January 24, 2021
A Dialogue with Professor Rafila
Yesterday evening, on 23 January 2021, I had a very interesting discussion, live on RTV, with Professor Rafila on the subject of the “anti-CoVid” vaccine Comirnaty produced by Pfizer.
Below I leave the transcript of that discussion:
DR ALEXANDRU RAFILA —
Dr Al. Rafila:
… you cannot make a planning so perfect that everyone comes at the same time; there are people who for objective reasons do not turn up, and because the vaccine has a high perishability — you know that if you keep it longer in the refrigerator, there are losses. We must always relate the loss to the total number of doses administered.
…
Do you know what the problem is? That is how I see the problem. We now have a priority category that is too large, or priority categories that are too numerous; that is, we have come to have six million or over six million persons who have registered or ought to register for vaccination — now, that means we have 60% of those whom THE GOVERNMENT WOULD LIKE TO VACCINATE by September as a priority category. So there are more people in the priority category than in the ordinary category, which obviously creates, if you like, problems, because people cannot register on the computer platform in such large numbers, and the scheduling, you know, is only for 3 weeks; now, this matter creates certain pressures on the system.
Adv. Dan MV Chitic:
…
The question is simple: once both doses of vaccine have been given, for what period is immunisation obtained, ensured?
Dr Al. Rafila:
Here we can speak at present of a minimum period of immunity.
Adv. Dan MV Chitic:
Minimum, yes, please.
Dr Al. Rafila:
Now we are PROBABLY speaking of a period of 6–8 months as the minimum period, but time will show us, because we have known the vaccine for only a short time; the research was begun after the new coronavirus appeared, and then probably — excuse me, a parallel: when the vaccine against HPV infection with the Papilloma virus appeared, exactly the same question was asked: “how long will the immunity of the girls who are vaccinated now last?” They were then between 11 and 14 years old, and look, there were discussions whether it lasts one year, two or three, and here we are 12 years after vaccination and they still show immunity. It is the same with this vaccine.
Adv. Dan MV Chitic:
This question of 6–8 months is a very simple matter.
In the leaflet of Comirnaty, as this vaccine is called, the manufacturer Pfizer said that it DOES NOT KNOW the period of immunisation. Not at all! It does not know it.
So that is why I now come and ask you: on the basis of what studies have we here in Romania been able to say something that the manufacturer does not say?
Dr Al. Rafila:
It does not say it. I told you a minimum duration.
Adv. Dan MV Chitic:
Well yes, but the manufacturer does not give this minimum duration!
Dr Al. Rafila:
No, but let me explain to you. The manufacturer does not give the duration because it is possible that the duration, as I was saying, may be longer.
Adv. Dan MV Chitic:
Well, it could have given the minimum one!
Dr Al. Rafila:
All right, but it is not obligatory; yet if it says it gives 6–8 months and it turns out to be valid for 3 years, then…
Adv. Dan MV Chitic:
Well no, but it may be one day! That is the problem. Why did it not say 6 months, and then I would go to be vaccinated with an easy mind: for 6 months I am at peace. It could have said something minimal. There it says “NOT KNOWN”.
Dr Al. Rafila:
One moment, if you please. The persons who were vaccinated during the clinical trials — because we are speaking not only of the phase 3 clinical trials but also of phase 2, which took place at least 6 months earlier — are still protected.
Adv. Dan MV Chitic:
Well yes, but they do not write that!
Dr Al. Rafila:
Well, they do not write it in the leaflet, but I am telling you that this is the situation.
Adv. Dan MV Chitic:
But wait a moment: for the time being, what engages liability is the leaflet, that little slip of paper they put in front of us.
Dr Al. Rafila:
Well yes, but it is not a matter of liability here, it is a matter of the duration of immunity.
We cannot treat a medicine or a vaccine as a legal case. It is not a legal case, it is a medicine.
Adv. Dan MV Chitic:
It can turn into a legal case at any time, Professor. Everything can turn into a legal case.
If I am not immunised, to whom do I complain? To you, to the ministry or to Pfizer?
Post scriptum: I thank Mrs Mariana Alecu for transcribing my dialogue with Professor Rafila.
Post post scriptum: below I leave once again the official leaflet of the “Anti-CoVid” vaccine Comirnaty produced by Pfizer, together with two extracts from that leaflet:
https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_ro.pdf
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