The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee -- Aduhelm manufacturer Biogen. The probe also cited Biogen documents saying the company intended to “make history” when it set what investigators called an “unjustifiably high” initial price of $56,000 a year for the drug. The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. Thursday’s report urged the agency to “take swift action” to ensure that any future Alzheimer’s approvals aren’t met with “the same doubts about the integrity of FDA’s review.” Read more: Drug slows Alzheimer's but can it make a real difference? The FDA and Biogen issued statements Thursday defending the Aduhelm approval process. In 2021, the FDA overruled its own independent scientific advisers when it approved Aduhelm even though research studies failed to prove it really helped patients. Biogen had halted two studies after disappointing results suggested the drug wasn’t slowing Alzheimer’s inevitable worsening -- only to later contend that a new analysis of one study showed higher doses offered an incremental benefit. The FDA argued the drug’s ability to reduce a hallmark of Alzheimer’s, a buildup of plaque in the brain, suggested it was likely to slow the disease. Backlash was immediate as three FDA advisers resigned in protest and the agency’s then-acting chief called for an internal investigation. Eventually Medicare refused to pay for the drug -- even after the yearly price was dropped to $28,000 -- unless patients enrolled in clinical trials to prove if it indeed slowed cognitive decline. Thursday’s report said FDA and Biogen engaged in an unusually high volume of phone calls, meetings and emails, some of them not properly documented. In addition, the regulators and company spent months working together to prepare a briefing document for FDA’s advisers that didn’t adequately represent substantial disagreement within the FDA about how to handle Aduhelm, the report said. Read more: Alzheimer's Disease: Symptoms, Causes, Preventions The investigators recommended that FDA take steps to restore trust in the approval process that include properly documenting interactions with drugmakers. They also urged manufacturers to take into account advice from patient groups and other outside experts on fair drug pricing. In a statement Thursday, FDA said the Aduhelm decision “was based on our scientific evaluation of the data” and that the agency’s own internal review found its interactions with Biogen were appropriate. But it said it plans to update guidance on Alzheimer’s drug development and will review the investigation’s findings. In its own statement, Biogen said: “Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm” but that it “stands by the integrity of the actions we have taken.”

U.S. regulators on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week. The Food and Drug Administration’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer. That means U.S. kids under 5 — roughly 18 million youngsters — are eligible for the shots. The nation’s vaccination campaign began about 1 1/2 years ago with older adults, the hardest hit during the coronavirus pandemic. There’s one step left: The Centers for Disease Control and Prevention recommends how to use vaccines. Its independent advisers began debating the two-dose Moderna and the three-dose Pfizer vaccines on Friday and will make its recommendation Saturday. A final signoff is expected soon after from CDC Director Dr. Rochelle Walensky. At a Senate hearing Thursday, Walensky said her staff was working over the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents.” She said pediatric deaths from COVID-19 have been higher than what is generally seen from the flu each year. “So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders,” she said. The FDA also authorized Moderna’s vaccines for school-aged children and teens; CDC’s review is next week. Pfizer’s shots had been the only option for those age groups. For weeks, the Biden administration has been preparing to roll out the vaccines for little kids, with states, tribes, community health centers and pharmacies preordering millions of doses. With FDA’s emergency use authorization, manufacturers can begin shipping vaccine across the country. The shots are expected to start early next week but it’s not clear how popular they will be. Without protection for their tots, some families had put off birthday parties, vacations and visits with grandparents. “Today is a day of huge relief for parents and families across America,” President Joe Biden said in a statement. While young children generally don’t get as sick from COVID-19 as older kids and adults, their hospitalizations surged during the omicron wave and FDA’s advisers determined that benefits from vaccination outweighed the minimal risks. Studies from Moderna and Pfizer showed side effects, including fever and fatigue, were mostly minor. White House COVID-19 coordinator Dr. Ashish Jha predicted the pace of vaccinations for kids under 5 to be far slower than it was for older populations and said the administration doesn’t have any internal targets for the pace of vaccinations. “At the end of the day, our goal is very clear: We want to get as many kids vaccinated as possible,” Jha told The Associated Press. In testing, the littlest children developed high levels of virus-fighting antibodies, comparable to what is seen in young adults, the FDA said. Moderna’s vaccine was about 40% to 50% effective at preventing infections but there were too few cases during Pfizer’s study to give a reliable, exact estimate of effectiveness, the agency said. “Both of these vaccines have been authorized with science and safety at the forefront of our minds,” Dr. Peter Marks, FDA’s vaccine chief, said at a news briefing. Marks said parents should feel comfortable with either vaccine, and should get their kids vaccinated as soon as possible, rather than waiting until fall, when a different virus variant might be circulating. He said adjustments in the vaccines would be made to account for that. “Whatever vaccine your health care provider, pediatrician has, that’s what I would give my child,” Marks said. The two brands use the same technology but there are differences. Pfizer’s vaccine for kids younger than 5 is one-tenth of the adult dose. Three shots are needed: the first two given three weeks apart and the last at least two months later. Moderna’s is two shots, each a quarter of its adult dose, given about four weeks apart for kids under 6. The FDA also authorized a third dose, at least a month after the second shot, for children who have immune conditions that make them more vulnerable to serious illness. Both vaccines are for children as young as 6 months. Moderna next plans to study its shots for babies as young as 3 months. Pfizer has not finalized plans for shots in younger infants. A dozen countries, including China, already vaccinate kids under 5, with other brands. Immediately upon hearing of the FDA’s decision, Dr. Toma Omofoye, a Houston radiologist, made appointments for her 4-year-old daughter and 3-year-old son. Without the shots, her family has missed out on family gatherings, indoor concerts, even trips to the grocery store, she said. During a recent pharmacy stop, Omofoye said her daughter stared and walked around like it was Disneyland, and thanked her. “My heart broke in that moment, which is why my heart is so elated now,” Omofoye said. But will other parents be as eager to get their youngest vaccinated? By some estimates, three-quarters of all U.S. children have already been infected. And only about 30% of children aged 5 to 11 have gotten vaccinated since Pfizer’s shots opened to them last November. The FDA officials acknowledged those low rates and said the government is committed to getting more older kids vaccinated and having better success with younger kids. “It’s a real tragedy, when you have something free with so few side effects that prevents deaths and hospitalization,” said FDA Commissioner Robert Califf. Roughly 440 children under age 5 have died from COVID-19, federal data show. Read: UNICEF finds Bangladesh as Covid-19 vaccine success story Dr. Beth Ebel of the University of Washington School of Medicine in Seattle, said the tot-sized vaccines would be especially welcomed by parents with children in day care where outbreaks can sideline parents from jobs, adding to financial strain. “A lot of people are going to be happy and a lot of grandparents are going to be happy, too, because we’ve missed those babies who grew up when you weren’t able to see them,” Ebel said.

U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to the ongoing risk of rare but serious blood clots. The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J’s vaccine. U.S. authorities for months have recommended that Americans get Pfizer or Moderna shots instead of J&J’s vaccine. FDA’s vaccine chief Dr. Peter Marks said the agency decided to restrict the vaccine after taking another look at the data on the risks of life-threatening blood clots and concluding that they are limited to J&J’s vaccine. Also read:Moderna seeks FDA authorization for 4th dose of COVID shot “If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks said. “But we’ve been careful to say that-- compared to no vaccine-- this is still a better option.” The problem occurs in the first two weeks after vaccination, he added: “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.” The FDA authorized J&J’s shot in February last year for adults 18 and up. The vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines. In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots over J&J’s because of its safety issues. As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that were fatal. That amounts to 3.23 blood clot cases per 1 million J&J shots. The problem is more common in women under 50, where the death rate was roughly 1 per million shots, according to Marks. Marks said the FDA spent extra time analyzing the problem to be sure it wasn’t connected to a separate issue, such as women taking birth control medications that raise their risk of clotting. The J&J vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the side effect. Under the new FDA instructions, J&J’s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t receive an additional dose. J&J’s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said. A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.” Also read: In reversal, FDA puts brakes on COVID shots for kids under 5 The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare ri sk — as long as recipients were warned. COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. Clots form in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea. The New Brunswick, New Jersey-based company announced last month that it didn’t expect a profit from the vaccine this year and was suspending sales projections. The rollout of the company’s vaccine was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas. Additionally, regulators added warnings about the blood clots and a rare neurological reaction called Guillain-Barré syndrome. Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 17 million Americans got the J&J shot.

Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans. J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company's one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators. Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity. Read:FDA adds warning about rare reaction to J&J COVID-19 vaccine Government advisers backed the extra Pfizer shots, but they also worried about creating confusion for tens of millions of other Americans who received the Moderna and J&J shots. U.S. officials don't recommend mixing and matching different vaccine brands. The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month. J&J previously released data suggesting its vaccine remains highly effective against COVID-19 at least five months after vaccination, demonstrating 81% effectiveness against hospitalizations in the U.S. But company research shows a booster dose at either two or six months revved up immunity even further. Data released last month showed giving a booster at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet released clinical data on a six-month booster shot. FDA's advisers will review studies from the company and other researchers next Friday and vote on whether to recommend boosters. The timing of the J&J filing was unusual given that the FDA had already scheduled its meeting on the company's data. Companies normally submit their requests well in advance of meeting announcements. A J&J executive said the company has been working with FDA on the review. Read: To launch J&J Covid shot in India, Biological E begins talks with govt lab to test vaccine “Both J&J and FDA have a sense of urgency because it’s COVID and we want good data out there converted into action as soon as possible,” said Dr. Mathai Mammen, head of research for J&J's Janssen unit. The vaccine from the New Brunswick, New Jersey, company was considered an important tool in fighting the pandemic because it requires only one shot. But its rollout was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas. Additionally, regulators have added warnings of several rare side effects to the shot, including a blood clot disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided the benefits of the shot still outweighed those uncommon risks. Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 15 million Americans got the J&J shot.

U.S. regulators on Monday added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it’s not entirely clear the shot caused the problem. The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis. Health officials described the side effect as a “small possible risk” for those getting the shot. Read: Bangladesh approves single-dose Janssen Covid-19 vaccine The action comes after the FDA and the Centers for Disease Control and Prevention reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine. Almost all of were hospitalized and one person died, the FDA said. Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that typically is temporary. An estimated 3,000 to 6,000 people develop the syndrome each year, according to the CDC. The number of cases reported in connection with J&J’s vaccine represents a tiny fraction of the nearly 13 million Americans who have received the one-dose shot. Most cases were reported in men — many 50 years old and up — and usually about two weeks after vaccination. Read: Australia won't buy J&J coronavirus vaccine J&J said in a statement it has been discussing the reports with the FDA and other health regulators around the world. The CDC said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting. The government said the vaccines most used in the U.S., made by Pfizer and Moderna, show no risk of the disorder after more than 320 million doses have been administered. The new warning will be included in pamphlets given to people getting the J&J shot. They should seek medical attention if they experience any symptoms, which include tingling sensations, trouble walking and double vision, the FDA said. Read: Johnson & Johnson COVID-19 vaccine batch fails quality check Vaccines historically provide broad protection with little risk but come with occasional side effects just like other drugs and medical therapies. The three COVID-19 vaccines used in the U.S. were each tested in tens of thousands of people, but even such huge studies can’t rule out extremely rare side effects. The CDC and the FDA have been monitoring side effect reports submitted by physicians, drugmakers and patients to a federal vaccine safety database. Guillain-Barre can be triggered by a number of infections, including flu, cytomegalovirus and Zika virus. But there have been rare cases in which people develop the disorder days or weeks after receiving certain vaccines. J&J’s vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration. But early on, it was linked to another rare risk, of blood clots, and the company hasn’t been able to produce as much as expected because of problems at a Baltimore factory that helps make the shots.  

Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. The Food and Drug Administration approved the drug from Biogen based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients. It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia. The decision, which could impact millions of Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits. The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks. Read:Justice Dept. says it’ll no longer seize reporters’ records Dr. Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision. “The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a medical researcher at Johns Hopkins University. The FDA’s top drug regulator acknowledged that “residual uncertainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain is expected to help slow dementia. “The data supports patients and caregivers having the choice to use this drug,” Dr. Patrizia Cavazzoni told reporters. She said the FDA carefully weighed the input of people living with the “devastating, debilitating and deadly disease.” Under terms of the so-called accelerated approval, the FDA is requiring Biogen to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so. Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and said the price would not be raised for four years. Most patients won’t pay anywhere near that thanks to insurance coverage and other discounts. The company said it aims to complete the FDA-mandated follow-up trial by 2030. Biogen shares jumped 38% in trading Monday on the news, with analysts forecasting billions in future sales. The Cambridge, Massachusetts-based company plans to begin shipping millions of doses within two weeks. The non-profit Institute for Clinical and Economic Review, which studies drug value, said Biogen’s drug would have to halt dementia entirely to justify its $56,000 per-year price tag. Some 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks. In the final stages of the disease, those afflicted lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s. Read:Facebook suspends Trump for 2 years, then will reassess Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) helps clear a protein called beta-amyloid from the brain. Other experimental drugs have done that but they made no difference in patients’ ability to think, care for themselves or live independently. The pharmaceutical industry’s drug pipeline has been littered for years with failed Alzheimer’s treatments. The FDA’s greenlight Monday is likely to revive investments in therapies previously shelved by drugmakers. The new medicine is manufactured from living cells and will be given via infusion at a doctor’s office or hospital. Researchers don’t fully understand what causes Alzheimer’s but there’s broad agreement the brain plaque targeted by aducanumab is just one contributor. Evidence suggests family history, education and chronic conditions like diabetes and heart disease may all play a role. “This is a sign of hope but not the final answer,” said Dr. Richard Hodes, director of the National Institute on Aging, which wasn’t involved in the Biogen studies but funds research into how Alzheimer’s forms. “Amyloid is important but not the only contributing factor.” Patients taking aducanumab saw their thinking skills decline 22% more slowly than patients taking a placebo. But that meant a difference of just 0.39 on an 18-point score of cognitive and functional ability. And it’s unclear how such metrics translate into practical benefits, like greater independence or ability to recall important details. The FDA’s review of the drug has become a flashpoint in longstanding debates over standards used to evaluate therapies for hard-to-treat conditions. On one side, groups representing Alzheimer’s patients and their families say any new therapy — even one of small benefit — warrants approval. But many experts warn that greenlighting the drug could set a dangerous precedent, opening the door to treatments of questionable benefit. The approval came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. The group voted “no” to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed the drug was effective. Biogen halted two studies in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer’s patients. Read:Heart reaction probed as possible rare vaccine link in teens Several months later, the company reversed course, announcing that a new analysis of one study showed the drug was effective at higher doses and the FDA had advised that it warranted review. Company scientists said the drug’s initial failure was due to some patients not receiving high enough doses to slow the disease. But the changes to dosing and the company’s after-the-fact analysis made the results hard to interpret, raising skepticism among many experts, including those on the FDA panel. The FDA isn’t required to follow the advice of its outside panelists and has previously disregarded their input when making similarly high-profile drug decisions. About 900 U.S. medical facilities are ready to begin prescribing the drug, according to Biogen, with many more expected in coming months. But key practical questions remain: How long do patients benefit? How do physicians determine when to discontinue the drug? Does the drug have any benefit in patients with more advanced dementia? With FDA approval, aducanumab is almost certain to be covered by most insurers, including Medicare, the government plan for seniors that covers more than 60 million people. Insurers could try to manage the drug’s costs by requiring strict conditions, including brain scans to confirm plaque, before agreeing to cover it. Additional scans will be needed to monitor potential side effects. The drug carries a warning about temporary brain swelling that can sometimes cause headaches, confusion and dizziness. Other side effects included allergic reactions, diarrhea and disorientation. Although Biogen studied the drug in people with mild dementia or early-stage Alzheimer’s, the FDA label approved the drug for anyone with Alzheimer’s, a sweeping population given doctors have broad leeway in diagnosing the condition. “The FDA is empowering the physician to make the decision on diagnosis,” Biogen CEO Michel Vounatsos said in an interview. Read:US to swiftly boost global vaccine sharing, Biden announces For patients already enrolled in Biogen’s trials, Monday’s announcement means they can continue taking a drug many believe has helped. Phillip Lynn, 63, was diagnosed with Alzheimer’s in the spring of 2017 after having trouble with conversation and memory, including forgetting a recent vacation to Hawaii. His husband Kurt Rehwinkel says Lynn’s cognitive ability has stabilized since starting on Biogen’s drug more than three years ago. And his performance on short-term memory tests has actually improved, though the couple acknowledges most patients are unlikely to see similar results. “But even for those who it has little or no effect, I think hope is a good thing,” said Rehwinkel. “I don’t think there’s such a thing as false hope.”

U.S. regulators on Monday expanded the use of Pfizer’s COVID-19 vaccine to children as young as 12, offering a way to protect the nation’s adolescents before they head back to school in the fall and paving the way for them to return to more normal activities. Shots could begin as soon as Thursday, after a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds. An announcement is expected Wednesday. Most COVID-19 vaccines worldwide have been authorized for adults. Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up. Parents, school administrators and public health officials elsewhere have eagerly awaited approval for the shot to be made available to more kids. Read:Vaccine deserts: Some countries have no COVID-19 jabs at all “This is a watershed moment in our ability to fight back the COVID-19 pandemic,” Dr. Bill Gruber, a Pfizer senior vice president who’s also a pediatrician, told The Associated Press. The Food and Drug Administration declared that the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers ages 12 to 15. The agency noted there were no cases of COVID-19 among fully vaccinated adolescents compared with 16 among kids given dummy shots. More intriguing, researchers found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults. The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose. Pfizer’s testing in adolescents “met our rigorous standards,” FDA vaccine chief Dr. Peter Marks said. “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.” Pfizer and its German partner BioNTech recently requested similar authorization in the European Union, with other countries to follow. The latest news is welcome for U.S. families struggling to decide what activities are safe to resume when the youngest family members remain unvaccinated. “I can’t feel totally comfortable because my boys aren’t vaccinated,” said Carrie Vittitoe, a substitute teacher and freelance writer in Louisville, Kentucky, who is fully vaccinated, as are her husband and 17-year-old daughter. The FDA decision means her 13-year-old son soon could be eligible, leaving only her 11-year-old son unvaccinated. The family has not yet resumed going to church, and summer vacation will be a road trip so they do not have to get on a plane. Read: Vexed over vaccines “We can’t really go back to normal because two-fifths of our family don’t have protection,” Vittitoe said. President Joe Biden said Monday’s decision marked another important step in the nation’s march back to regular life. “The light at the end of the tunnel is growing, and today it got a little brighter,” Biden said in a statement. Pfizer is not the only company seeking to lower the age limit for its vaccine. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects. Another U.S. company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds. Next up is testing whether the vaccine works for even younger children. Both Pfizer and Moderna have begun U.S. studies in children ages 6 months to 11 years. Those studies explore whether babies, preschoolers and elementary-age kids will need different doses than teens and adults. Gruber said Pfizer expects its first results in the fall. Outside of the U.S., AstraZeneca is studying its vaccine among 6- to 17-year-olds in Britain. And in China, Sinovac recently announced that it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3. Children are far less likely than adults to get seriously ill from COVID-19, yet they represent nearly 14% of the nation’s coronavirus cases. At least 296 have died from COVID-19 in the U.S. alone, and more than 15,000 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s not counting the toll of family members becoming ill or dying -- or the disruption to school, sports and other activities so crucial to children’s overall well-being. The AAP welcomed the FDA’s decision. Read:Russian Vaccine Sputnik V: Things we should know to fight COVID-19 “Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development,” said AAP President Dr. Lee Savio Beers in a statement. Experts say children must get the shots if the country is to vaccinate the 70% to 85% of the population necessary to reach what’s called herd immunity. In the meantime, the Centers for Disease Control and Prevention says unvaccinated people — including children — should continue taking precautions such as wearing masks indoors and keeping their distance from other unvaccinated people outside of their households.

Jharkhand Chief Minister Hemant Soren has sought permission from the Indian central government to import 50,000 vials of Remdesivir from Bangladeshi pharmaceutical companies for emergency use. He has written to D.V. Sadananda Gowda, Indian Cabinet Minister, Ministry of Chemicals and Fertilizers, requesting him to allow import and use of the medicine. Read Nigeria collects coronavirus medicine from Bangladesh “With the increasing demand for Remedisivir for critical patients in Jharkhand & its unavailability, we have reached out to Pharma companies in Bangladesh for buying around 50,000 vials for emergency use. I have written to DV Sadanand Gowda for permission to import as soon as possible,” Chief Minister Soren tweeted. He said they have been able to get a quotation from Beximco Pharmaceuticals Ltd for 50,000 vials of Demsivir Injection (Remdesivir) at a total cost of US$ 1 million, which the Jharkhand government is willing to procure at the earliest in light of the pressing needs of this medicine. Also read: Covid-19 turns India into vaccine importer from exporter “I would request you to kindly allow us to import and use the above mentioned medicine from the said company of Bangladesh so that we are able to save the precious lives,” Soren wrote in his letter to Minister Gowda. Currently Eskayef (SK-F), Beacon, Incepta, Beximco, Healthcare and Square are producing the drug, which was first developed by US biopharmaceutical company Gilead Sciences. Also read: Beximco Pharmaceuticals hands over 1000 doses of Remdesivir to Health Ministry Remdesivir was the first drug approved by US regulator the Food and Drug Administration (FDA) for treating the SARS-CoV-2 virus. It is indicated for treatment of COVID-19 disease in hospitalized adults and children aged 12 years and older.  Full approval was preceded by the US FDA issuing an EUA (emergency use authorization) on May 1, 2020 to allow prescribing remdesivir for severe COVID-19 (confirmed or suspected) in hospitalized adults and children, according to Medscape. Read Beximco Pharmaceuticals hands over 1000 doses of Remdesivir to Health Ministry

The company at the center of quality problems that led Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems. Emergent BioSolutons, a little-known company at the center of the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the U.S. by the end of May. But the company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017. Johnson & Johnson said Wednesday that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, can’t be used because it didn’t meet quality standards. It wasn’t clear exactly how many doses were involved or how the problem would affect future delivers of J&J’s vaccine. The company said in a statement it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.” J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal funding. At the time, Emergent’s Bayview facility wasn’t scaled for making millions of doses of a potential COVID-19 vaccine, according to the FDA records that describe the plant as a contract testing laboratory that “did not manufacture products for distribution.” Upgrades in technology and personnel were required before Bayview could begin making what’s known as “drug substance” material for the vaccine, a two-month process during which the required biological cells are grown. Also read: EU regulator approves J&J’s one-shot COVID-19 vaccine The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced. The federal agency criticized the company for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA’s lead investigator cited the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices.” On the same day, Johnson & Johnson, in a separate news release, heralded its partnership with Emergent as a step toward the pharmaceutical giant’s goal of supplying more than 1 billion doses of the vaccine globally by the end of 2021. Other problems cited by the FDA during the April 2020 inspection included failures by the Bayview plant “to ensure that electronically held data generated during analytical testing” of material “was protected from deletion or manipulation.” The FDA’s lead investigator, Marcellinus Dordunoo, wrote that Emergent hadn’t investigated what he described as “data integrity concerns.” The inspection was the most recent in a series of critical reports from the FDA about Emergent, including one following a December 2017 inspection at a plant in Canton, Massachusetts, in which the FDA said the company hadn’t corrected “continued low level mold and yeast isolates” found in the facility. Nearly a year later, agency investigators questioned why Emergent had “an unwritten policy of not conducting routine compliance audits” at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials. Also read: Merck to help produce rival J&J’s COVID-19 vaccine Emergent’s revenues skyrocketed during the Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone. Emergent is one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine, the company said. The Bayview factory where the tainted vaccine ingredient was found had not yet been approved by the FDA, so no vaccine in circulation is affected. Emergent declined to comment. President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million single-dose shots from J&J. A federal official said Wednesday evening the administration’s goal can be met without additional J&J doses. A J&J spokesman said earlier Wednesday that the company met the end-of-March goal, and the Centers for Disease Control and Prevention’s online vaccine tracker showed J&J had provided about 6.8 million doses to the U.S. vaccine effort. J&J has been shipping finished vaccines from its factory in the Netherlands to the U.S. Also read: FDA says single-dose shot from J&J prevents severe COVID J&J said it was putting more of its manufacturing and quality experts inside Emergent’s factory to supervise production of the COVID-19 vaccine, a move meant to enable delivery of an additional 24 million vaccine doses through April. J&J said it still expects to deliver more than 1 billion vaccine doses globally by the end of the year. The J&J vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency. The problem with the vaccine batch was first reported by The New York Times. The FDA said it was aware of the situation but declined further comment.

A batch of Johnson & Johnson’s COVID-19 vaccine failed quality standards and can’t be used, the drug giant said Wednesday. The drugmaker didn’t say how many doses were lost, and it wasn’t clear how the problem would impact future deliveries. A vaccine ingredient made by Emergent BioSolutions — one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine — did not meet quality standards, J&J said. J&J said the Emergent BioSolutions factory involved had not yet been approved by the U.S. Food and Drug Administration to make part of the vaccine. Emergent declined to comment. J&J had pledged to provide 20 million doses of its vaccine to the U.S. government by the end of March, and 80 million more doses by the end of May. Its statement on the manufacturing problem said it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.” Also read: Canada clears Johnson & Johnson vaccine, first to approve 4 President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million shots from J&J. A federal official said Wednesday evening the administration’s goal can be met without additional J&J doses. A J&J spokesman said earlier Wednesday that the company met the end-of-March goal, but did not respond to questions about whether the Emergent plant in Baltimore, known as Bayview, had been cleared by FDA. As of Wednesday, J&J had provided about 6.8 million doses to the U.S. vaccine effort, according to the Centers for Disease Control and Prevention’s online vaccine tracker. Some additional doses may not yet have been recorded as delivered, and federal health officials said Wednesday that another 11 million doses of the vaccine would be available for shipments starting on Thursday. It was not immediately clear where those 11 million doses originated, but J&J has been shipping finished vaccines from its factory in the Netherlands to the U.S. Also read: Johnson & Johnson’s 1-dose shot prevents COVID-19, but less than some others Emergent, a little known pharmaceutical company granted a major role in the federal government’s response to coronavirus pandemic, has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn’t corrected “continued low level mold and yeast isolates” found in the facility. Nearly a year later, agency investigators questioned why Emergent had “an unwritten policy of not conducting routine compliance audits” at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials. Emergent’s revenues skyrocketed during the Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone. Also Read: Why it’s hard to make vaccines and boost supplies J&J said it was putting more of its manufacturing and quality experts inside Emergent’s factory to supervise production of the COVID-19 vaccine, a move meant to enable delivery of an additional 24 million vaccine doses through April. J&J said it still expects to deliver more than 1 billion vaccine doses globally by the end of the year. The J&J vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.   The problem with the vaccine batch was first reported by The New York Times. The FDA said it was aware of the situation but declined further comment.