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 release stated that between March 1, 2020 and April 30, 2021 there were approximately 1.5 million cases of COVID-19 in children aged 11 to 17. In March, Pfizer announced that the vaccine showed 100% efficacy in children aged 12-15. Pfizer also announced that they were beginning a global Phase 1/2/3 study for children aged six months to 11 years old. On the same day, Novavax announced it would delay seeking regulatory approval for its COVID-19 vaccine until the third quarter of the year. The company expects to be producing 150 million doses per month in the fourth quarter of 2021.
In contrast to the positive vaccine news, the World Health Organization (“WHO”) classified the triple-mutant COVID variant, B.1.617 present in India as a “variant of concern.” The WHO stated that early studies show that the variant may spread easier than other COVID-19 variations. On May 10, 2021, India reported over 366,000 new cases of COVID-19. The variant has spread to over 30 countries, including the United States, United Kingdom, France, and Japan. According to the WHO COVID-19 dashboard, as of May 11, 2021, there have been over 158 million cases of COVID-19 worldwide, and over 1.2 billion doses of COVID-19 vaccines have been administered.
Norton Rose Fulbright lawyers will continue to provide relevant updates on the COVID-19 PHE on the Health Law Pulse.