A safe vaccine to fight against coronavirus… This is what a report guarantees this Tuesday December 8, 2020. This report was written by the FDA – the Food & Drug Administration – about the product developed by the Pfizer and BioNTech laboratories, after unveiling results from the first safety data focusing on 38,000 volunteers from the clinical trial “with median follow-up of 2 months”.
Data that “suggest a favorable safety profile, with no specific safety concerns identified that would preclude” emergency issuance, the FDA explains. As for the most common side-effects, the report from the Food & Drug Administration reads they noticed, out of 43,000 people (including children and teenagers over 12 years old), injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%).
The report also reads that between 0 and 4.6% of the volunteers taking part in the clinical trial developed severe reactions, less common in volunteers aged 55+. As for serious adverse events leading to hospitalization, they remain exceptional, below 0.5%, “without meaningful imbalances between study arms”.
The FDA also explains the vaccine is 95% effective for sure and has a meaningful effect from the first dose, even for those that already caught the virus, “although available data for these outcomes did not allow for firm conclusions”.
As for the definitive approval for issuance, the Food & Drug Administration is expected to deliver an answer on Thursday December 10 during a meeting of the committee. Issuance yet seems to be on the right track.
