CategoryBrazil

Brazil’s average daily Covid-19 deaths drops 28% in last 30 days

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The number of daily deaths by Covid-19 in Brazil dropped 28.3% in a month, according to the 7-day rolling average released by the Oswaldo Cruz Foundation (Fiocruz). The data show that on May 9th, the daily average stood at 2,100 deaths, down from 2,930 on April 9th.

In 14 days, the rolling average of deaths dropped 15.8%, given that on April 25th the daily number of deaths reached 2,495.

The peak of deaths was recorded on April 12th (3,124). Since then, records have been showing a downward trajectory.

https://riotimesonline.com/brazil-news/miscellaneous/covid-19/daily-covid-19-deaths-average-drops-28-in-one-month-in-brazil/

Existing coronavirus jabs may protect against Brazilian variant as strain ‘may be less resistant to antibodies’

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The University of Oxford has said existing COVID-19 vaccines may protect against the Brazilian coronavirus variant as the P1 strain may be less resistant to antibodies than first thought.

A study by the university – which jointly developed the AstraZeneca coronavirus jab with the British-Swedish firm – examined the impact of natural and vaccine-induced antibodies on different strains.

The research, which has not yet been peer-reviewed, measured the level of antibodies that can neutralise – or stop infection from – variants that are circulating in South Africa, Brazil and elsewhere.

It found that vaccines do not work as well against the variants as against the original strain of coronavirus, but that the P1 Brazilian variant may be less resistant to vaccine-induced antibodies than first feared.

“These data suggest that natural and vaccine-induced antibodies can still neutralise these variants, but at lower levels,” the university said.

https://news.sky.com/story/covid-19-existing-coronavirus-jabs-may-protect-against-brazilian-variant-as-strain-may-be-less-resistant-to-antibodies-12249523

Lab test shows Pfizer Covid vaccine is effective against Brazil variant

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The coronavirus vaccine developed by Pfizer and BioNTech was able to combat a new variant that was rapidly circulating in Brazil, a new study has found.

The research published in the New England Journal of Medicine found that the engineered version of the virus, containing the same mutation carried on the spike protein as the highly contagious P1 variant first identified in Brazil, was effectively neutralised among people who were given the jab.

The new variants are observed to carry changes in the spike, which is used by the virus to enter the human cells. These changes, in turn, affects how transmissible the virus is and therefore, is the primary target of the many coronavirus vaccines.

Scientists from the two companies and the University of Texas Medical Branch said that the neutralising ability of the vaccine on the new variant was equivalent to the effect on the less contagious version of the virus from the last year.

https://www.independent.co.uk/news/health/covid-brazil-variant-pfizer-vaccine-b1814332.html

Oxford scientists preparing vaccine versions to combat emerging virus variants

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Oxford scientists are preparing to rapidly produce new versions of their vaccine to combat emerging more contagious COVID-19 variants discovered in the UK, South Africa and Brazil, The Telegraph reported on Wednesday.

The team behind the vaccine from Oxford and AstraZeneca Plc is undertaking feasibility studies to reconfigure the technology, the newspaper bit.ly/3o1DNRf said, citing a confirmation from Oxford University.

The scientists were working on estimating how quickly they could reconfigure their ChAdOx vaccine platform, the report said.

Recent laboratory tests have indicated that the COVID-19 vaccine developed by Pfizer Inc and partner BioNTech SE is likely to work against the UK variant spreading around the world.

BioNTech has said it plans to publish a more detailed analysis of the likely effect of its vaccine on the South African variant within a few days.

AstraZeneca Plc, Moderna Inc and CureVac NV are also testing whether their respective shots will protect against the fast-spreading variants.

https://www.reuters.com/article/uk-health-coronavirus-britain-vaccine-idUSKBN29P2QV

White House considers lifting European travel restrictions

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The White House is considering rescinding entry bans for most non-U.S. citizens who recently were in Brazil, Britain, Ireland and 26 other European countries, five U.S. and airline officials told Reuters.

The Trump administration imposed the bans in a bid to contain the novel coronavirus pandemic. It is not considering lifting separate entry bans on most non-U.S. citizens who have recently been in China or Iran, the officials said.

The plan has won the backing of White House coronavirus task-force members, public health and other federal agencies, the people briefed on the matter said, but President Donald Trump has not made a final decision and the timing remains uncertain.

The White House, Department of Homeland Security and Centers for Disease Control and Prevention (CDC) did not comment.

Many administration officials argue the restrictions no longer make sense given that most countries around the world are not subject to the entry ban. They contend lifting the restrictions would be a boost to struggling U.S. airlines, which have seen international travel fall by 70%, according to airline industry data.

https://www.reuters.com/article/BigStory12/idUSKBN2851EPHELP US SPREAD GOOD NEWS!

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Oxford-AstraZeneca vaccine ‘behaves as desired’, analysis finds

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The COVID-19 vaccine being developed by Oxford University and AstraZeneca has been shown to work as planned by new analysis.

A method to check the inoculation contains all the correct parts was developed by a team at Bristol University, providing greater evidence that the vaccine works.

Even though the research has not yet been peer reviewed, it has been hailed as a “wonderful example of cross-disciplinary collaboration”.

The vaccine is currently undergoing Phase 3 clinical trials to further establish the safety of the treatment.

It comes after confirmation the trials will continue after a man taking part died in Brazil. It is understood that the man was taking a placebo and not the active vaccine.

The new method of analysis allowed scientists to check that the vaccine was properly designed to replicate the parts of the COVID-19 make-up needed to train the immune system to fight the disease.

The study proved that the vaccine is correctly programmed to replicate the “spike protein” associated with COVID-19 that has been inserted into the immunisation shot.

“Until now, the technology hasn’t been able to provide answers with such clarity, but we now know the vaccine is doing everything we expected and that is only good news in our fight against the illness.”

Sarah Gilbert, professor of vaccinology at the University of Oxford and lead on the Oxford vaccine trial, added: “This is a wonderful example of cross-disciplinary collaboration, using new technology to examine exactly what the vaccine does when it gets inside a human cell.

“The study confirms that large amounts of the coronavirus spike protein are produced with great accuracy, and this goes a long way to explaining the success of the vaccine in inducing a strong immune response.”

https://news.sky.com/story/coronavirus-oxford-astrazeneca-vaccine-behaves-as-desired-analysis-finds-12111085HELP US SPREAD GOOD NEWS!

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BCG: Can a vaccine from 1921 save lives from Covid-19?

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Scientists in the UK have begun testing the BCG vaccine, developed in 1921, to see if it can save lives from Covid.

The vaccine was designed to stop tuberculosis, but there is some evidence it can protect against other infections as well.

Around 1,000 people will take part in the trial at the University of Exeter.

But while millions of people in the UK will have had the BCG jab as a child, it is thought they would need to be vaccinated again to benefit.

Vaccines are designed to train the immune system in a highly targeted way that leaves lasting protection against one particular infection.

But this process also causes wide-spread changes in the immune system. This seems to heighten the response to other infections and scientists hope it may even give our bodies an advantage against coronavirus.

Previous clinical trials have shown the BCG jab reduced deaths by 38% in newborns in Guinea-Bissau, mostly by reducing cases of pneumonia and sepsis.

Studies in South Africa linked the vaccine to a 73% reduction in infections in the nose, throat and lungs; experiments in the Netherlands showed BCG reduced the amount of yellow fever virus in the body.

“This could be of major importance globally,” Prof John Campbell, of the University of Exeter Medical School, told the BBC.

“Whilst we don’t think it [the protection] will be specific to Covid, it has the potential to buy several years of time for the Covid vaccines to come through and perhaps other treatments to be developed.”

The UK trial is part of the international Brace-study, which is also taking place in Australia, the Netherlands, Spain and Brazil, recruiting 10,000 people in total.

https://www.bbc.co.uk/news/health-54465733HELP US SPREAD GOOD NEWS!

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Dozens of COVID-19 vaccines are in development. Here are the ones to follow

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More than 150 coronavirus vaccines are in development across the world—and hopes are high to bring one to market in record time to ease the global crisis. Several efforts are underway to help make that possible, including the U.S. government’s Operation Warp Speed initiative, which has pledged $10 billion and aims to develop and deliver 300 million doses of a safe, effective coronavirus vaccine by January 2021. The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021.

Vaccine prospects

The COVID-19 candidates, like all vaccines, essentially aim to instruct the immune system to mount a defense, which is sometimes stronger than what would be provided through natural infection and comes with fewer health consequences.

To do so, some vaccines use the whole coronavirus, but in a killed or weakened state. Others use only part of the virus—whether a protein or a fragment. Some transfer the coronavirus proteins into a different virus that is unlikely to cause disease or even incapable of it. Finally, some vaccines under development rely on deploying pieces of the coronavirus’s genetic material, so our cells can temporarily make the coronavirus proteins needed to stimulate our immune systems. 

Novavax

Name: NVX-CoV2373

What: Novavax has bioengineered the coronavirus’s spike proteins, the parts that help the virus invade cells but cannot replicate or cause COVID-19. Its vaccine candidate combines those proteins into a knucklebone-shaped nanoparticle. This can be injected along with its proprietary Matrix-M adjuvant—a compound that stimulates immune cells—to elicit an immune response. The vaccine is administered in two doses, 21 days apart. On September 2, a study of the company’s phase one trial published in the New England Journal of Medicine found that the vaccine was safe and produced coronavirus antibodies at a higher level than is seen among those who have recovered from COVID-19. It also stimulated T cells, another arm of the human immune response.

Status: On September 24, Novavax announced the launch of its phase three trial in the United Kingdom, which will evaluate the vaccine in up to 10,000 people, both with and without underlying conditions. Up to 400 participants will also be vaccinated against the seasonal flu as part of a sub-study that will help determine whether it is safe to give patients both vaccines at the same time.

Johnson & Johnson

Name: JNJ-78436735

What: Johnson & Johnson is developing an adenovector vaccine, which introduces a piece of DNA from SARS-CoV-2 into the common cold-causing adenovirus that has been genetically changed so that it can’t replicate in the body. This vaccine builds on the technology Johnson & Johnson used to develop an Ebola vaccine as well as vaccine candidates for Zika and HIV. In July, a study published in Nature showed that the vaccine elicited neutralizing antibodies in monkeys and provided “complete or near-complete” protection with just one dose.

Status: On September 23, Johnson & Johnson announced the launch of a phase three ENSEMBLE trial that will evaluate the safety of the vaccine—and how well it works—among up to 60,000 adults from a variety of countries. The trial will include “significant representation” from older populations and will include those with underlying conditions that make them more susceptible to COVID-19.

Moderna Therapeutics

Name: mRNA-1273

What: This vaccine candidate relies on injecting snippets of a virus’s genetic material, in this case mRNA, into human cells. They create viral proteins that mimic the coronavirus, training the immune system to recognize its presence. This technology has never been licensed for any disease. If successful, it would be the first mRNA vaccine approved for human use. This vaccine requires two doses, four weeks apart.

Status: On July 27, Moderna announced it had started the third phase of its clinical trials, even as it continues to monitor phase two results. Preliminary findings from phase one have shown that healthy subjects—including elderly patients—produced coronavirus antibodies and a reaction from T cells. Phase three will test the vaccine in 30,000 U.S. participants; Moderna says it is on track to deliver at least 500 million doses per year beginning in 2021, thanks in part to the deal it has struck with Swiss manufacturer Lonza that will allow it to manufacture up to one billion doses a year. In September, however, Moderna’s chief executive Stéphane Bancel told the New York Times that it was unlikely the vaccine would be widely available in the first half of 2021.

Pfizer

Name: BNT162b2

What: Pfizer and BioNTech are also developing an mRNA vaccine based on the German company’s earlier efforts to use the technology in experimental cancer vaccines. Pfizer has signed a nearly $2 billion contract with the U.S. government to provide 100 million doses by December 2020—an agreement that goes into effect when and if the drug is approved and delivered.

Status: On July 27, Pfizer and BioNTech launched a trial that combines phase two and three by enrolling a diverse population in areas with significant SARS-CoV-2 transmission. It has expanded the trial to include 44,000 people across multiple countries. The project is aiming to seek regulatory review before the end of the year—and hopes to supply 1.3 billion doses by the end of 2021. Preliminary results of phase one/two data show the vaccine produces antibodies and T-cell responses specific to the SARS-CoV-2 protein.

University of Oxford

Name: ChAdOx1 nCoV-19

What: Oxford’s candidate is what’s known as a viral vector vaccine, essentially a “Trojan horse” presented to the immune system. Oxford’s research team has transferred the SARS-CoV-2 spike protein—which helps the coronavirus invade cells—into a weakened version of an adenovirus, which typically causes the common cold. When this adenovirus is injected into humans, the hope is that the spike protein will trigger an immune response. AstraZeneca and Oxford plan to produce a billion doses of vaccine that they’ve agreed to sell at cost.

Status: Preliminary results from this candidate’s first two clinical trial phases revealed that the vaccine had triggered a strong immune response—including increased antibodies and responses from T-cells—with only minor side effects such as fatigue and headache. It is in phase three of clinical trials, aiming to recruit up to 50,000 volunteers in Brazil, the United Kingdom, the United States, and South Africa. On September 8, AstraZeneca paused the trials for a safety review due to an adverse reaction in one participant in the U.K. The details remain unclear, though the company has described the pause as a “routine action.” After an investigation by independent regulators, the trials resumed in the U.K., Brazil, South Africa, and India but remained on hold in the U.S. as of September 23.

Sinovac

Name: CoronaVac

What: CoronaVac is an inactivated vaccine, meaning it uses a non-infectious version of the coronavirus. While inactivated pathogens can no longer produce disease, they can still provoke an immune response, such as with the annual influenza vaccine.

Status: On July 3, Brazil’s regulatory agency granted this vaccine candidate approval to move ahead to phase three, as it continues to monitor the results of the phase two clinical trials. Preliminary results in macaque monkeys, published in Science, revealed that the vaccine produced antibodies that neutralized 10 strains of SARS-CoV-2. Sinovac has also released preprint results of its phase two human trial that likewise showed the vaccine produced antibodies with no severe adverse reactions. Phase three will recruit nearly 9,000 healthcare professionals in Brazil. Sinovac will also conduct phase three trials in Indonesia and Bangladesh.

Sinopharm

What: Sinopharm is also using an inactivated SARS-CoV-2 vaccine that it hopes will reach the public by the end of 2020. Preliminary findings from two randomized trials, published in JAMA, have shown the vaccine can trigger an antibody response with no serious adverse effects. The study did not measure T cell-mediated immune responses. These results are significant, though, as they are the first published data from human clinical trials for a COVID-19 vaccine that uses a whole, inactivated virus.

Status: On September 29, the New Yorker reported that Sinoparm is filing its application to China’s regulatory commission for approval of the vaccine, which could arrive sometime in October. The story also notes that hundreds of thousands of Chinese civilians have already been vaccinated under the government’s emergency-use approval. China began to innoculate medical workers and other high-risk groups with the Sinopharm trial vaccines in July, making it the first experimental vaccine available to civilians beyond clinical volunteers. Also in July, Sinopharm launched its first phase three trial among 15,000 volunteers—aged 18 to 60, with no serious underlying conditions—in the United Arab Emirates. The company selected the UAE because it has a diverse population made up of approximately 200 nationalities, making it an ideal testing ground. Sinopharm will also undertake phase three trials in locations such as Peru and Bahrain.

Murdoch Children’s Research Institute

Name: Bacillus Calmette-Guerin BRACE trial

What: For nearly a hundred years, the Bacillus Calmette-Guerin (BCG) vaccine has been used to prevent tuberculosis by exposing patients to a small dose of live bacteria. Evidence has emerged over the years that this vaccine may boost the immune system and help the body fight off other diseases as well. Researchers are investigating whether these benefits may also extend to SARS-CoV-2, and this trial has reached phase three in Australia. Though as of April 12, the World Health Organization says there is no evidence that the BCG vaccine protects people against infection with the coronavirus.

Status: In April, researchers from the Murdoch Children’s Research Institute began a series of randomized controlled trials that will test whether BCG might work on the coronavirus as well. They aim to recruit 10,000 healthcare workers in the study.

CanSino Biologics

Name: Ad5-nCoV

What: CanSino has also developed a viral vector vaccine, using a weakened version of the adenovirus as a vehicle for introducing the SARS-CoV-2 spike protein to the body. Preliminary results from phase two trials, published in The Lancet, have shown that the vaccine produces “significant immune responses in the majority of recipients after a single immunisation.” There were no serious adverse reactions documented.

Status: Though the company was still technically in phase two of its trial, on June 25, CanSino became the first company to receive limited approval to use its vaccine in people. The Chinese government has approved the vaccine for military use only, for a period of one year. On August 15, Russian biopharmaceutical company Petrovax announced it had launched the first phase three clinical trial of Ad5-nCoV.

The Gamaleya National Center of Epidemiology and Microbiology

Name: Sputnik V

What: Gamaleya has developed a viral vector vaccine that also uses a weakened version of the common cold-causing adenovirus to introduce the SARS-CoV-2 spike protein to the body. This vaccine uses two strains of adenovirus, and it requires a second injection after 21 days to boost the immune response. Russia has not published any data from its clinical trials, but officials with the institute state that they have completed phases one and two. The researchers also claim the vaccine produced strong antibody and cellular immune responses.

Status: Despite the lack of published evidence, Russia has cleared the Sputnik V vaccine for widespread use and claimed it as the first registered COVID-19 vaccine on the market. Russia reports that it will start phase three clinical trials on August 12; the World Health Organization, however, lists the Sputnik V vaccine as being in phase one of clinical trials.

BioNTech, Pfizer start rolling EMA approval filing for COVID-19 vaccine

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BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca’s AZD1222 as the first COVID-19 vaccine to start the rolling review process.

The EMA uses rolling reviews to start assessing data on an experimental candidate before all the evidence needed to make a final decision is available, cutting the time it takes to decide whether to approve a prospect once the pivotal clinical trial results are submitted to the agency. The pressing need for COVID-19 vaccines potentially makes the mechanism important to the current crisis.

After receiving the first part of a rolling submission, the EMA’s Committee for Medicinal Products for Human Use has begun evaluating the preclinical evidence on mRNA vaccine BNT162b2. The rolling review format provides opportunities to file additional data before the complete application. Each cycle typically requires a two-week review. The duration of the review of the final application will depend on the proportion of data already assessed by EMA under the rolling review. 

The EMA accepted BNT162b2 for rolling review on the strength of the preclinical and early clinical data on the vaccine. BioNTech and Pfizer have linked BNT162b2, which encodes a SARS-CoV-2 spike glycoprotein, to antibody and T-cell responses in people dosed in early-phase trials. The data led the partners to start a phase 3 clinical trial.

That trial has now enrolled around 37,000 participants at sites in countries including the U.S., Brazil, South Africa and Argentina, with centers in Turkey coming online to help push BioNTech and Pfizer to their enrollment target of 44,000 subjects. More than 28,000 participants have received their second dose. BioNTech and Pfizer originally planned to enroll 30,000 subjects.

https://www.fiercebiotech.com/biotech/biontech-pfizer-start-rolling-ema-approval-filing-for-covid-19-vaccineHELP US SPREAD GOOD NEWS!

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Five Thousand Brazilians Have Tested Oxford Vaccine with No Severe Side Effects

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The Oxford vaccine trials in Brazil are continuing at a speedy pace. To date, at least 5,000 volunteers have been administered the drug – or a placebo drug – and have not presented any serious adverse reactions.

https://riotimesonline.com/brazil-news/miscellaneous/covid-19/five-thousand-brazilians-have-been-administered-oxford-vaccine-with-no-severe-side-effects/HELP US SPREAD GOOD NEWS!

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