Home » Covid, the FDA rejects the third dose of vaccine for all and recommends it for over 65 and vulnerable categories

Covid, the FDA rejects the third dose of vaccine for all and recommends it for over 65 and vulnerable categories

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No to the third dose of the anti Covid Pfizer vaccine indiscriminately for all people aged 16 and over, yes instead for the age group from 65 and up and for the most vulnerable, starting from the sixth month after the second dose: it is the conclusion of the scientific advisory committee of the Food and Drug Administration (Fda), the US federal agency responsible for drug safety. The position matured after a long discussion, with a large majority vote, 16 to 3. Now the final decision, next week, rests with the FDA, which generally follows the recommendations of its independent experts. The latter, including doctors who deal with infectious diseases and statistics, have disputed that the data – even those from Israel – justify an extra dose when in fact vaccines appear to offer robust protection against the most serious forms of coronavirus and hospitalizations, at least in the US.

“It is not clear that everyone needs reinforcement, except for a sub-category of the population that clearly would be at high risk of a serious illness,” explained Dr. Michael G. Kurilla, a committee member and executive of the National Institutes of Health (Nih).

A bad blow for the Biden administration, but also for the governments that have launched or are launching campaigns for the third dose because the American recommendations will sow doubts and perplexities. The US president announced a month ago a plan to be launched on September 20 for the ‘booster’ to be administered at least eight months after the second dose (or the first in the case of Johnson & Johnson), subject to the approval of the FDA and the Centers for Disease Control and Prevention (Cdc), the highest US health authority. But after two weeks, executives from both agencies told the White House that they needed more time to analyze the data and would only speak on Pfizer.

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Now comes the cold shower on this vaccine and Biden will be forced to back down, having promised to always follow science. On the eve of the discussion, two scientific fronts had arisen: one in favor of the third dose, which included White House medical adviser Anthony Fauci, and one against. Among the detractors are two FDA scientists who have resigned, co-authors with a group of international colleagues of a medical article in which they argued that there is no credible evidence to support the ‘booster’ for the entire population. Now the advisory committee of the CDC will also have to decide, which from previous discussions could move towards “tailor-made” inoculations for older or more vulnerable people. Meanwhile, Biden is negotiating with Pfizer to purchase another 500 million doses to donate abroad, which will bring the total number to 1.15 billion doses, about one-tenth of the world‘s needs.

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