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Multitope Peptide-Based Coronavirus Vaccine / United Biomedical; CoronaVac / Sinovac, Bio Farma Indonesia; AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford; Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research InstituteBrazil Trials of Sinovac COVID-19 Vaccine Show Promising Results: Governor (US News and World Report) - Sep 9, 2020 - "...Phase 3 clinical trials of a potential COVID-19 vaccine developed by China's Sinovac Biotech Ltd have shown promising results and it may be available to Brazilians as early as December....Phase 2 trials of the potential vaccine had shown an immune response of 98% in the elderly....Trials for the AstraZeneca vaccine on 5,000 volunteers in Brazil are well advanced and have not produced any problems in participants....At the start of next year, Phase 3 trials of Russia's 'Sputnik-V' COVID-19 vaccine will also be conducted on 10,000 volunteers...Brazilian lab and hospital group DASA SA said on Wednesday it had agreed to conduct Phase 2 and 3 trials in Brazil for a COVID-19 vaccine developed by COVAXX..."CT-P59 / CelltrionCelltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate (Businesswire) - Sep 11, 2020 - P1, N=32; NCT04525079; Sponsor: Celltrion; "Celltrion has also launched commercial production of CT-P59 as part of the preparation process; The results demonstrated no significant drug-related adverse events (AEs), and importantly there were no adverse events from the maximum tolerated dose cohort.....'We intend to request emergency use authorisation'....Celltrion...plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea. Celltrion anticipates the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial....The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021."Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research InstituteHelping Russia Conduct Sputnik V Vaccine Trials, Make It In India: Centre (NDTV) - Sep 8, 2020 - "India has received Russia's request for conducting phase 3 human trials and manufacturing the Sputnik V coronavirus vaccine, the government said today. It said India is working to facilitate Russia's request....Russian Health minister Mikhail Murashko said the country will start mass inoculation from November or December, with a focus on high-risk groups."AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of OxfordSerum Institute pauses India trials of AstraZeneca's COVID-19 vaccine (Reuters) - Sep 10, 2020 - "Serum Institute of India has put on hold trials of AstraZeneca's AZN.L potential COVID-19 vaccine in the country until the British drugmaker restarts them, the company said on Thursday....The move to pause the trials in India comes after the Drugs Controller General of India (DCGI) V.G. Somani asked Serum for details on the suspension of trials overseas, in a show-cause notice....Somani asked the company to explain why the trials should not be suspended in India until patient safety is established..."AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of OxfordAstraZeneca COVID-19 vaccine on track for 2020 filing despite delay: Soriot (FierceBiotech) - Sep 10, 2020 - "AstraZeneca is still on track to file for approval of its COVID-19 vaccine this year, according to its CEO....It is unclear how long the trial will be paused in response to a recent adverse event, but a 2020 approval is still on the cards....AstraZeneca said it was on track to show whether its COVID-19 vaccine worked by September. Hopes of a fall approval had begun to fade long before AstraZeneca placed development of the vaccine on hold....Depending on how quickly regulators review the filing, that could enable AstraZeneca to win approval this year."AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of OxfordOxford Vaccine Trials Resume In UK, Were Paused Over Volunteer's Illness (NDTV) - Sep 12, 2020 - "Pharma giant AstraZeneca on Saturday said it had resumed a Covid-19 vaccine trial after getting the all-clear from British regulators, following a pause caused by a UK volunteer falling ill....An independent committee was drafted in to review safety, in what the company and the World Health Organization described as a routine step. The committee 'has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume', AstraZeneca said."Dr Anthony Fauci Discusses the Systemic Effects of COVID-19 (AJMC) - Sep 7, 2020 - "While coronavirus disease 2019 (COVID-19) is largely a respiratory disease, it is actually a systemic disease that has a wide range of effects and postinfection sequelae that aren't yet fully known, said Anthony S. Fauci, MD..."Dr Anthony Fauci Speaks to the Likelihood of Vaccines for HIV and COVID-19 (AJMC) - Sep 10, 2020 - "In an interview to mark the 25th anniversary of The American Journal of Managed Care®, Anthony S. Fauci, MD...noted how there's never a guarantee with vaccinology but that he and other officials feel fairly confident that we'll get a vaccine for coronavirus disease 2019 (COVID-19), possibly by the end of the year and the beginning of 2021"COVID-19: Fauci says he takes vitamin D and C supplements to reduce his 'susceptibility to infection' (Times Now) - Sep 13, 2020 - "'If you're deficient in vitamin D, that does have an impact on your susceptibility to infection. I would not mind recommending, and I do it myself, taking vitamin D supplements,' he said. 'The other vitamin that people take is vitamin C because it's a good antioxidant, so if people want to take a gram or so of vitamin C, that would be fine.'"Vaccine scientist: 'Smart business practice' for companies to not seek premature FDA approval (The Hill) - Sep 7, 2020 - "Vaccine scientist Peter Hotez on Monday called a safety pledge by pharmaceutical companies for the development of a coronavirus vaccine 'smart business.' 'What they're doing is a smart business practice to make certain they're releasing a vaccine that's both safe and effective, because they know that if there's a mistake, and if things don't go well, it could bring down the entire company,' he added."Coronavirus expert Dr. Peter Hotez reveals when we can expect a vaccine (Houston Chronicle) - Sep 11, 2020 - "Peter Hotez...explains the COVID-19 vaccine development process to the Houston Chronicle Thursday, June 18, 2020, in Houston. Hotez predicted COVID-19 vaccine will be available for general public by quarter three of 2021, if they are safe and work."Coronavirus: Commission completes vaccines portfolio following talks with a sixth manufacturer (European Commission) - Sep 9, 2020 - "Stella Kyriakides, Commissioner for Health and Food Safety, said: 'Today's final talks with BioNTech-Pfizer is yet another important step in our efforts to build a sound and diverse portfolio of vaccine candidates. This was the objective of our EU Vaccine Strategy, and we are delivering on it. We are optimistic that among these candidates there will be a safe and effective vaccine against COVID-19 to help us defeat this pandemic.'"GSK and Sanofi: another COVID-19 vaccine in the testing phase (Born2Invest) - Sep 9, 2020 - "In the global race, Sanofi and GSK would appear to be running a few months behind AZ, Pfizer, Moderna and the Chinese CanSino and SinoVac, who have already begun Phase III studies. However, John Shiver...said they can still catch up with their competitors thanks to the French company's experience with 'very similar viruses.' Shiver also said that many clinical trials so far have recruited mostly white people. Meanwhile, Sanofi and GSK are going to select a 'tremendous diversity' of participants in the clinical trials, across multiple countries for their final research stage in December."
