European Medicines Agency’s letter to members of the European Parliament on COVID-19 vaccines

The European Medicines Agency (EMA) on 18 October wrote an interesting letter on COVID-19 vaccines to members of the European Parliament.
Unfortunately, I could not find the letter on EMA’s own site, I only found it on an Austrian site (here). I have not come across any coverage of the letter in the mainstream media [*], which is unfortunate because the issue of transmission was a major argument for asking the entire population to be vaccinated.

Since the letter seems genuine, there is every reason to discuss its contents.

Benefits of vaccination
EMA makes clear that they believe the benefits of the vaccines outweigh the drawbacks. Regarding site effects they write:

As shown in the product information for both vaccines, most side effects are mild, although more serious ones can occur.

but the organisation stresses that the choice to vaccinate should be made well-considered:

All safety information should be considered carefully before administering or recommending vaccination.

and:

When EMA recommends the authorisation of a vaccine, it provides information on the data it assessed to help vaccination authorities and healthcare professionals make recommendations to the wider public.

which did not happen during the Dutch vaccination campaigns.
There has been a Dutch disciplinary ruling saying that patient consent should be sought, but it was not widely reported.

Transmission: the vaccine has no role in limiting the spread of COVID-19
EMA’s letter is particularly interesting because it states that the vaccine has no role in limiting the spread of COVID-19, undermining the slogan “you’re doing it for your grandma” and the COVID-19 certificates:

You are indeed correct to point out that COVID-19 vaccines have not been authorised for preventing transmission from one person to another. The indications are for protecting the vaccinated individuals only.

The product information for COVID-19 vaccines clearly states that the vaccines are for active immunisation to prevent COVID-19. In addition, EMA’s assessment reports on the authorisation of the vaccines note the lack of data on transmissibility.

EMA will continue to be transparent about the approved uses of COVID -19 vaccines and identify areas where we need to tackle misconceptions

Waning protection
Regarding the quickly waning protection of COVID-19 vaccines EMA writes:

While long-term protection is always desirable, imposing such a requirement would have severe consequences for public health and put vulnerable people in danger. Establishing long-term protection may also not be feasible and, in the case of COVID-19, will be complicated by the evolution of SARS-CoV-2, a situation that we also observe with influenza.

Informed consent
EMA also answers questions on the product information:

You note that the summaries of product characteristics (SmPCs) for Comirnaty and Spikevax ‘are so voluminous that they have become de facto illegible for both doctors and citizens making informed consent impossible’. You also note a similar problem with the package leaflets.
These documents have indeed grown in size as new strengths and new adapted vaccines have been approved. EMA is currently considering ways to improve the way information is presented in SmPCs and package leaflets, not only for COVID-19 vaccines but for all medicines evaluated centrally in the EU. We are also looking at other ways to present information in our lay language questions and answers (Q&A) documents (what we call medicines overviews).

 

 

[*] I found a few articles on sites that are unknown to me, like this one (German) on a corona-blog (German) and another one (German) on a science site.

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