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

This system had the goal of reducing costs and centralizing purchases and distribution. What, do you think, is the best approach in all these cases? 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. Italy is also taking part in these discussions. What do you think about such initiatives? Heath is still a national competence, but in this type of emergency, we have all to be in synch. 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. 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. 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. GIORGIO PALU (GP): Yes, there is a big discussion about Sputnik V because of a study by Lancet, which came out in February. When you go to inspect a factory, you have to be sure that the product is also the same. 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. style=”font-size:40px; line-height: 1.3em; font-weight: 800; padding:7px;”>INTERVIEW: Professor Giorgio Palu, President of Italy’s medicines agency

By Federico Grandesso
Italian Editor, Journalist

epaselect epa08783894 Italian Army performs swab tests for the detection of the Covid-19 coronavirus for residents in Caserta, Italy, 29 October 2020. Therefore, I think that the approval process will still take a few months before a final green light is given. 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. Another natural step will be an inspection of the production sites. In any case, I think that Europe is still in wishful thinking mode. NE: There are also discussions on other vaccines, including India’s Covaxin. What do you think about that? We are in the middle of an emergency that includes the circulation of goods and people. 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. EPA-EFE/CESARE ABBATE

A member of the Italian Army performs swab tests for COVID-19 in the southern region of Caserta. The individual countries of the EU should have a common action plan. 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). NE: One of the parameters for the EU vaccine passport will be to include people who already had the virus and have developed antibodies. The mass test for residents are performed in the barracks where the Garibaldi Brigade is based, managed by the mobile laboratories of the Italian Army, with the ‘drive-through’ mode. Some EU of the 27 nations of the European Union has decided to take an independent path to obtain vaccine supplies. GP: We are bound by a European treaty. Do you think that this is a good strategy? We have to visit the production site and check all of the standard operations for the production of the vaccine. NEW EUROPE (NE): There is a big debate in Italy about using Russia’s Sputnik V vaccine. Finally, it is important to have the same processes validated by the pharma house. As a result, we need to go in this direction. EPA-EFE//CESARE ABBATE

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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. We don’t know how long the immunity could last, but it is important to know and identify it. NE: There is a big discussion in Europe about individual countries within the EU buying vaccines out of the European Union’s circuit. NE: What do you think about the European idea to create a vaccine passport to allow people to travel? It was used for the Ebola emergency. We still need to build up a single procurement plan, and this is the time to do it. Even Italy’s Prime Minister, (Mario) Draghi, wants to keep the vaccines in Europe and not to export them outside the bloc. 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. GP: This idea is also supported by the ECDC, we have to be pro-active about it. GP: Yes, the infection gives a natural immunity as with other viral diseases. 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. NE: What is the situation regarding monoclonal antibodies? Now we have to recognize that this system hasn’t work well and everybody is complaining.