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Tag: COVID-19 vaccine rollout

  • FDA approves updated Covid vaccines from Pfizer and Moderna as hospitalizations rise

    FDA approves updated Covid vaccines from Pfizer and Moderna as hospitalizations rise

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    A health-care worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic in the Peabody Institute Library in Peabody, Massachusetts, Jan. 26, 2022.

    Vanessa Leroy | Bloomberg | Getty Images

    The Food and Drug Administration on Monday approved updated Covid vaccines from Pfizer and Moderna, putting the shots on track to reach Americans within days as U.S. hospitalizations from the virus rise.

    The new vaccines, which target the omicron variant XBB.1.5, are approved for people 12 and older and are authorized under emergency use for children 6 months through 11 years old, according to an FDA release.

    The updated vaccines from Pfizer and Moderna won’t be available to Americans just yet.

    A CDC advisory panel is scheduled to meet Tuesday to vote on a recommendation on the use of those jabs. After the CDC director signs off on those recommendations, the shots can be administered at pharmacies, health clinics and other vaccine distribution sites.

    The Biden administration said in August that it expects new single-strain vaccines from Pfizer, Moderna and Novavax targeting XBB.1.5 to be available to the public in mid-September. 

    The FDA did not announce a decision Monday on an updated Covid shot from Novavax, but the company said in a statement that the agency is still reviewing its vaccine. Shares of Novavax closed nearly 13% lower Monday following the approval of the other updated jabs.

    Novavax’s vaccine uses protein-based technology, a decades-old method deployed in routine vaccinations against hepatitis B and shingles. Meanwhile, Pfizer’s and Moderna’s shots use messenger RNA, which teaches cells how to make proteins that trigger an immune response against Covid.

    The upcoming arrival of updated vaccines offers some reassurance to Americans as the nation sees an increase in Covid cases and hospitalizations.

    While the shots do not target the variants dominant now, the vaccine makers have said the shots will still offer protection against those strains as children return to school and the weather gets cooler.

    “We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities,” Pfizer CEO Albert Bourla said in a release following the approval.

    Bourla and Moderna CEO Stéphane Bancel, in a separate statement, urged Americans to receive their updated Covid shot during the same appointment as their annual flu shot.

    Hospitalizations have increased for seven straight weeks, and rose more than 15% for the week ending Aug. 26, to 17,418, according to the latest data from the CDC. But that number remains below the surge the nation saw in summer 2022, when hospitalizations climbed to more than 40,000.

    The uptick is fueled by newer — but closely related to XBB.1.5 — strains of the virus such as EG.5, or Eris. That omicron strain accounted for 21.5% of all cases as of Sept. 2, according to the CDC. 

    Meanwhile, XBB.1.5 is declining in the U.S., the CDC said. 

    A resident receives a Covid-19 booster shots at a vaccine clinic inside Trinity Evangelic Lutheran Church in Lansdale, Pennsylvania, U.S, on Tuesday, Apr. 5, 2022.

    Hannah Beier | Bloomberg | Getty Images

    Pfizer, Moderna and Novavax have released early trial data indicating their new shots provide protection against Eris.

    Both Pfizer and Moderna have also said their updated shots produced a strong immune response against BA.2.86, a highly mutated omicron subvariant that health officials are watching closely.

    “The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants,” the FDA said in the release Monday.

    The agency noted that last year’s Covid boosters from Pfizer and Moderna are no longer authorized in the U.S.

    The upcoming vaccine rollout will be the first since the end of the U.S. Covid public health emergency, which expired in May. 

    The end of that declaration means the federal government will shift vaccine distribution to the private market, where manufacturers will sell their updated shots directly to health-care providers at higher prices. Previously, the government purchased vaccines directly from manufacturers at a discount to distribute to all Americans for free. 

    Private insurers and government payers such as Medicare, which cover the vast majority of Americans, are expected to provide the vaccines to people for no fee. Federal efforts such as the Biden administration’s Bridge Access Program aim to provide free Covid shots to uninsured people.

    The Biden administration will urge Americans to receive an updated Covid shot this fall, White House press secretary Karine Jean-Pierre said last week.

    “Vaccinations against Covid-19 remains the safest protection for avoiding hospitalization, long-term health outcomes, and death,” Jean-Pierre said during a briefing.

    But it’s unclear how many Americans will actually roll up their sleeves to get another shot in the coming months.

    Only around 17% of the U.S. population — around 56 million people — have received Pfizer’s and Moderna’s latest boosters since they were approved in September 2022, according to the CDC. 

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  • Biden administration to provide free Covid vaccines to uninsured Americans this fall through end of 2024

    Biden administration to provide free Covid vaccines to uninsured Americans this fall through end of 2024

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    A healthcare worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic in the Peabody Institute Library in Peabody, Massachusetts, on Wednesday, Jan. 26, 2022.

    Vanessa Leroy | Bloomberg | Getty Images

    The Biden administration on Thursday announced a program to provide free Covid vaccines to uninsured Americans through December 2024 after the federal government’s supply of shots runs out this fall.

    Those free shots, which the government is purchasing at a discount, will be available to the uninsured at pharmacies and 64 state and local health departments.

    The Health and Human Services Department also is hoping that vaccine makers will donate shots to pharmacies as part of the program.

    There are between 25 to 30 million uninsured adults in the United States and other Americans whose insurance will not cover free Covid products this fall, according to the federal Centers for Disease Control and Prevention.

    Currently, the government has an inventory of vaccines purchased from three manufacturers, Pfizer, Moderna and Novavax, and those companies do not sell the shots to health-care providers.

    In the fall, the companies will begin selling shots directly to health providers, and the government’s supply is expected to run out.

    The Health and Human Services Department in April first announced the Bridge Access Program, but had not said when the program would stop providing shots for free to the uninsured until Thursday.

     The program reflects a broad shift on the pandemic’s effects worldwide. As Covid cases and deaths have dropped to new lows, governments have rolled back stringent health mandates like masking and social distancing, and the rate at which people get Covid vaccines has slowed to a crawl over the past year.

    Earlier this year, the World Health Organization declared an end to the global Covid public health emergency earlier this year. In May, HHS declared an end to the emergency in the United States.

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  • Pfizer says COVID-19 vaccine will cost $110-$130 per dose

    Pfizer says COVID-19 vaccine will cost $110-$130 per dose

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    Pfizer will charge $110 to $130 for a dose of its COVID-19 vaccine once the U.S. government stops buying the shots, but the drugmaker says it expects many people will continue receiving it for free.

    Pfizer executives said the commercial pricing for adult doses could start early next year, depending on when the government phases out its program of buying and distributing the shots.

    The drugmaker said it expects that people with private health insurance or coverage through public programs like Medicare or Medicaid will pay nothing. The Affordable Care Act requires insurers to cover many recommended vaccines without charging any out-of-pocket expenses.

    A spokesman said the company also has an income-based assistance program that helps eligible U.S. residents with no insurance get the shots.

    The price would make the two-dose vaccine more expensive for cash-paying customers than annual flu shots. Those can range in price from around $50 to $95, depending on the type, according to CVS Health, which runs one of the nation’s biggest drugstore chains.

    A Pfizer executive said Thursday that the price reflects increased costs for switching to single-dose vials and commercial distribution. The executive, Angela Lukin, said the price was well below the thresholds “for what would be considered a highly effective vaccine.”

    The drugmaker said last year that it was charging the U.S. $19.50 per dose, and that it had three tiers of pricing globally, depending on each country’s financial situation. In June, the company said the U.S. government would buy an additional 105 million doses in a deal that amounted to roughly $30 per shot. The government has the option to purchase more doses after that.

    Pfizer’s two-shot vaccine debuted in late 2020 and has been the most common preventive shot used to fight COVID-19 in the U.S.

    More than 375 million doses of the original vaccine, which Pfizer developed with the German drugmaker BioNTech, have been distributed in the U.S., according to the Centers for Disease Control and Prevention.

    That doesn’t count another 12 million doses of an updated booster that was approved earlier this year.

    The vaccine brought in $36.78 billion in revenue last year for Pfizer and was the drugmaker’s top-selling product.

    Analysts predict that it will rack up another $32 billion this year, according to FactSet. But they also expect sales to fall rapidly after that.

    More than 90% of the adult U.S. population has already received at least one dose of COVID-19 vaccine, according to the CDC. But only about half that population has also received a booster dose.

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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.

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