ACIP Public Hearing on COVID Vaccines
Today's CDC LIVE Blog Summary of Meningococcal Vaccine Speakers
Around 10:15 am PST, a series of speakers began speaking
https://www.voicesforvaccines.org/
In the near future, videos, CHATS and LIVE Meetings will be hosted on my paid subscriptions.
Mrs. Kim Freitas: It is a complete shame you open these meetings for comment, you ignore your own reporting. These vaccines are not FDA approved. Data shows kids are more adversely affected by the injections than COVID itself. Why is this even classified as a “vaccine”? The CDC changed its definition - it is time for this agency to pivot away from this dangerous injection, which is the most dangerous and least effective than all others combined.
The VARES and VSAFE data all confirm this vaccine needs to be removed immediately. We need to form committees with pathologists and others
Biggest experiment ever. (Your time is up. Thank you for your comment). Then she was silenced.
10:20 AM: It is time to vote. THis is for the adults and children vaccination schedule.
I’m going to ask first if there are any clarifying questions. then she asked for everyone to be on camera, leaving out several that were blacked out.
One at a time, they all said in sequential order,
“___ (Their last name) No conflicts. Yes”.
Next UP: Meningococcal Vaccine
Dr. Payling. From 1996 through 2019, the incidence has gone down from 1.3 to 0.11 cases per 100,000 population. For all three serogroups, B, C and Y, all have decreased with a lower decrease for B than for C and Y. Non-groupable also remained low. Age group distribution: Overall, the highest incident was in children under 5 with Group B accounting for about 1/2 the cases.
There are 5 meningococcal vaccines in the USA, for all 4 serogroups B, C, W and Y. The FDA approved a one-vial versus a two-vial product. MenAC WY is recommended for all adolescences from age 12-16. MenD is a 2-dose for adults ages 16-23.
Dr. Sam Crow: Presenting on Menveo on-vial preparation. THis was the first project in the Mengococcal Work Group. The main consideration is that the two vaccines are approved for two age ranges, a challenge.
The original Menveo 2-vial: 2 months - age 55 years; Menveo 1 vial: ages 10-55 years. Challenge: providers to reserve the 2-vial for children under age 2. GSK plans to maintain a supply, but providers still need to save the 2-vial for those under 2. They will send providers and update their website to remind providers of this supply issue. CDC is updating the VFC resolution.
Dr. Scott PReese, US Medical on GSK: the FDA approved the 1-vial for ages 10-55, more convenient for providers. For those under age 10 at high risk, they intend to supply the 2-vial supply for young children from 2 mo-10yrs. They will monitor volumes and adjust, if required. They will change the vial appearances so they appear differently for visual distinctions.
Q & A’s:
What if you are over age 55 and without a spleen, who need the meningococcal vaccine?
Dr Crowe: it is an off-label use, ok to use.
Different shelf life between the two products?
18 months, to be expanded to 24 months. This is shorter than the 2-vial, which may be 24 months.
What about the “Why” Question? Is this a Short-Term or Long-Term situation? What if a young child received the 1-vial?
Dr. Crease: We don’t have any specific data for children under age 10 for this presentation. But we don’t have an indication for the age under 10 for this presentation.
Dr. Pailey: Are there plans to study this plan down to age 2 months, and what is the plan?
Dr. Crease: There are no plans to study for those under age 10 and we are studying that.
Sandra Frigh… for AMA: I’ve had some patients who needed meningococcal vaccine but it has been difficult for the pharmacist to do the injection, taking screenshots for them. Can we make some of these off-label uses known? Can we make it easier for those who need them?
Menquafe is FDA approved for age 2 and over, available. We can investigate this further.
To Dr. Preese: There are to be color-coding differences. Recognizing that a portion of the population is color-blind, what other changes are planned?
Dr. Crease: The carton states either 1 vial per dose, or 2; one is purple and one is dull gray; age indications are on the box carton; one required reconstitution and the other does not. One vial is gray, with liquid. The second is a powder. One-color lid is pink and the contents are liquid. On the vial itself is the age-group and whether or not it requires reconstitution, i.e., powder requires added liquid, shaking, and then injection.
FINAL PRESENTATION: ETR the MenABCWY Vaccines
These are the 2nd and 3rd projects of this group. GSK and Pfizer are the two manufacturers. The meningococcal work groups will analyse each separately. The GSK is a Men1 vial serovaccine. Both are available in the USA. Company is studying safety in ages 10-25 years of age. Tremenba is is licensed in the USA. Nimenrix is not, but widely used in the UK.
The work group with study safety data for each vaccine. There are 3 questions for each vaccine:
The work group added questions 2 and 3 because once the pentavalent vaccines are available, there will be a need.
Question 1: Population Intervention, Comparison, and Outcomes (PICOs) are similar to one another.
He showed the PICOs on the 2nd and 3rd Questions.
Work group rated outcomes of 6 issues:
Anticipated February 2023 epidemiology on these two vaccines, with GPR and Pfizer to present their data.
Questions:
Dr. Chen: Are outcomes of immunity, is this some proportion of seroconversion over baseline? What is the immunologic measure?
A: I’m new at this. Can Dr. Macnemera from CDC Team: The manufacturers are on the line for specific answers; the FDA will look at this. Happy to share - raise your hand, if so.
Dr. Lare: I want to reemphasize something on Slide 7, the three questions. We thought only one question would be needed, but we thought it was reasonable to decide if questions 2 and 3 needed to be asked.
Dr. Lowe: I think the use of a pentavalent vaccine would shift to a recommendation and I would want the work group to think a lot about the low burden of the disease. The public is taking a risk, however small, that each vaccine holds. Immunizing millions of teenagers for a vaccine, for the very low risk of a disease, is something I would like to hear a lot about.
(Dr. someone) I want to thank them for each of the three questions, so thank you for highlighting it.
Dr. Daly: Question on presentation. It will be a true pentavalent, 0.5 ml, yes. It feels like there is precendent for giving a muli vaccine, like giving an MMR for an outbreak.
(Someone) The AICP pointed me to a document showing a pentavalent can be used if it contains one of the products. There is some precedent for that.
Miss McNally: I just want to be sure I understand the policy questions, thinking through a scenario. Someone vaccinated at aget 12 and 16 for ABCWY - only had one dose. Is the consideration they would get the pentavalent, and should they get the ABCWY?
A: That is the question we are asking, thank you.
Dr. Sanchez: I’d like to see a reassessment of the meningococcal vaccine for 11-12 year olds? Do we need to give it to them, with a low burden of disease? Should we reserve if for pre-college 16 year olds? I’d like you to reassess it.
A: We are going to look at the pentavalent vaccines first, but these types of questions are arising over the years… we will look at it later.
Q: I thought the idea was to come in at teen age, are they getting HPV at the same time? Does the adolescent platform apply, or do we need a “late-adolescent” platform?
More questions continue; nearing the end. I am taking a break and apologize for any typos or misspellings. I also missed some volume at 10:23 am. This is not a complete transcript. I ended at about 10:50 am PST.
… Moving on to the next session
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