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United States
Open the way to the final decision
A recommendation that opens the way to the final decision. From the United States Food and Drug Administration comes the recommendation of the expert advisory commission to authorize the distribution of the coronavirus vaccine developed by the pharmaceutical companies Pfizer and BionTech. There were 17 votes in favor in the commission, 4 against and there was only one abstention.
This is not necessarily a binding opinion, but the recommendation paves the way for authorization of the vaccine and the green light for its distribution. According to New York Times in the last hours, the authorization could also arrive on these days, perhaps even during the weekend. The benefits outweigh the risks: the text approved by the commission stands out, at least as regards people over 16 years of age.
Regarding the quantity of the first availability, the administration expects that they will be ready in the first tranche at least 2.9 million dose rates for US states The first to benefit from the vaccine will be medical and hospital staff and guests of long-term care facilities.
Nyt: “Authorization for emergency use already this weekend?”
“Saturday or Sunday already.” Pfizer BioNtech’s vaccine could receive a “full emergency use authorization” from the Food and Drug Administration starting this weekend, according to the New York Times in recent hours, citing sources close to the FDA. Although for now, FDA Commissioner Stephen Hahn said only in an interview that “the agency intends to act quickly.”
The expert committee recommendation that came in a few hours ago is actually starting the countdown to getting the vaccine. Healthcare professionals in the US right now expect to receive the first doses next week. According to the NYT, executives from Operation Warp Speed They guaranteed shipment of the vaccine within 24 hours of the FDA green light.
Australia
Stop Testing Australian Csl Vaccine Due To False HIV Positive
The bad news comes from Australia, where one of the four vaccine clinical trials in development has been abandoned due to unexpected effects. We are talking about the tests started by the University of Queensland and the biotech body Commonwealth Serum Laboratories (Csl) that halted further work after some test participants reported false positive results for the HIV virus. This failed vaccine was one of four that the Australian executive had promised to buy so much that they were already reserved. 52 million dose.
At this point, the government had to turn its attention to other vaccines with successful results. Prime Minister Scott Morrison has announced that he will increase orders for AstraZeneca and Novavax. Meanwhile, Csl has announced to the Australian Stock Exchange that it will not go any further with the second and third phase of the experiments on 216 volunteers.
In a note from Commonwealth Serum Laboratories, it is explained that the vaccine that failed tests generated additional antibodies, triggering some false-positive HIV diagnostic tests. However, the institute recommends that there is no possibility that the vaccine has caused HIV infection or other adverse health implications.
And to confirm it, several tests have been carried out. The vaccine is based on a technology called molecular clamp (molecular clamp) that uses two fragments of a protein found in HIV to hold the key part of the SARS-Cov-2 virus together, allowing the immune system to learn to recognize it.
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