Pfizer vaccine, here are truths and lies about doses and delays
"Initially, the leaflet of the Pfizer anti Covid vaccine identified the presence of 5 doses in each vial, then the EMA said that 6 doses must be extracted, then Pfizer rescheduled the delivery of the doses", commented Cartabellotta, president of the Gimbe Foundation. Facts, numbers and insights
Also next week the Italianvaccination campaign will have to deal with a delivery of doses of the Pfizer vaccine lower than expected. The American pharmaceutical giant has warned that the incoming cargo, again due to logistical problems, will be 20% lower.
The delays irritate the extraordinary commissioner Domenico Arcuri, who denounces an important slowdown in vaccination. But is Pfizer really late in delivering the doses? If you also count the sixth dose that can be extracted from each vial, the pharmaceutical company appears to be on schedule, according to many observers.
So much so that Nino Cartabellotta, president of the Gimbe Foundation, commented: "Since we are talking about dose reduction, it must be explained that initially the product leaflet identified the presence of 5 doses in each vial, then the Ema said that it is necessary to extract 6 doses, then Pfizer has rescheduled the delivery of the doses ”.
All the details.
THE DELAYS OF PFIZER
Let's start with the facts. In the current week Pfizer has delivered 29% fewer doses of the vaccine developed with the German Biontech and next week “we will receive 20% less next week. The delay continues ”, said the commissioner for the Covid emergency, Domenico Arcuri, in the press conference held on Thursday 21 January.
VACCINATIONS SLOW DOWN
The percentages that Italy had to give up, explained Arcuri, led to significant slowdowns in vaccination. "Due to the delays in the delivery of vaccines by Pfizer, Italy has gone from an average of 80 thousand people vaccinated per day , with a peak of 92 thousand, at an average of 28 thousand per day. The delays have significantly slowed the vaccination campaign ”. Arcuri added.
PRECEDENCE AT SECOND DOSE
The slowdown “is the consequence of the need to keep the doses needed for recalls in the warehouses. We have shared with the regions the criteria that we have been forced to put in place to remedy the delays in the arrival of doses. Our campaign slows down due to a lack of raw materials ”, said the commissioner, underlining that Italy is“ anxiously awaiting the decisions that EMA will implement on the marketing of AstraZeneca ”.
ARCURI: WE HAVE INTERESTED LAWYER
And in the name of those delays, the Government, after the state-region conference, decided to interest "the State Attorney General, which is preparing dossiers that could lead to a series of initiatives that will assess the potential damage that its interruption or slowdown it would produce ”, Arcuri recalled.
THE PFIZER AGREEMENTS
But is Pfizer really late? The answer, as La Verità recalls, was the pharmaceutical company itself, which in an interview with the Financial Times said that its agreements with governments "have always been based" on the delivery "of doses and not vials".
VIALS-DOSES
What does it mean? That Pfizer is not late, since the Ema, on January 8, changing the vaccine leaflet, decided that each vial contains 6 doses, and not 5. And that extra dose is certainly not free and goes counted in deliveries,
“And if someone has already used the sixth free dose to speed up the race to see who vaccinated the most, that's not Pfizer's problem. But of those who let it go without properly planning supplies. Playing with numbers and with a «misunderstanding» that was actually clear from the beginning ”, writes Camilla Conti of the daily La Verità.
PIERPAOLO SILERI: THE CAUSE MUST WAIT
And just thinking of a delay – no delay, Pierpaolo Sileri, Deputy Minister of Health, tries to calm the hot spirits of Arcuri, holding back the involvement of the Advocacy. “I would wait for the two weeks Pfizer has asked to expand production. If for a few weeks you have a reduction in the number of doses supplied, which you then recover, in the face of a greater production in its entirety that will guarantee more doses in the coming months, I see nothing wrong ”, said Sileri.
AGOSTINO MIOZZO: THE DELAY WILL BE RECOVERED
Agostino Miozzo, coordinator of the Scientific Technical Committee, also calmed the waters: “Pfizer assured us that the delays have already been overcome. It was a logistical problem, not a production one, and so this week's delay will be made up for, ”Miozzo said.
CARTABELLOTTA: IT IS NECESSARY TO DISTINGUISH DELAY AND DOSAGE DISTRIBUTION
But delays and the number of doses that, to date, can be extracted from each vial are two issues to be kept very distinct.
“I know that contracts are not public. You should ask who signed these contracts. Since we are talking about dose reduction, it is necessary to explain that initially the product leaflet identified the presence of 5 doses in each vial, then the EMA said that 6 doses must be extracted, so Pfizer has reshaped the delivery of the doses ", said Nino Cartabellotta, president of the Gimbe Foundation. “We now have to distinguish two aspects: the delay in deliveries and the reparameterization of doses. Pfizer says that as the European authority authorizes 6 doses to be extracted from vials, the sixth dose is not free. This must be clear. Delays are another issue, ”added Cartabellotta.
WHAT PFIZER SAYS ABOUT THE SIXTH DOSE
And that the dose is not free, Pfizer also clarifies, which claims : “After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Fact Sheet regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons ", ie:" After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and packages may indicate that, after dilution, one vial contains 5 doses of 0.3 mL. The information contained in this information sheet regarding the number of doses per vial after dilution supersedes the number of doses indicated on the bottle labels and cartons ”.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccino-pfizer-ecco-verita-e-bugie-su-dosi-e-ritardi/ on Fri, 22 Jan 2021 13:55:21 +0000.