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United States surpasses 8 million COVID-19 cases

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The United States has surpassed 8 million confirmed cases of COVID-19 today since the start of the pandemic, as a new wave of infections in the Midwest and West brings the number of daily cases down to lows. levels never seen since the peak days of July and early August.

The United States reported 63,610 new cases of COVID-19 yesterday, with 820 new deaths, according to the Johns Hopkins COVID-19 Dashboard. This is the first time since August 1 that the country has recorded more than 60,000 new infections in a single day. The total number of new daily infections has been increasing since mid-September and the national 7-day moving average of new cases is 53,400.

The impact of the increase in new cases is reflected in the number of hospitalizations in the country. Data from the COVID Tracking Project shows that 37,308 people are currently hospitalized with COVID-19, up from 28,608 on September 28. Throughout the pandemic, COVID-19 hospitalizations typically began to increase within weeks of the increase in new infections.

Among the states where hospitals are starting to feel the strain is Wisconsin, where COVID-19-related 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 newspaper that the state’s intensive care units are over 90% full and that hospitals in every region are reporting current or imminent staff shortages.

Elsewhere in the country, Indiana health officials say COVID-19 hospitalizations have reached their highest level since May, and the Kansas City Star reports that some Kansas City area hospitals are refusing ambulances with COVID-19 patients because their beds are already full. Missouri and Kansas are seeing increases in COVID-19 cases and hospitalizations.

“I have to ask people to keep doing, or start doing, what we know it takes to mitigate the spread of this disease,” Kansas governess Laura Kelly said at a conference. press earlier this week.

Pfizer says it won’t seek vaccine clearance until November

Meanwhile, news from drugmaker Pfizer today indicates that emergency authorization of a COVID-19 vaccine before election day, an idea that has been pushed repeatedly by President Donald Trump is unlikely.

In a letter posted on the company’s website, Pfizer Chairman and CEO Albert Bourla, DVM, said that because the Food and Drug Administration (FDA) is asking companies to provide 2 months of data on the vaccine safety on half of the participants in the Phase 3 trial after the final dose of the vaccine, the first time the company could apply for an 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 its effectiveness would only meet one of the requirements of an EUA application. In addition to safety data, the company must also present manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced.

“So let me be clear, assuming positive data, Pfizer will apply for emergency use authorization in the United States shortly after the safety milestone is reached in the third week of November,” said Bourla.

The vaccine from Pfizer and German biopharmaceutical company BioNTech is one of many Phase 3 trials, and has been widely seen as having the potential to be the first COVID-19 vaccine to be granted an EUA or be approved. The late stage trials of AstraZeneca and Johnson & Johnson vaccine candidates are currently on hold due to adverse events among trial participants.

Although the FDA’s requirement that vaccine manufacturers provide a median of 2 months of follow-up data after the completion of the full vaccination schedule was pushed back by the White House in early October, FDA officials continued. and have included this requirement in guidelines posted on the FDA website. In an editorial published today in the New England Journal of Medicine, FDA officials defended their decision to require 2 months of data.

“From a safety perspective, a median follow-up of 2 months (meaning that at least half of those vaccinated in clinical trials have at least 2 months of follow-up) after completion of the full vaccination schedule will allow ‘identify potential adverse events that were not apparent in the immediate post-vaccination period and will also provide greater confidence in their absence, if none are observed, “wrote Philip Krause, MD, and Marion Gruber, PhD , FDA Office of Vaccine Research and Review.

Krause and Gruber said the 2-month follow-up data could also provide more information on the length of protection offered by a COVID-19 vaccine.

“Although 2 months of follow-up is insufficient to fully assess the duration of vaccine protection, a substantial decline in protective responses may begin to manifest during the second month,” they wrote. “So a median of 2 months is the shortest follow-up period needed to achieve some confidence that any protection against Covid-19 is likely to be more than very short.”

As the country waits for news on a potential COVID-19 vaccine, state health officials are rushing to submit plans to the federal government on how they will distribute a vaccine once it’s approved, reports National Public Radio. The deadline for the first draft of these plans is today.

Also today, the Trump administration announced an agreement with drugstore chains CVS and Walgreens to administer a future COVID-19 vaccine free of charge to seniors and nursing home staff, the Associated Press reported. As part of the program, trained staff from CVS and Walgreens would deliver and administer the injections.

Racial disparities from COVID-19 persist

In other American developments:

Data released today by the Centers for Disease Control and Prevention in its Weekly Morbidity and Mortality Report shows that blacks and American Hispanics continue to be disproportionately represented in deaths associated with COVID-19. Analysis of 114,411 deaths recorded from May to August in 50 states and the District of Columbia found that 51.3% were among non-Hispanic whites, 24.2% were Hispanic or Latin American, and 18.7% were non-Hispanic blacks. Hispanics make up 18.5 percent of the U.S. population, while non-Hispanic blacks make up 12.5 percent. Treasury Secretary Steven Mnuchin has accepted House Democrats’ requests to include a national coronavirus testing strategy in a broader coronavirus relief program, according to the Wall Street Journal. But the aid package, which is approaching $ 2 trillion, still faces opposition from Senate Republicans, many of whom believe it is too expensive. Former New Jersey Gov. Chris Christie, who has recently released from hospital after spending 7 days in intensive care with COVID-19, said in a statement yesterday that Americans should take the coronavirus very seriously. “No one should be happy to catch the virus and no one should be a horse rider to get infected or infect other people,” he said. Christie also said he regretted not wearing a mask at the Sept. 26 rose garden ceremony for Judge Amy Coney Barrett or several pre-debate sessions with President Trump.

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