Discover more from Meryl’s COVID Newsletter
Will you be one of the guinea pigs used by the world's public health organizations to find out whether monkeypox vaccine works?
And how much myocarditis and HIV worsening it causes?
CDC claims the smallpox-moneypox vaccine Jynneos (a.k.a. Imvanex, Imvamune and MVA-BN) is 85% effective against moneypox. But the WHO, European Medicines Association (EMA) and Nature magazine spilled the beans. No one has any idea how effective these new vaccines will be against monkeypox, or smallpox for that matter, because no trials for efficacy were ever conducted in humans. And results in animals usually fail to predict results in humans.
The WHO on July 6 pointed out that if the vaccines get used--and of course they were already being used internationally--then we must immediately collect data to learn whether they actually work.
Sadly, what WHO failed to mention, is that we need to know how much myocarditis they cause, and what are their other safety issues? Many people in the Jynneos clinical trials (which did not attempt to determine efficacy) developed EKG changes and/or elevated cardiac enzymes. Subjects who were HIV positive developed falling CD-4 counts and rising HIV virus counts. These problematic findings were ignored by FDA, which licensed the vaccine just before the COVID outbreak, on September 24, 2019.
So safety is a huge unresolved issue with the new $MONEYPOX vaccines.
From the EMA:
The use of the vaccine in either indication (monkeypox or smallpox) is based on immunogenicity data generated both in humans and animals and on protection in animals challenged with the virus...
... previous generation vaccines against smallpox are estimated to have an effectiveness against monkeypox disease of approximately 85%, based on observational data from Zaire collected during monkeypox outbreaks in the ‘80s in individuals previously vaccinated against smallpox vs. unvaccinated individuals. [In other words, 40 years ago in what is now the DRC/Congo, based on vaccination status with a smallpox vaccine that caused so many side effects it is no longer used, public health officials ESTIMATED that the old vaccine was 85% effective against monkeypox. Calling Neil Ferguson to verify this guesstimate.]
... Jynneos is not contraindicated in pregnancy. The limited clinical data on use in pregnancy and the animal studies on fertility and developmental toxicity did not identify any specific reason for concern. [If you are pregnant and get this vaccine, you can be sure that you are the guinea pig.--Nass]
... Despite the lack of clinical data on the level of protection conferred in the context of post-exposure prophylaxis (PEP) against monkeypox, vaccination of cases’ contacts is being considered based on estimates of vaccine effectiveness calculated with previous generation smallpox vaccines and based on clinical experience with other viral diseases. [Neil Ferguson, we need a graph immediately to make this look like science!]
... Jynneos is manufactured at the Danish Bavarian Nordic site, which is currently not authorised for EU production.
From the WHO:
WHO has recently developed interim guidance on vaccines and immunization for monkeypox. WHO has strongly encouraged Member States to consider the context of the current multi-country outbreak of monkeypox and convene their national immunization technical advisory groups (NITAGs) to review the evidence and develop policy recommendations for the use of vaccines as relevant to the national context. All decisions around immunization of individuals with smallpox or monkeypox vaccines (pre-exposure or post-exposure) should be by shared clinical decision-making between health care provider and prospective vaccinee, based on a joint assessment of risks and benefits, on a case-by-case basis.
Member States using vaccines against monkeypox are encouraged to do so within a framework of collaborative clinical studies using standardized design methods and data collection tools for clinical and outcome data to rapidly increase evidence generation, especially on vaccine efficacy/effectiveness and safety. Where participation in placebo-controlled clinical efficacy trials for monkeypox vaccines and schedules is not considered feasible, the use of a range of other robust study designs to assess vaccine effectiveness should be rapidly put in place employing standard data collection methods.