All the news on vaccines: questions, answers and unknowns (on distribution)

All the news on vaccines: questions, answers and unknowns (on distribution)

While the ok for new Covid vaccines is awaited, Pfizer-Biontech's vaccine inoculation kicks off on December 27, but not all hospitals are yet equipped to store the drug. All the details

Aifa, the Italian drug agency chaired by Giorgio Palù, has also given the green light to Pfizer-Biontech's Comirnaty vaccine. The vaccine will be given to anyone over the age of 16, but not to anyone with various allergies.

It starts on December 27, but it is (at least for now) a symbolic beginning. Of the 294 hospitals that will have the task of carrying out vaccinations, writes Il Sole 24 ore , over 70 structures do not yet have super cold rooms to store vaccines at -75 degrees. Meanwhile, new green light is awaited for new drugs.

All the details.


Let's start with the green light of the Italian Medicines Agency. Aifa, after the approval of the EMA and the EU Commission, authorized the distribution of the anti Covid-19 Comirnaty vaccine, developed by BioNTech and Pfizer.

It is not just a question of “acknowledging European approval. In addition to authorizing their marketing and reimbursement for all at the expense of the NHS, Aifa has provided for an information and communication program on vaccines for Covid-19, starting from a series of answers to the most frequently asked questions , already available on the Aifa website ”, said Aifa General Manager, Nicola Magrini.


The vaccine that got the go-ahead is a messenger RNA-based drug, encased in liposomes formed by ALC-0315 and ALC-0159 to facilitate entry into cells. The vaccine also contains:

• 1,2-Distearoyl-sn-glycero-3-phosphocholine

• cholesterol

• dibasic sodium phosphate dihydrate

• monobasic potassium phosphate

• potassium chloride

• sodium chloride

• sucrose

• water for injections


How does it work? The messenger ribonucleic acid (mRNA) molecules contain the instructions for the vaccinated person's cells to synthesize Spike proteins.

“In the vaccine, the mRNA molecules are inserted into a microscopic lipid vesicle that allows the mRNA to enter the cells. Once injected, the mRNA is absorbed into the cytoplasm of cells and initiates the synthesis of Spike proteins. The proteins produced stimulate the immune system to produce specific antibodies. In those who have been vaccinated and are exposed to viral infection, the antibodies thus produced block the Spike proteins and prevent their entry into the cells. Furthermore, vaccination also activates the T cells that prepare the immune system to respond to further exposure to SARS-CoV-2 ”, explains Aifa.


The drug also boasts very high efficacy. Based on a study conducted in the United States, Germany, Brazil, Argentina, South Africa and Turkey, with the participation of over 44,000 people, it was established that two doses of the mRNA vaccine BNT162b2 (or Comirnaty) administered 21 days apart one on the other can prevent 95% of adults aged 16 and over from developing Covid-19 disease.


"We have available, just ten months after the publication of the genome sequences of the virus, a vaccine against Covid-19 with a very high efficacy, around 95%, and another 5-6 are in the pipeline", commented yesterday the new president of Aifa, Giorgio Palù .


Very high numbers, those announced, which however hide some uncertainties about the drug. We still "do not know how long his coverage lasts and if a recall is needed," Marco Cavaleri, pharmacologist, has worked for over 10 years at the EU Medicines Agency (EMA), where he is head of the vaccine strategy, told Corriere della Sera .

"At the moment we have data up to about 100 days, the duration of the third phase of experimentation, although we expect the efficacy to remain much longer", adds Cavaleri, who assumes it can last at least a year, "like the vaccine for the flu".


The vaccine will be administered “to the entire population over the age of 16, has no absolute contraindications and special precautions are not required for specific subpopulations such as the elderly, immunosuppressed or subjects with coagulation disorders and bleeding risks. There are no contraindications even for pregnant and lactating women ”, said Nicola Magrini of Aifa.


Adverse reactions are also "mild or moderate in severity and resolved within a few days of vaccination," explains Aifa . “These included pain and swelling at the injection site, fatigue, headache, pain in muscles and joints, chills and fever. Injection site redness and nausea occurred in less than 1 in 10 people. Injection site itching, pain in limbs, swollen lymph nodes, difficulty falling asleep and feeling sick were uncommon, affecting fewer than 1 in 100 people. Weakness in the muscles of one side of the face (acute peripheral facial paralysis) has occurred rarely, in less than 1 in 1000 people ”.


Pfizer's vaccine, however, is not recommended “if there are allergies or hypersensitivity to its active ingredients and its excipients. Anyone who has asthma or is allergic to cats or grasses will not have any problems, although we always recommend talking to your doctor. Serious food allergies, which in themselves do not represent a contraindication, should be discussed with the doctor because they could be a sign of hypersensitivity to the vaccine, ”said Marco Cavaleri.


After the Aifa's ok, therefore, also in Italy we will start on December 27 with the vaccination.

"The 27th is European vaccination day, a symbolic appointment that makes us feel part of a wider community, in the context of a global pandemic, and that inaugurates the mass vaccination campaign that will take place throughout Europe", he concluded the General Manager Magrini.


The vaccination day machine has already started. The Pfizer truck, writes Corriere della Sera , will enter Italy on the night between 25 and 26 escorted by the police. It will carry the first 9,750 doses of Pfizer-Biontech's vaccine.

The doses will arrive at Spallanzani, where the vaccines will be divided into 20 packs, one for each region. As early as the 27th, a limited group of health workers will be vaccinated in each region.

From January, however, we should start in a more decisive way, vaccinating at least one million health workers, and then moving on to the RSA.


The operations will be closely followed by the extraordinary Commissioner Domenico Arcuri. I will be at Spallanzani “as early as the morning of the 26th, because Pfizer has assured that the first ten thousand doses will arrive a day earlier. The load will be divided by 21 and from Rome the doses will be distributed for twenty regional presidia. The trips from the capital will be managed by the armed forces. In subsequent years, starting from January 30, Pfizer will bring the doses to the three hundred regional centers, ”Arcuri told the Fatto Quotidiano today.


In total, Arcuri added, “Italy will have 202 million doses, 13.4% of the EU. Right away from Pfizer we will have 27 million: 8.8 in the first quarter of 2021, 8.1 in the second quarter, 10.1 in the third. And the EU is negotiating with the company to get us another 13.5 million. If Ema approves Moderna on January 6, we are ready to receive 10.8 million: 1.4 in the first quarter, 4.7 in the second and as many in the third. And the EU is negotiating for another 10.8 million to arrive. So we already have the certainty of 38 million for the first three quarters: first dose and recall for 20 million Italians in nine months ". Furthermore, “to the 38 million certain vaccines of Pfizer and Moderna we must add those that the EU is negotiating with the same two pharmaceutical companies, and then the others that will arrive for approval. I trust that the 40 million doses of Astrazeneca will also arrive ”.


Yet, numbers and dates aside, the Italian one is only a symbolic departure. The real vaccination campaign seems to still have to wait. According to Il Sole 24 Ore , "of the 294 hospitals that will have the task of carrying out vaccinations, over 70 structures do not yet have super cold rooms to store vaccines at -75 degrees".

“The Regions ensure that the hospitals will be ready by 7 January, while for 6 hospitals the commissioner will supply the super-cells directly. Furthermore, the lists of vaccinating personnel who will have to deal with the inoculations of healthcare colleagues are not yet complete in various Regions. As known in the midst of this second wave, the problem is to distract doctors and nurses from their work ”, adds Il Sole.

This is a machine translation from Italian language of a post published on Start Magazine at the URL on Wed, 23 Dec 2020 11:35:07 +0000.