The vaccine landscape changed today. To keep you up to date, here is a summary of changes and a new vaccine chart.
New Factsheets for Healthcare Providers have been issued for Pfizer Purple, Gray, and Orange vaccines. The Pfizer family of vaccines are now authorized for two booster doses, the first of which may be given five months after a primary series in individuals 12 and older, and a second may be given four months after the first booster in individuals 50 and older and in individuals 12 and older with “certain immunodeficiencies” defined in the authorization letter as individuals “who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.” Pfizer Orange is authorized for a third shot in the primary series for individuals 5 through 11 with the same “certain immunodeficiencies,” but not for boosters. Each of these new factsheets (Purple, page 44; Gray, page 41; Orange, page 33) contain a statement I don’t remember seeing before: “Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.” Show this to your OB if you are pressured to get a vaccine while pregnant. I am unable to explain why CDC still recommends COVID vaccines for “people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.” These authorizations also extend the vaccine expiration dates. COMIRNATY, the only vaccine approved for individuals 16 and older, is still unavailable in the United States.
Moderna vaccines now have a complicated color scheme. The authorized Moderna COVID-19 Vaccine, and the approved SPIKEVAX (COVID-19 Vaccine, mRNA) both have red caps with a light-blue border. These are given in full dose (0.5 ml) for primary series and half dose (0.25 ml) for booster. The Moderna COVID-19 Vaccine also comes in a booster-only half-strength vial recognized by its dark blue cap with purple border given as a full dose (0.5 ml). Presumably, this is to cut down on confusion between the primary series and booster dosing, but it has resulted in a very complicated updated authorization letter. Moderna first boosters are authorized five months after the primary series for a first booster in individuals 18 and older, and four months later as a second boosters for individuals 50 and older and in individuals 18 and older with “certain immunodeficiencies,” defined the same as for Pfizer. On page 29 of the Blue/Purple factsheet is the same warning issued for Pfizer: “Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.” Moderna boosters may be preferred by your doctor since they are thought to produce the encouraged highest antibody response; I’m not convinced that is a good thing. SPIKEVAX, Moderna’s approved vaccine, is still unavailable in the United States.
FDA has limited its authorization for the Johnson and Johnsons vaccine. There is a new Factsheet for Healthcare Providers that starts with a prominent warning about its blood clot complication. Page 26 contains the familiar pregnancy warning: “Available data on Janssen COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.” CDC recommends Moderna’s and Pfizer’s family of vaccines over Janssen. The vaccine expiration dates have been extended.
The FDA has announced a tentative schedule for it’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). On June 7, the committee will consider an EUA request for the Noravax COVID-19 Vaccine. It will be live-streamed on FDA’s YouTube channel.
3 replies on “FDA Limits Janssen EUA”
Thank you I love the feedback you share with all your followers. We love to stay informed thank you.
I am not a doctor nor a scientist but I do invite feedback. Here are my thoughts:
1. None of the vaccines / boosters available in the United States are approved and licensed biologics making them experimental regardless of their color coded packaging.
2. Opaque, sloppy, and perhaps fraudulent clinical trials in combination with mandates born from unholy public / private copulation has resulted in non-existent informed consent. Vaccination largely came about from fear, ignorance, and coercion.
3. The vaccines / boosters are built upon the same spike protein present in the virus making the vaccines / boosters an extension of GoF research.
4. A preparation that does not sterilize a virus is not a vaccine.
5. The virus can spread among the fully vaccinated and boosted calling into question the purpose of the vaccine. The tag line “Thanks to the vaccine I didn’t get as sick as I could have” cannot be substantiated.
6. Nobody knows the evolutionary potential of this particular GoF virus making for a very uncertain future.
7. Can The Gang That Couldn’t Shoot Straight (Collins, Fauci, Daszak, Gates, et al) spell Nuremberg?
8. The HHS, FDA, CDC, NIH, NIAID, DOD hasn’t examined or treated a single patient.
[…] children is an emergency. At the same time, we have stumbled on the answer to a question I asked a few weeks ago. Why does CDC recommend COVID-19 vaccines to pregnant […]