Tag: updated COVID-19 booster

  • Food and Drug Administration approves COVID boosters for upcoming season

    Food and Drug Administration approves COVID boosters for upcoming season

    BY:  Ohio Capital Journal

    WASHINGTON — The U.S. Food and Drug Administration on Monday approved the latest round of COVID-19 boosters, as public health officials brace for another cold and flu season.

    An advisory panel at the Centers for Disease Control and Prevention is scheduled to vote on recommendations Tuesday, the final step in the process before people will be able to get the shots.

    “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

    “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” Marks added. “We very much encourage those who are eligible to consider getting vaccinated.”

    The updated COVID-19 booster shots are made by Moderna and Pfizer.

    The FDA said in a statement that people 5 and older can get one dose of the updated mRNA COVID-19 vaccine as long as it’s been at least two months since their last dose of the vaccine.

    Vaccinated children between six months and 4 years old can get one or two doses of the updated vaccine. Unvaccinated children in the same age range are eligible for three doses of the updated Pfizer-BioNTech vaccine or two doses of the updated Moderna shot.

    “The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants,” the FDA said in a statement. “Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.”

    Hospitalizations and deaths from COVID-19 have been trending upward in recent weeks, though officials aren’t expressing alarm at the rise in severe illness.

    The number of hospitalizations has risen by nearly 16% while deaths increased by almost 11%, according to data from the CDC.

    The percentage of Americans getting COVID-19 shots has steadily decreased since the first round of vaccinations rolled out in the last weeks of 2020.

    More than 81% of the country got at least one dose of the original vaccine, but 70% completed the primary two-dose series. Just 17% of the U.S. population decided to get the bivalent vaccine that was approved last year, according to CDC data.


    Jennifer Shutt
    JENNIFER SHUTT

    Jennifer covers the nation’s capital as a senior reporter for States Newsroom. Her coverage areas include congressional policy, politics and legal challenges with a focus on health care, unemployment, housing and aid to families.

    MORE FROM AUTHOR

  • FDA, CDC greenlight updated COVID-19 booster for kids 5 to 11

    FDA, CDC greenlight updated COVID-19 booster for kids 5 to 11

    Gavin Smits receives a first dose of the Pfizer COVID-19 vaccine at Harborview Medical Center on May 13, 2021 in Seattle, Washington. (Photo by David Ryder/Getty Images)

    BY: JENNIFER SHUTT – Ohio Capital Journal

    WASHINGTON — The federal government on Wednesday recommended an updated COVID-19 booster for kids between 5 and 11, expanding use of the new bivalent shots beyond people 12 and older.

    The U.S. Food and Drug Administration first authorized the updated vaccines use in the morning before the Centers for Disease Control and Prevention recommended them in the afternoon, completing the two-step process needed before shots could begin

    CDC Director Rochelle Walensky announced her recommendation in a tweet, saying it’s “a critical step in our fight against COVID-19.”

    “An updated vaccine can help bolster protection for our children this winter,” she added, encouraging parents to talk to their child’s healthcare provider.

    The announcement Wednesday for kids between 5 and 11 follows the FDA authorizing and the CDC recommending the bivalent booster dose for people 12 and older in early September.

    “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

    “Children may also experience long-term effects, even following initially mild disease,” Marks added.

    The shot is updated to provide protection against the latest omicron variants of COVID-19, known as BA.4 and BA.5.

    The move comes as public health officials are monitoring new variants that could cause disruptions this winter during the annual cold and flu season.

    Winter surge in cases possible

    White House COVID-19 Response Coordinator Ashish Jha said Tuesday during a press briefing that everyone eligible for the latest booster should get it as soon as they can, though he declined to list any goals for the new shot.

    Jha then warned that a surge of COVID-19 cases could be on the horizon this winter.

    “We have seen an increase in COVID infections, hospitalizations, and deaths each of the last two winters. And we are carefully monitoring the rise of several subvariants that are evolving rapidly and emerging around the world, including ones that evade some of our treatments,” Jha said.

    The Biden administration, he said, is tracking COVID-19 variants that “either have a lot more immune invasiveness or they render many of our treatments ineffective.”

    The good news, however, is that the variants public health officials are tracking come from omicron strains BA.2 and BA.5, Jha said.

    “That means our updated bivalent vaccines should provide a much higher degree of protection than the original prototype vaccine would have,” he said. “Obviously, we’re going to do the studies to figure out how much protection, but I’m confident that our vaccines will continue to work very well.”

    No vaccine goals set

    Despite encouraging everyone eligible for the updated COVID-19 bivalent booster dose to get vaccinated, Jha said the White House hasn’t set any goals for how many people it wants to get the shot.

    “We’re not setting targets,” Jha said. “We are focused on driving deaths down, getting more people vaccinated.”

    The U.S. Centers for Disease Control and Prevention’s website shows that 11.5 million people have received the updated booster dose, a fraction of those eligible.

    The COVID-19 boosters are expected to become an annual recommendation for most people, similar to the annual flu shot.