EMA gives procedural guidance on variant COVID vaccines

Regulatory NewsRegulatory News | 28 June 2021 |  By 

A new document from the European Medicines Agency (EMA) will give vaccine developers procedural guidance when the time comes for them to update COVID-19 vaccines to include protection against variant strains of SARS-CoV-2.
The procedural guidance was adopted by EMA’s human medicines committee on 24 June, and is meant to apply to vaccines against other human coronaviruses as well. Marketing authorization holders may submit a variation to change the composition of a COVID-19 vaccine that has been authorized under the centralized procedure to account for variant strains of the virus, “provided the technological platform of the vaccine remains similar,” according to the introduction to the guidance.
The guidance should be read in conjunction with EU regulations and a reflection paper that outline regulatory requirements for vaccines that protect against SARS-CoV-2 variant strains. Modifications to COVID-19 vaccines permitted by the collection of documents include replacing or adding one or more serotypes, strains, antigens or coding sequences. (RELATED: EMA releases guidance for COVID variant vaccine development, Regulatory Focus 25 February 2021)
Vaccine variations that are classed as type II variations should be submitted under scope B.I.a.6, if the vaccine platform is similar to the originally authorized vaccine. Other types of changes, for example, a request for a new manufacturing site along with a strain change or addition, should be submitted “as appropriate” through a grouped variation.
“Based on the pandemic situation, it could be necessary to have vaccines available that allow dedicated response to different variants circulating,” wrote EMA in the guidance. A case-by-case approach would guide which variants of concern are targeted, and marketing authorization holders should seek consultation early with the relevant competent authority to identify the variant or variants of concern, and whether the variants should be added to, or replace, the strain in the parent vaccine.
EMA suggests a 3-month lead time between early communication and submission; manufacturers should also consider whether the pediatric investigation plan needs to be adjusted to account for new strains, “taking into account the epidemiological situation.”
In compiling the dossier, applicants should follow the electronic Common Technical Document (eCTD). “Changes made in all modules and the product information to accommodate the new strain(s) should be detailed in the present and proposed section of the application form,” according to the guidance. An environmental risk assessment should be conducted if applicable under Module 1.6; an updated risk management plan that provides for monitoring the safety profile of the updated vaccine should be filed, as provided in Module 1.8.2.
The guidance also addresses how Module 3 requirements should be met depending on whether the new vaccine replaces an old strain, or whether the parent vaccine and a new version “will co-exist within the marketing authorization.”  Supporting documentation, including non-clinical data if applicable, should accompany the variation application.
To facilitate review, “Applicants are strongly advised to include the summary of the main quality and efficacy results as part of the ‘working documents’ outside the eCTD structure,” notes the guidance.
Separate product information should be provided for each vaccine version. The guidance provides detailed information about how the variant vaccine should be identified for traceability and conformity with international non-proprietary naming (INN). The guidance references the World Health Organization’s (WHO’s) document setting forth considerations in selecting INNs for variant COVID-19 vaccine active substances.
The variant vaccine name should have a variant strain qualifier added to the parent vaccine name, both to facilitate traceability and help healthcare professional and patients ensure the correct vaccine version is used. The qualifier should be based on the WHO’s strain nomenclature system, and should be used both with invented names and names that use the INN/common name plus the company name/trademark.
The guidance gives examples of the application of the nomenclature structure and provides additional examples showing how the “name + WHO label” format can be printed and affixed to individual vials of COVID-19 vaccine, which are quite small and create constraints on the number of characters that can be used in identifiers. EMA will require mock-ups of packaging for vaccines targeting different strains but covered under the same marketing authorization “in order to ensure clear identification.”
EMA will expedite evaluation of a pandemic variation of a human coronavirus vaccine, to include the possibility of a rolling review. If quality, non-clinical or clinical data are missing at the time of authorization during the exceptional circumstances of a pandemic, the agency will identify a timeframe for the marketing authorization holder to submit the missing data.


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