FDA & EMA viewpoints: regulating adjuvanted #influenza #vaccines
Dr Pieter Neels, Member Committee for Medicinal Products for Human Use at the European Medicines Agency spoke at last year’s World Influenza Congress in Vienna on the reasoning behind regulatory standpoints in Europe.
And he did address the elephant in the room before getting started, saying that:
“Regulators cannot do any good:
- If we are critical: we are delaying new medicinal products to the market
- If we are pragmatic: we are not severe enough, and we are accused to work for bigpharma,…”
Setting the tone for the presentation, Pieter then continued to analyse the reasons behind why adjuvants should be used in influenza vaccines and what needs to be proven to achieve global approval.
Talking about safety, a serious point to be taken into consideration when talking about adjuvants in vaccines, Pieter Neels raised some important discussion points and gave his view on how these might be resolved:
- What makes the adjuvant more dangerous than a
- How large must the database be to get a registration
for an adjuvant?
- What is an acceptable time frame for follow-up to be
- Should we register a new vaccine with an old
antigen with an adjuvant with an increased GMT but
comparable response rate?
- In case of pandemic flu, what risk can we take to use
an adjuvant in order to have an antigen sparing
effect and to increase the number of doses even
above the amount needed for the EU/US market?
What are your thoughts? Do we need adjuvants and are they safe to be used? We would love to hear your thoughts in the comment box below.