The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.
Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.
The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.
Alex Azar, Health and Human Services Secretary:
“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said Secretary Azar. “The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far. We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma.”
Stephen M. Hahn, M.D., FDA Commissioner:
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
Scientific Evidence on Convalescent Plasma
Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.
The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.
The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence.
Terms of EUA
The EUA requires that fact sheets providing important information about using COVID-19 convalescent plasma in treating COVID-19 be made available to health care providers and patients, including dosing instructions and potential side effects. Possible side effects of COVID-19 convalescent plasma include allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.
Mayo Clinic Expanded Access Program
The FDA initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications.
An Expanded Access ProgramExternal Link Disclaimer for convalescent plasma was initiated in early April to fill an urgent need to provide patient access to a medical product of possible benefit during a time that the FDA was working with researchers to facilitate the initiation of randomized clinical trials to study convalescent plasma. As the number of single patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date, the program has facilitated the infusion of over 70,000 patients with convalescent plasma.
The EUA was issued to the HHS Office of the Assistant Secretary for Preparedness and Response.
The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The Russian President Vladimir Putin has launched a coronavirus vaccine amid the global race to develop and distribute it. The world’s first vaccine comes even with the final stages of clinical trials to test efficiency and safety still going on.
The announcement came in the wake of the Covid-19 pandemic that has infected more than 20 million people and killed around 0.75 million people all over the world. It has also resulted in crippling world economies.
The Russian vaccine has been developed by the Gamaleya Institute in Moscow. The vaccine uses two strains of adenovirus that is known to cause mild cold in humans. Adenovirus vaccine is under trial in many other countries as well. The strains are genetically modified which can cause infected cells to create proteins from the spike of the coronavirus. This is a similar approach to a vaccine under development by AstraZeneca and Oxford University.
As per reports, Russia has dubbed the newly created vaccine “Sputnik V” after its Soviet satellite. Kirill Dmitriev, who is the head of the Russian Direct Investment Fund, an organization responsible for financing the vaccine project, announced that the Phase 3 trials would start by Wednesday. This means that mass production can be expected from September. He also mentioned that around 20 countries have already pre-ordered more than a billion doses.
Putin thanked everyone who has worked on the vaccine’s development and mentioned that this is a very important step for the world. He also hopes that the country’s research body should start the mass production of the vaccine very soon.
When talking about the vaccine, Putin mentions that it works effectively, helps build strong immunity, and has passed all the needed checks. He also added that one of his two daughters have received a shot of the vaccine and is doing well.
The CEO & Chief Architect of Dokat, Inc, Ram Chella led a team to devise a fully Made in India Deep UV-C Air Sanitizer called as ‘Dokat Air’. This product has better germ-killing efficiency than any air purifier in the market because of its ‘Deep UV germicidal irradiation technology’ that helps to make indoors safer for people by killing disease-causing germs from the air.
It's a patent-pending novel product that can sanitize 1000-cubic feet of air within 15 minutes killing 99.99% germs. It's capable of killing various kinds of bacteria, viruses & molds like SARS, MERS, COVID-19, SARS-CoV-2 & Influenza Virus. The UV-C ray penetrates the cell of the micro-organisms and kills them by breaking their DNA. Having met international regulatory standards like ISO 9000:2015, FCC (US standard for electronic products) and European CE, this product helps in giving us an effective and efficient disinfecting solution to face the ongoing pandemic along with other numerous airborne diseases. This product is different from the regular air purifiers as it kills various kinds of disease-causing micro-organisms while filtering the air too. Regular air purifiers do not kill germs this well, instead, increases the germs’ spread. Here, comes the need for such a device that can sanitize the air while filtering pollutants along with.
Dokat-Air’s 100% UV leak proof ‘Germ Squash’ chamber uses the most effective broad-spectrum UV-C light and when the air passes through, it gives an optimal flow with maximum germicidal exposure, therefore making it better than the traditional UV-C technology.
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New research conducted by scientists from various US based universities like Harvard University, University of Nebraska Medical Center, University of Illinois at Urbana-Champaign concluded that SARS-CoV-2 (novel coronavirus) RNA exists in respired aerosols less than 5 μm in diameter; that aerosols containing SARS-CoV-2 RNA exist in particle modes that are produced during respiration, vocalization, and coughing.
This study sought to characterize the presence of SARS-CoV-2 in particles consistent with the potential to result in aerosol transmission between patients. Although not all particles measured by the Aerodynamic Particle Sizer Spectrometer (APS) may be attributable to patient extrusions, increases in particle count while measurements were being taken using the APS were anecdotally observed to occur when patients were talking and coughing.
The aerosol modes observed in this study were compared to those from previous observations of human aerosol production during respiratory activities. The small aerosol mode, with a mean diameter between 0.64 and 0.80, is consistent with particles found in exhaled breath in previous studies. This mode of aerosol was observed in all manner of human respiration including breathing, vocalization and coughing and has been attributed to particles produced deep in the bronchial region, referred to as the Bronchiolar Fluid Film Burst (BFFB) mechanisms. Particles in the larger modes observed in this study are more consistent with those produced in the larynx during vocalization and coughing.
As per this finding, observation of fine mode aerosol particles containing infectious SARS-CoV-2 particles leads to several general observations about the potential transmission of SARS-CoV-2. The results of this study, along with the evidence of the stability of SARS-CoV-2 in aerosol and that SARS-CoV-2 infects respiratory tissue provide indications that SARS-CoV-2 may be transmitted via the airborne route.
The results were published in medRxiv on 21st July, 2020.
This study supports the use of efficient respiratory protection and airborne isolation precautions to protect from exposure to fine SARS-CoV-2 aerosol when interacting with infected individuals, regardless of symptoms or medical procedure being performed.
Mylan, a global pharmaceutical company announced the commercial launch of its Remdesivir under the brand name DESREM™ in India to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The company also launched a 24/7 helpline where patients and healthcare practitioners can access information about Mylan’s Remdesivir and its availability.
Mylan released the first batch of its generic Remdesivir (DESREM™) and will continue to increase its supply across the country in the wake of the rising demand for the drug.
Mylan will manufacture DESREM™ in its state-of-the-art injectable facility in Bangalore, which will work to service the demand in India and other export markets where Mylan has received a license from Gilead for the commercialization of Remdesivir. The previously announced agreement between Mylan and Gilead is part of a long-standing history between the two organizations to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending its partnership to include COVID-19 treatments.
President, India and Emerging Markets, Rakesh Bamzai said: “In the wake of increasing cases of COVID-19 across India, Mylan remains committed to continue its efforts in the fight against the pandemic. With the launch of DESREM™ and our national 24/7 COVID-19 helpline, we aim to enhance access to this critical medicine, used for treating adults and children with severe presentations of Covid-19. At Mylan, we believe we have a responsibility to help make the world a better place and the entire team at Mylan has stepped up in this time of need to serve patients and deliver better health for a better world.”
Mylan is committed to continue doing its part in support of public health needs as the situation around COVID-19 continues to evolve. Mylan’s priorities remain protecting the health and safety of its workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.
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