released Thursday, according to two people familiar with the matter.

The menthol ban would be one of FDA’s most aggressive tobacco reform efforts since the agency first began regulating the industry in 2009, and one long-awaited by scores of public health groups. But it also will likely take years to implement, and FDA does not yet have a permanent commissioner in place for what could be a lengthy battle with industry.

The agency will issue the plan as a response to a 2013 citizen’s petition brought by public health groups. A court ordered FDA to respond to the petition by April 29 after two anti-tobacco groups sued for a decision last year. The agency can implement a menthol ban through rule-making, which would involved a draft rule and seeking months of public comments.

Efforts to enact a federal menthol ban have stalled for years even as traction grew in major cities and amid Democratic lawmakers to bar the cigarettes, which — after decades of targeted marketing by industry — are disproportionately popular among Black Americans.

Opponents of a ban argue that it will translate to more over policing of Black communities. Supporters — including most, but not all, of the Congressional Black Caucus — say that industry’s intentional advertising and outreach towards Black Americans resulted in millions of tobacco-related deaths.

The Washington Post first reported details of the impending response. FDA declined to comment.

Biden has pledged to address racial inequities in both criminal justice and health care, setting up for what could be an intense balancing act with critics arguing that a ban could increase police brutality and Black incarceration.

Anti-tobacco advocates are counting on the court order and heightened pressure around Black health inequities to trump what are sure to be legal battles with the tobacco industry. But there is also some concern that the president still has not nominated a permanent chief for FDA.

“It would certainly be better to have a permanent commissioner and would certainly be better not to have a person in the job who was not worried about possibly being appointed or not, and facing a confirmation or not,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. “My suspicion is that if there was not a court deadline, this would not be front and center at this moment.”

Previous FDA commissioners who have taken on tobacco issues have earned industry ire and sometimes GOP backlash. In 2018, Trump appointee Scott Gottlieb released plans to ban menthol after introducing a framework a year earlier that would have capped nicotine levels across tobacco products. His actions led Sen. Richard Burr, a Republican from tobacco state North Carolina, to slam Gottlieb on the Senate floor and question his loyalty to Trump.

But some Democrats are also wary of a menthol ban, arguing that it would lead to escalated police encounters in already over-policed Black communities. New York Rep. Yvette Clarke, who voted against a menthol ban that passed the House last year, told POLITICO at the time that she was thinking of harmful stop-and-frisk policies and the death of Eric Garner, who suffocated in a police headlock while detained for illicitly selling cigarettes.

Supporters of barring menthol products say that a federal ban would focus on retailers selling products and would not criminalize personal use or possession. But critics say that it could be inevitable as a black market grows for illegal cigarettes.

“We’re seeing time and time again in police encounters for really minor offenses that these encounters will escalate into violence and killings of people of color,” said Aamra Ahmed, senior policy counsel at the American Civil Liberties Union. The justice organization and roughly two-dozen other groups including police organizations and Drug Policy Alliance sent a letter to FDA this week outlining criminal justice concerns.

More than 85 percent of Black smokers report using menthol products, as do more than half of all youth who smoke, according to government data. While overall smoking has trended downwards in recent years, menthol declines has dragged behind other products.

“I understand the concerns of lawmakers, but I also think when we’re talking about saving people’s lives, it becomes an even bigger issue we’re talking about preventing the next generation of Black and brown smokers,” said Nia Heard-Garris, a Chicago-area pediatrician and chair of the American Academy of Pediatrics Section on Minority Health, Equity and Inclusion.

Tobacco companies have historically targeted Black communities through music festival sponsorships, free samples and ads in Black-focused magazines such as Jet and Ebony. While those types of advertising have since been barred, there are still more tobacco retailers in predominantly Black communities compared to white communities and sometimes lower prices.

Heard-Garris described issues at her practice with children picking up menthol use after seeing family members and “cool” kids using certain brands. “When we’re talking about this as a pediatric disease we’re specifically talking about Black and brown kids. Among like Black children 12 to 17 that have ever used a tobacco product about 72 percent use menthol,” she said.

Source: https://www.politico.com/news/2021/04/28/fda-menthol-cigarette-nationwide-ban-484899
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US states resume Johnson & Johnson vaccine in push to end Covid ‘nightmare’

Indiana, New York, Virginia, Missouri and Michigan among states ordering or recommending resumption after US officials lift pause

Seeking in the words of one governor to put “the long Covid nightmare behind us”, several US states on Saturday resumed use of the one-shot Johnson & Johnson coronavirus vaccine.

Related: ‘No data’ linking Covid vaccines to menstrual changes, US experts say

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Source: https://www.theguardian.com/us-news/2021/apr/24/johnson-and-johnson-vaccine-covid-coronavirus-us
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FDA lifts curbs on dispensing abortion pills during pandemic

The Biden administration is lifting restrictions on dispensing abortion pills by mail during the Covid-19 pandemic, reversing a Trump administration policy that the Supreme Court backed in January.

Acting FDA Commissioner Janet Woodcock informed the American College of Obstetricians and Gynecologists in a letter Monday that her agency concluded that allowing patients to receive the pills via telemedicine and through the mail will not increase risks and will keep people safe from contracting the virus.

The decision marked the latest turn in a battle over longstanding FDA rules on the drug mifepristone that require people seeking medication abortions to obtain the pills in-person from a medical provider.

ACOG challenged the requirement last year but a short-handed Supreme Court following the death of Justice Ruth Bader Ginsburg in October declined to intervene. That allowed abortion clinics to continue dispensing the pills remotely, which they say has kept patients and staff safer during the pandemic.

The justices in January granted the Trump administration’s request to reinstate the rules, in a 6-3 decision that broke along ideological lines and marked the high court’s first major action on abortion since Justice Amy Coney Barrett was confirmed.

The Biden administration earlier this month asked an appeals court for more time to respond to ACOG’s lawsuit, and indicated that the FDA could decide to “exercise its enforcement discretion.”

ACOG’s Chief Executive Officer Maureen G. Phipps said Monday the lifting of the restrictions means “those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail — just as they would any other medication with a similarly strong safety profile.”

The move only covers the public health emergency and doesn’t spell out how the Biden administration will deal with the restrictions after the pandemic is over. Permanently lifting the curbs would vastly expand access to the drugs.

Demand for abortion pills has soared as conservative states have moved aggressively in recent years to restrict access to surgical abortions. In 2001, the drugs were used in just 5 percent of abortions in the U.S. By 2017, that jumped to 39 percent, according to the Guttmacher Institute, a research organization that supports abortion rights.

Scientists and doctors are increasingly supportive of medication abortions, which can only be used during the first 10 weeks of a pregnancy, and have long called for looser rules around how patients can obtain the pills. The pandemic brought the issue into high relief, as the government has moved to limit in-person dispensing and promote telemedicine.

Mifepristone “has very few risks at all,” said Jen Villavicencio, a health policy fellow with ACOG. “It is more safe than over-the-counter medications like ibuprofen and Tylenol. We know this medication can be safely administered via telemedicine because we’ve studied it.”

ACOG, along with the American Medical Association and other leading medical groups, has been lobbying the Biden administration and arguing in court that the federal rules for dispensing the pills should be loosened permanently. Their push has been echoed by Democrats in Congress, who have urged Biden to allow telemedicine abortions both during the pandemic and beyond.

But anti-abortion lawmakers and advocacy groups, anticipating Monday’s policy shift, have been working to preemptively ban the pills or make them more difficult to obtain.

A new ban on telemedicine abortions in Ohio that was set to take effect on Monday was blocked by a state court, while others are still advancing in Indiana, Arkansas, Iowa, Alabama, Texas, Oklahoma, Wyoming and West Virginia.

Source: https://www.politico.com/news/2021/04/12/abortion-pills-481092
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Biden’s FDA looks to tackle heavy metals in baby food

The Biden administration said Friday it plans to clamp down on toxic heavy metals commonly found in baby food.

The move comes after a House Oversight subcommittee last month released a report finding that major baby food companies sold products that their own internal testing showed contained arsenic, lead and cadmium at levels far higher than what most health experts consider safe for infants. The findings panicked parents already under considerable stress during the pandemic.

What’s new: The Food and Drug Administration plans to soon begin the lengthy process of setting more standards for heavy metals in baby foods.

In the interim, the agency told baby food makers they are expected to actively reduce heavy metal levels in their products as part of their internal food safety controls. The maneuver leverages a sweeping Obama-era food safety law that’s been on the books since 2011.

“It’s a positive but limited step,” said Tom Neltner, chemicals policy director at the Environmental Defense Fund, lamenting the agency didn’t set any deadlines for taking action.

How we got here: The FDA has been criticized for being extremely slow to act on reducing heavy metals exposure for infants and young children. The agency launched a working group to look into toxic elements across the food supply in 2017 after an EPA study found that food was a surprisingly significant source of lead exposure in children, as POLITICO reported this week.

It had taken the agency several years to set voluntary standards for how much inorganic arsenic could be in infant rice cereal — standards that public health advocates argue are largely unenforced and far too lax. Another voluntary standard for inorganic arsenic in apple juice also took years to develop, and that draft guidance released in 2013 still hasn’t been finalized.

The U.S. does not otherwise have any heavy metals standards for baby food.

A ‘sea change’: The House Oversight subcommittee’s report last month put major pressure on FDA to take action.

“We presented evidence of a pervasive problem of toxic heavy metals in baby foods, and when we asked the Biden administration’s FDA for help in addressing it, they were very concerned and responsive,” said Rep. Raja Krishnamoorthi, chair of the House Oversight subcommittee that released the landmark report last month.

“This represents a sea change at FDA,” the Illinois Democrat added.

The agency said Friday working on this issue is now a high priority.

“Research has shown that reducing exposure to toxic elements is important to minimizing any potential long-term effects on the developing brains of infants and children,” FDA said in a statement. “As such, this issue is among FDA’s highest priorities and we are actively working to make progress on identifying and implementing impactful solutions to make foods commonly consumed by infants and young children safer.”

In the “near term,” FDA said it would look at developing new standards, ramp up enforcement efforts, and issue guidance to help food companies lower their levels. The agency also plans to host a meeting on the issue.

Health advocates were hoping the agency would commit to action within a more specific timeframe.

“I’m disappointed that there is no timeline for action,” said Netlner, of EDF. “Like all of us, deadlines help ensure decisions are made in a timely manner.”

What should the limits be: Krishnamoorthi, who took office in 2017, had recently shared a bill with FDA that aimed to set strict limits for heavy metals. The effort has the backing of Sens. Amy Klobuchar (D-Minn.) and Tammy Duckworth (D-Ill.) as well as Rep. Tony Cárdenas (D-Calif.).

The standards in discussion by lawmakers were 10 parts per billion for inorganic arsenic, 5 parts per billion for cadmium and lead and 2 parts per billion for mercury across baby food products, according to a source familiar with the discussions.

A significant share of baby food on the market today would not meet these proposed standards. It is not uncommon for rice puff snacks, for example, to contain well above 100 parts per billion of inorganic arsenic.

It would be unusual for Congress to set such specific food safety standards in statute. Health advocates have historically preferred letting public health agencies set their own limits. But lawmakers appear ready to act if the agency doesn’t move on this.

Advice to parents: FDA said it continues to recommend parents and caregivers feed children a varied diet, in consultation with their pediatrician.

“The FDA does not advise parents and caregivers to throw out their supply of packaged baby foods or to stop feeding their babies and children certain foods altogether,” the agency said.

FDA does not recommend eliminating food groups over concerns about heavy metal exposure.

Other health groups continue to recommend avoiding or limiting rice products fed to infants and young children, including snacks like rice puffs. Parents can also cut back on juice, which can contain arsenic and lead. Serving a variety of vegetables is recommended, because some root vegetables like sweet potatoes and carrots can contain higher levels of lead and cadmium.

The agency also strongly warned parents against making their own infant formula “as this is extremely unlikely to reduce exposure to toxic elements and has resulted in infants suffering life-threatening consequences, including severe nutritional deficiencies and microbial foodborne illness.”

What’s next: It’s not clear what standards FDA will ultimately set. In the meantime, companies are expected to get to work reducing contaminants in their ingredients.

Source: https://www.politico.com/news/2021/03/05/biden-fda-baby-food-metal-473883
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FDA says ricotta and string cheese added to Listeria outbreak recall

The cheese recall announced earlier this month has expanded to include additional types of cheese, according to El Abuelito Cheese. Multiple brands are covered by this recall, which now includes Quesillo and Requeson products in addition to queso fresco soft cheeses. The reason for the recall is a Listeria outbreak that has caused cases in four states. Earlier this month, … Continue reading

Source: https://www.slashgear.com/fda-says-ricotta-and-string-cheese-added-to-listeria-outbreak-recall-28661589/
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