Reg requirements for vaccines against variant strain(s) of SARS-CoV-2

Yesterday, EMA published a Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

Yesterday, EMA published a Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2
February 26, 2021

Yesterday, EMA published a Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2. This paper is a guidance document for the manufacturers developing variant vaccines from already authorized vaccines against SARS-CoV-2, and it details which information should be provided to support its approval, covering quality, nonclinical and clinical data. These requirements apply only when the parent vaccine has been granted a Marketing Authorisation in the EU and the manufacturing process and controls and the facilities for vaccine production are the same or very similar to those for the parent vaccine.

As a summary, the information to include is:

  • For Module 3: Update of the starting materials, justification of any changes to the registered specifications, demonstration of manufacturing consistency and confirmation of the suitability of the active substance and finished product registered shelf-life.
  • For Module 4: no need to perform additional in vitro or in vivo studies.
  • For Module 5: data on the efficacy of the variant vaccine. Regarding its safety, the data collected during the immunogenicity trials with the variant vaccine shall suffice, unless there were safety concerns for the parent vaccine or safety concerns emerge from trials with the variant vaccine.

Do not hesitate to contact us if you need further information or assistance: [email protected]

 

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | DIA RAPS Regulatory Policy Forum

Many key takeaways and highlights from the DIA RAPs Regulatory Policy Forum!! Capitalizing on the success of their joint collaboration this past January for 2024 Combination Products in the EU, DIA and the Regulatory Affairs Professionals Society (RAPS) are coming together once again to produce the 2024 Regulatory Policy Forum.
Designed specifically for regulatory policy leaders, senior decision makers, and regulators across the pharmaceutical community, this summit will explore the new EU pharmaceutical legislation and how it will shape the future of the pharmaceutical arena—including research, development and manufacturing—in Europe for decades to come.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting