New Europe spoke to Professor Giorgio Palu, President of AIFA (Italian Medicines Agency) and newly appointed member of the Scientific and Technical Committee, about the unexpected challenges facing the EU in the supply of vaccines. Some EU states of the 27 nations of the European Union have decided to take an independent route to obtain vaccines. Italy also takes part in these discussions.
NEW EUROPE (NE): There is a big debate in Italy about the use of the Russian vaccine Sputnik V. What do you think about it?
GIORGIO PALU (GP): Yes, there is a lot of discussion going on about Sputnik V based on a study by Lancet that was published in February. This study was well done and the result was 91-92% effectiveness. I know that Sputnik’s dossier was sent to the EMA (European Medicines Agency) for evaluation. Another natural step will be an inspection of the manufacturing facilities. So I think the approval process will take a few more months before a final go-ahead is given.
NE: There is also discussion of other vaccines including the Indian Covaxin. What do you think is the best approach in all of these cases?
GP: India also makes vaccines, including for AstraZeneca. In this case, however, the EMA or AIFA (the Italian Medicines Agency) or the FDA (the US Food and Drug Administration) must inspect the manufacturing facilities. The EMA could then hire someone from the AIFA or from German or French pharmaceutical companies to conduct an on-site assessment to determine whether the lots are being produced at the same pace. When inspecting a factory, you need to make sure that the product is the same too. It must always have the same concentration if it is a viral vector or microgram of MRNA (messenger RNA, the single-stranded RNA molecule that corresponds to the genetic sequence of a gene and is read by a ribosome for the synthesis of a protein ). After all, it is important that the same processes are validated by the pharmaceutical company. We need to visit the manufacturing facility and review all standard procedures for making the vaccine.
NE: What is the situation like with monoclonal antibodies?
GP: I personally fought for their use and found support from Italian Health Minister Roberto Speranza to pass an EU directive in 2006 that was incorporated into a national bill. It was used for the Ebola emergency. In this case, the minister issued an emergency decree authorizing the use of monoclonal antibodies, as the law provides for emergency use when an experimental drug has already been approved by another international regulatory agency such as the FDA.
NE: What do you think of the European idea of creating a vaccination pass that people can travel with?
GP: This idea is also supported by the ECDC, we have to be proactive. We are in the midst of an emergency involving the movement of goods and people. As a result, we have to go in that direction. Remember that not all countries will have rapid vaccine supplies. So it is important to protect the rest of the world for economic, social and industrial reasons.
NE: One of the parameters for the EU vaccination pass will be to include people who have already had the virus and have developed antibodies. Do you think this is a good strategy?
GP: Yes, the infection provides natural immunity like other viral diseases. We don’t know how long immunity could last, but it’s important to know and identify it. Regarding the ability to give just one dose of the vaccine, there is data from Jama and Lancet showing that a single dose of the vaccine after 3 to 6 months of a person who already had the virus had very high growth in neutralizing Antibody confers.
NE: There is a lot of discussion in Europe about the fact that individual countries within the EU are buying vaccines from the European Union’s cycle. What do you think of such initiatives?
GP: We are bound by a European treaty. This was a very sensible idea and when I was in Brussels we discussed the possibility of having a single procurement for influenza vaccines. The aim of this system was to reduce costs and centralize purchasing and sales. Now we have to realize that this system is not working well and everyone is complaining. Even Italy’s Prime Minister (Mario) Draghi wants to keep the vaccines in Europe and not export them outside the bloc. If Austria and Denmark decided to buy vaccines outside the EU, they could because there is an EU law that provides for such exceptional measures in emergency conditions. In any case, I think Europe is still wishful thinking. We still have a single procurement plan to develop and this is the right time to do it. The individual countries of the EU should have a joint action plan. Heath is still a national competence, but in this type of emergency we all need to be in sync.