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Page 12 n THE ASIAN REPORTER HEALTH February 6, 2023 FDA’s advisers back plan to simplify COVID-19 vaccinations By Lauran Neergaard The Associated Press he U.S. is poised to make COVID-19 vaccinations more like a yearly flu shot, a major shift in strategy despite a long list of questions about how to best protect against a still rapidly mutating virus. The Food and Drug Administration (FDA) asked its scientific advisers to help lay the groundwork for switching to once-a-year boosters for most Americans — and how and when to periodically update the shots’ recipe. “This is a consequential meeting to determine if we’ve reached the point in the pandemic that allows for simplifying the use of current COVID-19 vaccines,” said FDA’s Dr. David Kaslow. The advisory panel mostly agreed with the FDA’s approach. COVID-19 vaccines have saved millions of lives and booster doses continue to help the most vulnerable even as more contagious variants have popped up. But protection does wane and the shots don’t fend off milder infections for long. And people are tired of getting vaccinated. While more than 80% of the U.S. population has had at least one COVID-19 shot, only 16% of those eligible for the latest boosters — so-called bivalent doses updated to better match more recent virus strains — have gotten one. That makes for tough decisions on how to move forward: Who really needs another shot, how often, and what kind? “We’re still protected against severe disease, thank goodness,” even after the latest mutated omicron strains cropped up, noted FDA adviser Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. The first step: The FDA advisory panel voted unanimously that people should get T the same vaccine formula whether they’re receiving their initial vaccinations or a booster. Today, Americans get one formula based on the original coronavirus strain that emerged in 2020 for their first two or three doses — and their latest booster is a combination shot made by Pfizer or Moderna that adds omicron protection. The FDA would have to decide how to phase in that change. But “this isn’t only a convenience thing” to ease confusion about different kinds of shots, said Dr. Archana Chatterjee, dean of Chicago Medical School. Since the original coronavirus strain has disappeared, “moving towards the strains that are circulating is very important.” Who needs another shot and when sparked more debate. Looking ahead, the FDA said most Americans should do fine if they get a once-a-year booster targeted to the newest variants in the fall. The agency asked if some people might need two doses — adults with weakened immune systems and very young children who’ve never been previously vaccinated. That’s similar to how youngsters get their first-ever flu vaccination. But more data is needed to show exactly who might need two yearly doses — such as a careful count of who still gets hospitalized with COVID-19 despite being up-to-date with today’s vaccinations, Offit said. “Only then can we really best make the decision about who gets vaccinated with what and when,” he said. Nor is it clear that younger, healthier people would need a COVID-19 booster every year. “It’s hard to say it’s going to be annual at this point,” said Harvard’s Dr. Eric Rubin. Fall might not even be the best time to boost, something that would depend on when infections start rising and how long a booster’s protection might last, said FDA adviser Dr. Arthur Reingold of the University of California, Berkeley. Unlike flu which in the U.S. circulates PANDEMIC PROTECTION. Syringes with vaccines are prepared at the L.A. Care and Blue Shield of California Promise Health Plans’ Community Re- source Center, where they were offering members and the public free flu and COVID-19 vaccines, in Lynwood, California. The U.S. is poised to make COVID-19 vaccinations more like a yearly flu shot, a major shift in strategy despite a long list of questions about how to best protect against a still rapidly mutat- ing virus. The Food and Drug Administration has asked its scientific advisers to help lay the groundwork for switching to once-a-year boosters for most Americans — and how and when to periodically update the rec- ipe of the shots. (AP Photo/Mark J. Terrill) mostly during late fall and winter, COVID-19 waves have occurred year-round. As for the recipe, the FDA’s plan is to call its advisory panel for another meeting in late May or early June to decide if the vaccine recipe needs tweaking — including which virus strain to target and whether it should be a single-strain or multi-strain shot. Pfizer and Moderna said that would give enough time to produce needed doses by fall while a third manufacturer, Novavax, urged an earlier start to any recipe change. U.S. officials also updated how they’re tracking that the newest COVID-19 boosters are safe. The Centers for Disease Control and Prevention spotted a possible warning signal that seniors getting Pfizer’s updated booster might have a slightly higher risk of stroke. But FDA safety expert Richard Forshee said data from Medicare and multiple other health systems — including in other countries — found no sign of trouble, leading the government to conclude it’s unlikely the red flag was real. AP Health Writer Matthew Perrone contributed to this report. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content. How will life change once the COVID-19 emergency ends? By Amanda Seitz The Associated Press W ASHINGTON — The declara- tion of a COVID-19 public health emergency three years ago changed the lives of millions of Americans by offering increased healthcare coverage, beefed-up food assistance, and universal access to coronavirus vaccines and tests. Much of that is now coming to an end, with President Joe Biden’s administration saying it plans to end the emergency declarations on May 11. Here’s a look at what will stay and what will go once the emergency order is lifted: COVID-19 tests, treatments & vaccines The at-home nasal swabs, COVID-19 vaccines, as well as their accompanying boosters, treatments, and other products that scientists have developed over the last three years will still be authorized for emergency use by the Food and Drug Administration (FDA) once the public health emergency is over. But how much people pay for certain COVID-related products may change. Insurers will no longer be required to cover the cost of free at-home COVID-19 tests. Free vaccines, however, won’t come to an end with the public health emergency. “There’s no one right now who cannot get a free vaccine or booster,” said Cynthia Cox, vice president at Kaiser Family Foundation. “Right now all the vaccines that are being administered are still the ones purchased by the federal govern- ment.” But the Biden administration has said it is running out of money to buy up vaccines and congress has not budged on the president’s requests for more funding. Many states expect they can make it through the spring and summer, but there are questions around what their vaccine supply will look like going into the fall — when respiratory illness typically start to spike, said Anne Zink, the president of the Association of State and Territorial Health Officials. “We’re all anxious to find out more about that,” Zink said. Medicaid Medicaid enrollment ballooned during the pandemic, in part because the federal government prohibited states from removing people from the program during the public health emergency once they had enrolled. The program offers healthcare coverage to roughly 90 million children and adults — or 1 out of every 4 Americans. Late last year, congress told states they could start removing ineligible people in April. Millions of people are expected to lose their coverage, either because they now make too much money to qualify for Medicare or they’ve moved. Many are ex- pected to be eligible for low-cost insurance plans through the Affordable Care Act’s private marketplace or their employer. Student loans Payments on federal student loans were halted in March 2020 under the Trump administration and have been on hold since. The Biden administration announced a plan to forgive up to $10,000 in federal student loan debts for individuals with incomes of less than $125,000 or households with incomes under $250,000. But that forgiveness plan — which more than 26 million people have applied for — is on pause, thrown into legal limbo while awaiting a ruling from the Supreme Court. The Justice Department initially argued that the Secretary of Education has “sweeping authority” to waive rules relating to student financial aid during a national emergency, per the 2003 HEROES Act that was adopted during the wars in Afghanistan and Iraq. A Biden administration official told The Associated Press that ending the health emergencies will not change the legal argument for student loan debt cancellation, saying the COVID-19 pandemic affected millions of student borrowers who might have fallen behind on their loans during the emergency. The pause on student loan payments is expected to end 60 days after the Supreme Court ruling. Immigration at the border Border officials will still be able to deny people the right to seek asylum, a rule that was introduced in March 2020 as COVID-19 began its spread. Those restrictions remain in place at the U.S.-Mexico border, pending a Supreme Court review, regardless of the COVID-19 emergency’s expiration. Republican law- makers sued after the Biden administra- tion moved to end the restrictions, known as Title 42, last year. The Supreme Court kept the restrictions in place in December Continued on page 17