Pfizer will submit an emergency use authorization for their coronavirus disease 2019 (COVID-19) vaccine; WHO panel recommends against remdesivir; CDC urges Americans to stay put during Thanksgiving.
Pfizer and BioNTech will submit to the FDA today for an emergency use authorization (EUA) of their coronavirus disease 2019 (COVID-19) vaccine, CNN reports, making the companies the first to seek such an approval in the United States. The announcement comes on the heels of data reports showing the vaccine is 95% effective among those who developed at least 1 symptom of COVID-19. The finding was based on a nearly 44,000-person trial, which found no serious safety issues with the immunization. The EUA submission will also include safety data on about 100 children aged 12 to 15. Roughly 43% of global trial participants and 30% of US participants have racially diverse backgrounds. According to the companies, the vaccine could be available for high-risk US populations by the middle to end of December.
A WHO panel is recommending against the use of remdesivir in hospitalized patients with COVID-19, STAT News reports. The drug, manufactured by Gilead Sciences, was the first COVID-19 treatment approved by the FDA back in October. The WHO’s Guideline Development Group stated there is no evidence remdesivir improves mortality in those infected or has a meaningful effect on whether patients need to be put on ventilators. The new recommendations are based on currently available data and panelists noted the certainty of the evidence was low. In the early days of the pandemic, hopes around the drug’s potential increased as lab experiments had previously shown it was effective against other coronavirus infections.
Amid national spikes in COVID-19 cases and hospitalizations, the CDC is urging Americans to stay home for the upcoming Thanksgiving holiday and to avoid mingling with people who have not resided in their household in the past 14 days, Politico reports. The new recommendations, announced during the agency’s first press briefing since October, could include college students returning home for the holidays. CDC officials recommend wearing masks and observing social distancing at gatherings in addition to making guests use separate bathrooms if possible. This week, the number of COVID-19 cases in the United States surpassed 11 million, prompting alarm among CDC officials, who worry things could get worse during the upcoming holiday season.