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Biden administration officials are expected to change tack with a recommendation that immunocompromised people receive a third dose of the COVID-19 vaccine, facing pressure from vaccine experts who argue those patients are still vulnerable to the disease.
The administration is close to resolving just one part of the debate over the necessity of booster shots, the Wall Street Journal reported. The Food and Drug Administration expects to release updated clinical vaccine guidelines as soon as September, allowing for a third dose in the relatively small subset of people with fragile immune systems.
Federal health officials have also faced public pressure to issue guidelines for distributing third doses to people with fully functional immune systems, a move the World Health Organization condemned this week, citing dismal vaccine supplies in developing countries.
“We're going to make the decision about booster shots based on a compilation of evidence, one of which will most definitely be the immune responses … as well as our cohort data that monitor the safety and the effectiveness of our vaccines in many different populations,” said Centers for Disease Control and Prevention Director Rochelle Walensky.
Immunocompromised adults were among the first to be prioritized for vaccines earlier this year, given their susceptibility to severe illness and death due to COVID-19. But virologists have pointed to a series of studies concluding those patients produced a limited antibody response, leaving them vulnerable even after the full two-dose vaccination regimen.
A New England Journal of Medicine report, for instance, showed 101 organ transplant recipients given a third dose of the vaccine saw their prevalence of antibodies to the coronavirus increase from 4% after the first dose, 40% after the second dose, and 68% after a third dose.
“It is clear now from the observational data that was made that [immunocompromised people] … with some exceptions, but in general, do not make an adequate response that we feel would be adequately protected,” Dr. Anthony Fauci, President Joe Biden’s chief medical adviser, said Thursday.
He added that federal health officials “are now working on” guidelines for those people.
“We'll make that be implemented as quickly as possible because for us, and for the individuals involved, it is a very high priority,” Fauci said.
Last month, several vaccine experts on a federal panel endorsed giving a third dose of Pfizer or Moderna vaccines to people with weakened immune systems due to organ transplants, certain treatments for cancer, lupus, and other health conditions. They reported that of the patients who had no antibody response to the first two shots, 33%-50% developed one after receiving the third dose.
The FDA would have to authorize the extra shots before being distributed. Despite mounting evidence to show people with the most fragile immune systems would benefit from a booster dose, Biden administration officials have dragged their feet in issuing guidelines for administering them. Reports have made it to the White House of people receiving third doses from their doctors or through more disingenuous means, such as traveling to another state or pharmacy with no record of the person's vaccination status.
“We are just starting to get data on [people who were able to get a third shot],” Walensky said on Monday. “We are trying hard to encourage people to report on the safety side if people have taken the initiative to get their third shot — again, not yet recommended.”
The administration’s shift toward revising guidance on booster shots for a specific sector of the population comes amid fears the highly contagious delta variant can evade the two-dose Pfizer and Moderna vaccines and the single-dose Johnson & Johnson vaccine. Still, infectious disease experts have tried to alleviate those fears by citing expansive evidence the vaccines are highly effective.
The Biden administration and vaccine makers have said vaccinated people are protected from severe illness, but breakthrough cases can happen. While the CDC does not keep track of the total number of confirmed breakthrough cases, the agency reports that just over 7,500 people out of the more than 165 million people to have been fully vaccinated were hospitalized or died due to COVID-19.
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Original Author: Cassidy Morrison
Original Location: New guidelines will call for third COVID shot for vulnerable people