BREAKING—Trump FDA just left final kick in the teeth—Pfizer will now ship fewer #COVID19 vaccine vials after it lobbied to count & **pay for** “extra” doses found in vials. Now Pfizer can count 6 per vial to meet dose orders—ie shipping less vials. When FDA approved? Jan 6th! 🧵
2) “For weeks, Pfizer execs pushed officials at Trump FDA to change the wording of vaccine’s emergency use authorization so it formally acknowledged that vials contained 6 doses, not 5. Distinction critical: Pfizer’s contract requires paid by the dose.” nytimes.com/2021/01/22/hea…
3) “Now, it appears, the bill is due. Pfizer plans to count the surprise sixth dose toward its previous commitment of 200 million doses of Covid vaccine by the end of July and therefore will be providing fewer vials than once expected for the US.
4) “And yet, pharmacists at some vaccination sites say they are still struggling to reliably extract the extra doses, which require the use of a specialty syringe.”
5) “At one point, Pfizer executives lashed out at top federal vaccine regulator over govt reluctance to budge on request. On Jan 6, Pfizer got what it wanted”—Trump FDA changed the language.
➡️ Instead of 1000 vials, Pfizer can now just send 833 vials because of Pfizer lobbying.
6) To be clear—the 6th dose is not always extractable with standard syringes—one often needs special “low dead volume” syringes. There is a shortage that Biden had to invoke DPA for making it. If so, then it’s not fair to charge for 6 doses/vial @pfizer!
7) Looks like Pfizer also likely lobbies EU regulators as well on the 6th dose. EU also changed their label in early Jan on 6th dose per vial. ema.europa.eu/en/news/extra-…
8) Oh fresh hell— “Pfizer’s efforts to capitalize on the discovery were for weeks camouflaged in a bureaucratic language dispute. Before Christmas, Pfizer approached FDA requesting a formal change to its fact sheet so that it said each vial contained 6 doses of instead of 5....”
9) “But regulators instead suggested the phrase “up to six doses,” depending on what kinds of syringes were used to extract the vaccine.
After FDA signed a new fact sheet with that more cautious language, Pfizer approached FDA again, saying it was crucial to say “six doses.”
10) “The company suggested altering the language to indicate that low dead volume syringes should be used. At one point, Pfizer executives lashed out at Dr. Peter Marks, the top vaccine regulator at the F.D.A., according to two people who heard about the exchange.
11) Okay folks— I’ve seen enough. I’m calling it...
Mulling 🇬🇧 disclosure that new #B117 variant could increase #COVID19 deaths ~30%. 🇬🇧 is expected to prolong & tighten lockdown—Schools may close until Easter, overseas travelers maybe quarantined in hotels for 10 days. I’ve looked at data—it’s worrying. 🧵 nytimes.com/2021/01/24/wor…
2) Notably, 6 out of 10 studies conducted on the mortality risk show significantly increased risk of #COVID19 death, ranging from 28% to 91% higher relative risk. They are circled in red below. A 7th (purple) study also shows a 30% increase, albeit not quite sig, but compatible.
3) Notably, I want people to focus on the two studies from @LSHTM - circled in green. These were prospective cohorts that used full Cox models that detailed followed individual person-time from beginning to end—much better than others. These 2 show 28-35% #COVID19 death increase.
Denmark🇩🇰 even more worried than ever about new #B117 variant—B117 cases increasing 70% a week **despite strict lockdown**, says Denmark’s CDC genome sequencing *every single case in the country* for mutation. By contrast, 🇺🇸 sequencing 0.3%. #COVID19 🧵 washingtonpost.com/world/europe/u…
2) “We’re losing some of the tools that we have to control the epidemic,” said Tyra Grove Krause, scientific director of Denmark CDC @SSI_dk
3) “Because it can spread more easily, it can also quickly overwhelm medical systems, turning previously survivable bouts with the virus into perilous ones if hospitals are full and medical care is limited.
OH SHIT—Outbreak infects 124 of 127 nursing home residents & half the staff with #COVID19 in Ontario 🇨🇦. 29 people have died. Worse—#B117 variant is now confirmed in 6 of 6 samples—but expert believes widespread. Patients with #COVID19 even shared rooms!
2) They believe it was a relative of a staff member who brought it after traveling overseas. But supposedly they followed quarantine.
This is bad—Berlin has just put an entire hospital under quarantine lockdown & diverting all patients after *20 patients & staff* tested positive for more infectious #B117 variant of #SARSCoV2 from UK. Spokesperson expects to confirm more soon. #COVID19 reuters.com/article/us-hea…
2) This is why I urgently ask everyone to switch to premium masks ASAP if you can.
SWITCH TO PREMIUM MASKS—I’ve been saying it for months. We need to switch to KN95, KF94, or European FFP2 masks ASAP. The new #b117#COVID19 is just too contagious. Cloth isn’t enough anymore folks. Germany 🇩🇪 & Austria 🇦🇹 mandating on all public transits. washingtonpost.com/world/europe/e…
2) there are many masks that have 94/95% filtration...
3) N95 masks are more rare outside of hospitals because they are in shortage and needed by HCWs. You might find some NIOSH N95 from wood working, but note those are often not fluid resistant.