Het Amerikaanse FDA heeft op 10.12.2020 een 56p. rapport vrij gegeven omtrent het Pfizer BioNtech vaccin waarin zij het volgende stelt:
8.3. Known Risks The vaccine has been shown to elicit increased local and systemic adverse reactions as compared to those in the placebo arm, usually lasting a few days.
The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%). Adverse reactions characterized as reactogenicity were generally mild to moderate. The number of subjects reporting hypersensitivity-related adverse events was numerically higher in the vaccine group compared with the placebo group (137 [0.63%] vs. 111 [0.51%]).
Severe adverse reactions occurred in 0.0-4.6% of participants, were more frequent after Dose 2 than after Dose 1 and were generally less frequent in older adults (>55 years of age) (<2.8%) as compared to younger participants (≤4.6%). Among reported unsolicited adverse events, lymphadenopathy occurred much more frequently in the vaccine group than the placebo group and is plausibly related to vaccination. Serious adverse events, while uncommon (<1.0%), represented medical events that occur in the general population at similar frequency as observed in the study. Three SAEs in the BNT162b2 group were considered related by the investigator, but not the Sponsor, as related to study vaccination: shoulder injury (n=1), ventricular arrhythmia in a participant with known cardiac conditions (n=1), and lymphadenopathy temporally related following vaccination (n=1).
We considered two of the events as possibly related to vaccine: the shoulder injury possibly due to vaccine administration or the vaccine itself and lymphadenopathy. Lymphadenopathy was temporally associated and biologically plausible.
8.4. Unknown Risks/Data Gaps Safety in certain subpopulations. There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.
Adverse reactions that are very uncommon or that require longer follow-up to be detected.Following authorization of the vaccine, use in large numbers of individuals may reveal additional, potentially less frequent and/or more serious adverse events not detected in the trial safety population of nearly 44,000 participants over the period of follow up at this time. Active and passive safety surveillance will continue during the post authorization period to detect new safety signals."
Het Pfizer vaccin is nog niet goedgekeurd in Europa.
Het is nog in onderzoek bij het EMA dat aangekondigd heeft dat haar rapport rond 29.12.2020 zal klaar zijn.
Pfizer zelve heeft haar grote wetenschappelijke studie nog niet gepubliceerd.
Alles wat we weten is dixit een van de experten (zie eerdere post) gebaseerd op... de persberichten die Pfizer de wereld in gestuurd heeft.
Maar toch ... wil Vandenbroucke al op 27.12.2020 beginnen met de vaccinatie???
(ofwel 10 dagen vroeger dan eerder aangekondigd en VOOR dat het EMA haar rapport goedgekeurd heeft??)
Euhhhh....??? Kan de minister deze overhaaste beslissing even uitleggen?