Vaccino Coronavirus, Moderna pubblica protocollo della sperimentazione: mai successo prima

L’azienda ha preso una decisione senza precedenti scegliendo di rendere pubblico lo studio che sta conducendo su 30mila pazienti con l’obiettivo di raggiungere un’efficacia del 60% contro il Covid-19. Una percentuale molto alta per Roberto Burioni: “Firmerei con il sangue”

The Moderna headquarters are seen in Cambridge, Massachusetts on May 18, 2020. - US biotech firm Moderna reported promising early results from the first clinical tests of an experimental vaccine against the novel coronavirus performed on a small number of volunteers. The Cambridge, Massachusetts-based company said the vaccine candidate, mRNA-1273, appeared to produce an immune response in eight people who received it similar to that seen in people convalescing from the virus. (Photo by Joseph Prezioso / AFP) (Photo by JOSEPH PREZIOSO/AFP via Getty Images)

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L’azienda Moderna, che sta lavorando alla sperimentazione di un vaccino contro il Covid-19, con una decisione senza precedenti ha scelto di rendere pubblico il proprio protocollo sperimentale

Covid-19 o influenza, come distinguerli? Diagnosi, cure e vaccino: i consigli dei medici

A man stands outside Moderna headquarters in Cambridge, Massachusetts on May 18, 2020. - US biotech firm Moderna reported promising early results from the first clinical tests of an experimental vaccine against the novel coronavirus performed on a small number of volunteers. The Cambridge, Massachusetts-based company said the vaccine candidate, mRNA-1273, appeared to produce an immune response in eight people who received it similar to that seen in people convalescing from the virus. (Photo by Joseph Prezioso / AFP) (Photo by JOSEPH PREZIOSO/AFP via Getty Images)

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L’obiettivo prefissato è quello di raggiungere un’efficacia del 60%

La corsa al vaccino

A women cleans the entrance doors to Moderna headquarters in Cambridge, Massachusetts on May 18, 2020. - US biotech firm Moderna reported promising early results from the first clinical tests of an experimental vaccine against the novel coronavirus performed on a small number of volunteers. The Cambridge, Massachusetts-based company said the vaccine candidate, mRNA-1273, appeared to produce an immune response in eight people who received it similar to that seen in people convalescing from the virus. (Photo by Joseph Prezioso / AFP) (Photo by JOSEPH PREZIOSO/AFP via Getty Images)

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Per la delicata sperimentazione sono stati arruolati 30mila pazienti

Oxford-AstraZeneca: se test ok, a novembre prime dosi di vaccino in Italia

CAMBRIDGE, MASSACHUSETTS - MAY 08: A view of Moderna headquarters on May 08, 2020 in Cambridge, Massachusetts. Moderna was given FDA approval to continue to phase 2 of Coronavirus (COVID-19) vaccine trials with 600 participants. (Photo by Maddie Meyer/Getty Images)

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Di questi, 15mila hanno ricevuto il vaccino e 15mila una finta vaccinazione, il placebo

Coronavirus, tutti gli aggiornamenti in diretta

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Si potrà dire che il vaccino funziona se nel gruppo placebo si infetterà lo 0,75%, mentre nel gruppo dei vaccinati gli infettati saranno lo 0,30%

Biotechnology company Moderna protocol files for COVID-19 vaccinations are kept at the Research Centers of America in Hollywood, Florida, on August 13, 2020. (Photo by CHANDAN KHANNA / AFP) (Photo by CHANDAN KHANNA/AFP via Getty Images)

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Si dovranno raggiungere 151 casi di contagio complessivi per poter cominciare a tirare le somme dello studio

A nurse prepares to inoculate volunteer Ilya Dubrovin, 36, with Russia's new coronavirus vaccine in a post-registration trials at a clinic in Moscow on September 10, 2020. - Russia announced last month that its vaccine, named "Sputnik V" after the Soviet-era satellite that was the first launched into space in 1957, had already received approval. The vaccine was developed by the Gamaleya research institute in Moscow in coordination with the Russian defence ministry. (Photo by Natalia KOLESNIKOVA / AFP) (Photo by NATALIA KOLESNIKOVA/AFP via Getty Images)

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E si dovrà sperare che gli infettati siano soprattutto tra i non vaccinati

Laboratory technicians handle capped vials as part of filling and packaging tests for the large-scale production and supply of the University of Oxfords COVID-19 vaccine candidate, AZD1222, conducted on a high-performance aseptic vial filling line on September 11, 2020 at the Italian biologics manufacturing facility of multinational corporation Catalent in Anagni, southeast of Rome, during the COVID-19 infection, caused by the novel coronavirus. - Catalent Biologics manufacturing facility in Anagni, Italy will serve as the launch facility for the large-scale production and supply of the University of Oxfords Covid-19 vaccine candidate, AZD1222, providing large-scale vial filling and packaging to British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca. (Photo by Vincenzo PINTO / AFP) (Photo by VINCENZO PINTO/AFP via Getty Images)

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Il virologo Roberto Burioni, sul suo sito Medical Fact, ha spiegato che questa procedura richiederà comunque tempi lunghi: "Dovrebbe richiedere circa 10 mesi dal momento in cui si è vaccinato il primo partecipante allo studio (non tutti vengono vaccinati contemporaneamente)"

HOLLYWOOD, FLORIDA - AUGUST 07: Leyda Valentine, an assistant coordinator, takes blood from Lisa Taylor as she participates in a COVID-19 vaccination study at Research Centers of America on August 07, 2020 in Hollywood, Florida. Research Centers of America is currently conducting COVID-19 vaccine trials, implemented under the federal government's Operation Warp Speed program. The center is recruiting volunteers to participate in the clinical trials, working with the Federal Government and major Pharmaceutical Companies, that are racing to develop a vaccine to potentially prevent COVID-19. (Photo by Joe Raedle/Getty Images)

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Tuttavia, chiarisce il virologo, il tempo resta una variabile incerta: "Ovviamente se il virus circola più intensamente si fa prima, se il virus circola poco ci vuole più tempo"

A scientist is pictured working during a visit by Britain's Prince William, Duke of Cambridge (unseen), to Oxford Vaccine Group's laboratory facility at the Churchill Hospital in Oxford, west of London on June 24, 2020, on his visit to learn more about the group's work to establish a viable vaccine against coronavirus COVID-19. (Photo by Steve Parsons / POOL / AFP) (Photo by STEVE PARSONS/POOL/AFP via Getty Images)

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L’obiettivo fissato al 60%, chiarisce Burioni, è da considerarsi molto alto: "In questo momento firmerei con il sangue per avere un vaccino sicuro ed efficace al 60%"

A researcher works in the laboratory of the Amsterdam UMC, in Amsterdam, the Netherlands, 28 May 2020. - Griffioen's team is developing a vaccine against the COVID-19 disease caused by the novel coronavirus. (Photo by Koen Van WEEL / ANP / AFP) / Netherlands OUT (Photo by KOEN VAN WEEL/ANP/AFP via Getty Images)

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Quanto allo studio, si svolgerà senza che nessuno dei medici sappia chi ha ricevuto il placebo al posto del vaccino

This picture taken on May 23, 2020 shows a laboratory technician holding a dose of a COVID-19 novel coronavirus vaccine candidate ready for trial on monkeys at the National Primate Research Center of Thailand at Chulalongkorn University in Saraburi. - After conclusive results on mice, Thai scientists from the centre have begun testing a COVID-19 novel coronavirus vaccine candidate on monkeys, the phase before human trials. (Photo by Mladen ANTONOV / AFP) (Photo by MLADEN ANTONOV/AFP via Getty Images)

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"Nessuno - neanche i medici o i capi dell'azienda - sa chi è stato vaccinato (due somministrazioni a distanza di quattro settimane) per davvero e chi è stato vaccinato per finta con una soluzione salina", ha detto il virologo

In this picture taken on April 29, 2020, an engineer shows an experimental vaccine for the COVID-19 coronavirus that was tested at the Quality Control Laboratory at the Sinovac Biotech facilities in Beijing. - Sinovac Biotech, which is conducting one of the four clinical trials that have been authorised in China, has claimed great progress in its research and promising results among monkeys. (Photo by NICOLAS ASFOURI / AFP) / TO GO WITH Health-virus-China-vaccine,FOCUS by Patrick Baert (Photo by NICOLAS ASFOURI/AFP via Getty Images)

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I dati sui pazienti, su chi ha ricevuto il vaccino e chi il placebo, sono disponibili solo a un comitato ristretto che ha il potere di fermare lo studio in ogni momento

Health personal handle a sample as they run a test for COVID-19 behind a screen at the General Hospital in Tijuana, Baja California State, Mexico, on April 13, 2020 during the novel coronavirus pandemic. - The novel coronavirus is 10 times more deadly than swine flu, which caused a global pandemic in 2009, the World Health Organization said Monday, stressing a vaccine would be necessary to fully halt transmission. (Photo by Guillermo Arias / AFP) (Photo by GUILLERMO ARIAS/AFP via Getty Images)

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Nonostante l’importanza di studi come questo, resta chi potrebbe chiederne l’interruzione per motivi etici, spiega Roberto Burioni: "Se ci si accorgesse che nessuno dei vaccinati si ammala e diversi dei non vaccinati si ammalano, con una forte validità statistica, sarebbe non etico privare chi è stato vaccinato per finta del vaccino vero"

A scientist is at work in the VirPath university laboratory, classified as "P3" level of safety, on February 5, 2020 as they try to find an effective treatment against the new SARS-like coronavirus, which has already caused more than 560 deaths. - When most are busy developing vaccines or testing the few anti-virals available, VirPath will go after drugs used for diseases that have nothing to do with a respiratory infection such as 2019-nCoV. (Photo by JEFF PACHOUD / AFP) (Photo by JEFF PACHOUD/AFP via Getty Images)

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"Attenzione però: se si interrompe lo studio dopo avere vaccinato 7.000 persone invece che 15.000 si avranno magari dati affidabili sull'efficacia, ma si dovrà rinunciare a qualcosa sul fronte della sicurezza"

TOPSHOT - A researcher works on a vaccine against the new coronavirus COVID-19 at the Copenhagen's University research lab in Copenhagen, Denmark, on March 23, 2020. - At Copenhagen university, a team of about 10 researchers is working around the clock to develop a vaccine against Covid-19 that could apply for clinical trial before within nine months. The vaccine will be based on two components : the protein which is on the surface of the coronavirus, called the spike protein that researchers express in the lab and then attach it on the surface of a virus-like particle. (Photo by Thibault Savary / AFP) (Photo by THIBAULT SAVARY/AFP via Getty Images)

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Tra le ipotesi c’è anche quella contraria, ovvero che tra i vaccinati si registrino effetti collaterali gravi, o una malattia più grave e in questo caso sarebbe inaccettabile continuare a vaccinare i partecipanti

CARACAS, VENEZUELA - MARCH 14: A person is vaccinated during a national campaign of vaccination implemented by the government after having decreed a state of health emergency at CDI Dr. Alcides Rodriguez on March 14, 2020 in Caracas, Venezuela. Delcy Rodriguez, Vice President of Venezuela, confirmed on Friday 13th the first two cases of COVID-19. President Nicolas Maduro had decreed a state of emergency in the health sector, suspended all flights from Europe and Colombia and mass public gatherings are banned. There is international concern about the management of the COVID-19 epidemic in Venezuela due to its collapsed health system. (Photo by Leonardo Fernandez Viloria/Getty Images)

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Ma il virologo precisa: "Nessuna di queste due eventualità si è verificata nel momento in cui scrivo, per cui dobbiamo aspettare incrociando le dita"

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Sulla data per il confezionamento del vaccino il direttore dei Centers for Disease Control ha detto che - nella migliore delle ipotesi - non sarà disponibile su larga scala prima dell'estate 2021

SAN SALVADOR, EL SALVADOR - APRIL 08: A nurse extracts an influenza vaccine from its container on April 8, 2020 in San Salvador, El Salvador. President Nayib Bukele declared a 30-day mandatory quarantine and curfew to control the spread of the Coronavirus. 93 positive cases have been confirmed and 5 deaths related to the virus and over 1,200 people have been arrested for violating the mandatory quarantine and curfew. (Photo by Camilo Freedman/APHOTOGRAFIA/Getty Images)

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Anche se il presidente degli Stati Uniti Donald Trump ha smentito dicendo che il vaccino potrebbe essere disponibile di qui a poche settimane

Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland on March 20, 2020, one of the labs developing a vaccine for the coronavirus, COVID-19. (Photo by ANDREW CABALLERO-REYNOLDS / AFP) / The erroneous mention[s] appearing in the metadata of this photo by ANDREW CABALLERO-REYNOLDS has been modified in AFP systems in the following manner: [Gaithersburg] instead of [Rockville]. Please immediately remove the erroneous mention[s] from all your online services and delete it (them) from your servers. If you have been authorized by AFP to distribute it (them) to third parties, please ensure that the same actions are carried out by them. Failure to promptly comply with these instructions will entail liability on your part for any continued or post notification usage. Therefore we thank you very much for all your attention and prompt action. We are sorry for the inconvenience this notification may cause and remain at your disposal for any further information you may require. (Photo by ANDREW CABALLERO-REYNOLDS/AFP via Getty Images)

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"La fretta in questo caso è una cattiva consigliera – ha detto Roberto Burioni - Intanto teniamo duro, usiamo le mascherine, manteniamo le distanze, evitiamo i luoghi affollati e se le cose vanno bene questo è l'ultimo inverno con questo virus tra i piedi in modo massiccio. Poi ci rifaremo"