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FDA experts among group opposing US booster shot plan


An international group of scientists is arguing that the average person does not yet need a COVID-19 booster – an opinion that highlights a deep scientific divide on the question

The average person does not yet need a COVID-19 booster, an international group of scientists – including two top US regulators – wrote in a scientific journal on Monday.

Experts reviewed studies of the performance of vaccines and concluded that the shots are working well, especially against severe disease, despite the additional infectious delta variant.

“Even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission” at this stage of the epidemic. he concluded.

The opinion piece, published in The Lancet, reflects the intense scientific debate about who needs a booster dose and when, a decision the US and other countries are grappling with.

Following revelations of political interference in the Trump administration’s coronavirus response, President Joe Biden has promised to “follow the science.” But the review raises questions about whether his administration is moving faster than experts think.

The authors include two leading vaccine reviewers at the Food and Drug Administration, Drs. Phil Krause and Marion Gruber, who recently announced they would be leaving this fall. The other 16 authors are leading vaccine researchers in the US, UK, France, South Africa and India, as well as scientists from the World Health Organization, who have already urged a moratorium on boosters until poor countries are better vaccinated. Happens.

In the US, the White House will begin planning a booster later this month, if both the FDA and the Centers for Disease Control and Prevention agree. FDA advisors will weigh evidence about an additional Pfizer shot at a major public meeting on Friday.

Larry Gostin of Georgetown University said the paper “throws gasoline on the fire” in the debate over whether most Americans really need boosters and whether the White House has overtaken scientists.

“It’s always a fundamental error of procedure to make a scientific declaration before public health agencies act, and that’s exactly what happened here,” said Gostin, an attorney and public health expert.

The FDA did not respond to requests for comment on Monday morning.

The US provides an additional dose of the Pfizer or Moderna vaccines to people with already severely weakened immune systems.

For the general population, the debate is boiling over whether boosters should be given, even though vaccines still offer high protection against serious disease – possibly between complete vaccinations to block minor “breakthrough” infections. in expectation.

Last week, CDC Director Dr. Rochelle Valensky said: new data showed that as delta increased, uninfected people were 4.5 times more likely to be infected than those who were fully vaccinated, 10 times more likely to be hospitalized and 11 times more likely to die. Still, government scientists are also weighing signs that protection is waning in older adults who were vaccinated early last winter.

The authors of Monday’s remarks reported reviewing studies from around the world as Delta began to rise, mostly of US and European vaccines. The team concluded “none of these studies have provided reliable evidence of decreased protection against serious disease.”

Because the body builds up layers of immunity, a gradual drop in antibody levels does not necessarily mean that overall effectiveness is falling “and a decrease in vaccine efficacy against mild disease does not necessarily mean that against severe disease (usually but high) predict a decrease in efficacy,” he wrote.

The more the virus spreads, the more chance it has to evolve into strains that can survive current vaccines. Lancet reviewers suggest that there could be a big benefit from creating booster doses that better match regularly updated variants, like the flu vaccine, than giving additional doses of the original vaccine.

“There is now an opportunity to study different types of boosters before they are widely needed,” the scientists wrote.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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