Home » Vaccine, in the US FDA experts hold back on third dose with Pfizer: yes only to over 65

Vaccine, in the US FDA experts hold back on third dose with Pfizer: yes only to over 65

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No to the third dose of Pfizer’s Covid vaccine indiscriminately for all people aged 16 and over. Green light, however, for the over 65 age group and for the most vulnerable, starting from the sixth month after the second dose. This 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 (LIVE UPDATES – SPECIAL).

The reflections of the experts

deepening


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Experts have disputed that the data – even those from Israel – justify an extra dose when in reality 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 member of the committee and an executive of the National Institutes of Health (Nih ). A few days before the meeting of the FDA panel of experts, moreover, a study was published in ‘The Lancet’ in which a group of scientists had pointed out that the protection of the vaccine decreases, over time, for mild diseases, but continues to persist for severe symptoms. The study, also signed by two senior FDA officials, therefore concluded that a large-scale distribution of recalls is not appropriate at the moment.

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Biden’s strategy

US President Joe Biden announced a month ago a plan to start 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). 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. And now Biden will most likely be forced to back down permanently. Meanwhile, 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 also negotiating with Pfizer to purchase another 500 million doses to donate overseas, which will bring the total number to 1.15 million doses, about one-tenth of the world‘s needs.

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