Booster vaccine, FDA experts oppose US plan – Outney.net

Individuals in good health do not yet need a dose of booster vaccine against COVID-19, according to an article published Monday in a scientific journal signed by an international group of scientists, including two senior executives from the US Drug Enforcement Administration. FDA).

Experts reviewed studies on vaccine capacities and concluded that vaccinations are working well, despite the highly infectious Delta variant, especially against severe symptoms.

“Even in populations with very high vaccination rates, the unvaccinated are still the main spreaders of infections” at this stage of the pandemic, says the group of scientists.

The scientists’ opinion, published in the prestigious Lancet magazine, illustrates the deep scientific debate over who needs a booster dose and when, a decision that the United States and other countries are facing.

After the emergence of political interference in the reaction of the President Trump administration to the coronavirus, President Joe Biden has promised that his decisions will be based on science. But consideration for a booster dose is raising the question of whether his administration is moving faster than experts.

Among the authors of the article are also two senior experts of the American agency for drugs (FDA) Dr. Phil Krause and Marion Gruber, who recently announced they will resign this fall.

Among the other 16 authors are leading vaccine researchers in the US, Britain, France, South Africa and India, as well as scientists with the World Health Organization, which has already called for a booster dose moratorium until poor countries are better vaccinated. .

Meanwhile, the White House has begun plans to receive the booster dose by the end of this month, if the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention agree.

Larry Gostin with Georgetown University said the opinion published in the scientific journal “throws gasoline on the fire” in the debate over whether most Americans really need the boost dose and whether the White House is coming before scientists.

“It is always a fundamental mistake of the process to make a scientific announcement before public health agencies act, and that is exactly what happened,” said Gostin, a public health activist and specialist.

The Federal Drug Administration (FDA) did not respond to requests for comment Monday.

Already, the United States is offering an additional dose of Pfizer or Moderna vaccines to people with severely weakened immune systems.

Meanwhile, the debate among the population over whether to take a booster dose is waning, although vaccines still offer high protection against serious diseases – perhaps in the hope of blocking milder infections among those who have been vaccinated completely.

Last week, the director of the American Centers for Disease Control and Prevention, Dr. Rochelle Walensky said the data show that unvaccinated people were 4.5 times more likely to become infected than fully vaccinated and 10 times more likely to be hospitalized and 11 times more likely to die.

However, scientists working with state agencies are also examining allegations that protection is declining among older adults who were vaccinated early last winter.

The authors of the commentary published Monday in the Lancet said they had reviewed studies from around the world since the beginning of the increase in cases with the Delta variant, mainly of American and European vaccines. The team concluded that “none of these studies have provided reliable evidence of a weakening of the protective power of vaccines against severe symptoms” of coronavirus.

Because the body builds layers of immunity, a gradual drop in antibody levels does not necessarily mean a decrease in overall effectiveness, and a reduction in the effectiveness of the mild symptom vaccine does not necessarily mean a decrease in efficacy (usually higher) against heavy “, they say.

The more the virus spreads, the more likely it is to evolve into variants that current vaccines can penetrate. In their article in The Lancet, the scientists suggest that there may be greater benefits to creating booster doses that better match circulating variants, such as regularly improving the flu vaccine, than giving additional doses of the initial vaccine.

“There is now an opportunity to study booster doses based on the variant before there is a great need for them,” the scientists said.

/FLY