Pfizer Inc. said that on Tuesday, participants were seeing either mild-to-moderate side effects in an ongoing late-stage study in the company’s experimental coronavirus vaccine or placebo.
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The company said in a presentation to investors that side effects include fatigue, headaches, chills and muscle aches. Some participants in the trial also developed fever – including some high fever. The data have been blinded, meaning that Pfizer does not know which patients have received the vaccine or placebo.
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Pfizer’s head of vaccine research and development, Catherine Janssen, stressed that the independent data monitoring committee “has access to ambiguous data, so they will inform us if they have any security concerns and have not done so to date.”
The company has enrolled more than 29,000 people in its 44,000-volunteer trial, developing it with German partner BioNTech to experimentally test the COVID-19 vaccine.
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More than 12,000 study participants had received a second dose of the vaccine, Pfizer officials said on an investor conference call.
Rival AstraZeneca’s COVID-19 vaccine is being tested worldwide on 6 September after a volunteer in the UK reported serious side effects.
AstraZeneca’s trial resumed in the UK and Brazil on Monday following a green light from British regulators, but remained on hold in the United States.
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Pfizer expects the results to be in place as to whether the vaccine works in October.
“We believe – also very strong immune profile and preclinical profile … that vaccine efficacy is likely to be 60% or more,” said Pfizer’s chief scientific officer, Mikel Dolston.
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