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☆ Covid Vaccines May Roll Out Within Days
▼ + stars: | 2023-09-11 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

The latest Covid boosters are expected to be approved by the Food and Drug Administration as early as Monday, arriving alongside the seasonal flu vaccine and shots to protect infants and older adults from R.S.V., a potentially lethal respiratory virus. After a final decision by the C.D.C.’s director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days. As Covid cases creep up, the prevention measures could portend the first winter of the decade without a crush of patients pushing hospitals beyond capacity. But a healthy winter is far from a lock: Last year, the updated Covid vaccine made it into the arms of only 20 percent of adults in the United States. Others see this year as an opportunity to protect more vulnerable people from severe illness or death.

Persons: ’ Organizations: Food and Drug Administration, Disease Control, Pfizer, BioNTech Locations: R.S.V, Moderna, United States

☆ Some Older Adults Are Being Charged Over $300 for the New R.S.V. Vaccine
▼ + stars: | 2023-08-25 | by ( Dana G. Smith | More About Dana G. Smith | ) www.nytimes.com time to read: +1 min

Amanda Jaffe, 69, went to her local pharmacy at the Safeway in Helena, Mont., to get the R.S.V. Upon hearing the price (over $300), Ms. Jaffe thought “that’s ridiculous” and left without getting it. Several common vaccines, including those for the flu and Covid-19, are included under Medicare Part B, which provides medical coverage. vaccines, as well as a few others, including the vaccine for shingles, are covered under Medicare Part D, which pays for prescription drugs. As a result, Medicare enrollees without a Part D plan — roughly 16 million people — may have to pay for the R.S.V.

Persons: Amanda Jaffe, “, ” Ms, Jaffe, ”, Richard Hughes IV, Epstein Becker Green Organizations: Safeway, Medicare, Moderna, Centers, Medicaid Services, New York Times Locations: Helena, Mont

☆ F.D.A. Approves R.S.V. Shot for Infants
▼ + stars: | 2023-07-17 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections for an illness that fills children’s hospitals year after year. The monoclonal antibody shot is expected to be available at the start of the fall R.S.V. vaccine by Pfizer for pregnant women that is meant to protect infants from the virus. can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” Dr. John Farley, an official in the F.D.A. “Today’s approval addresses the great need for products to help reduce the impact of R.S.V.

Persons: ” Dr, John Farley, “ Organizations: Drug Administration, Pfizer, Sanofi, AstraZeneca, Centers for Disease Control, Center, Drug, Research

☆ Federal Officials Hatch a Three-Pronged Defense Against Another ‘Tripledemic’
▼ + stars: | 2023-07-05 | by ( Apoorva Mandavilli | ) www.nytimes.com time to read: +1 min

To prevent a repeat of last winter’s “tripledemic” of respiratory illnesses, Americans will be encouraged to roll up their sleeves not just for flu shots but for two other vaccines, one of them entirely new. Federal health officials have already asked manufacturers to produce reformulated Covid vaccines to be distributed later this year. Recently, the Centers for Disease Control and Prevention took an additional step, endorsing two new vaccines against respiratory syncytial virus for older Americans. The three shots — flu, Covid and R.S.V. But there are uncertainties about how the vaccines are best administered, who is most likely to benefit, and what the risks may be.

Persons: ”, Ofer Levy Organizations: Centers for Disease Control, Boston Children’s Hospital, Food and Drug Administration Locations: Federal

☆ Three Vaccines for Fall: What You Need to Know
▼ + stars: | 2023-07-05 | by ( Apoorva Mandavilli | ) www.nytimes.com time to read: +1 min

Most Americans have had one or more shots of the flu and Covid vaccines. Federal health officials are hoping that widespread use of these three vaccines will head off another “tripledemic” of respiratory illnesses, like the one seen last winter. Here’s what he and other experts say about who should receive which vaccines, and when. What respiratory illnesses are coming our way? are all likely to resurge this fall, but exactly when and how much damage they will do are unknown.

Persons: ”, Ofer Levy Organizations: Boston Children’s Hospital, Food and Drug Administration Locations: hospitalizations

☆ F.D.A. Panel Advises Vaccine Makers to Aim at Only One Covid Variant
▼ + stars: | 2023-06-15 | by ( Christina Jewett | ) www.nytimes.com time to read: +2 min

The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines. It remains unclear whether or when the vaccine makers or the F.D.A.

Persons: ”, Peter Marks, Natalie Thornburg Organizations: Pfizer, Moderna, Centers for Disease Control, World Health Organization, Agency Locations: United States

☆ F.D.A. Approves Pfizer’s R.S.V. Vaccine for Older Adults
▼ + stars: | 2023-05-31 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

Each year, about 60,000 adults 65 and older are hospitalized with R.S.V. The Centers for Disease Control and Prevention estimated that in one year, more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. Several treatments, including a maternal vaccine and a monoclonal antibody for infants against R.S.V., are under agency review. The GSK vaccine, called Arexvy, was nearly 83 percent effective against severe R.S.V. The final vote of the F.D.A.’s advisory panel in favor of the Pfizer vaccine’s safety and efficacy was 7 to 4.

Persons: Miller Fisher, Jerica Pitts Organizations: Disease Control, GSK, Pfizer, Infants, R.S.V

☆ F.D.A. Panel Recommends R.S.V. Vaccine to Protect Young Infants
▼ + stars: | 2023-05-18 | by ( Christina Jewett | ) www.nytimes.com time to read: 1 min

An advisory panel to the Food and Drug Administration voted on Thursday in favor of approving a vaccine by Pfizer to prevent the severe respiratory virus that is a potentially deadly threat to infants. The vaccine would be the first to protect babies from respiratory syncytial virus, or R.S.V., which is the reason many infants are admitted to children’s hospitals each year and kills several hundred under 5 each year. Fourteen agency advisers unanimously agreed that the vaccine was effective, and the F.D.A. typically follows the recommendations of its advisory panels. Ten of the 14 agreed that the vaccine was safe, with some airing concerns about elevated rates — not all statistically significant — of preterm births among mothers who got the vaccine compared to those who received a placebo.

☆ R.S.V. Vaccine Approved for Older Adults
▼ + stars: | 2023-05-03 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes. vaccine for older adults is also expected to receive F.D.A. in older adults and said it expected authorization in the first half of this year. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.

☆ Just How Bad Is the ‘Tripledemic’?
▼ + stars: | 2022-12-16 | by ( Amy Schoenfeld Walker | ) www.nytimes.com time to read: +6 min

R.S.V., or respiratory syncytial virus, has made so many young children ill this fall that weekly pediatric hospitalizations for R.S.V. Public health officials have been warning for weeks that a “tripledemic” of Covid-19, flu and R.S.V. Weekly hospitalizations for Covid-19, R.S.V. With flu surging and Covid-19 circulating, respiratory illness has overwhelmed pediatric units across the country, shifting the strain to emergency rooms and children’s hospitals. The predominant type of flu circulating right now, a subtype of influenza A known as H3, also tends to result in higher flu hospitalizations among the elderly, according to the C.D.C.

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