“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”The FDA followed up with a Pfizer approval soon after. They await the usual CDC rubber stamp. [P.S.: Halfway stamped already... Smell that rubber burn!]
The booster dose is to be administered at least six months after completion of any primary series COVID-19 vaccination. On October 20th, the FDA authorized for emergency use a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2. The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets. This follows the earlier approval of the 100 µg mRNA 1273 third dose in immunocompromised individuals.
The FDA based this EUA on the totality of scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.
Meanwhile, Austria is rapidly leaping from Reich to Reich, with the recent lockdown of the unvaccinated expanding now to a full lockdown and universal vaccination mandate. Martin Lichtmesz describes the eerily familiar demonization of the unvaxxed at eugyppius' blog, without mentioning a single yellow star:
When will the police be at the door? When will vaccine refusal have criminal consequences? When will it result in fines of the sort that will destroy people of modest means? In the climate that is descending around us, anything seems possible. Social, legal, and medical-ethical standards are rapidly disintegrating, state overreach is becoming the norm. Already, among the unvaccinated, the feeling is spreading that they are outlaws and have their backs against the wall.Read the whole thing. It makes Massachusetts' groupthink look positively open-minded.
Of course, these “tightened measures” at the expense of the unvaccinated have not had the slightest effect on “the numbers,” which, according to the press, are once again “exploding.” They have finally, and totally predictably, resulted in this “lockdown for all.” Perhaps they intended this from the beginning, and were merely waiting for a dramatic spike to cause emotions to boil over.
This renewed “lockdown for all” will make a lot of people who have dutifully gone along with everything to this point extremely angry, and so the political and the media establishment have already provided a target for this anger and frustration: The blame for everything – for the lockdown, the high incidences, the high ICU occupancy, the alleged triage, the corpses piling up in the corridors [link to an article in German about false media propaganda], and so forth – lies with the well-poisoners, the “vaccine refuseniks”, the “hesitants,” the “Querdenker” [the “lateral thinkers” – a populist grassroots Corona sceptic movement in Germany and Austria], etc. No few people are now openly wishing death upon these noncompliants.
Had they been vaccinated – so goes their conspiratorial narrative – we’d all be free of Corona and the national government would not be forced by lack of alternative to impose these draconian measures. They’ve brought all of this on themselves. Whining just amounts to an insubordinate miming of the victim's role. They must be punished, educated, and forced, if argument and persuasion cannot help. The mob are so certain of themselves, they have even produced smiling priests who publicly boast that they have “no sympathy for the unvaccinated.”
P.S. Massachusetts cases were up a third of a percentage point today.
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