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Pfizer pharmaceutical company plans to apply for authorization for its Covid vaccine from the US agency FDA in third week of november. This was announced by the managing director, Albert Bourla, through a letter published on the company’s website. There are three key areas in which, as with all vaccines, we must demonstrate success to first obtain approval for public use – writes the CEO -. First, the vaccine must prove itself effective, which means it can help prevent COVID-19 disease in at least the majority of vaccinated patients. Second, and just as important, the vaccine must prove its safety, with reliable data generated by thousands of patients. Lastly, we must demonstrate that the vaccine can be consistently produced to the highest quality standards.
Good news?
It would still be an incredible and impressive result: the force of despair and technology have led us to shorten times – he says Sergio Abrignani, immunologist, tenured professor of General Pathology at Milan State University and director of the National Institute of Molecular Genetics “Romeo and Enrica Invernizzi” -. We have come a long way: we have started the production of the vaccine, we have prepared the documentation, there is two good news and in the middle we are waiting for something that has not yet been proven to be effective and safe. We cannot fool ourselves but be optimistic, yes.
Let’s take a step back, what does “request authorization” mean in practical terms?
Pfizer is completing Phase 3 (a large-scale trial of a candidate vaccine to demonstrate its efficacy and safety, ed). With the hope of success and in the absence of setbacks, what can happen is that at the end of November, at the same time that the trial ends, the documentation on the vaccine can be sent to be sent to the regulatory agencies that are the FDA in the USA and the EMA in Europe. , you will receive a very substantial document consisting of several volumes. Documentation is usually prepared after the end of Phase 3, but in this case it is done earlier. They are saving all the time, they have probably already put the whole team of the regulatory department to work (where the documentation is prepared) and probably the same day that the biostatistical data says that the vaccine is at least 50-60% effective and safe , at that time they will send all the documentation immediately.
So what’s up?
It generally takes months to review documents: there are two types of approval / registration for a vaccine, the classic, then the emergency. If the pandemic were to rise again at the end of November, approval could also come in a month, which is a very short time. If there is an approval for emergency use, quickly, the vaccine registration could take place between January and February. At that time, if it worked, production was already started and paid for by Europe from the United States and, therefore, since the vaccine was already produced, distribution could begin.
Distribution between January and February: to whom? How many doses, with what criteria?
The World Health Organization (WHO) has already written a document with suggestions on the order of priority: generally during pandemics they are doctors, nurses, health workers, law enforcement officials and government officials. Then, depending on the epidemiological situation, the weakest and highest risk groups, which for Covid-19 we have seen are those over 65 years of age with comorbidities. So it depends from country to country.
In Italy, the Minister of Health, Roberto Speranza, anticipated that 2-3 million doses could arrive in the first trance and that the idea of vaccinating health workers and the elderly with diseases first. For how many people will the doses be enough?
Each person must receive two doses, we will vaccinate approximately one and a half million people in the first phase.
How long will it take to complete this first phase?
Protection takes months: the two doses are made a month apart and after the second dose you have to wait at least 15 days, so the first to get vaccinated, if you start in February, could be well protected in mid-March . The immune response takes time to “mount” and become optimal. At the end of spring, we may have exhausted this first trance, especially if we are confident in the logistics of the flu vaccine, that is, for June. If all the stages go well. For the entire vaccinated population we will arrive at the end of the year at the beginning of the 22nd.
Does this mean that fragile people still have to protect themselves for months and survive the winter?
This winter no one will be protected yet. Also, weak people still need to protect themselves in any case because there is flu, there is pneumonia, there are respiratory infections parainfluenza that can kill an immunosuppressed and fragile person. The headlines I’ve read are enthusiastic: good news, because Pfizer is ending soon, so we have to wait and see the results.
Will Pfizer’s Candidate Come First?
The first should be the vaccine candidates in which Phase 3 studies began first, Moderna and Astrazeneca are also in the race (with the last multinational, Europe has signed an agreement for 300 million doses with the option to purchase another 100 millions, ed).
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