The nation’s first federally backed test-to-treat site is opening Thursday in Rhode Island, providing patients with immediate access to the drug once they test positive. More federally supported sites are set to open in the coming weeks in Massachusetts and New York City, both hit by a marked rise in infections.
Next week, the U.S. will send authorized federal prescribers to several Minnesota-run testing sites, turning them into test-to-treat locations. Federal regulators have also sent clearer guidance to physicians to help them determine how to manage Paxlovid’s interactions with other drugs, with an eye toward helping prescribers find ways to get the life-saving medication to more patients.
Despite a nationwide surge in COVID-19 cases, deaths from the virus have remained largely stable over the past eight weeks, as vaccine booster shots and widely accessible treatments have helped to delink infections and mortality.
Confirmed infections in the U.S. have quadrupled since late March, from about 25,000 a day to more than 105,000 daily now. But deaths, which have tended to lag infections by three to four weeks over the course of the coronavirus pandemic, have declined steadily and are now plateaued at fewer than 300 per day.
It’s the first time in the course of the pandemic that the two have not trended together, said White House COVID-19 coordinator Dr. Ashish Jha. He called it an important development in helping Americans get back to normal life.
“What has been remarkable in the latest increase in infections we’re seeing is how steady serious illness and particularly deaths are eight weeks into this,” he said. “COVID is no longer the killer that it was even a year ago.”
Jha said that given the wider use of at-home rapid tests, whose results often go unreported to public health officials, the true number of daily infections is likely 200,000 or more — double the reported rate — which he said only makes the death rate plateau more significant.
He credited vaccines but also a more than four-fold increase in prescriptions over the last six weeks for the highly effective treatment Paxlovid.
Jha said about 25,000 to 30,000 courses of Paxlovid are being prescribed each day. When administered within five days of symptoms appearing, the drug has been proven to bring about a 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.
Due to a change in the way Paxlovid is allocated to states, the number of pharmacies where it is available has doubled in the last month to almost 40,000.
“We are now at a point where I believe fundamentally most COVID deaths are preventable, that the deaths that are happening out there are mostly unnecessary, and there are a lot of tools we have now to make sure people do not die of this disease,” Jha told The Associated Press on Wednesday.
As the summer months approach, Jha said the “number one” thing people need to do is to “go and get boosted” — and if they have a breakthrough infection, they should consult with their doctor about getting Paxlovid. He said gatherings of all sizes can take place more safely because of the tools available — if people make use of them.
“In places in the country where boosting rates are much lower, where the infection is starting to spread more, I am absolutely concerned that we’re going to see, unfortunately, we may see more serious illness,” he said.
“Being vaccinated and boosted is a huge part of making sure that those kinds of activities are substantially safer,” he added. “And then, of course, we want to make Paxlovid as widely available across the entire country, so that if you do end up getting a breakthrough infection, you’re still protected against serious illness.”
The U.S. has ordered 20 million courses of Paxlovid from the drugmaker Pfizer, and the country risks running out this winter if the drug continues to be used widely. The White House has been pressing Congress for additional funds for months to support purchasing more Paxlovid and other treatments, as well as additional boosters.
While the administration has started planning for the potential need to ration the federal supply of vaccines if Congress doesn’t act, Jha said right now his message to prescribers is that they shouldn’t worry about the supply.
“I believe that we should be using as much as it’s necessary to protect Americans now,” Jha said.
Total Doses Distributed = 743,369,455. Total Doses Administered = 585,416,027. Number of People Receiving 1 or More Doses = 258,312,266. Number of People Fully Vaccinated = 221,050,854.
New U.S. research on long COVID-19 provides fresh evidence that it can happen even after breakthrough infections in vaccinated people, and that older adults face higher risks for the long-term effects.
In a study of veterans published Wednesday, about one-third who had breakthrough infections showed signs of long COVID.
A separate report from the Centers for Disease Control and Prevention found that up to a year after an initial coronavirus infection, 1 in 4 adults aged 65 and older had at least one potential long COVID health problem, compared with 1 in 5 younger adults.
Long COVID refers to any of more than two dozens symptoms that linger, recur or first appear at least one month after a coronavirus infection. These can affect all parts of the body and may include fatigue, shortness of breath, brain fog and blood clots.
Coronavirus vaccines that help prevent initial infections and serious illnesses provide some protection against long COVID but mounting research shows not as much as scientists had first hoped.
The veterans study published in Nature Medicine reviewed medical records of mostly white male veterans, aged 60, on average. Of the 13 million veterans, almost 3 million had been vaccinated last year, through October.
About 1%, or nearly 34,000, developed breakthrough infections. Lead author Dr. Ziyad Al-Aly noted that the study was done before the highly contagious omicron variant appeared at the end of the year and said the rate of breakthrough infections has likely increased.
Breakthrough infections and long COVID symptoms were more common among those who had received Johnson & Johnson’s single-dose shot compared with two doses of either Moderna or Pfizer vaccines. Whether any had received booster shots is not known; the first booster wasn’t OK’d in the U.S. until late September.
Overall, 32% had long COVID symptoms up to six months after breakthrough infections. That’s compared with 36% of unvaccinated veterans who had been infected and developed long COVID.
Vaccination reduced the chances for any long COVID symptoms by a “modest” 15%,” although it cut the risk in half for lingering respiratory or clotting problems, said Al-Aly, a researcher with Washington University and the Veterans Affairs health system in St. Louis. These symptoms included persistent shortness of breath or cough and blood clots in lungs or veins in the legs.
Infectious disease expert Dr. Kristin Englund, who runs a center for long COVID patients at the Cleveland Clinic, said the Nature Medicine study mirrors what she sees at her clinic. Long COVID patients there include people who were vaccinated and received boosters.
“As we have no clear treatments for long COVID, it is important for everyone to get vaccinated and use other proven methods of prevention such as masking and social distancing in order to prevent infections with COVID and thus long COVID,’’ Englund said.
The CDC report, released Tuesday, used medical records for almost 2 million U.S. adults from the start of the pandemic in March 2020 to last November. They included 353,000 who had COVID-19. Patients were tracked for up to a year to determine if they developed any of 26 health conditions that have been attributed to long COVID.
Those who had COVID were much more likely than other adults without COVID to develop at least one of these conditions, and risks were greatest for those aged 65 and older. Information on vaccination, sex and race was not included.
Breathing problems and muscle aches were among the most common conditions.
Older adults’ risks were higher for certain conditions, including strokes, brain fog, kidney failure and mental health problems. The findings are worrisome because those conditions can hasten older adults’ needs for long-term care, the report authors said.
They stressed that routine assessment of all COVID patients “is critical to reduce the incidence” of long COVID.
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Follow AP Medical Writer Lindsey Tanner at @LindseyTanner.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
The head of the Food and Drug Administration said Wednesday that efforts to investigate problems at a baby formula plant linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and even a missing piece of mail.
FDA Commissioner Robert Califf laid out a series of setbacks in congressional testimony that slowed his agency’s response by months, including a whistleblower complaint that didn’t reach FDA leadership due to a “mailroom failure.”
Califf testified before a House subcommittee probing the shortage, which has forced the U.S. to begin airlifting products from Europe while many parents still hunt for scarce supplies in stores.
Califf told lawmakers FDA’s response was: “Too slow and there were decisions that were suboptimal along the way.”
The FDA and President Joe Biden face mounting pollical pressure to explain why they didn’t intervene earlier to try and address the supply problems. The oversight subcommittee’s ranking Republican quickly zeroed in on the slow response.
“Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant formula shortage?” asked Rep. Morgan Griffith, R-Virginia. The panel will also hear from three formula manufacturers, including Abbott Nutrition.
The shortage mostly stems from Abbott’s Michigan plant, the largest in the U.S., which the FDA shut down in February due to contamination.
“We knew that ceasing plant operations would create supply problems but we had no choice given the insanitary conditions,” Califf said in opening testimony.
Califf gave the first detailed account of why his agency took months to inspect the plant despite learning of potential problems as early as September.
FDA staff began honing in on Abbott’s plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. The four cases occurred between September and January, leading to hospitalization and two deaths.
Califf told lawmakers the FDA began planning to visit the Sturgis, Michigan, plant in early December, with inspectors set to arrive on Dec. 30. But Abbott said that about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA didn’t begin its inspection until Jan. 31.
After detecting positive samples of bacteria in multiple parts of the plant, the FDA closed the facility and Abbott announced a massive recall of its formula on Feb. 17.
Abbott and the FDA have reached an agreement to reopen the plant next week, requiring the company to regularly undergo outside safety audits.
Califf also laid out the agency’s months-long timeline responding to an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records.
Several FDA staffers reviewed the complaint in late October, but officials didn’t request an interview until early December. Because of conflicts with the whistleblower’s schedule, the interview didn’t take place until Dec. 22, according to the FDA testimony.
Senior FDA officials eventually received emailed copies of the complaint, but not until February due to “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the prepared remarks. A mailed copy addressed to then-acting commissioner Dr. Janet Woodcock has still not been located, according to the FDA.
Political fury over the shortage has landed squarely on the FDA and Califf, the only administration official who has testified thus far on the issue. The problems have quickly snowballed into a political firestorm for President Joe Biden, who has invoked the Defense Production Act and emergency flights to shore up supplies.
Califf is also facing questions about why his agency didn’t anticipate the shortage, given that Abbott’s plant supplies roughly one-sixth of the U.S. formula supply. FDA regulators did not contact the U.S. Department of Agriculture about impacts to the formula supply until Feb. 11. Califf’s testimony states that his agency does not have the “authority, resources, or dedicated staff” to track supply chain disruptions. He asked lawmakers for new powers and resources to monitor the information.
Behind the shortage are other distinct factors, including industry consolidation that’s made the U.S. formula market vulnerable to disruptions at individual companies.
An Abbott executive is expected to tell the committee that his company will invest in additional capacity and supply chain safeguards. After the company restarts production next month it will be able to produce more formula than before the recall, according to prepared remarks from Abbott’s senior vice president, Christopher Calamari.
The company will restate its contention that there is no direct link between its formula and the infant infections investigated by the FDA. Agency regulators have said the small number of cases and incomplete testing data make it hard to draw a direct connection between the illnesses and Abbott’s plant.
Executives from Reckitt and Gerber are also scheduled to testify.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Germany’s health minister says the government plans to suspend a pandemic rule requiring people to show proof of vaccination, a negative test result or recent recovery from COVID-19 to enter the country over the summer.
Health Minister Karl Lauterbach told the Funke newspaper group in comments published Wednesday that the rule, which applies to everyone age 12 and above regardless of where they are traveling from, will be suspended from June 1 to the end of August.
Germany has not had any countries on its list of “high-risk areas” for the coronavirus since early March.
Confirmed coronavirus case numbers have declined steadily in Germany in recent weeks, and most restrictions have been lifted.
However, the government last week announced plans to spend another 830 million euros ($889 million) to buy vaccines that would help the country deal with a series of possible variants in the fall.
Total Doses Distributed = 742,543,055. Total Doses Administered = 585,029,684. Number of People Receiving 1 or More Doses = 258,256,059. Number of People Fully Vaccinated = 221,001,614.
