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Cases in Florida and Texas exceed 600,000, California. Life in China, where the pandemic began, is returning to normal.
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Italy reported 1,210 new cases, at the time the number exceeded 1,000 and the highest number in the country since May 4.
Transcription
“Today I am pleased to make a historical announcement indeed in our fight against the ‘Chinese virus’ that will save countless lives: the FDA issued an emergency use authorization, and it is such a harsh term “emergency use authorization” for a remedy called convalescence plasma. It is a harsh cure that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients fighting an existing infection. At an incredible rate of good luck. Today’s action will greatly expand access to this remedy. »
The Food and Drug Administration (FDA) on Sunday legalized the emergency use of blood plasma from others who have recovered from coronavirus infections for the remedy of patients hospitalized with Covid-19.
The decision, which was delayed after major federal scientists called for a more in-depth examination of treatment, was well received by President Trump at a news convention where he said plasma was “very effective,” and that no rigorous clinical trial has proven effective. .
“This is a hard treatment that transfuses very, very strong antibodies from the blood of recovered patients to treat patients fighting an existing infection,” Trump said.
Despite the president’s approval, convalescent plasma, however promising, has not been shown in randomized clinical trials, considered to be the most productive form of treatment effectiveness.
While Trump said the new approval would “significantly expand access” to treatment, convalescent plasma can be seamlessly changed to millions of doses, such as manufactured drugs, because it is derived from blood donations.
However, many researchers have seen it as a possible bridge until a more effective remedy, or a vaccine, is available.
In a previous day with reporters, Food and Drug Administration Commissioner Dr. Stephen M. Hahn said
that data from studies conducted this year showed that the remedy was safe and had the prospect of being useful. However, he added that the firm will continue to work with researchers who read the remedy and will update the authorization if necessary.
But recruitment into randomized trials (at least ten of these studies have begun in the United States) has failed, jointly recruiting a few hundred people.
Sunday’s resolution was based mainly on an initial data investigation. Prior authorization for the use of chloroquine and hydroxychloroquine revoked on the basis of the effects of the next studies.
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The authorization includes recommendations for physicians where patients deserve to be considered. Dr. Peter Marks, director of the FDA’s Center for Biological Products, Evaluation and Research, said those who were treated “within 3 days of diagnosis, with a plasma containing the best degrees of antibodies, compared to the lowest degrees of antibodies seemed to gain more advantages from this remedy than others, and those who seemed to make the most of it were those under 80 who had no fan”.
The F.D.A. The announcement was expected to come sooner, but an intervention through the most sensible scientists, adding Dr. Anthony S. Fauci, caused a delay that appeared to have angered President Trump. In the appeal, Dr. Hahn stated that the resolution authorizing redress was taken “only on the basis of science and knowledge and not on anything else.”
At Sunday’s press conference, however, Trump gave the impression of taking a photo against scientists asking for additional studies.
“To be honest, we broke the week of stagnation,” he said.
Then, addressing Alex M. Azar II, the secretary of fitness and social services, Trump said there were other people in “his biggest department” who “saw things crumble and that wouldn’t bother me so much, that’s my opinion. Express my firm opinion, and it is for political reasons.
Trump management officials met with Congressional leaders last month and told them they were likely to give an emergency approval to a coronavirus vaccine before phase 3 clinical trials in the United States ended, in all likelihood as early as last September, according to two others. people reported on the discussion.
This resolution would be very important and would probably raise considerations as to whether management is cutting approvals for political purposes.
The two-hour assembly with Treasury Secretary Steven Mnuchin; White House chief of staff Mark Meadows; House Speaker Nancy Pelosi; and Senator Chuck Schumer, the Democratic leader, held the night of July 30 at the Pelosi convention hall.
During the discussion, those briefed on this topic stated that Meadows indicated that a vaccine evolved through AstraZeneca and Oxford University as the most likely candidate.
The planned timetable shows hopes for managing a primary victory over the pandemic before the election. It also suggests that officials expect a lot from the effects of drug trials abroad, which began before national trials.
Senior management officials disputed the narrative, saying that Mr. Meadows and Mr. Mnuchin were misrepresented or misinterpreted on each and every major issue.
The AstraZeneca-Oxford team is recently conducting Phase 2 and Phase 3 trials in the UK, Brazil and South Africa. Investigators said they expected effects until September at the earliest. Along with other pharmaceutical companies, AstraZeneca has also begun large-scale trials in the United States, starting recruiting volunteers just a few days ago.
The Food and Drug Administration requests clinical trials with U.S. patients. Before approving vaccines for use in this country.
Comments from management officials at the assembly recommend that the White House be more positive about customers of an immediate vaccine that opposes a virus that has killed 176,000 Americans than their own clinical experts.
In a briefing with reporters on August 13, Francis Collins, director of the National Institutes of Health, said it would be “surprising” if the vaccine progression progressed quickly enough for the Food and Drug Administration to approve one until the end of next month. Maybe November, December would be my bet,” he says.
Dr. Anthony S. Fauci, the infectious disease expert in the coronavirus runners group, said that early next year is the maximum possible time.
Trump’s political fate has plummeted to voters’ deep discontent at how he and his administration have treated the pandemic, which his Democratic opponent, former Vice-President Joseph R. Biden Jr., has put in the spotlight of his campaign.
A White House spokeswoman did not respond to a request for comment.
A senior management official who reported on the assembly said that neither Meadows nor Mnuchin had warned that a vaccine could be approved by the end of September. The official insisted that management would not approve a vaccine solely on the basis of clinical trials abroad.
A spokesman for Meadows denied that he had the prospects of AstraZeneca. Neither Mnuchin, according to Treasury Department spokeswoman.
President Vladimir V. Putin and officials announced this month that a billion doses of a Russian coronavirus vaccine would soon be deployed.
But if they now imagined themselves bowing to save the world, Russian fitness officers themselves on the defensive.
“Some foreign colleagues, who must have felt some festivals and competitive benefits of Russian product, have tried to make explicit reviews that we consider absolutely unfounded,” Health Minister Mikhail Murashko said at a press convention in Moscow.
Skeptics noted that the vaccine, which Russians call Sputnik V, has not been tested in the type of giant randomized controlled trials that must identify protection and efficacy. By skipping such tests, Russia can put other people in danger to earn propaganda points, fitness experts warn.
“If we seek to accept the threat of hurting many other people or giving them something that doesn’t work, we might start doing it, you know, next week if we want to,” said Dr. Anthony S Fauci, director of the National Institute of Allergy and Infectious Diseases.
Aleksandr Gintsburg, director of the Gamaleya Institute, the clinical framework that designed the vaccine, said that refusal is simply “a struggle for market share.”
The wonderful powers of the world are suffering to produce vaccines that, if successful and accepted by their own citizens and other countries, will only bring prestige but also geopolitical and economic benefits to the winner. The United States has invested billions of dollars in an effort called Operation Warp Speed.
Florida and Texas Sunday is the time and third state to exceed 600,000 reported cases since the start of the pandemic, according to a New York Times database. Both states joined California, which crossed that threshold on August 14.
Texas, with more than 5,000 cases reported in the following week, reached 600,099 cases on Sunday.
Texas and Florida, the time and the third most populous state in California, experienced an increase in infections this summer after state officials eased the blocking measures.
However, new instances in the 3 states have declined in recent weeks, and Florida recorded a 40% drop in its seven-day average from the two-week-old average. The decline in Texas less dramatic, with a decline of 22% during the same period. The minimum in the number of instances in California 7%.
However, reported deaths remain the main ones in the 3 states. Florida recorded 106 new deaths Saturday, for a total of 10,324 since the start of the pandemic. Texas recorded 167 deaths, for a total of 11650, and California counted at least 153 new deaths on August 22, for a total of 12,141.
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