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Oxford-Astra Covid Vaccine Review to Start in Europe

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European regulators are set to start an accelerated review of a Covid-19 vaccine front-runner from the University of Oxford and AstraZeneca Plc, according to a person with knowledge of the situation, in a sign the shot could be the first to seek approval in the region.

The European Medicines Agency is expected to announce the “rolling review” as soon as this week, according to the person, who didn’t want to be identified because the decision is still private. Such assessments are used in emergencies to allow regulators to see trial data while the development is ongoing to speed up approvals of drugs and vaccines that are urgently needed.

The move would be a key step forward for the Oxford-AstraZeneca shot after trials were halted earlier this month due to concerns about a participant in the U.K. study who became ill. The partners, along with companies such as Pfizer Inc. and Moderna Inc., are sprinting ahead with experimental shots as governments look for a way out of the global crisis.

While the British regulator cleared the Oxford-Astra trial to restart less than a week after it was paused, U.S. authorities have yet to give the go-ahead for trials to resume in the country. Studies in South Africa, Brazil and India have also restarted.

The EMA’s head of vaccines, Marco Cavaleri, said in July the agency would start rolling reviews of potential candidates after the summer. The approach means that a final approval could be granted a matter of days after the review period ends. Cavaleri said at the time the first approval of a vaccine could come by the end of the year.

In emergencies like a pandemic, a rolling review avoids delays so that an EMA recommendation and approval from the European Commission can be sought as quickly as possible. The agency started such an evaluation of remdesivir to treat Covid-19 in April, while trials were ongoing, and the drug was given conditional approval three months later.

https://www.bloomberg.com/news/articles/2020-09-30/oxford-astra-covid-vaccine-review-said-to-start-in-europeHELP US SPREAD GOOD NEWS!

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A new study in Italy found that deaths from Covid-19 are less likely to occur in the communities with higher rates of flu vaccines

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What is the relationship between influenza vaccination and Sars-Cov-2? A new study by the Monzino cardiology center reveals that in the period of the lockdown it was possible to observe an inversely proportional relationship between coverage of influenza vaccinations and the number of infections and deaths from Covid in the Italian regions. And what data in hand, a 1% increase in vaccination coverage would have made it possible to avoid 1,989 deaths from Covid 19.

“What we did was to relate the regional data on last year’s influenza vaccination rates with those on the spread of Covid in the over 65s”, explains Mauro Amato , researcher at the Monzino cardiology center and first author of the article. “A rather clear situation emerged from the results: the prevalence of Sars-Cov-2 infections, admissions to hospital with symptoms attributable to Covid, admissions to intensive care and deaths, all resulted higher in regions where vaccination had been lower ”.

A fact – explains Amato – which is also confirmed by the results of similar research carried out in countries such as Brazil. And that if for now it cannot prove a causal link between the flu vaccine and Covid, it still allows us to formulate some hypotheses. “It is known that Covid 19 in children has a lower incidence and symptoms that tend to be milder”, emphasizes Damiano Baldassare,coordinator of the study, head of the Unit for the study of morphology and arterial function of Monzino and professor of the Department of Medical Biotechnology and Translational Medicine of the University of Milan. “Among the hypotheses proposed to explain this resistance there is also the fact that in the pediatric age one is more often subjected to vaccinations of some kind: it is known that vaccines can lead to cross immunity, or better trained, even against other infectious pathologies “.

In short, vaccines do not only protect against the pathogen they are addressed to, but tend to enhance the body’s immune reactions in a generalized way. And this could help defend against Sars-Cov-2 as well, decreasing the chances of infection and reducing the severity of symptoms and complications.

https://www.repubblica.it/salute/2020/09/28/news/coronavirus_meno_decessi_dove_ci_si_e_vaccinati_di_piu_contro_l_influenza-268786544/HELP US SPREAD GOOD NEWS!

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Russia’s RDIF agrees to manufacture Covid-19 vaccine in Brazil

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Russia’s sovereign wealth fund RDIF said on Thursday that it had agreed to manufacture Russia’s first registered COVID-19 vaccine “Sputnik-V” in Brazil.

RDIF, which is backing the vaccine’s development, also said it planned to supply up to 100 million doses of the vaccine to Latin America.

https://www.reuters.com/article/health-coronavirus-russia-brazil/russias-rdif-agrees-to-manufacture-covid-19-vaccine-in-brazil-idUSR4N2FT028HELP US SPREAD GOOD NEWS!

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Brazil could launch Chinese coronavirus vaccine this year, says governor, citing ‘extremely positive’ results

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Clinical trials in Brazil of a Chinese-made vaccine against Covid-19 have shown “extremely positive” results, and a widespread vaccination campaign could begin as early as December, the governor of Sao Paulo state said on Wednesday.

Sao Paulo, the epicentre of the coronavirus pandemic in hard-hit Brazil, is one of six states helping to test the so-called CoronaVac vaccine developed by Chinese pharmaceutical firm Sinovac Biotech.

The vaccine produced an immune response in 98 per cent of recipients over 60 years old, with no adverse side-effects reported so far, said Governor Joao Doria.

“The results have been extremely positive,” he told a news conference. “We will soon be able to immunise Brazilians in Sao Paulo and across the country with the CoronaVac vaccine … The projected delivery date is in December this year.”

https://www.scmp.com/news/world/americas/article/3100930/brazil-could-launch-chinese-coronavirus-vaccine-year-saysHELP US SPREAD GOOD NEWS!

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Pause in Oxford coronavirus vaccine trial not necessarily a setback, says Hancock

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Nobody can know where the first safe and effective vaccine against Covid-19 will come from, warned one of the UK’s leading medical experts, as the trials of the frontrunner, from Oxford University, were put on hold.

The Oxford vaccine appeared to be storming ahead, amid hopes it would have the data to get it approved by a regulator before the end of the year. Last month, Donald Trump was said to be considering pushing for it to be fast-tracked in the US before the presidential election in November.

But the phase 3 trials, the final stage involving tens of thousands of people, have been paused because of the illness of one of the UK volunteers. Studies are also under way in the US, Brazil and South Africa, with a view to getting a quicker answer because of the greater numbers of cases in those countries.

Sir Jeremy Farrar, the head of Wellcome and an infectious diseases specialist, said vaccine development “is an inherently risky endeavour, and you cannot back on a single vaccine candidate. You have to have a portfolio, you have to be pragmatic that not all of these vaccines in late stage development will make it through.”

Safety is absolutely critical, he said. Large-scale trials and follow-up of people who have been vaccinated after licensing were vital.

Farrar, who is also a member of the government’s Sage scientific advisory body, called for scientists worldwide to share their data, as Oxford/AstraZeneca has. It is “absolutely critical that we know what’s happening in the US and Europe in China and Russia and everywhere else, developing these vaccines”.

The UK health secretary, Matt Hancock, said he was not overly concerned about the decision by the pharmaceuticals firm AstraZeneca to halt vaccine trials, he said, adding that it had already overcome a similar delay.

“This is a normal part of a vaccine development that, when you find a problem, the system is paused while you investigate that particular problem,” he told LBC radio.

“What it underlines is that we won’t bring forward a vaccine unless it is safe, no matter how enthusiastic I am for a vaccine.”

Hancock told Sky News: “It is obviously a challenge to this particular vaccine. It’s not actually the first time it has happened to the Oxford vaccine and it’s a standard process in clinical trials.”

Asked if it was a setback, Hancock said: “Not necessarily – it depends on what they find when they do the investigation. There was a pause earlier in the summer and that was resolved without a problem.”

He told LBC the UK had “other irons in the fire”. The government has ordered 340m doses of six different vaccines, which was “far more” than was needed for the UK population, said Hancock.

https://www.theguardian.com/world/2020/sep/09/pause-in-oxford-coronavirus-vaccine-trial-not-necessarily-a-setback-says-hancockHELP US SPREAD GOOD NEWS!

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Brazil Has 12% Drop in Deaths by Covid-19 in August

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As the second country in the world most affected by the novel coronavirus pandemic, Brazil recorded a fall in total deaths in August compared to the previous month. There were 28,947 deaths from the disease in August against 32,912 in July, a decrease of 12%.

Worldwide, there were 180,649 deaths in August – 16% of this total in Brazil. According to the World Health Organization, 844,312 deaths have been registered since the beginning of the pandemic.

Brazil has a total of 121,515 Covid-19 victims since March. The disease has infected 3,910,901 people in the country.

According to epidemiologists, there is a sustained fall when the decrease exceeds 15%. At this point, therefore, the outlook would indicate stability.

https://www1.folha.uol.com.br/internacional/en/scienceandhealth/2020/09/brazil-has-12-drop-in-deaths-by-covid-19-in-august.shtmlHELP US SPREAD GOOD NEWS!

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New virus cases decline in the US and experts credit masks

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The number of Americans newly diagnosed with the coronavirus is falling — a development experts credit at least partly to increased wearing of masks — even as the outbreak continues to claim nearly 1,000 lives in the U.S. each day.

About 43,000 new cases are being reported daily across the country, down 21% from early August, according to data compiled by Johns Hopkins University. While the U.S., India and Brazil still have the highest numbers of new cases in the world, the downward trend is encouraging.

“It’s profoundly hopeful news,” said Dr. Monica Gandhi, an infectious-diseases expert at the University of California, San Francisco, who credits the American public’s growing understanding of how the virus spreads, more mask-wearing and, possibly, an increasing level of immunity.

https://www.ksat.com/health/2020/08/25/new-virus-cases-decline-in-the-us-and-experts-credit-masks/HELP US SPREAD GOOD NEWS!

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Johnson & Johnson to test coronavirus vaccine in 60,000 volunteers

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Johnson & Johnson (JNJ.N) aims to test its experimental coronavirus vaccine in up to 60,000 volunteers in a late-stage trial scheduled to start in September, according to a U.S. government database of clinical trials.

The trial would be conducted in nearly 180 sites across the United States and other countries, including Brazil and Mexico, according to the information posted on clinicaltrials.gov on Aug. 10.

“We can confirm that planning and recruitment is underway for our Phase 3 program, which is subject to interim data of the Phase 1/2a trials and approval of regulators,” a Johnson & Johnson spokesman said.

“Our Phase 3 program is intended to be as robust as possible, could include up to 60,000 participants and will be conducted in places with high incidence rates,” he added.

The spokesman said J&J is using epidiological data to decide where studies should take place and will make a final decision soon. The phase 3 trial will likely lock off in late September, with the first vaccines available for use by early 2021, he said.

https://www.reuters.com/article/us-health-coronavirus-johnson-johnson/johnson-johnson-to-test-coronavirus-vaccine-in-60000-volunteers-idUSKBN25G1WUHELP US SPREAD GOOD NEWS!

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Brazil greenlights human trials for J&J’s potential COVID-19 vaccine

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Brazil approved on Tuesday human clinical trials for a potential COVID-19 vaccine developed by Johnson & Johnson, the fourth candidate to trial in the Latin American country that has become key to the global race for a vaccine.

Health regulator Anvisa said it had given the green light to the study which will see 6,000 people in Brazil volunteer to trial the vaccine contender of Johnson & Johnson’s pharmaceutical subsidiary Janssen.

With the world’s biggest coronavirus outbreak outside the United States, Brazil has become a hub for mass clinical trials of potential vaccines.

https://www.reuters.com/article/us-health-coronoavirus-brazil-johnson-jo/brazil-approves-human-trials-for-potential-johnson-johnson-covid-19-vaccine-idUSKCN25E1MPHELP US SPREAD GOOD NEWS!

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Oxford Coronavirus vaccine update: Phase III trials to conclude by November, mass production expected by 2021

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The University of Oxford-AstraZeneca backed novel coronavirus vaccine has been one of the leading vaccine candidates in the global race. The vaccine, currently in phase III of its trials, which was considered to be the first one to get launched for the public in 2020 will be most likely available for public deployment by 2021, according to latest reports.

Currently, phase III clinical trials are being conducted in research facilities across UK, US, Brazil and South Africa. Trials are also expected to start from next week in India in partnership with Serum Institute of India.

https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/oxford-coronavirus-vaccine-update-phase-iii-trials-to-conclude-by-november-mass-production-expected-by-2021/photostory/77538743.cms?picid=77538804HELP US SPREAD GOOD NEWS!

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