Thread by @rooikat51

Best used for intelligence gathering from the coal face, Delphi studies can be criticized due to a lack of clarity on what is meant by ‘consensus’ and concerns about quality of evidence. Expert opinion has proven to be a poor basis for making judgements on health interventions.

Should pregnant women be included in medical trials,asks shabir mahdi? I picked at study at random from the referring website. It's a modified delphi, a consensus building exercise, a kind of corporate bully session. No competing interests were disclosed,....

...but the consensus build was financed by the Bill & Melinda Gates Foundation. Representatives of the Foundation also participated in the final virtual meeting, and the decision to submit the manuscript for publication.
safeinpregnancy.org/resources/1288…

Additional experts identified by the Foundation were nominated to integrate the panel.

In spite of this heavy loading, close reading reveals that there is no consensus about "the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities."

The writers of the bully sessions do admit that "limited data from clinical trials is available on COVID-19 vaccine safety, immunogenicity, reactogenicity, and efficacy in pregnancy and their potential effects on the fetus or the neonate"

They also admit that "Pregnant women have been historically excluded from clinical trials for drugs and vaccines that do not target obstetric conditions."

The suitability of the inclusion of pregnant women in the target population for novel COVID-19 vaccine R&D activities was evaluated according to two factors: “Potential benefits versus the potential risks” and “Time appropriateness”.

The WHO interim guidance recommends COVID-19 vaccines for pregnant women on the basis of the elusive benefit vs risk assessment, but no link to this study has been provided to date. There is a link to a feature story from the WHO news room. who.int/news-room/feat….

Even though a limited report suggests pregnant women are at increased risk from COVID-19 is introduced in an attempt to force consensus, the panel only weakly agreed that the "potential benefits outweigh the potential risks" of including pregnant women for COVID-19 vaccine R&D.

Six members reported uncertainty. One expert considered the risks to outweigh the benefits. Other experts, whose voices have been excluded from this delphic delusion,...

...... are highly unlikely to support the forced inclusion of pregnant women in research and development as this would be a grotesque violation of human rights.

The feasibility of including pregnant women in the target population for novel COVID-19 vaccine R&D activities was evaluated according to two factors: “Vaccine R&D decision-makers’ acceptability” and “Capacity of existing research networks”

Here there was no consensus, indicating a considerable level of expert uncertainty on vaccine R&D decision-makers’ acceptability of including pregnant women in the target population for novel COVID-19 vaccine R&D activities.

There is acknowledgement by the authors that it may be difficult to obtain the necessary regulatory/ethics approvals for inclusion of pregnant women within the time frame. It is further suggested that vaccine developers might not want to take the risk .....

.... of involving pregnant women particularly for vaccines using novel platforms, and that this might be sorted out with trials conducted by government agencies.

The panel also disagreed about feasibility or even that adequate active safety surveillance can be performed. The concern of the panel was mainly about including pregnant women in early clinical studies to be cautious during a time of high uncertainty with little data available.

The report further states that "The introduction of maternal vaccinations must occur almost concurrently across the globe in the high,middle and low-income countries" although no rationale is offered.

On a curious side note, the only other vaccine with a similar schedule to the COVID19 shots is the equine contraceptive vaccine developed by albert bourla.
#protectourchildren #exitthewho
referendums.co.za/@ProtectTheChi…

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