In light of recent developments concerning the Coronavirus (COVID-19), Ivowen has put in place contingency measures to safeguard the health and well-being of our staff and to maintain business continuity.
Ivowen will monitor and adhere to Irish Government advice on delaying the spread of the virus, including but not limited to:
Staff members who exhibit relevant symptoms are to self-isolate for a period of 14 days.
Staff members travelling back from affected regions are to self-isolate for a period of 14 days.
Ivowen will withdraw from attending conferences/meetings if it is feared that attendance may pose a risk to the health of our team or help spread the virus.
In the unlikely event that Ivowen must enforce a company-wide policy of self-quarantine, our team will continue to manage and deliver your projects in a secure and reliable manner and will be contactable via e-mail and telephone.
We will endeavour to avoid delays but ask for your understanding should we need to delegate projects internally due to illness.
Notably, the three initial vaccines that were granted ‘Conditional marketing authorisations’ in December 2020 and January 2021 (Comirnaty – developed by BioNTech & Pfizer, Spikevax – developed by Moderna and Vaxzevria – developed by AstraZeneca) were all issued as ‘Standard marketing authorisations’ in October 2022.
Four adaptive vaccines
Adapted vaccines are intended to provide broader protection against different virus variants following initial vaccination. They include:
Comirnaty Original/Omicron BA.1
Comirnaty Original/Omicron BA.4-5
Spikevax bivalent Original/Omicron BA.1
Spikevax bivalent Original/Omicron BA.4-5
All these authorisations were just recently issued by the EMA, in September and October 2022.
The majority were developed specifically to treat COVID-19. However, some were already marketed for other indications but have also been proven to be effective in treating COVID-19. These include several pharmaceutical forms i.e., tablets, injections and solutions for infusions.
Update on potential new COVID-19 vaccines:
With the continuous emergence of variants, it is difficult to keep vaccines fully equipped to match the variants in circulation. However, developing further adaptive vaccines will help to improve neutralisation against circulating strains.
The EMA are still reviewing two other adaptive vaccines which target other strains of the virus. These include the Sanofi Pasteur vaccine called Vidprevtyn containing the beta strain. A possible CHMP opinion of this vaccine is expected at the November meeting.
Another vaccine under review contains both alpha and beta strains. The EMA is still waiting on additional data from the company before a decision on this adaptive vaccine can be made.
Updates and comments on COVID-19 treatments:
With the rise of new omicron sub-variants, currently available monoclonal antibodies will lack activity. Due to this, the EMA is exploring, with developers and international regulators, pathways for rapidly approving new monoclonal antibodies based on an established platform that could be rapidly deployed to tackle emerging variants.
Currently authorised antiviral treatments such as Paxlovid or Veklury, don’t target the spike protein but target other parts of the virus. This makes it more likely that they will remain effective as other viral proteins are less effective. However, it will be important to confirm their activity is not impacted by all these variants that are still emerging.
New antivirals that can be administered orally are currently under development and may provide a wider range of antiviral agents for treating COVID-19 patients in the future.
https://eureg.ie/wp-content/uploads/2020/05/Corona-virus-image-11-05-20.jpg102130ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2022-11-09 17:02:452023-11-06 11:15:48COVID-19: Still on your Radar? Current vaccine approval status and what’s on the horizon
In response to the significant impact the COVID-19 pandemic is having on European regulatory activity, the European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have approved a number of measures to help the management of marketing authorisations for human medicinal products considered crucial during the pandemic period.
The objective of these measures agreed at European level is to promote regulatory flexibility, facilitate, simplify and accelerate the administrative procedures, as far as possible, in order to respond more efficiently to emerging needs during this period.
As a result, the EC recently published questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic:
This Q & A document which provides guidance to marketing authorisation holders (MAH) includes the following topics:
renewal applications
sunset clause
an exceptional change management process (ECMP) for crucial medicines for use in COVID-19 patients
circumstances under which the validity GMP certificates and authorisations to manufacture/import can be extended
circumstances under which the validity GDP certificates and wholesale authorisations can be extended
adaptions to the work of a Qualified Person (QP)
the possibility of adapting quality requirements for medicines intended to be used for the treatment of COVID-19 patients
the impact on reporting into EudraVigilance of Individual Case Safety Reports (ICSRs)
flexibility in the labelling and packaging requirements to facilitate the movement of medicinal products within the EU
Further to the European Commission’s Q&A document, the CMDh has agreed additional questions and answers that provide practical information on how to specifically address and apply the provisions determined by the European Commission for MR/DC procedures:
The CMDh document addresses issues such as the impact of COVID-19 on assessment timelines, how to use the ECMP procedure (which is only applicable for products that are crucial for the treatment of COVID-19 patients) and QP declarations based on a desktop audits. It also includes a useful annex that details Member States’ email addresses and links to relevant published guidance on MS websites.
Both documents will be updated and supplemented with additional information, as appropriate during the pandemic.
Everyone at Ivowen is working tirelessly to keep our clients applications on track. We are liaising with the National Competent Authorities all the time to ensure we avoid delays and get the best results possible in these unprecedented times.
If you need any assistance in this regard please don’t hesitate to contact us.
Written by Claire Brown.
https://eureg.ie/wp-content/uploads/2020/05/Corona-virus-image-11-05-20-1.jpg405720ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2020-05-11 16:24:572023-11-06 11:15:46European Procedural Guidance during COVID-19 Pandemic
