The derby, for the moment all-American, on anti Covid-19 vaccines continues to the sound of announcements.
After Pfizer's first announcement arrived last November 9 and Yesterday's response from Moderna, the New York company is once again back in the spotlight and announced today, November 18, the final results of phase 3 (the last) of its experimentation. Well Pfizer, together with its partner BionTech, let it be known that the final tests on the vaccine against Sars-Cov-2 show 95% efficacy in preventing the onset of symptoms, with encouraging results in the elderly. Furthermore, no serious side effects were found on the patients to whom the preparation was administered.
THE RESULTS OF PFIZER-BIONTECH
The definitive data released today by Pfizer is higher than that communicated last week, which however was based on intermediate data. The effectiveness of the vaccine at the conclusion of the phase 3 trial has in fact risen from 90 to 95%, an encouraging percentage above all because, underlines the New York Times these are the first complete results arrived so far.
The vaccine has also proven to be 94% effective in the elderly, the weakest group on which everyone's concerns are concentrated.
The experimentation was carried out on 44 volunteers. Half were given the vaccine, the other half a placebo. In total there were 170 patients who developed Covid-19, 162 belonging to the group that received the placebo, only 8 among the vaccinated. Overall there were 10 cases of acute Covid, 9 of which belonged to the placebo group.
As regards side effects, the most common was fatigue, followed by tiredness (3,7%) and headache (2%). Mild side effects among the elderly.
Based on these results, Pfizer has confirmed that it intends to request emergency authorization from the FDA within "a few days", an indispensable prerequisite for the distribution of the vaccine.
“The study results mark an important step in this historic 8-month journey for a vaccine that can help end this devastating pandemic,” said Albert Bourla, chief executive officer of Pfizer.
“The study indicates that a high rate of protection against Covid can be achieved very quickly already after the first dose. These results highlight the potential of mRNA as a new class of drugs,” continued Ugur Sahin, CEO and co-founder of BioNTech. “We will continue to work with our partners and Governments around the world to prepare for global deployment in 2020 and beyond,” continued the manager.
Pfizer has ensured it can produce 50 million doses by the end of 2020 and up to 1,3 billion by December 2021. Half of the doses supplied this year will go to the United States, which has signed an agreement with the company for a total of 100 million doses.
The European Union, thanks to a contract signed on November 10, will instead receive 200 million doses (plus an option for another 100 million). About 27 million doses should arrive in Italy during the first tranche, 13,51% of the total.
We remind you that the Pfizer-BionTech vaccine has a weak point: it must be stored at -70 degrees, a characteristic that makes it difficult to store and transport. The US company has ensured that it can ship the vaccine in refrigerated boxes with dry ice containing from one thousand to five thousand doses. The vaccine can be stored for a maximum of 5 days in conventional freezers and 15 days in special refrigerators.
THE VACCINE OF MODERN
Moderna's vaccine, like Pfizer's, is messenger RNA, that is, it stimulates the production of antibodies against the spike protein attacked by the virus. The preparation is currently in the third phase of experimentation, the one on humans, which however has not yet been completed.
The tests in this case were conducted on 30 patients divided into two groups: the first was given the vaccine in two doses, the second a placebo. 95 fell ill, 90 belonging to the group that had received the placebo and 5 to that of the vaccinated. Among the latter, no significant side effects were found, at most a few degrees of fever, a little tiredness and soreness at the injection site. None of the vaccinated had severe symptoms from Covid-19, while 11 of the unvaccinated positives were affected by severe Covid. An efficacy value of 94,5% was calculated from these data.
The vaccine can be stored for 30 days in a refrigerator or freezer and can remain at room temperature for up to 12 hours, making it easier to transport than its rivals, which instead require storage at -80 degrees.
Also in this case the EU Commission “agreed with Moderna the supply of up to 160 million doses of vaccine.
AT WHAT POINT IS ASTRAZENECA
The American derby between Pfizer and Moderna has overshadowed the work of another company which is developing an anti-Covid-19 vaccine and which had been talked about a lot in recent months: it is the British AstraZeneca, which is experimenting with its preparation together to the University of Oxford and which has entrusted its production to Irbm of Pomezia.
Unlike the first two, which as mentioned are based on messenger RNA, the AstraZeneca-Oxford vaccine is based on an adenovirus, a weakened version of a common cold virus whose genetic information has been modified to carry parts of the Covid -19.
AstraZeneca's vaccine is also in phase 3 of the trial, but the company has not yet announced preliminary data. The communication of the first results should arrive in the coming weeks and, in the event that they prove to be positive, the British company could also request emergency authorization for the use of the vaccine, distributing the first doses by the end of the year.
The European Union, as happened in the two previous cases, has already booked a first supply of doses, this time equal to 400 million, while the US has booked 300 million.
A few weeks ago, the president of the IRBM research center in Pomezia, Piero Di Lorenzo explained to the Financial Lounge website: "if sudden problems do not arise, it is reasonable to think that the clinical trial phase can be completed by the end of November or early December". "After phase 3 - he continued - the ball passes to the EMA (the European Medicines Agency, ed) for any validation".
“Hopefully – added Di Lorenzo – it is reasonable to expect that the first doses of the vaccine, 2-3 million, will arrive in Italy by the end of the year. The contract between AstraZeneca and the EU provides for the delivery of 300 million doses by June 2021. About ten million doses will arrive in Italy every month. By June 2021, all those who want to get vaccinated in Italy will be able to do so ”.
