For much of the past two years, America has been first in line for COVID-19 vaccines and treatments. Now, as drugmakers develop the next generation of therapies, the White House is warning that if Congress doesn’t act urgently the U.S. will have to take a number.
Already the congressional stalemate over virus funding has forced the federal government to curtail free treatment for the uninsured and to ration monoclonal antibody supplies. And Biden administration officials are expressing increasing alarm that the U.S. is also losing out on critical opportunities to secure booster doses and new antiviral pills that could help the country maintain its reemerging sense of normalcy, even in the face of potential new variants and case spikes.
Japan, Vietnam, the Philippines, and Hong Kong have all placed orders for treatments and vaccine doses that the U.S. can’t yet commit to, according to the White House.
Months ago, the White House began warning that the country had spent through the money in the $1.9 trillion American Rescue Plan that was dedicated directly to COVID-19 response. It requested an additional $22.5 billion for what it called “urgent” needs in both the U.S. and abroad.
The Senate last month closed in on smaller $10 billion package focused on domestic needs. But even that deal fell apart as lawmakers objected to an announcement from the Centers for Disease Control and Prevention that it would end Trump-era border restrictions related to the pandemic.
The White House this week is mounting a push for doctors to get less stingy about prescribing the antiviral pill Paxlovid, which was initially rationed for those at the highest risk for severe outcomes from COVID-19 but is now more widely available. A 20 million-dose order placed last year by the government helped boost manufacturing capacity.
Paxlovid, when administered within five days of symptoms appearing, has been proven to bring about a 90% reduction in hospitalizations and deaths among patients most likely to get severe disease. Some 314 Americans are now dying each day from the coronavirus, down from more than 2,600 during the height of the omicron wave earlier this year.
The U.S. used similar advance-purchase agreements to boost the domestic supply and manufacture of COVID-19 vaccines, through what was known in the Trump administration as “Operation Warp Speed.”
Now, with a new generation of treatments on the horizon, the U.S. is falling behind.
Japan has already placed an initial order for drugmaker Shionogi’s upcoming COVID-19 antiviral pill, which studies have shown to be at least as effective as Pfizer’s treatment and has fewer drug-to-drug interactions and is easier to administer.
Because of the funding delays, officials say, the U.S. has yet to place an advance order, which would help the company scale manufacturing to widely produce the pill.
“We know companies are working on additional, promising life-saving treatments that could protect the American people, and without additional funding from Congress, we risk losing out on accessing these treatments, as well as tests and vaccines, while other countries get in front of us in line,” said White House spokesman Kevin Munoz. “Congress must act urgently upon return from recess to provide the funding needed to secure new treatments for the American people and to avoid this dangerous outcome.”
Complicating matters further are the long lead times to manufacture the antiviral and antibody treatments. Paxlovid takes about six months to produce, and monoclonal antibody treatments used to treat COVID-19 and prevent serious disease in the immunocompromised take similarly long, meaning the U.S. is running out of time to replenish its stockpile before the end of the year.
Last month the White House began cutting back shipments of monoclonal antibody treatments to states to make supplies last longer.
Administration officials declined to discuss specific treatments they are stymied from ordering because of contracting requirements.
The funding debate is also holding up U.S. purchases of COVID-19 vaccine booster doses, including an upcoming new generation of vaccines that may better protect against the omicron variant.
Moderna and Pfizer both are testing what scientists call “bivalent” shots — a mix of each company’s original vaccine and an omicron-targeted version — with Moderna announcing last week it hopes to have its version ready this fall.
The Biden administration has said that while the U.S. has enough vaccine doses for children under 5, once they are approved by regulators, and for fourth shots for high-risk people over 50, it doesn’t have the money to order the new generation of doses.
Earlier this month, former White House COVID-19 coordinator Jeff Zients said Japan, Vietnam, the Philippines, and Hong Kong had already secured future booster doses.
Republicans have shown no signs of backing down from their insistence that before supplying the 10 GOP votes needed for the COVID-19 funding package to pass the Senate, the chamber must vote on their effort to extend the Trump-era Title 42 order. That COVID-linked order, which requires authorities to immediately expel nearly all migrants at the border, is set to be lifted on May 23.
An election-year vote to extend that order would be perilous for Democrats, and many hope no such vote occurs. Many say privately they hope Biden will keep the immigration curbs in place or that a court will postpone the rules’ termination, but Republicans could well force a vote anyway.
“Congress would have to take action in order for the day not to be May 23,” White House press secretary Jen Psaki said Monday.
Senate Majority Leader Chuck Schumer, D-N.Y., said early this month that he expected legislation this spring that would wrap together funds for COVID-19 and Ukraine. Aid for Ukraine has wide bipartisan support and could help propel such a package through Congress, but Republican opposition has already forced legislators to strip out pandemic response funding once.
There are at least six Democrats, and potentially 10 or more, who would be expected to back the Republican amendment to extend the immigration order, enough to secure its passage.
Such a vote would be dangerous for Democrats from swing districts, who must appeal to pro-immigration core Democratic voters without alienating moderates leery of the increase in migrants that lifting the curbs is expected to prompt.
Republicans haven’t said what language they would embrace, but they could turn to a bipartisan bill by Sens. James Lankford, R-Okla., and Kyrsten Sinema, D-Ariz.
It would delay any suspension of the immigration limits until at least 60 days after the U.S. surgeon general declares the pandemic emergency to be over. The administration would also have to propose a plan for handling the anticipated increase in migrants crossing the border. Democrats expressing support for keeping the immigration restrictions in place have cited a lack of planning by the administration as their chief concern although the Biden administration has insisted it is preparing for an increase in border crossings.
Total Doses Distributed = 723,209,645. Total Doses Administered = 572,829,658. Number of People Receiving 1 or More Doses = 257,296,710. Number of People Fully Vaccinated = 219,370,557.
Total Doses Distributed = 723,183,845. Total Doses Administered = 572,595,338. Number of People Receiving 1 or More Doses = 257,255,601. Number of People Fully Vaccinated = 219,338,297.
COVID-19 vaccinations are at a critical juncture as companies test whether new approaches like combination shots or nasal drops can keep up with a mutating coronavirus — even though it’s not clear if changes are needed.
Already there’s public confusion about who should get a second booster now and who can wait. There’s also debate about whether pretty much everyone might need an extra dose in the fall.
“I’m very concerned about booster fatigue” causing a loss of confidence in vaccines that still offer very strong protection against COVID-19’s worst outcomes, said Dr. Beth Bell of the University of Washington, an adviser to the U.S. Centers for Disease Control and Prevention.
Despite success in preventing serious illness and death, there’s growing pressure to develop vaccines better at fending off milder infections, too — as well as options to counter scary variants.
“We go through a fire drill it seems like every quarter, every three months or so” when another mutant causes frantic tests to determine if the shots are holding, Pfizer vaccine chief Kathrin Jansen told a recent meeting of the New York Academy of Sciences.
Yet seeking improvements for the next round of vaccinations may seem like a luxury for U.S. families anxious to protect their littlest children — kids under 5 who are not yet eligible for a shot. Moderna’s Dr. Jacqueline Miller told The Associated Press that its application to give two low-dose shots to the youngest children would be submitted to the Food and Drug Administration “fairly soon.” Pfizer hasn’t yet reported data on a third dose of its extra-small shot for tots, after two didn’t prove strong enough.
COMBINATION SHOTS MAY BE NEXT
The original COVID-19 vaccines remain strongly protective against serious illness, hospitalization and death, especially after a booster dose, even against the most contagious variants.
Updating the vaccine recipe to match the latest variants is risky, because the next mutant could be completely unrelated. So companies are taking a cue from the flu vaccine, which offers protection against three or four different strains in one shot every year.
Moderna and Pfizer are testing 2-in-1 COVID-19 protection that they hope to offer this fall. Each “bivalent” shot would mix the original, proven vaccine with an omicron-targeted version.
Moderna has a hint the approach could work. It tested a combo shot that targeted the original version of the virus and an earlier variant named beta — and found vaccine recipients developed modest levels of antibodies capable of fighting not just beta but also newer mutants like omicron. Moderna now is testing its omicron-targeted bivalent candidate.
But there’s a looming deadline. FDA’s Dr. Doran Fink said if any updated shots are to be given in the fall, the agency would have to decide on a recipe change by early summer.
DON’T EXPECT BOOSTERS EVERY FEW MONTHS
For the average person, two doses of the Pfizer or Moderna vaccine plus one booster — a total of three shots — “gets you set up” and ready for what may become an annual booster, said Dr. David Kimberlin, a CDC adviser from the University of Alabama at Birmingham.
After that first booster, CDC data suggests an additional dose offers most people an incremental, temporary benefit.
Why the emphasis on three shots? Vaccination triggers development of antibodies that can fend off coronavirus infection but naturally wane over time. The next line of defense: Memory cells that jump into action to make new virus-fighters if an infection sneaks in. Rockefeller University researchers found those memory cells become more potent and able to target more diverse versions of the virus after the third shot.
Even if someone who’s vaccinated gets a mild infection, thanks to those memory cells “there’s still plenty of time to protect you against severe illness,” said Dr. Paul Offit of the Children’s Hospital of Philadelphia.
But some people — those with severely weakened immune systems — need more doses up-front for a better chance at protection.
And Americans 50 and older are being offered a second booster, following similar decisions by Israel and other countries that offer the extra shot to give older people a little more protection.
The CDC is developing advice to help those eligible decide whether to get an extra shot now or wait. Among those who might want a second booster sooner are the elderly, people with health problems that make them particularly vulnerable, or who are at high risk of exposure from work or travel.
COULD NASAL VACCINES BLOCK INFECTION?
It’s hard for a shot in the arm to form lots of virus-fighting antibodies inside the nose where the coronavirus latches on. But a nasal vaccine might offer a new strategy to prevent infections that disrupt people’s everyday lives even if they’re mild.
“When I think about what would make me get a second booster, I actually would want to prevent infection,” said Dr. Grace Lee of Stanford University, who chairs CDC’s immunization advisory committee. “I think we need to do better.”
Nasal vaccines are tricky to develop and it’s not clear how quickly any could become available. But several are in clinical trials globally. One in late-stage testing, manufactured by India’s Bharat Biotech, uses a chimpanzee cold virus to deliver a harmless copy of the coronavirus spike protein to the lining of the nose.
“I certainly do not want to abandon the success we have had” with COVID-19 shots, said Dr. Michael Diamond of Washington University in St. Louis, who helped create the candidate that’s now licensed to Bharat.
But “we’re going to have a difficult time stopping transmission with the current systemic vaccines,” Diamond added. “We have all learned that.”
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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.
Volunteers and government workers in Shanghai erected metal barriers in multiple districts to block off small streets and entrances to apartment complexes, as China hardens its strict “zero-COVID” approach in its largest city despite growing complaints from residents.
In the city’s financial district, Pudong, the barriers — thin metal sheets or mesh fences — were put up in several neighborhoods under a local government directive, according to Caixin, a Chinese business media outlet. Buildings where cases have been found sealed up their main entrances, with a small opening for pandemic prevention workers to pass through.
China reported 21,796 new community transmitted COVID-19 infections on Sunday, with the vast majority being asymptomatic cases in Shanghai. Across the country, many cities and provinces have enforced some version of a lockdown in an attempt to slow the spread of the virus.
The latest outbreak, driven by the highly contagious omicron variant, has spread nationwide, but has been particularly large in Shanghai. The city, a financial hub with 25 million residents, has counted hundreds of thousands of cases but fewer than 100 deaths since the outbreak began nearly two months ago.
An Associated Press examination of the death toll found that despite a history of narrow criteria for linking deaths to particular diseases, especially COVID-19, authorities have changed how they count positive cases, leading to wiggle room in how they arrive at a final death count. The result is almost certainly an undercount of the true death toll.
On social media, people posted videos of the new barriers being put up Saturday, with some expressing anger over the measures. The barriers are meant to leave main roads unblocked, Caixin reported.
In one video, verified by the AP, residents leaving a building in Shanghai’s Xuhui district broke down the mesh fence barricade at their front entrance and went looking for the security guard they believed to be responsible for putting it up.
Shanghai is using a tiered system in which neighborhoods are divided into three categories based on the risk of transmission. Those in the first category face the strictest COVID-19 controls and were the main target of the new heightened measures. In the third category, some buildings allow people to leave their homes and visit public areas.
In Shanghai, authorities reported 39 new COVID-19 deaths, raising the official death toll to 4,725 as of the end of Saturday, the National Health Commission said Sunday.
The city’s lockdown has drawn global attention for its strict approach and sometimes dangerous consequences. Many residents in the city have had difficulties getting groceries, resorting to bartering and bulk buying. Others have been unable get adequate medical attention in time, owing to the strict controls on movement.
On Friday, Chinese internet users shared a six-minute video called “Voices of April” that documents some of the most challenging public moments the city has experienced in the nearly month-long lockdown. One part features audio of residents in one Shanghai community who protested on April 8, screaming: “Send us food! Send us food! Send us food!” in unison.
The video blanketed WeChat timelines before it was abruptly removed by censors Saturday.
Chinese authorities have continued to say that the “zero-COVID” strategy is the best way forward given low vaccination rates in people over age 60, and that omicron would result in many deaths and severe illnesses if the country ended its strict approach.
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Associated Press journalist Penny Wang in Bangkok contributed to this report.
Israel has lifted an indoor mask mandate in place for nearly a year as the country’s new cases of coronavirus continue to drop.
The end of the masking requirement took effect Saturday night. Masks remain mandatory in hospitals, elderly care facilities and on international flights.
Israel has seen new cases of COVID-19 drop since the peak of the latest wave of infections in January. Serious cases of coronavirus have plummeted from a high of over 1,200 during the omicron variant outbreak to around 200.
Since the start of the pandemic two years ago, Israel has recorded over 4 million cases of coronavirus and at least 10,658 deaths — over one-fifth of them since January, according to the Health Ministry.
Over 72% of the country’s 9.4 million people have at least one dose of the Pfizer/BioNTech vaccine, and nearly half have received three shots.
Israel closed its borders in November after the emergence of the novel omicron variant of the virus, but in the months since has reopened the country to foreign visitors and lifted almost all coronavirus restrictions.
