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What actions will Pfizer and BioNTech take in response to the batch-dependent safety signal findings by end of 2024?
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Resolution / Starting Odds
Recall of early batches • 25%
Modification of production process • 25%
Increased monitoring/reporting • 25%
No significant action taken • 25%
Official statements, press releases, or news reports
Story
Study Finds Batch-Dependent Safety Signal in BNT162b2 Vaccine Using Swedish Data, SAE Rate 1 in 800
Aug 19, 2024, 12:32 PM
A recent study has replicated findings from Danish data using Swedish data, indicating a batch-dependent safety signal for the BNT162b2 vaccine, developed by Pfizer and BioNTech. The study suggests that early commercial batches may have differed from those used later, resulting in more severe adverse events (SAE) in earlier batches, with an SAE rate of 1 in 800. The replication of these findings calls for further investigation into the causes of these differences. Reporting of adverse events, particularly by healthcare professionals, was notably low in Sweden.
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No issues found • 25%
Minor issues found • 25%
Moderate issues found • 25%
Severe issues found • 25%
No response • 25%
Denial of contamination claims • 25%
Acknowledgement of contamination and corrective measures • 25%
Legal action against claimants • 25%
Acknowledge and propose further studies • 25%
Deny correlation and defend vaccine safety • 25%
Announce new vaccine formulations • 25%
No official response • 25%
Partnership with another company • 25%
Focus on different vaccine candidates • 25%
Continue with current strategy • 25%
Other strategic response • 25%
New regulations on mRNA vaccines • 25%
Public health advisory • 25%
No action taken • 25%
Further studies commissioned • 25%
No significant contamination found • 25%
Contamination confirmed, no recall • 25%
Contamination confirmed, recall issued • 25%
Investigation inconclusive • 25%
Warning issued • 25%
Recall issued • 25%
Investigation initiated • 25%
No action taken • 25%
Elements confirmed and deemed unsafe • 25%
Elements confirmed but deemed safe • 25%
Elements not confirmed • 25%
Investigation inconclusive • 25%
