The Scientific technical commission (CTS) dell’Italian drug agency (Aifa) gave the ok to Astrazeneca vaccine also for the over 55. However it suggests a preferential use for the band 18 – 55 years. We talked about it with Guido Rasi, former executive director of EMA and Aifa and professor of Microbiology at the University of Rome Tor Vergata.
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If the CTS suggestion is followed, could it speed up the path to broad coverage? If so, how?
“In my opinion it doesn’t speed it up much. Aifa has no right to authorize something already authorized by the EMA. It should explain why it suggests this preferential use, given that previously, sitting at the table with the EMA, she approved Astrazeneca. Furthermore, distributing the doses according to a vaccination strategy is the responsibility of the Ministry of Health, not AIFA”;
Why, in your opinion, does the AIFA suggest giving the vaccine to citizens under the age of 55?
“Data on actual efficiency over the age of 55 are not available. It was not possible to define the final level of effectiveness. However, there is one consideration: the vaccine has three possible levels of targets. The first is to reduce the negative effects of the disease, the second is to prevent it, the third is to prevent its spread. The first level was reached without any restrictions: in other words, no participant in clinical trials who was vaccinated then died of Covid. So there is 100% effectiveness in preventing severe disease. Faced with a logistical difficulty in delivering the Pfizer vaccine, and an intermediate difficulty with Moderna, there is the ease of administration of Astrazeneca. Furthermore, if it prevents serious illness in 100% of cases, there is no reason to set an age limit. With a clear vaccination strategy you can decide which to administer and where. The vaccination strategy is up to the ministry, the indication is up to the EMA”;
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Anti-Covid vaccines, Guido Rasi: “70% of vaccinated in Europe by mid-summer is possible”
The European Union, through the President of the Commission Ursula von der Leyen, has ensured that by the summer, 70% of European citizens will be vaccinated. However, there are discordant opinions and skeptical positions on this matter. What do you think?
“I think mid-summer doses will be available. 500 thousand doses per day are an easily achievable goal in many European countries. The Janssen vaccine should also arrive by the end of April. I am a little more cautious, however, to say that the vaccination machines of the various states will be able to keep pace, given that for now they have not taken it. In Italy, for example, there was some difficulty in vaccinating in hospitals, and it was the easier part. What will happen on the territories? There you will have to break in the car. In a month we will see. The launch of the campaigns in the various countries leaves many uncertainties, but it is theoretically possible that by the summer 70% of European citizens vaccinated will be reached”;
The emergency commissioner Domenico Arcuri has claimed the Italian record in Europe on the number of vaccine administration.
“Italy hasn’t done badly. Between delivery of the doses and use, it didn’t go wrong. The problem, as I said, is figuring out how it will go when the hard part comes. If we do not administer Astrazeneca to the over 55, which is easy to administer and transport, I do not understand how they intend to vaccinate the elderly population in disadvantaged areas, given that the logistical difficulties given by conservation are a complication. In the face of a tool that has been shown to prevent serious illness and death, it is singular to advise against administering it”;
“To reach about 7-8 approved vaccines, to deal with the variants of the virus”
With Astrazeneca we are at the third approved vaccine. Discordant voices say that there are too many and that we must continue to produce those that already exist.
“Each vaccine could give a different answer towards the variants. Let us remember that they all have different characteristics both for the technology used and for the response to potentially different constituents of the virus. It would be prudent to have more vaccines, about seven or eight. Also because if variants with geographic prevalence were to emerge, those already produced or still valid could be allocated to those areas and favor the conversion of those to Rna, which are faster. More vaccines are a guarantee”;
The World Health Organization (WHO) has urged member states to stop vaccinations, when they have been given to doctors and the vulnerable, in order to distribute it equally around the world.
“This is a singular thing, which I do not understand what strategy it implies. It means letting the virus circulate and favoring variants. The problem is not solved by leaving the vaccination incomplete. If the virus does not circulate in entire communities, it spreads much less easily than leaving an incomplete band everywhere. Unfortunately, the only solution is to reach world production. We take into account that sometimes having vaccines available is not enough. The problem is having the means to go and administer them. If we have difficulties in Western systems, let alone in difficult situations. In addition to nice words, you also need to have a realistic approach and understand what you put in place. WHO pursues good principles, but it should also aggregate the forces that they can distribute and administer”;
According to some, it would be better for companies to give up patents, so that everyone can produce the vaccines.
“This is an ideological position of senseless goodness. Making a plant that develops a vaccine means having a specific bio-reactor for each type of vaccine. Then a very complex technological adjustment would be needed which would take a few months. Rna technology would be faster once fully operational, but it requires new plants. There is therefore a technological problem, and one that concerns the transfer of know-how from those who developed the vaccine to those who will have to produce it. This also takes time. If we left now, we would be ready in at least five or six months and considerable capital would have to be invested. The right path therefore is the one already undertaken. The big producers are already making agreements with other production sites. In this sense, the Government can intervene by making a local mapping of the plants that can be more easily converted, and ask the producers what supports they need to reach a certain production capacity.”;
“Reithera is not the immediate solution”
Reithera, the Italian vaccine, seems to be the hope of politicians and experts
“Unfortunately, Reithera is not the immediate solution. He is now in phase 1 and will have a big problem recruiting volunteers. There is an ethical question: do you volunteer for a vaccine to be developed right now or do you choose to make the vaccine available? We still don’t know what Reithera’s protection is, but it appears to be worthy of development and attention. Only it started too late, with a technology identical to that of Astrazeneca. There are serious doubts about the conflict of interest of those who should also evaluate it. I don’t see it as a solution, but it’s worth moving forward for future strategies”;
What are the differences between the three vaccines in use to date, Pfizer, Moderna and Astrazeneca?
“RNA vaccines (Moderna and Pfizer) have realized a hope we had. We were all aware of their great potential, but there was never the time and opportunity to develop this technology. Now it has given spectacular results, since it allows for much faster productions. It is the technology of the next decades. It gave 94% results in preventing the onset of the disease. Early Israeli data are telling us it could prevent the spread of the infection as well. Furthermore, the manufacturers would be able to develop a vaccine on the variants in 6-8 weeks. While Pfizer should be stored between -60 and -80 degrees and therefore has a logistical complication, Moderna should be stored at -20, the easiest fridge to find. For the rest they are similar. Both prevent severe disease and possibly even transmission. Astrazeneca, on the other hand, has been shown to prevent Covid and serious illness in 100% of cases. And in 59% of cases also the onset of the disease in subjects under the age of 55. In subjects from this age onwards, there is no certainty about the percentage of prevention of the disease, but there is the certainty that it will not become serious and of zero mortality. This means there is no such dramatic pandemic foreclosure to use any vaccine for anyone. At this time, most of the population must be reached by the means by which it is easiest to reach them”.
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