On May 10, 2021 the U.S. Food and Drug Administration (“FDA”) announced that the Pfizer-BioNTech Emergency Use Authorization (“EUA”) would be expanded to include children ages 12-15. Previously, the vaccine had been approved for individuals 16 and older. The press
On Tuesday, April 27, 2021, the U.S. Centers for Disease Control and Prevention (“CDC) unveiled updated guidelines detailing activities that vaccinated people can safely resume. The guidelines continue the trend of public health authorities relaxing previous guidelines for
On April 13, 2021, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published a press release with resources, including from the Administration for Community Living (“ACL”) and the Office of the Assistant Secretary for Planning
Ever since the U.S. declaration of a public health emergency on March 13, 2020, Americans have wondered what life would look like if and when a vaccine was developed. In December, the first vaccine was administered in the U.S.
Almost eleven months after the first confirmed coronavirus patient in the State of Washington (HL Pulse post here), the first dose of Pfizer and BioNTech’s COVID-19 vaccine was administered in the U.S. to a critical care nurse a little
On December 2, 2020 the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (“MHRA”) announced approval of Pfizer and BioNTech’s coronavirus vaccine. According to a press release from the U.K. government:
This was done using a regulatory process known
On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate. Earlier this week, the companies announced that at the completion of
On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and
Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging
In an opinion that could significantly lower the threshold for proof of general causation in product liability lawsuits if adopted elsewhere, on June 21, 2017, the European Court of Justice held that a court could find a vaccine “defective” and