According to a report from Center for Infectious Disease Research and Policy (CIDRAP), the United States reported 63,610 new COVID-19 cases, with 820 new deaths, according to the Johns Hopkins COVID-19 dashboard.
It's the first time since August 1 that the nation has recorded more than 60,000 new infections in a single day. The overall number of new daily infections has been climbing since mid-September, and the national seven-day moving average of new cases is at 53,400.
The US total is now 8,216,723 cases, with 220,150 deaths and there are 40,485,384 cases worldwide with 1,119,545 global deaths, according to the Johns Hopkins COVID-19 dashboard.
The impact of the rise in new cases is reflected in the country's hospitalization numbers. Data from the COVID Tracking Project show that 37,308 people are currently hospitalized with COVID-19, up from 28,608 on September 28. Throughout the pandemic, COVID-19 hospitalizations have typically started rising a few weeks after increases in new infections.
Among the states where hospitals are starting to feel the strain is Wisconsin, where COVID-19 hospitalizations yesterday hit an all-time high of 1,043, with 264 people in intensive care units (ICUs), according to the Milwaukee Journal Sentinel. State health officials told the paper that ICUs across the state are more than 90 percent full, and hospitals in every region are reporting current or imminent staffing shortages.
In a letter posted on the company's website, Pfizer Chairman and CEO Albert Bourla, DVM, said that, because the US Food and Drug Administration (FDA) is requiring companies to provide two months of vaccine safety data on half of the phase 3 trial participants following final dose of the vaccine, the earliest the company could apply for Emergency Use Authorization (EUA) is the third week of November.
Bourla, who has said in recent months that Pfizer will know by the end of October whether the vaccine is effective, said effectiveness would satisfy only one of the requirements of an EUA application. In addition to safety data, the company also has to show manufacturing data that demonstrate the quality and consistency of the vaccine that will be produced.
The vaccine from Pfizer and German biopharmaceutical company BioNTech is one of several in phase 3 trials and has widely been viewed as having the potential to be the first COVID-19 vaccine to be granted an EUA or approved. The late-stage trials of vaccine candidates from AstraZeneca and Johnson & Johnson are currently on hold due to adverse events among trial participants.
Although the FDA requirement that vaccine makers provide a median two months of follow-up data after completion of the full vaccine regimen received pushback from the White House, in early October FDA officials went ahead and included the requirement in guidance published on the FDA website.
