According to the Twitter of Andrej Babiš (Czech prime minister):

This evening I have asked the EC President @vonderleyen to explore and approve together with @EMA_News as soon as possible the possibility of using a Pfizer ampule for six doses instead of five. It would mean 360 million doses instead of 300 million doses of Pfizer vaccine for the EU. I strongly hope that the EC President will find a solution shortly.

But why is EU approval required in the first place? Couldn't the Czech government unilaterally mandate that all six doses are used instead of five? Is there anything in EU rules that precludes such experimentation?

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    "It would mean 360 million doses instead of 300 million doses of Pfizer vaccine for the EU" For the EU, not just Czechia. There's nothing in the tweet that indicates the Czech prime minister is asking for approval for how the Czech government will proceed with vaccinations. – yannis Dec 28 '20 at 23:56
  • This is not about experimentation. – Relaxed Dec 29 '20 at 1:18
  • This is irrelevant to your actual question but you seem to imply that the Pfizer vaccine contains 6 doses and according to EU regulations only 5 are used. The original tweet rather says that the vaccine is sold in ampules with a certain quantity of vaccine. EU regulations say this is enough for making 5 doses. The Czech prime minister suggest giving everyone 5/6 of a dose so that it covers more people, hoping that the smaller quantity is just as effective as the full dose. Whether this is a good idea should be jugded with medical expertise not by politicians. – quarague Dec 29 '20 at 9:23
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    @quarague Sorry if I wasn't clear, I am indeed talking about an extra full dose or more that would otherwise be discarded. Personnally, it's not something I knew or assumed to be there before this issue came up but US healthcare providers reportedly noticed that more than one full dose remained in the vial at the end (some sources suggest it might even be possible to get two). AFAIK, the FDA only allows using any remaining full doses but not administering smaller doses nor mixing different vials. That's the basis for the whole discussion. – Relaxed Dec 30 '20 at 11:02
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    @quarague Multidose vials are routinely filled with more than required for the intended number of doses, so that any slight spillage doesn't mean the last dose is too small. Apparently in this case the "extra" vaccine Pfizer has included in its vials is more than one full extra dose. See e.g. politico.com/news/2020/12/16/pfizer-vaccine-extra-doses-447117 – Ben Dec 30 '20 at 20:23

Right now, this vaccine is distributed under an EU-wide “Conditional Marketing Authorisation” based on a recommendation from the European Medicines Agency. This authorisation constrains what can be done with the vaccine, certainly as far as the manufacturer, marketing authorisation holder, and national governements are concerned (legally, individual practitioners might have some leeway in how they administer a medicine). Similar processes exist elsewhere.

Under existing European law, neither national governments nor even the EU Commission itself are supposed to circumvent this process and allow random compounds to be used as medicinal products or issue arbitrary recommendations for their use without consulting the agencies they set up to regulate this. From that perspective, unless it wants to issue another authorisation, the Czech government cannot unilaterally do anything.

EU law does however foresee other types of approvals for medicinal products that could be issued at the national level:

  • Emergency Use Authorisation
  • National/Mutual Recognition Procedure

Legally, the Czech Republic could issue an Emergency Use Authorisation for a Covid-19 vaccine without asking the EU for permission but all EU countries indicated earlier this year that they preferred to follow the regular “Conditional Marketing Authorization” process. Consequently, I assume that no manufacturer applied for approval at the national level.

In many cases, manufacturers can also apply for approval through a National/Mutual Recognition Procedure but EU law restricts those. In particular, the centralised procedure is mandatory for products developed with certain techniques like recombinant DNA technology. If I understand the Pfizer/BioNTec vaccine correctly, this rule seems to preclude a national marketing authorisation for that particular product (but that will not necessarily be the case for all other vaccines).

In both cases, the approval would not be solely in the hands of the Czech cabinet but should be initiated by an application by the manufacturer and go through the National Competent Authority, namely the State Institute for Drug Control. That, rather than EU harmonization, is what ties the hands of the Czech government.

  • Minor correction. should be initiated by an application by the manufacturer and go through the National Competent Authority, namely the State Institute for Drug Control => the Czech parliament (controlled by the Prime Minister, to a certain degree) could pass a special law that abolishes these requirements, if they wanted. – JonathanReez Dec 29 '20 at 1:54
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    @JonathanReez No, not under existing EU law. Of course, the Czech Republic could also leave the EU, etc. etc. but that's not a very useful way to look at this. In other words: EU law did not fully harmonise the authorisation process nor does it require EU permission for each and every medicine but it does require each member state to have a standard process. – Relaxed Dec 29 '20 at 1:55
  • I seem to recall that there are differences in liabilities for emergency and conditional authoritzation. Do you know anything about that? – o.m. Dec 29 '20 at 11:00
  • +1 but I think you're wrong about "reverse genetics" as applicable here. The EU has some specific rules which exclude vaccines (even those with DNA/RNA) from being categorized as recombinant products. "In EU, there is one exclusion criterion that explicitly vetoed a product from being classified as a gene therapy: those products aimed at the treatment or prophylaxis of infectious diseases." – Fizz Dec 30 '20 at 7:05
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    @Fizz You're right about that, the rules are based on how a product is manufactured, not how it's discovered. The terminology used in regulation 726/2004 is "recombinant DNA technology” but I came across the phrase “reverse genetics” in this guideline on influenza vaccines from the EMA. – Relaxed Dec 30 '20 at 15:13

The 300 million refers to the number of doses procured from BioNTech and Pfizer by the European Union. As such, the requested increase to 360 million (which corresponds to going from five to six doses) appears to be an EU-wide increase.

One clear reason why the EU would be involved in such a request is that the vaccines were procured jointly through the EU. If more doses are needed per person, fewer people can be vaccinated by the existing order. The easiest option is to amend the order to buy more doses of the vaccine, which is what the Czech prime minister requests here.

Couldn't the Czech government unilaterally mandate that all six doses are used instead of five? Is there anything in EU rules that precludes such experimentation?

That seems to be more of a regulatory question. I don't think that's an issue here as member states are allowed to authorize medicines at the national level:

While the majority of new, innovative medicines are evaluated by EMA and authorised by the European Commission in order to be marketed in the EU, most generic medicines and medicines available without a prescription are assessed and authorised at national level in the EU.

Of course, the tweet does mention EMA exploration and approval, so there is some regulatory angle. Considering that the EMA has been in charge of the vaccine's approval in the EU up to now, it makes sense for them to evaluate this change as well. Furthermore, approval by the EMA applies to the EU as a whole whereas national authorization would require a mutual recognition procedure to apply the change in other member states.

In that regard, the same reasons for centralizing procurement and authorization EU-wide any medicine apply to the vaccines for a disease which clearly affects all countries in the EU.

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