Record of cases, hospitalization and deaths from covid-19 before meeting on Moderna vaccine



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(CNN) – The United States reported record numbers of COVID-19 cases, hospitalizations and deaths on Wednesday, ahead of a key meeting for what could be the country’s second COVID-19 vaccine to get the green light.

Vaccine advisers from the Food and Drug Administration (FDA) will meet Thursday to discuss Moderna’s vaccine and officials expect a swift emergency use authorization process, even faster than last week for the vaccine. from Pfizer.

Hundreds of American healthcare workers have received their first dose of the Pfizer vaccine, and many states have announced that they also expect vaccinations for nursing home residents to begin this week. And on Wednesday, the FDA said that people who administer that vaccine can squeeze extra doses out of the vials if there is leftover solution in them after giving the five standard doses.

Politico was the first to report that some pharmacists found that they could get six, and possibly seven, doses of vaccine from the vials, each of which is designed to provide five doses of vaccine. An FDA spokeswoman told CNN that the agency was aware of the issue and “was working with Pfizer to determine the best way forward.”

“At this time, given the public health emergency, the FDA advises that it is acceptable to use every obtainable full dose (the sixth, or possibly up to the seventh) from each vial, pending resolution of the matter,” he said. the spokeswoman. “However, since the vials do not contain preservatives, it is critical to note that any remaining product that does not constitute a full dose should not be combined from multiple vials to create one.

More than 2.9 million doses were assigned to states for the first doses of the Pfizer vaccine, according to a list released Wednesday by the Centers for Disease Control and Prevention (CDC). Another more than 2.9 million will be available for second doses about 21 days later.

The first shots and a possible green light for Moderna are all good news. But the pandemic ravaging the United States is still far from over and is more brutal than ever.

Disappointing numbers were recorded everywhere on Wednesday: the highest covid-19 infections and deaths ever reported in a single day, and the highest number of covid-19 hospitalizations the country has seen since the start of the pandemic.

More than 247,000 new cases were reported. More than 113,000 Americans are hospitalized with the virus, according to COVID monitoring project. And more than 3,600 deaths were added to the death toll in the country.

‘Still in a dangerous and critical part’ of the pandemic

While there has been some progress in slowing the spread of the virus in the northern and central US, according to the White House coronavirus task force, cases continue to rise in the most populous states.

“Stabilization in the Northern Plains, Upper Midwest, and some Rocky Mountain states and the heartland of the US is being offset by significant deterioration in the most populous states (82% of the population),” according to the reports sent to the states by the task force and obtained by CNN.

And now, Americans have big decisions to make: The upcoming vacation could help fuel another surge in cases, hospitalizations and, inevitably, deaths, if people choose to travel and meet again. Despite a CDC warning before Thanksgiving urging not to travel, more than four million spent the holidays away from home.

In California, where Los Angeles County health officials continue to report a dizzying number of cases, the director of health services, Dr. Christina Ghaly, attributed the increase to residents who gathered during the Thanksgiving break. despite repeated pleas to stay home.

And the worst is yet to come, Ghaly added, saying “we’re still in for a very tough few weeks at least, and potentially into January.”

Governors across the Northeast and Midwest released a video message this week encouraging residents to “double down” security measures and reconsider their vacation plans.

“If you are planning to travel or meet with other households for the holidays, we urge you to reconsider,” the governors said. “A single infection can cause an outbreak in your community, which could overwhelm our hospitals and put you and your loved ones at risk.”

Hoping to help curb the spread during the holidays, El Paso County Judge Ricardo Samaniego announced curfews from 10 p.m. to 5 a.m. during December 23 to December 26 and December 30 to January 4th.

“What people need to know is: we are still in a dangerous and critical part of this pandemic, and tens of thousands of American lives are at stake,” said Admiral Brett Giroir, deputy secretary of health for the Department of Health and Services. Humans.

“If you can avoid traveling, it is a good measure,” he added.

More covid-19 tests were authorized at home

Meanwhile, the FDA also issued an emergency use authorization Wednesday for another covid-19 home test, Abbott’s BinaxNOW Covid-19 Ag Card home test.

The test is licensed for ‘home prescription use with self-collected nasal swab samples from people 15 years of age or older who are suspected of having COVID-19 by their healthcare provider within the first seven days of the appearance of the symptoms, “the agency said in a statement. Adults can take samples for younger children.

Abbott has said that the new test will cost $ 25.

“The FDA continues to authorize COVID-19 tests that will give more Americans access to greater flexibility and testing options,” FDA Commissioner Stephen Hahn said in a statement.

That comes a day after the FDA also granted emergency use authorization to a $ 30 over-the-counter test made by Ellume that people can take home and do themselves.

On Wednesday, Giroir said there will probably be more good news from the FDA soon about “other home tests that are not exactly the OTC type but are in the same ballpark.”

“You will see that more and more tests are authorized, and then they will increase very soon in the first part of the year,” he added.

LEEWARD: Who should get the Covid-19 vaccine (and who shouldn’t)?

FDA investigates allergic reaction to vaccine

The FDA is also investigating an allergic reaction suffered by an Alaskan healthcare worker who, according to doctors, received the Pfizer vaccine on Tuesday and felt flushed within 10 minutes, then reported symptoms including shortness of breath and rapid frequency. cardiac.

The case is the first allergic reaction to the vaccine to be reported in the U.S., but officials say they expect an occasional reaction and are prepared to treat anyone with it.

The health worker, a middle-aged woman, had no known history of a severe allergic reaction to vaccines, her doctors said Wednesday.

“About one in a million people who receive a vaccine may have a severe allergic reaction to the vaccine,” Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, told CNN. “What we have to find out is what specifically seems to be inducing this allergic reaction.”

The case is something that health officials should investigate, Offit said.

“Currently, the CDC recommendation is that if you have ever had a severe allergic reaction to an injectable medical product, you should not receive this vaccine,” he said. “If you have a history of severe allergic reactions, what you should do is get vaccinated, but you must wait 30 minutes in the area to make sure you can get the epinephrine injection that will make those symptoms disappear.

“If you have never had a severe allergic reaction, you should wait 15 minutes for the same reason.”

CNN’s Maggie Fox, Jacqueline Howard, Raja Razek, and Andrea Diaz contributed to this report.



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