Adverse Reactions To Pfizer Vaccine Weaken Case For India Trial Waiver
Indian regulator is likely to ask Pfizer/BioNTech to conduct clinical trials before granting an accelerated approval, but recruitment could prove challenging for the COVID-19 vaccine as anaphylactic reactions in the US and UK sparks worry.
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Which vaccines will India use for immunizing its 1.35 billion population against COVID-19? Where will the money come from? Will it allow sales of these vaccines in the market? As the world’s largest democracy gets set to roll out its immunization plan, here’s a look at a few pertinent questions.
Agency could revisit contraindications and warnings regarding allergic reactions and anaphylaxis management depending upon what it hears from the MHRA; FDA and Pfizer say there was no signal for severe allergic reactions in the Phase III trial, but advisory committee member Paul Offit suggests a dedicated study is needed.
Individuals with history of significant allergic reactions are now being told not to have the vaccine after warnings were not included in healthcare professional information.