Pfizer-BioNTech coronavirus vaccine has been approved in the United States

Pfizer-BioNTech coronavirus vaccine has been approved in the United States

The use in emergency has just been authorized by the FDA and in the meantime the first results of the last phase of the experiment have arrived. Here's what the clinical studies say are published in the New England Journal of Medicine

(photo: Getty Images) The Food and Drug Administration has just authorized the Pfizer-BioNTech vaccine for emergency use in the United States. With this decision, the US becomes the sixth country, in addition to the United Kingdom, Bahrain, Canada, Saudi Arabia and Mexico, to start the administration thanks to the approval of the regulatory agencies. The first doses of the vaccine, about 2.9 million, will arrive in the US next week. The response of the European Medicines Agency is now awaited, which would open the doors to this vaccine also in Europe. What do we know about this vaccine?

In the fall of 2020, the announcements of the pharmaceutical companies of new effective or very effective vaccines against Covid-19 followed one after the other without stopping. But until a few days ago, we didn't have much data from peer reviewed and published clinical studies. Today, however, these data are arriving and, almost in conjunction with the approval in the first countries, we have seen the results of phase 3 clinical trials - the last stage of the experimentation - of the Pfizer-Biontech vaccine published in the New England Journal of Medicine. (but also that of Oxford-Astrazeneca, published in Lancet). In short, we can finally talk with information in hand.

The results of clinical trials on the Pfizer-Biontech vaccine

The results published in the Nejm confirm that the efficacy of the Pfizer-Biontech vaccine, in acronym BNT162b2, in protecting against the symptoms of Covid -19 is 95%, with a range between 90.3% and 97.6%. To study the vaccine, the researchers involved more than 43,000 volunteers, half of whom received the vaccination and the other half a placebo. The incidence of serious adverse reactions was low and comparable between those who received the vaccine and those who received the placebo. Among the short-lasting reactions there were mild or moderate pain at the injection site, fatigue and headache. There have been 170 cases of Covid-19, including 162 in people given placebo - and in all 10 severe cases, including 9 in the placebo group. This vaccine has recently been discussed in the case of the two anaphylactic reactions in the United Kingdom - a country that has already started to administer it - even if there is still not enough data on what triggered the reaction (like many drugs, the vaccine also contains preservatives ) and how to interpret this data.