By Scott Creighton
Dr. Meryl Nass is reporting the effort to get 'novel' vaccines into Africa has begun yet in her article she fails to specifically name the two vaccines approved by the WHO or how they would be qualified as 'novel' when BOTH have been around and approved for use for YEARS.
Meryl Nass https://merylnass.substack.com/p/its-begun-the-effort-to-get-novel
It's begun: the effort to get novel vaccines (?) into Africans
As you know, two vaccines for mpox are recommended by WHO’s Strategic Advisory Group of Experts on Immunization, and are also approved by WHO-listed national regulatory authorities, as well as by individual countries including Nigeria and the DRC.' Tedros
CDC: Two vaccines may be used to prevent mpox:
JYNNEOS is a third-generation vaccine based on a live, attenuated orthopoxvirus, Modified Vaccinia Ankara (MVA). MVA is a live virus that does not replicate efficiently in humans. JYNNEOS is known internationally as Imvamune® or Imvanex®; it is manufactured by Bavarian Nordic. It is fully licensed in the U.S. for subcutaneous administration in individuals 18 years of age and older. As of April 1, 2024, JYNNEOS is commercially available in the U.S.
... the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) in August 2022 to allow JYNNEOS vaccine to be used...
ACAM2000 is a second-generation vaccine that contains a live vaccinia virus that replicates efficiently in humans. It is manufactured by Emergent Bio Solutions and is indicated for the prevention of smallpox. It has been made available for use against mpox in the current outbreak under an Expanded Access Investigational New Drug (EA-IND) protocol, which requires informed consent along with completing additional forms. Available evidence supporting the use of smallpox vaccine for mpox prevention is derived from experience with Dryvax®, the vaccine used during smallpox eradication. Dryvax was a first-generation smallpox vaccine manufactured by Wyeth Laboratories. Routine use of this vaccine ended in the United States in 1972, and smallpox was declared eradicated globally in 1980 by the World Health Assembly. The license for Dryvax was withdrawn in 2008 and no supplies of this vaccine remain. Although the United States has a large supply of ACAM2000, this vaccine has more side effects and contraindications than JYNNEOS.' CDC
One is a third gen attenuated virus vax and the other is a second gen live virus vax. NEITHER are what you would call 'novel vaccines' and as far as I can tell, they are the ones the WHO approves for use in Africa. Neither are mRNA 'novel' vaccines. ACAM2000 has been around for a while used to prevent smallpox but now using it to prevent MPOX doesn't make it 'novel' (MPOX is Orthopoxvirus genus in the Poxviridae family like smallpox) and Jynneos just has a new name on an existing vaccine. Also not 'novel'
Back in Mar of 2023 the WHO had THREE vaccines on their approved list for use to prevent the spread of MPOX. What happened to the other one, I don't know.
'Currently, three vaccines are available, one second generation (ACAM2000 (Emergent Biosolutions)) and two third generation vaccines (modified vaccinia virus (MVA)-BN (Jynneos/Imvanex/Imvamune; Bavarian Nordic) and Lc16m8 (KM-Biologics)). WHO interim guidance published in November 2022 contains information on mpox vaccine safety)...
The safety profile of ACAM2000 includes risks for myocarditis and pericarditis and many of the risks associated with replication-competent smallpox vaccines. The safety of the third-generation vaccine, MVA-BN, has been assessed in 22 clinical trials that included over 7800 participants aged ≥18 years. Similar rates of adverse events (AEs) in vaccinia-naïve and previously vaccinated individuals were observed. The safety of this vaccine has been assessed in special populations (e.g., HIV, atopic dermatitis, children, pregnant and breastfeeding women) with no safety concerns identified, however, the size of the study samplea were small. The safety assessment of intradermal administration of the MVA-BN vaccine showed an increased rate of local reactogenicity reactions. The second third-generation vaccine, Lc16m8, has been used mainly in Japan, and two recent studies in Japan and USA reported no safety concerns.
The post marketing data available for MVA-BN (Jynneos) show no safety concerns but there are gaps in knowledge on safety and benefit-risk and more data are needed for specific populations, such as children, pregnant women, populations outside of USA, Europe and Australia, immunocompromised populations and those previously vaccinated.' WHO 2023
Perhaps I am confused by what she means by 'novel' but it would certainly have helped had she listed the vaccines approved by the WHO so we could do our research and formulate our own opinions.
Again, the most recent listing I could find from the WHO shows THREE having been approved a year ago and I am only guessing that the TWO they now accept for distribution align with what the CDC approves. But that is an assumption.
In a follow-up article Nass mentions the same two I mentioned from the CDC presumably because she found they are the ones the WHO has approved for distribution in Africa.
Again, both have been around for a while though one was used to treat smallpox and not MPOX so does she suggest the new crossover application qualifies as a 'novel' use of an established vaccine?
Seems like this is a money-grab and a chance for the WHO to create a much needed crisis in order to push for their PLANDEMIC treaty rather than some new round of testing 'novel' vaccines. But who knows.
Apologies -- the two vaccines the WHO planned for Africa as I stated in perhaps another earlier post are Jynneos and the unlicensed Japanese vaccine, LC16m8. Which is described here:
https://merylnass.substack.com/p/the-japanese-monkeypox-vaccine
While Jynneos is licensed in the US, the NIH is conducting a Phase 1 trial (safety only) on it now, and it is being used in the US under the PREP Act/CICP which is intended for unlicensed products or those used for an off label indication.
My point being is that the public knows very little about Jynneos despite its "license" and it does not have a license in Africa, which is why the WHO plans to prequalify it.
There is no bullshit here--you simply failed to read the earlier information as it became available.