The Danish Medicines Agency's response to inquiry regarding process 2, Comirnaty
- jearungby
- Apr 4
- 20 min read
By Jeanne Rungby, MD, Specialist.
AI-translated from danish:
Below are questions and answers to requests for access to documents from and to the Danish Health Authority and the Danish Medicines Agency regarding which clinical trials were the basis for the approval of Pfizer's COVID19 mRNA vaccine by Comirnaty. The full correspondence is reproduced below.
The wording has not been changed, but the most important answers have been marked with red.
New inquiry.
Date June 17, 2024.
Team leader Thor Svendsen
With copy to
Cc. The Minister of Health, Jacob Lundsteen and others.
date
Regarding the lack of evidence and lack of regulatory control as well as extensive contamination of the Covid-19 vaccines. Access to documents is hereby requested on the following questions.
On June 14, 2024, you responded to Michael Lind in response to his question about whether the Covid-19 vaccines that you approved for the Danish population are experimental.
You answer Michael Lind thus directly quoted:
“It is not correctly understood (that the vaccines are experimental). Prior to the approval of the mRNA vaccines, extensive clinical trials were conducted.”…
“We (are) as authorities of the clear opinion that the mRNA vaccines are not experimental treatments, … it (is) not something we decide “off the cuff”. It is based on the extensive approval process the vaccines have gone through in the EMA. In this process, very extensive evidence has been presented for the treatment's effect and side effects.”
Your first statement that the Covid-19 vaccines (Pfizer) underwent extensive clinical trials is not correct. This will be justified and documented below.
Your second statement. That the Covid-19 (Pfizer) vaccines went through an extensive approval process is also not correct. Reasoning follows.
Your third statement, that it is the Danish Medicines Agency's "opinion" that the Covid-19 vaccines were not experimental, nullifies the other two claims, for which you and your colleague Jacob Lundsteen, on behalf of the Minister of Health, have not yet provided documentation.
If you, as an authority, have issued a certificate for marketing, “perception” is not sufficient. You must know.
As a public official, you are responsible for the words you choose and have a duty to answer questions from citizens correctly. False information is a criminal offense.
On March 13, 2024, I received my second response from the Danish Minister of Health to my questions regarding the contamination of Covid-19 vaccines with DNA and SV40. The response came as usual through the Danish Medicines Agency (LMST, from Jacob Lundsteen).
None of the questions were answered by providing the direct regulatory documentation I requested.
Since this was the second time I asked these questions to the Minister of Health without receiving satisfactory answers, especially regarding product control and environmental regulation, the conclusion must be that
There has been no regular regulatory control of these gene-altering substances, called vaccines.
This conclusion is in line with the fact that the EU Council adopted a regulation in 2020 to exempt clinical trials and medicinal products for the treatment of SARS-CoV2 from the environmental risk assessment applicable in the EU. The EMA and the Danish Medicines Agency were aware that genetically modified organisms (GMOs) were involved in the production of vaccines and for the treatment and prevention of SARS-CoV2, as the EU Council adopted an emergency decision on 14 July 2020 that pharmaceutical companies did not have to carry out the prescribed environmental control of these GMO products as long as the pandemic was classified as a pandemic by the WHO and the EU Commission.
However, this exception could only enter into force if the regulation was adopted at national level in the form of a directive from the then Minister for the Environment.
After searching the Ministry of the Environment's website, no such directives exist in 2020 before these vaccines were approved for use in the population.
In my opinion, this makes the so-called vaccines illegal. This must be a reasonable assumption, since the Minister of Health fails to answer questions regarding this exception, including whether the then Danish government acceded to this regulation in 2020.
It seems strange and worrying that the health authorities have not openly communicated this current exemption to the population before the start of the vaccination campaign. This exemption from regular GMP (good manufacturing practice) allows, under the pretext of a pandemic, substances based on GMOs to be injected into humans without a proper environmental risk assessment having been carried out. One gets the impression from the EMA website that this unregulated procedure has been extended until 31 December 2024 , even though there is no longer a pandemic.
It is therefore obvious that these vaccines are experimental and that your answer is therefore incorrect. Alternatively, you must provide documentation.
I decline to provide documentation for the clinical trials regarding process 1 (PCR method), as they are irrelevant.
The Covid-19 vaccines that were approved by you were based on manufacturing process 2, as you probably know.
Pfizer chose, in agreement with the EMA and FDA, to waive the inspection of manufacturing process 2, which is significantly different from process 1.
Trial 2 was only studied for limited side effect measures on 252 test subjects, who were not compared to placebo, but rather with test subjects from trial 1, who were also not compared to placebo.
How does this align with extensive evidence?
In process 1, it was decided to stop all further control of the test subjects. This happened, among other things, because the original randomized study was made unblinded (after a few months) and therefore no longer fell under the definition of a randomized study, but instead became an observational study. This is stated on the EMA website, as already documented in my second letter to the Minister of Health. That decision was contrary to the study protocol and what had already been agreed. This destroyed the possibility of follow-up safety evaluation as planned. This was in practice an omission of GMP, good manufacturing practice.
The manufacturer then switched to process 2.
Have I understood correctly that you, as the certifying authority, did not object to this change in manufacturing process?
A response is requested including documentation, including any emails between you and EMA .
Could you please explain to me how this omission aligns with your assurance that a comprehensive approval procedure has taken place?
It appears from Pfizer's documents that no biodistribution studies have been conducted on the active substance. Nor have studies been conducted on the effect or possible damage the product has on various organs and whether the product can change genes, affect fetuses in pregnant women, affect fertility or cause cancer.
Why weren't these studies conducted?
If I have misunderstood this, documentation to the contrary is requested.
Why did you choose to approve these vaccines for children and pregnant women?
Documentation is required for the clinical studies based on the correct manufacturing process, with children and pregnant women as test subjects.
It has also recently emerged in a new study from Leipzig, published on May 8, 2024, that the finding of DNA contamination in Pfizer's Covid-19 vaccines exceeds the limits by more than 500 times compared to the permitted limits given by the European Medicines Agency, EMA.
The two independent researchers, Brigitte König and Jürgen O. Kirchner from Leipzig and Magdeburg, undertook the task of making quantitative measurements of the DNA contamination in the Covid-19 vaccines (Comirnaty/Pfizer). The researchers have found these large amounts of DNA using fluorescence staining and spectroscopy. They thus confirm the previously described findings of McKernan and Speicher et al, which are described in my letter of concern to the Minister of Health November 2023
Did you, the Danish Medicines Agency, not know that there were these large amounts of DNA in the vaccines before you gave the marketing authorization?
The two independent researchers have revealed that PEI, the Poul Erlich Institute, has consistently underestimated the amount of DNA in the vaccines, as they failed to use soap to release all the DNA from the fat package. They also chose to target qPCR to a small subsequence of the full plasmid DNA, which was used in process 2. The subsequence was about 1% of the full plasmid DNA (DNA template). The remaining 99% remained undetermined.
This form of data manipulation is called scientific misconduct and will usually be grounds for revocation of titles.
It thus appears that PEI - against their better judgment - has consistently used a control method that has underestimated the amount of DNA contamination in these vaccines.
PEI was fully capable of understanding that measuring the full amount of mRNA required pre-preparation with soap to include the mRNAs that were encapsulated in fat (NLP).
Why did PEI fail to do the same for DNA?
And how could this mistake slip past you at the Danish Medicines Agency?
According to the authors, qPCR is suitable if one wants to identify the presence of specific sequences. However, if one wants to quantify the total amount of DNA in the vaccine, the method is incorrect. Here, soap and fluorescence spectrometry should be used, as was done for the quantification of mRNA.
The authors conclude that PEI's controls are designed so that there has been a massive under-registration of DNA contamination and that this "should be the subject of extensive expert discussions and considerations".
One could sharpen the tone and argue that this should have legal repercussions for all ministers and supervisory authorities involved.
I would suggest that you consider your answer carefully, as it may involve liability.
I look forward to more complete answers.
Kind regards
Jeanne A. Rungby
Specialist in Otorhinolaryngology
Sources.
Answer:
Date: June 18, 2024
Dear Jeanne Rungby,
I hereby confirm receipt of your inquiry of June 17, 2024.
In your inquiry, you have asked us to answer a number of questions and have also requested access to documents.
With regard to your request for access to documents, I can inform you that we expect to be able to process the case (case number 20240625869 ) within 2 weeks.
As far as your specific questions are concerned, they will, as far as possible, be answered separately under case number 2024024182 .
You have addressed your inquiry to Thor Svendsen and provided the address “ thsv@sst.dk ”. Thor Svendsen is employed by the Danish Medicines Agency (and is the cc of this email), and if it was your intention to contact the Danish Health Authority, you therefore need to do so with a different addressee.
Kind regards,
Jacob Lundsteen
Head of Section for Center Law and International Relations
Head of Center Legal Service and International Relations
T (m.) + 45 20953243
The Danish Medicines Agency
Center for Drug Approval & Surveillance
Danish Medicines Agency Medicines Licensing & Pharmacovigilance
T +45 44 88 95 95
Answer
Date June 19, 2024
Dear Jeanne Rungby,
In your request for access to documents of June 17, 2024, you requested documentation that extensive clinical trials were conducted prior to the approval of the mRNA vaccines, that the vaccines went through a comprehensive approval procedure, and that the vaccines are not experimental treatments.
In the request, you have also stated: " The manufacturer then switched to process 2. Have I understood correctly that you, as the certifying authority, did not object to this change of manufacturing process? A response is requested including documentation, including any emails between you and EMA ."
The COVID-19 vaccines covered by your request have been authorised via the central procedure and the authorisations to market the medicines in the EU have therefore been issued by the EU Commission following an application submitted to and processed by the European Medicines Agency (EMA). Consequently, any changes to these marketing authorisations (variations) have also been authorised by the EU Commission following an application submitted to the EMA.
When applying for a marketing authorisation via the central procedure, the application, including documentation of the quality, efficacy and safety of the medicinal product, is submitted in electronic form to the EMA, which subsequently makes the documents available to the agency's scientific committees and to the Member States' medicines authorities.
The Danish Medicines Agency thus has access to applications for medicinal products that are being sought for approval via the central procedure, as well as the documents that the EMA and its scientific committees prepare in connection with the processing of the application. However, the applications and associated documents are not recorded in a file at the Danish Medicines Agency. Since the requested documents are therefore located at the EMA, I would ask you to address your request for access to documents to the EMA.
You can read more about EMA's process for access to documents via the following link: Access to documents | European Medicines Agency ( europa.eu ) .
Regarding the change of manufacturing process, I can inform you that the Danish Medicines Agency did not raise any objections in connection with the change, and that there is therefore no documentation of such objections.
Kind regards,
Jacob Lundsteen
Head of Section for Center Law and International Relations
Head of Center Legal Service and International Relations
T (m.) + 45 20953243
The Danish Medicines Agency
Center for Drug Approval & Surveillance
Danish Medicines Agency Medicines Licensing & Pharmacovigilance
T +45 44 88 95 95
Additional questions from Jeanne A. Rungby
Date: June 21, 2024
Case number 2024062586
Hello Jakob Lundsteen
Thank you for your prompt response to my letter of June 17th of this year.
I appreciate your honesty when you write that the Danish Medicines Agency did not object to the shift from process 1 to process 2 of the manufacturing process in connection with Pfizer's Covid-19 vaccines.
And thank you for the guidance on access to documents at EMA.
In your letter to me of 15.03.24 you were also kind enough to give me a link to an EMA page in response to my question about which authority issued the (conditional) certificate of approval for these vaccines for Denmark. I followed these links and therefore found that it was precisely the Danish
The Danish Medicines Agency, which issued these certificates. However, I did not find the certificates themselves.
I assume the certificates were signed during Thomas Senderovitz's tenure. Am I right?
I would like to request a copy of these certificates, so that the signature of the person responsible is visible and legible. This applies specifically to Pfizer's and Moderna's Covid-19 vaccines based on mRNA technology, including the first and second injection as well as the booster. In other words, I would like documentation of which person, by name and signature, has approved these vaccines, as specified.
If there has been any internal or external correspondence regarding doubts about the basis for the approval, I would very much like to see this correspondence as part of my request for access to documents.
Thank you in advance.
Kind regards
Jeanne A. Rungby
Specialist in Otorhinolaryngology
Answer:
Date: June 21, 2024
Dear Jeanne Rungby,
When it comes to centrally approved medicines (as is the case with the COVID vaccines), the marketing authorizations in the EU, including in Denmark, are issued by the EU Commission.
The EU Commission therefore issues one authorisation , which gives the holder of the authorisation the right to market the medicinal product concerned in all EU Member States, including Denmark.
Therefore, there is no authorization to market a centrally approved medicinal product issued by the Danish Medicines Agency.
If you would like a copy of an authorization to market a centrally approved medicinal product, I must therefore refer you again to the EMA.
Kind regards,
Jacob Lundsteen
Head of Section for Center Law and International Relations
Head of Center Legal Service and International Relations
T (m.) + 45 20953243
The Danish Medicines Agency
Center for Drug Approval & Surveillance
Danish Medicines Agency Medicines Licensing & Pharmacovigilance
T +45 44 88 95 95
New Question:
Date: June 22, 2024
Hello Jakob Lundsteen
Thanks for the quick response.
I understand from your answer that those responsible for the approval of the Covid-19 vaccines should be found in the EMA. However, the EMA says the opposite, namely that responsibility should be placed nationally.
However, there must be a department and a department head responsible for product monitoring in Denmark regarding the Covid-19 vaccines. I have discussed the issue with a lawyer who states that the agency has the right and duty to monitor and intervene if EMA-approved products do not work as intended.
Could you please tell me who is/are responsible for this monitoring for the first, second and subsequent injections of the Covid-19 vaccines. Full names, dates and department are required.
Kind regards
Jeanne A. Rungby
Specialist in Otorhinolaryngology
Answer.
Date. June 24, 2024.
Dear Jeanne Rungby,
The Danish Medicines Agency's Pharmacovigilance Unit is led by Unit Head Line Michan, who is cc this email.
Kind regards,
Jacob Lundsteen
Answer:
Date July 3, 2024
Dear Jeanne Rungby,
Below is our response to your inquiry regarding COVID-19 vaccines dated June 17, 2024.
Regarding GMP and GRP
In your inquiry you state:
"Pfizer chose, in agreement with the EMA and FDA, to omit the control of manufacturing process 2, which is significantly different from process 1. Process 2 was only studied for limited side effect measures on 252 test subjects, which were not compared to placebo, but on the contrary with test subjects from process 1, which were also not compared to placebo.
How does this align with extensive evidence ?
Have I understood correctly that you, as the certifying authority, did not object to this change in manufacturing process? A response is requested including documentation, including any emails between you and the EMA.
"Would you please explain to me how this omission aligns with your assurance that a comprehensive approval procedure has taken place? "
It is our assessment that we have already adequately answered these questions and refer to our response of March 13, 2024, specifically to the section on GMP and GRP.
Ad preclinical studies
In your inquiry, please state:
" It appears from Pfizer's documents that no biodistribution studies have been conducted on the active substance.
There have also been no studies conducted on the effect or possible damage the product has on various organs and whether the product can change genes, affect fetuses in pregnant women, affect fertility or cause cancer.
Why were these studies not conducted? If I have misunderstood this, documentation to the contrary is requested .
In this regard, we can inform you that for all medicines approved in the EU, parameters such as those you mention are evaluated preclinically, that is, in animal studies.
Thus, for the vaccine you mention, biodistribution studies and studies involving reproductive toxicity in animals have been conducted.
Carcinogenicity studies have not been conducted, as this is generally not required for vaccines, and the vaccine components in this case cannot be expected to have carcinogenic potential (RNA and lipids).
This is summarized as follows in the product information for the vaccine:
Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development.
Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Genotoxicity/carcinogenicity: Neither genotoxicity nor carcinogenicity studies have been performed. The vaccine components (lipids and mRNA) are not expected to have genotoxic potential.
See also details in the public assessment report on the European Medicines Agency's website for the vaccine.
We also refer to our response of March 13, 2024, specifically to the section on reproductive adverse effects and risk to the next generation.
Ad reproductive adverse effect and risk to the next generation
You state in your inquiry:
" Why did you choose to approve these vaccines for children and pregnant women?"
Documentation is required for the clinical studies based on the correct manufacturing process, with children and pregnant women as test subjects, which is the basis .
We can inform you that when approving medicines, controlled clinical studies in children and pregnant women are very rarely available (with the exception of medicines specifically intended for children or pregnant women).
This was also the case with Comirnaty (please see details in the public assessment report on the European Medicines Agency website for the Comirnaty vaccine).
Post-marketing, a large amount of observational data has confirmed the safety of the vaccine in pregnant women.
This is summarized as follows in the product information for the vaccine:
Pregnancy: A large amount of observational data from pregnant women vaccinated with Comirnaty during the second and third trimesters have not shown an increase in adverse pregnancy outcomes. Although there are currently limited data on pregnancy outcomes after vaccination during the first trimester, no increased risk of spontaneous abortion has been observed. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Comirnaty can be used during pregnancy.
Breastfeeding: No effects on newborns/infants breastfed by mothers receiving Comirnaty are expected, as systemic exposure is negligible. Observational data from women who breastfed after vaccination have not shown a risk of adverse reactions in breastfed newborns/infants. Comirnaty can be used during breast-feeding.
Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Examples of such observational data can be found on the European Medicines Agency's COVID-19 vaccine safety web page, (see link: COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy | European Medicines Agency (europa.eu ) , and current studies on this are also constantly being published (see e.g. Ellington S et al, Safety of mRNA COVID-19 vaccines during pregnancy. Lancet Infect Dis. 2022, 22:1514-1515, and Fleming-Dutra KE et al, Safety and Effectiveness of Maternal COVID-19 Vaccines Among Pregnant People and Infants. Obstet Gynecol Clin North Am. 2023, 50:279-297.
Studies supporting the use of the vaccine in children are summarized in section 5.1 of the product information.
Ad DNA and LNP in the vaccine and limit values
Referring to a published article (König B et al, Methodological Considerations Regarding the Quantification of DNA Impurities in the COVID-19 mRNA Vaccine Comirnaty. Methods Protoc. 2024, 7:41 ), you state the following:
" The two independent researchers have revealed that PEI, the Poul Erlich Institute, has consistently underestimated the amount of DNA in the vaccines, as they failed to use soap to release all the DNA from the fat package.
They also chose to target qPCR to a small subsequence of the full plasmid DNA, which was used in process 2.
The partial sequence was about 1% of the full plasmid DNA (DNA template). The remaining 99% remained undetermined ".
Based on this, you ask these questions:
"Didn't you, the Danish Medicines Agency, know that there were these large amounts of DNA in the vaccines before you gave the marketing authorization?"
"How could this mistake slip past you at the Danish Medicines Agency? "
First to your statements:
It is specifically stated in the König et al publication, to which you refer, that the quantification of DNA in the vaccine is based on the level of DNA determined by qPCR multiplied by a factor that precisely ensures that it is taken into account that the total plasmid is significantly larger than the plasmid fragment detected by PCR. This extrapolation thus determines the theoretical maximum level of plasmid DNA that can be present, i.e. constitutes a worst-case estimate for DNA contamination of the vaccine. This takes into account that there is more DNA than what is directly measured.
Likewise, the quantification of DNA is performed on the RNA preparation before it is encapsulated in nanoparticles, precisely to avoid interference from the nanoparticles in the DNA determination.
See specific details of the method in reference 11 of the König et al article, which is a published document from the German Parliament, dated 15.12.2023, https://dserver.bundestag.de/btd/20/098/2009807.pdf
Your questions thus seem to be based on a misunderstanding of the information in the König et al publication.
We can also inform you that analytical methods used for quality control of medicinal products including vaccines such as Comirnaty must be sufficiently validated according to applicable guidelines such as ICH Q2(R1) (see details in the public assessment report on the European Medicines Agency's website for the Comirnaty vaccine).
See also further details in our response of 13.03.2024 to your second inquiry of 05.02.2024, especially the sections on DNA and LNP in the vaccine and limit values, DNA and SV40 in the vaccine and the risk of cancer, and DNA residues and integration studies.
Other comments
Finally, we would like to emphasize that we do not share the concerns you have raised regarding the quality, safety, and effectiveness of COVID-19 vaccines.
We, like the EMA and other drug authorities worldwide, assess that the benefits of the COVID-19 vaccines far outweigh the disadvantages/side effects of the vaccines.
Furthermore, we would suggest that any further questions regarding the basis for the approval and subsequent variations of the affected COVID-19 vaccines be directed to the European Medicines Agency or the EU Commission, as the vaccines are centrally approved. A centrally approved medicinal product is approved by the EU Commission on the recommendation of the European Medicines Agency, which has previously processed the application for authorisation to market the medicinal product.
References
(1) Information on COVID-19 vaccine safety, on the European Medicines Agency website
Safety of COVID-19 vaccines
(2) General information on COVID-19 vaccines, on the European Medicines Agency's website
COVID-19 vaccines: key facts
(3) ICMRA statement on the safety of COVID-19 vaccines
(4) European Medicines Agency websites for Comirnaty and Spikevex.
(5) Danish product information for mRNA COVID-19 vaccines:
Kind regards,
Jacob Lundsteen
Head of Section for Center Law and International Relations
Head of Center Legal Service and International Relations
T (m.) + 45 20953243
The Danish Medicines Agency
Center for Drug Approval & Surveillance
Danish Medicines Agency Medicines Licensing & Pharmacovigilance
T +45 44 88 95 95
Question.
Date July 23, 2024
From Michael Lind.
Dear SST, have any of the vaccines, mRNA injections and boosters used in Denmark undergone a placebo safety study? If so, please list them and provide documentation for that claim.
Regards, Michael Lind
Answer:
Dear Michael Lind, date July 24, 2024
Thank you for your question about testing the vaccines used in the Danish vaccination program against COVID-19.
Yes, the vaccines have been tested in large placebo trials. The EMA has done an educational review of how the vaccines have been tested and assessed by the authorities here:
In phase 3 clinical trials, it is normal practice to use placebo studies.
____________________
Kind regards
Thor Svendsen
Team leader
New query
from Jeanne Rungby
Date: July 25, 2024
Att. Thor Svendsen, date 25 July 2024
National Board of Health
Thank you for your response to Michael Lind.
Below in the thread is your response to Michael Lind.
You write that the Covid-19 vaccines have been tested in large placebo trials.
You provide a link.
To my knowledge - after numerous document inspections and inquiries - this is not correct.
I have not been able 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 have gone through the link to the EMA below - and a long list of side links - to see if there were any references to placebo-controlled studies that I have overlooked.
We are sent through a labyrinth of pages that repeat themselves in a circular system. We 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 randomized, blinded trial tested against placebo 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 and human studies that I have reviewed have either been assessed on the basis of manufacturing process 1 (PCR) or the process by which the vaccine was manufactured is not stated. Incidentally, these studies have all been conducted by or with the support of the manufacturer.
You are therefore requested to answer the following questions accurately:
What placebo-controlled randomized clinical trials in humans (phase 3) exist where process 2 has been 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 switch 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.
Kind regards
Jeanne A. Rungby
Specialist in Otorhinolaryngology
On behalf of the Word Council for Health Denmark
Subject: | SV: Safe and effective vaccines |
Date: | Wed, 24 Jul 2024 11:02:31 +0000 |
From: | Danish Health Authority Institutional mailbox < sst@sst.dk > |
Thaw: |
Answer
Date: August 12, 2024
Dear Jeanne Rungby,
In your latest inquiry, you ask us to inform you of the placebo-controlled randomized clinical trials in humans (phase 3) where process 2 has been 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 thorough clinical studies, including phase III trials, are the basis for the approvals of both mRNA COVID-19 vaccines.
Specifically for Comirnaty, no placebo-controlled randomized clinical studies have been conducted in humans 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 drug/vaccine, and it was assessed at the time of approval by Comirnaty that the changes to the manufacturing process were acceptable and had no impact on the safety and/or efficacy of the vaccine.
The assessment of this is based on data from physical and biological analyses (so-called comparability studies).
This is described as follows in the public report for Comirnaty's approval:
"Process development changes were adequately summarized. 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".
We therefore do not share the concerns you have raised regarding the quality, safety and effectiveness of COVID-19 vaccines.
If you require further information regarding the basis for the approval and subsequent variations of the affected COVID-19 vaccines, please contact the European Medicines Agency or the EU Commission directly, as the vaccines are centrally approved.
A centrally approved medicinal product is approved by the EU Commission on the recommendation of the European Medicines Agency, which has previously processed the application for authorisation to market the medicinal product.
Kind regards,
Jacob Lundsteen
Head of Section for Center Law and International Relations
Head of Center Legal Service and International Relations
T (m.) + 45 20953243
The Danish Medicines Agency
Center for Drug Approval & Surveillance
Danish Medicines Agency Medicines Licensing & Pharmacovigilance
T +45 44 88 95 95
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