I would like to share with you some reflections on the current situation, so I will resume the discussion on why you see us "silent" in this historical moment.
The first reflection on this concerns the difficulty of finding fixed points in this phase. Both from the "clinical" point of view (which we cannot deal with anyway) and from the epidemiological point of view, there seems to be only a great confusion that reigns supreme.
The numbers, the discriminants, the methods of diagnosis, the reliability of the tests, and other crucial points that should instead be clear before being able to take a word on them are not clear.
Theses also contrasting with one another are seen everywhere, and this pushes us to continue to document and evaluate the various hypotheses and above all the developments of the situation BEFORE starting to sum up. We therefore believe that time is needed at this stage, for a cautious assessment of the facts that can only be feasible afterwards.
Those who have followed us for years know that this association has always tried to maintain a certain rigor in disseminating only those data, those theses and those considerations that seemed to us actually coherent and rational as well as, where possible, demonstrable and verifiable.
We would like to reassure you however: we are not "firm".
We are carefully following the evolution of the facts and we are also gradually collecting all the material that will be useful for post-emergency considerations.
We are carefully monitoring the news on the developments of the various candidate vaccines against Covid-19 (SARS-CoV-2 vaccine) and we are following with concern - like everyone else - the emergence of possible future scenarios on the consequences that this emergency (and the compression of rights civilians we are witnessing) may have on our future.
From what appears to date, the FDA together with the EMA is ready for the "fast-track" authorization of the trials of the candidate vaccines.
HERE an official link that talks about it: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/summary-fda-ema-global-regulators-meeting-data-requirements-supporting-first-human-clinical-trials
Some passages that I would like to underline:
- The global regulators teleconference of March 18, 2020 jointly convened by the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) under the auspices of the International Coalition of Medicines Regulators (ICMRA) discussed regulatory considerations related to the development of SARS - COV-2 vaccine candidates and preclinical data requirements to support the first human clinical trial (FIH) process.
- Participants noted that opportunities to leverage the knowledge accumulated with the platform's technology should be considered to accelerate the development of a SARS-CoV-2 vaccine produced using the same platform. For example, if a platform technology used to manufacture a licensed vaccine or other investigational vaccines is well characterized, toxicological data (e.g. data from repeated dose toxicity studies, biodistribution studies) and accumulated clinical data can be used. with other products using the same platform to support clinical trials on FIH for a SARS-CoV-2 vaccine candidate.
- Participants noted that the vaccine manufacturer should provide data-driven rationale to justify why some preclinical studies, such as toxicity studies, should not be conducted before proceeding to clinical trials on FIH.
- Animal data should be obtained for all SARS-CoV-2 vaccine candidates and the immune response induced by a SARS-CoV-2 vaccine candidate should be characterized.
- The efficacy of the SARS-CoV-2 vaccine candidate in animal testing models does not need to be demonstrated before proceeding to clinical trials on FIH.
- Participants acknowledged that there is a limited availability of non-human primates and that such studies cannot be required with every SARS-CoV-2 vaccine candidate prior to FIH studies and would significantly delay the clinical development of the vaccine.
- Participants discussed the need to address the potential for vaccine-induced enhanced disease by enabling clinical trials and FIH with SARS-CoV-2 vaccines, based on all available data related to the particular candidate SARS-CoV-2 vaccine including vaccine construct, the immune response induced by it, for example, Th1-type distorted immune responses and neutralizing antibody titers, and the FIH clinical study design.
- Regulators have expressed the need to develop mechanisms that allow the sharing of data from animal models and clinical trials to alert the global regulatory community about study outcomes in a continuous and timely manner.
We are therefore always present, simply the moment does not allow us, due to the type of work we aim to do, to let ourselves go to hypotheses and constructs; for us it is a phase of study and waiting for fixed points that inevitably we must have in order to then be able to offer you support (from all points of view) that can be solid and useful.