Add news
Нами Накагава — Kimi Wa Kirameki/Ты - Сияние! (feat. Ichigo Tanuki)
March 2010
April 2010
May 2010June 2010July 2010
August 2010
September 2010October 2010
November 2010
December 2010
January 2011
February 2011March 2011April 2011May 2011June 2011July 2011August 2011September 2011October 2011November 2011December 2011January 2012February 2012March 2012April 2012May 2012June 2012July 2012August 2012September 2012October 2012November 2012December 2012January 2013February 2013March 2013April 2013May 2013June 2013July 2013August 2013September 2013October 2013November 2013December 2013January 2014February 2014March 2014April 2014May 2014June 2014July 2014August 2014September 2014October 2014November 2014December 2014January 2015February 2015March 2015April 2015May 2015June 2015July 2015August 2015September 2015October 2015November 2015December 2015January 2016February 2016March 2016April 2016May 2016June 2016July 2016August 2016September 2016October 2016November 2016December 2016January 2017February 2017March 2017April 2017May 2017June 2017July 2017August 2017September 2017October 2017November 2017December 2017January 2018February 2018March 2018April 2018May 2018June 2018July 2018August 2018September 2018October 2018November 2018December 2018January 2019February 2019March 2019April 2019May 2019June 2019July 2019August 2019September 2019October 2019November 2019December 2019January 2020February 2020March 2020April 2020May 2020June 2020July 2020August 2020September 2020October 2020November 2020December 2020January 2021February 2021March 2021April 2021
123456789101112131415161718
19
20
21
22
23
24
25
26
27
28
29
30
News Every Day |

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.




Read also

Athletes at low risk of heart inflammation post-COVID-19 infection, study finds

Joy-Anna Duggar slammed as ‘clueless’ by fans for putting a necklace & bracelet on daughter Evy, 7 months

Who was in the car with the Queen today and what is a lady-in-waiting?





News, articles, comments, with a minute-by-minute update, now on Today24.pro



Today24.pro — latest news 24/7. You can add your news instantly now — here
News Every Day

Building an Outhouse with Cedar Logs at My Off Grid Wilderness Homestead