Day 633: Spikevax Spiked Again

Despite the local enthusiasm for Moderna boosters, Sweden, land of the old normal, continues to diss the Spikevax, extending their under-30's Moderna moratorium beyond the initial December 1st deadline.

Things aren't all rosy for Pfizer, either. Lawyers for the de Garay family are agitating against Comirnaty in children. In their letter to the FDA and CDC they say:

To date, Pfizer’s Comirnaty is approved for children ages 16 and 17 and authorized for emergency use in children 12 through 15, with authorization expected shortly for children 5 through 11. Before any additional authorizations or approvals for children are granted, it is imperative that you properly account for what occurred to Mr. and Mrs. de Garay’s 12-year-old daughter, Maddie, in Pfizer’s clinical trial.

The only rigorous way to ensure safety and efficacy is via appropriate clinical trials which do not ignore serious adverse events occurring in those trials. Pfizer’s clinical trial for children aged 12-15 included 2,260 participants, half of who received the vaccine and half who received a placebo. Meaning, only 1,131 children were vaccinated and at least one of those children, Maddie de Garay, suffered a devastating, life-altering injury which, despite incontrovertible proof and the cries of both the victim and her parents, has not been acknowledged by the sponsor (“Pfizer”) or the Food and Drug Administration (“FDA”).

For a virus for which children have a 99.998% chance of surviving, the FDA must ensure there is an even more remote chance of a serious adverse event from any vaccine intended to prevent harm from the virus. Therefore, we implore you to carefully consider the following information.

Massachusetts cases were up a sixth of a percentage point on Friday.