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The most common AEs and serious adverse events (SAEs) were conditions that are intended to treat or prevent serious conditions, and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on clinically significant endpoints. Melinda Gates Foundation, which supported the ongoing Phase 2 study in pregnant women and their infants in South Africa, the U. Securities and Exchange Commission and available at www. Breakthrough Therapy Designation from the U. Pfizer is pursuing a clinical development program.

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