• Sun. Oct 17th, 2021

Pfizer vaccine also single-dose? Leaflet, how it works, side effects

Byeditorial

May 5, 2021

Pfizer is studying a single-dose vaccine against the coronavirus. The current drug developed by Pfizer and Biontech – officially baptized as Comirnaty – is administered with two doses, as evidenced by the leaflet published on the Aifa website, at least 3 weeks apart. “We are also studying a single-dose” anti-Covid “vaccine, which could be more manageable and therefore more easily administered”, says Valentina Marino, medical director of Pfizer Italy, guest on ‘Che giorno รจ’ on Rai Radio 1. The Pfizer vaccine , in Italy, it has been administered since the end of December. “On Friday we submitted to Ema”, the European Medicines Agency, “the results of the studies” for the anti-Covid vaccine in the 12-15 year range. “Yesterday the examination of all the data began. The timing that Ema has given us is about a month, but it could be shorter. In principle, within 3-4 weeks we will also have the approval for this age group “. Pending news, currently Comirnaty – which must be stored at very low temperatures during shipment and storage after receipt – is indicated for active immunization for the prevention of Covid-19, a disease caused by the SARS-CoV-2 virus. , in individuals aged 16 years or older. The vaccine is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each) at least 21 days apart (see sections 4.4 and 5.1). The preferred site is the deltoid region of the arm. The ‘Package Leaflet: Information for the user’ explains that “like all vaccines, Comirnaty can cause side effects, although not everybody gets them. clinical studies: “The most frequent adverse reactions in subjects 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills ( > 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%). These reactions were generally mild to moderate in intensity and resolved within a few days of vaccination. A slightly lower frequency of reactogenicity reactions has been associated with an older age “. They are” very common side effects “, which” may affect more than 1 in 10 people: at the injection site: pain, swelling; fatigue; headache; muscular pain; joint pain; chills, fever “. These are” common side effects: may affect up to 1 in 10 people: redness at the injection site; nausea “. Instead, they are” uncommon side effects: may affect up to 1 in 100 people: swollen lymph nodes; feeling of malaise; pain in the limbs; insomnia; itching at the injection site “. Finally, as a rare side effect, which may” affect up to 1 in 1,000 people “is” temporary asymmetry of one side of the face “. No data are available on the interchangeability of Comirnaty with other vaccines against covid-19 to complete the vaccination course. This means that subjects who received 1 dose of Comirnaty must receive a second dose of the same product. Among general recommendations, “cases of anaphylaxis have been reported. Adequate medical care and treatment should always be readily available in the event of an anaphylactic reaction following the administration of the vaccine. “With vaccination” anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or reactions related to anxiety, may occur. stress, as a psychogenic response to needle injection. It is important that precautions are taken to avoid fainting injuries. “” Vaccination should be postponed in people with a severe acute fever or acute infection. The presence of a mild infection and / or mild fever should not lead to postponement of the vaccination “, reads again. The duration of the protection offered by the vaccine is not known; clinical trials aimed at establishing it are still underway. As with all vaccines, vaccination with Comirnaty may not protect everyone who receives it. Individuals may not be fully protected until 7 days after the second dose of the vaccine. In reaction to pregnant women, “the data related to the use of Comirnaty in pregnant women are limited in number. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Administration of Comirnaty during pregnancy should only be considered if the potential benefits outweigh the potential risks to the mother and fetus. It is not known whether Comirnaty is excreted in human milk. “Fertility chapter:” Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. “