Some in US getting Covid-19 boosters without FDA approval – News Vibe24

    Some in US getting Covid-19 boosters without FDA approval - Times of India
    DENVER, USA: When the delta variant began to spread, Gina Wells decided not to take the risk: She took a third, booster dose of the Covid-19 vaccine at a clinic and told them it was her first shot.
    The US government has not approved any antidotes to the virus, saying it has not yet seen the evidence it needs. But Welch and a myriad of other Americans have been able to obtain them by taking advantage of the country’s surplus of vaccines and the lax monitoring of those who have been fully vaccinated.
    Welch, a Maine graduate student studying chemical engineering, said she was following scientific studies on Covid-19 and was following several virologists and epidemiologists on social media who had supported the aid.
    “I will follow these specialists and go and protect myself,” said Welch, a 26-year-old with asthma and liver disease. “I will not wait another six months to a year to recommend a third dose.”
    While Pfizer has said it plans to seek approval from the US Food and Drug Administration for booster vaccines, health officials say that for now, fully vaccinated ones look well protected.
    However, U.S. health care providers reported more than 900 cases of people receiving the third dose of Covid-19 vaccine in a database managed by the Centers for Disease Control and Prevention, according to a review of system data by the Associated Press. Because the report is voluntary, the full extent of individuals receiving third doses is unknown. It is also unknown if all of these people were actively trying to get a third dose as a souvenir.
    “I don’t think anyone really has the watch” to know how widespread it is, said Claire Hannan, executive director of the Immunization Managers Association.
    An entry in the CDC database shows that a 52-year-old man took the third dose from a California pharmacy on July 14, saying he had never received it and provided his passport rather than a driver’s license as an ID. But when the pharmacy contacted the patient’s insurance provider, he was told he had received two installments in March.
    In Virginia, a 39-year-old man received his third shot from a military provider on April 27 after showing a vaccine card that showed he had taken only one dose. A review of the records showed his previous vaccinations. The patient then told the provider that the time between his first and second dose was over 21 days, “so they talked to their provider, who authorized them to ‘take a third shot,'” a post said.
    Colorado Gov. Jared Polis said in a recent statement that he knew residents who had taken the third dose using fake names, but neither his office nor the state health department could provide information.
    Despite the lack of FDA approval, public health officials in San Francisco said Tuesday they would provide an extra dose of the Pfizer or Moderna vaccine to people who received the Johnson and Johnson variety — citing it as a supplement. rather than a souvenir.
    Several studies have looked at booster shots for certain at-risk groups – people with weakened immune systems, adults over 60, and health care workers. But the verdict is still pending on whether the general population may need them, said Dr Michelle Barron, senior medical director for infection prevention at UCHealth, a nonprofit healthcare system based in Aurora, Colorado. He said the best data in favor of potential boosters is for people whose immune systems have deteriorated.
    Israel provides support to older adults and several countries, including Germany, Russia and the United Kingdom, have approved it for some people. The head of the World Health Organization recently called on richer countries to stop giving boosters to ensure that vaccine doses are available in other countries where few people have received their first vaccines.
    Will Clart, a 67-year-old patient at a Missouri hospital, took a third dose in May by going to a local drugstore. Clart said he gave the pharmacist all his information, but that the pharmacist did not realize until after receiving the shot that Clart’s name was on the vaccine system.
    “It seemed like there was a benefit to it. And there was also talk that we would eventually need an amplifier – mine was five or six months out and so I thought well I would go ahead, that would give me a souvenir,” Clart said.
    Ted Rall, a political cartoonist, explained in a Wall Street Journal article that he received a reminder from a history of lung problems such as asthma, swine flu and recurrent bouts of bronchitis and pneumonia.
    “I decided after reading a report that states were likely to dump 26.2 million unused doses due to low demand. My decision had no effect on policy and I saved a dose of the rubbish vaccine,” Rall said.
    Welch, a graduate student from Maine, blamed people who refused to get the vaccine for political reasons. About 60 percent of eligible individuals in the United States are fully vaccinated.
    “Their absolute demand and their cries for freedom are undermining our public health and our community.”


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