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jearungby

Answers from the Danish medicines Agency (LMST)

By Jeanne A. Rungby. MD.

Specialised physician, Otorhinolaryngology


Start on mail:


From: Jakob Lundsteen

Date: 12 August 2024

To Dr Jeanne A. Rungby

Specialised physician, Otorhinolaryngology


Subject: Our response to your enquiry of 25 July, 2024 - our case number 2024024182


Dear Jeanne Rungby,


In your latest inquiry, you ask us to inform you which placebo-controlled randomised clinical studies in humans (phase 3) exist where process 2 is used in the manufacture of the vaccine on which the conditional or final approval is based. This applies to both Pfizer and Moderna's vaccines.


The Danish Medicines Agency maintains that the authorisations of both mRNA COVID-19 vaccines are based on thorough clinical studies, including phase III trials.


Specifically for Comirnaty, no placebo-controlled randomised clinical trials in humans have been conducted with material from process 2.


It is not unusual for a pharmaceutical company to make changes to its manufacturing process during the development of a medicine/vaccine, and it was assessed at the time of authorisation of Comirnaty that the changes in the manufacturing process were acceptable and without impact on the safety and/or efficacy of the vaccine.


This assessment is based on data from physical and biological analyses (so-called comparability studies).


This is described in the public report for Comirnaty's authorisation:


Insertion: (My comment: In this assesment report provided by LMST in the link above the following is stateted about comparabilitystudies page 17-18/140: "In comparability studies, a decrease in RNA integrity was observed for the initial Process 2 batches compared to Process 1 batches. This is further discussed in the subsequent section on manufacturing process development....Manufacturing process development

Two active substance processes have been used during the development history; Process 1 (clinical trial material) and Process 2 (commercial process). Details about process differences, justification for making changes, and results from a comparability study are provided. The major changes between active substance process versions were described in the dossier.

Batch analysis results showing comparability between non-clinical and clinical batches are provided. Additional characterization of product-related species and their relation to final product specifications will be provided as a specific obligation.

Electropherograms were presented demonstrating similarities in the peak pattern of RNA species, but some differences between Process 1 and 2 were also noted. It can therefore not be concluded that identical species are obtained by the processes. It is likely that the fragmented species will not result in expressed proteins, due to their expected poor stability and poor translational efficiency (see below). However, the lack of experimental data on the truncated RNA and expressed proteins does not permit a definitive conclusion and needs further characterisation. Therefore, additional characterisation data remain to be provided as a specific obligation"

Process development changes were adequately summarised. Two active substance processes have been used during the development history; Process 1 (clinical trial material) and Process 2 (commercial process). Details about process differences, justification for making changes, and results from a comparability study are provided. The major changes between active substance process versions were described in the dossier.

Batch analysis results showing comparability between non-clinical and clinical batches are provided. Additional characterisation of product-related species and their relation to final product specifications will be provided as a specific obligation" my comments: The final comparattivity studies were never concluded/finished as is documented in Pfizers final report dec 2023 (EMA). So far no comparability studies have been presented by LMST).


Thus, we do not share the concerns you have raised regarding the quality, safety and efficacy of COVID-19 vaccines.


If you require further information regarding the basis for the authorisation and subsequent variations of the COVID-19 vaccines concerned, please contact the European Medicines Agency or the European Commission directly, as the vaccines are centrally authorised.


A centrally authorised medicinal product is authorised by the European Commission on the recommendation of the European Medicines Agency, which has previously processed the application for marketing authorisation.


Yours sincerely



Jakob Lundsteen

Head of Centre Legal Service and International Relations

Danish Medicines Agency







From: Jeanne A. Rungby

Sent: 25 July 2024 06:38


Subject: Open enquiry regarding Covid-19 products


Att. Thor Svendsen

Danish Health and Medicines Authority


Thank you for your reply to Michael Lind.


Below in the thread is your reply to Michael Lind.

You write that the Covid-19 vaccines have been tested in large placebo trials.

You provide a link.

As far as I know - after numerous inquiries and enquiries - this is not correct.

I have not managed to get either the Minister of Health or the health authorities to provide the relevant references.

But to give you the benefit of the doubt, I've gone through the link to the EMA below - and a large number of side links - to see if there are any references to placebo-controlled studies that I've missed.

We are sent around a maze of pages that repeat themselves in a circular system. You are met with repeated unsubstantiated claims that the vaccines have been thoroughly researched and that they are safe and effective.


I could not find a randomised, blinded, placebo-controlled trial for these Covid-19 vaccines as they are mass-produced in process 2.


The Danish Medicines Agency (by Jakob Lundsteen) has confirmed in writing that they - LMST - did not object when the manufacturer switched from process 1 to process 2.


The animal studies and human studies that I have reviewed have either been assessed on the basis of manufacturing process 1 (PCR) or they do not state which process the vaccine was manufactured using. These studies were all conducted by or with the support of the manufacturer.


You are therefore asked to answer the following questions precisely:


Which placebo-controlled randomised clinical studies in humans (phase 3) exist where process 2 was used in the manufacture of the vaccine on which the conditional or final approval is based? This applies to both Pfizer and Moderna vaccines. Direct references to scientific phase 3 studies are requested.


For an explanation of the shift from process 1 to process 2, please refer to my 2nd Letter to the Minister of Health at the following link.


Various explanations and interpretations of responses to access to documents can be read at wch-denmark.org under blogs.


Yours sincerely


Jeanne A. Rungby

Specialist in Otorhinolaryngology

On behalf of Word Council for Health Denmark



Wed, 24 Jul 2024

From:

Sundhedsstyrelsen Institutionspostkasse <sst@sst.dk>


Dear Michael Lind


Thank you for your question about testing the vaccines used in the Danish vaccination programme against COVID-19.


Yes, the vaccines have been tested in large placebo trials. The EMA has created an educational overview of how the vaccines have been tested and assessed by the authorities here:

In phase 3 clinical trials, it is standard practice to use placebo studies.


____________________


Yours sincerely


Thor Svendsen

Team Leader


National Board of Health

Information Centre

9359 6423


The Information Centre answers enquiries to both the Danish Medicines Agency and the Danish Health Authority


T +45 72 22 74 00




From: michael....

Sent: 23 July 2024 02:00

To: Danish Health Authority Institutional mailbox <SST@SST.DK>

Subject: Safe and effective vaccines


[EXTERNAL E-MAIL] This email was sent from an external sender.

Please be aware that it may contain links and attached documents that are not safe unless you trust the sender.


Dear SST


Are any of the vaccines, mRNA injections and boosters used in Denmark that have undergone a placebo safety study?


If so, please name them on a list and provide documentation for that claim.

Regards Michael Lind

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