Experts from the US Food and Drug Administration (FDA) estimate in a report released today that the Pfizer and BioNTech vaccine against Covid-19 did not present a security risk that would impede its approval, which could be decided by the end of the week.
Safety data from 38.000 participants in a two-month mid-term vaccine clinical trial "suggest a favorable safety profile, without identifying a specific safety issue that would impede" the emergency permit, FDA experts wrote in a two-day report. before a public meeting of the Vaccine Service Advisory Committee.
The most common side effects were the following in 43.252 participants, including children and adolescents 12 years of age and older: reactions around the injection site (84,1%), fatigue (62,9%), headache (55,1%). ), myalgias (38,3%), chills (31,9%), joint pain (23,6%), fever (14,2%).
Severe reactions occurred in 0 to 4,6% of participants and were less common in people over 55 (2,8%) than in young people (4,6%).
Serious side effects, ie requiring hospitalization, were very rare throughout the clinical trial (less than 0,5%) and were present in both the placebo group and the vaccinated group, suggesting that the vaccine was not had a relationship.
In addition to the non-serious side effects in people under the age of 55, no doubt due to the fact that the immune system of younger people is generally more active, the FDA notes that the vaccine, BNT162b2, is safe regardless of age, gender, nationality. or the initial presence of pathologies.
In terms of efficacy, the FDA confirms the very high level of efficacy of the vaccine at 95%, which was announced by Pfizer and BioNTech.
A new element emerged in this analysis: the vaccine seems to be not only very effective in preventing severe forms of Covid-19 after two doses, but also in its prevention Covid-19 after the first dose, as well as in those who had been infected before the coronavirus, "although the available data on these results do not allow definitive conclusions".
The FDA expects to wait for the committee meeting on Thursday before deciding whether or not to approve the vaccine, which has already been approved in Britain and other countries.
Source: newsbeast.gr