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INTERVIEW: Professor Giorgio Palu, President of Italy’s medicines agency

INTERVIEW: Professor Giorgio Palu, President of Italy’s medicines agency

New Europe spoke with Professor Giorgio Palu, President of AIFA (the Italian Medicines Agency) and a newly appointed member of the Scientific Technical Committee, about the unexpected challenges the EU is facing regarding the supply of vaccines. Some EU of the 27 nations of the European Union has decided to take an independent path to obtain vaccine supplies. Italy is also taking part in these discussions.

NEW EUROPE (NE): There is a big debate in Italy about using Russia’s Sputnik V vaccine. What do you think about that?

GIORGIO PALU (GP): Yes, there is a big discussion about Sputnik V because of a study by Lancet, which came out in February. That study was well done, and the result was an efficacy of 91-92%…I know that the dossier of Sputnik was sent to the EMA (European Medicines Agency) for evaluation. Another natural step will be an inspection of the production sites. Therefore, I think that the approval process will still take a few months before a final green light is given.

NE: There are also discussions on other vaccines, including India’s Covaxin. What, do you think, is the best approach in all these cases?

GP: India is also producing vaccines, they do it for AstraZeneca as well, but in this case, the EMA or AIFA (the Italian Medicines Agency) or the FDA (the US’ Food and Drug Administration) will have to inspect the production sites. The EMA could then delegate someone from AIFA or from Germany or France’s pharma agencies to carry out an onsite evaluation in order to see if the lots are produced at the same pace. When you go to inspect a factory, you have to be sure that the product is also the same. It then has to always have the same concentration in case of viral vector or micro-gramms of MRNA (messenger RNA, the single-stranded molecule of RNA that corresponds to the genetic sequence of a gene, and is read by a ribosome in the process of synthesizing a protein). Finally, it is important to have the same processes validated by the pharma house. We have to visit the production site and check all of the standard operations for the production of the vaccine.

NE: What is the situation regarding monoclonal antibodies?

GP: I personally fought for their use, and I found support from Italy’s Health Minister Roberto Speranza, in order to adopt an EU directive incorporated by a national draft law in 2006. It was used for the Ebola emergency. In this case, the minister issued an emergency decree to approve the use of monoclonal antibodies because the law allows for emergency use if an experimental drug has already been approved by another international oversight body, like the FDA.

NE: What do you think about the European idea to create a vaccine passport to allow people to travel?

GP: This idea is also supported by the ECDC, we have to be pro-active about it. We are in the middle of an emergency that includes the circulation of goods and people. As a result, we need to go in this direction. Remember,  not all of the countries are going to have a quick supply of vaccines, so it is important to safeguard the rest of the world for economic, social and industrial reasons.

NE: One of the parameters for the EU vaccine passport will be to include people who already had the virus and have developed antibodies. Do you think that this is a good strategy?

GP: Yes, the infection gives a natural immunity as with other viral diseases. We don’t know how long the immunity could last, but it is important to know and identify it. Regarding the possibility of giving only one dose of the vaccine, there is data by Jama and Lancet showing that after 3-6 months, a single dose of the vaccine gives a person who had already had the virus, very high growth of the neutralizing antibodies.

NE: There is a big discussion in Europe about individual countries within the EU buying vaccines out of the European Union’s circuit. What do you think about such initiatives?

GP: We are bound by a European treaty. This was a very reasonable idea, and when I was in Brussels, we discussed the possibility of putting in place a single procurement for influenza vaccines. This system had the goal of reducing costs and centralizing purchases and distribution. Now we have to recognize that this system hasn’t work well and everybody is complaining. Even Italy’s Prime Minister, (Mario) Draghi, wants to keep the vaccines in Europe and not to export them outside the bloc. If Austria and Denmark decided to buy vaccines outside the EU, they were able to do it because there is an EU law that in emergency conditions, allows for such exceptional measures. In any case, I think that Europe is still in wishful thinking mode. We still need to build up a single procurement plan, and this is the time to do it. The individual countries of the EU should have a common action plan. Heath is still a national competence, but in this type of emergency, we have all to be in synch.

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