Experts from the drug regulatory agency will examine the conclusions of clinical studies of the formula, which cover 38 thousand patients
Experts from the United States drug agency (FDA) considered in a report published on Tuesday that the vaccine against covid-19 from the laboratories Pfizer and BioNTech does not present safety risks, so everything seems to be aimed at regulators give the green light to the formula, which has already been approved by the British authorities.
Safety data from 38,000 of the participants in the clinical trial, with a mean follow-up of two months after the second dose, “suggest a favourable safety profile, without identifying specific safety issues preventing” authorization, the authors wrote. experts.
Thursday’s meeting will last several hours and will bring together numerous scientific experts to analyze the data available to the public, which are summarized in these points.
-The benefits of the vaccine (immunization) begin to be noticed 14 days after the first dose is applied, even a few days before, a period in which the body produces antibodies against the virus.
-After the first dose, the efficacy is around 52%, which is very positive for a single amount. However, experts warn that this protection could decline over time, so the second dose would be necessary to strengthen the system.
-After the second dose (applied 21 days later), the efficacy goes to 95%, a figure well above the expectations of the scientific community. The study is still in development, and the estimated range is 90-98%.
-The efficacy figures did not have a significant variation between the groups of different ages, races or comorbidities.
-Generally speaking, the Pfizer vaccine produces more adverse effects than a flu vaccine, but less than the chickenpox formula, for example.
-The most common were injection site reactions (84%), fatigue (63%), headache (55%), muscle pain (38%), chills (32%), joint pain ( 24%) and fever (14%).
-However, the chances of severe reactions were low, around 0.5%, being more likely after the second dose, and very rare among older adults.
-Among the unexpected symptoms, dozens of patients reported inflammation of the glands of the immune system (adenopathy)
-Four patients suffered from Bell’s palsy (a sudden weakness in the muscles on one side of the face that can be caused by a reaction to a viral infection). The proportion is similar to that found in the general population, so for now, it is something that requires attention, but not a cause of special concern.
-Six people died: four of them received placebos, and two of them were in the formula group, but no death has so far been linked to the vaccine.
Unknowns to be solved
-How long does the immunization last? It is an issue that will not be resolved this Thursday or in the next few days, but with the monitoring of patients over the months or, in the best of cases, over the years.
-Effectiveness against transmission. The fact that a person is protected does not necessarily imply that they cannot transmit the virus, a key issue epidemiologically.
-Efficacy and safety in non-evaluated groups. The clinical study did not include children under 16 years of age, pregnant women, or immunocompromised patients, so it is likely that the FDA will not include them in the emergency authorization.
-What effect does it have on a person who has already had coronavirus? It may have benefits to your system, with possible antibody boost, but the difference between “natural” and “artificial” immunization is not clear.