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BioNTech (BNTX) and Pfizer (PFE) Partnering with Biovac to Produce and Supply COVID-19 Vaccine in the Africa Union. – InvestorsObserver

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What’s Going on with BioNTech (BNTX)?

BioNTech (BNTX) and Pfizer (PFE) said July 21 that the two biopharmaceutical firms plan to partner with Cape Town’s Biovac “to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.” Pre-market, BNTX was trading at $245.90 a share, representing a 0.30% increase.

What Does This Mean for BNTX?

“We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses,” BioNTech CEO Ugur Sahin, M.D., explained. “We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”

Biovac’s Cape Town facility should be incorporated into the COVID-19 vaccine supply chain by the end of this year. Once the Cape Town facility reaches full operational capacity, yearly vaccine production is slated to surpass 100 million finished doses — with every dose to be delivered exclusively within the 55-member (nations) African Union.

BioNTech SE – ADR has a Bullish sentiment reading. Find out what this means for you and get the rest of the rankings on BNTX!

BioNTech SE is a Germany-based biotechnology company that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company’s oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

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‘Get tested’ for COVID-19 even if you’re fully vaccinated, Fauci says as Delta variant rages – Global News

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As health officials warn of an imminent 4th wave of Delta-driven COVID-19 infections, America’s top infectious diseases expert, Dr. Anthony Fauci, is stressing the importance of getting tested for the virus — even if you are fully vaccinated.

“We used to say if you’re vaccinated and you come into contact with an infected person, you don’t need to do anything. You don’t need to test. You don’t need to isolate,” Fauci said during an interview with Global News reporter Jackson Proskow. “Now, that’s changed. Now, the recommendation is that you should be tested even if you’re vaccinated.”

Fauci’s comments come on the heels of a new study by U.S. Centers for Disease Control and Prevention (CDC), which warns that the Delta COVID-19 variant could be as contagious as the chickenpox, and a report that points to a chain of outbreaks among vaccinated individuals.

The Delta variant, first detected in India, is “substantially more efficient in transmitting from person to person” when compared to other variants, and “no vaccine is 100 percent effective,” Fauci explained.

“When you measure the level of [the] virus in the nasal pharynx of a vaccinated person who has [had] a breakthrough infection with Delta,” Fauci said, the detected virus level is “high and equivalent to the level of virus in the nasal pharynx of an unvaccinated person.”

Read more:
Does Delta COVID-19 variant make you sicker? Doctors probing amid ‘wildfire’ spread

That is not the case with other variants.

For instance, the level of virus found in the nasal pharynx of a vaccinated individual who happens to be infected with the Alpha variant is much lower than that of an unvaccinated person.

This “strongly” suggests that the Delta variant’s ability to transmit is unhindered by an individual’s vaccination status, Fauci said.

“It is very clear now that [vaccinated people] can transmit the infection to others.”

Last week, the U.S. CDC recommended that fully vaccinated Americans should go back to wearing masks in indoor public places in regions where the coronavirus — and especially the Delta variant — are spreading rapidly.

The change marked a reversal of the agency’s earlier announcement in May that motivated millions of vaccinated Americans to drop their face coverings.


Click to play video: 'Delta COVID-19 variant now dominant worldwide, detected in 100 countries: Fauci'



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Delta COVID-19 variant now dominant worldwide, detected in 100 countries: Fauci


Delta COVID-19 variant now dominant worldwide, detected in 100 countries: Fauci – Jul 16, 2021

Dr. David Doudy, an epidemiologist at Johns Hopkins University, said the CDC guidance was motivated by a change in infection patterns.

“We’re seeing this doubling in the number of cases every 10 days or so,” he said.

The CDC said that 63 per cent of U.S. counties had high transmission rates that warranted mask-wearing.

New cases per day in the U.S. have increased six-fold over the past month to an average of nearly 80,000, a level not seen since mid-February. And deaths per day have climbed over the past two weeks from an average of 259 to 360.

Dr. Michelle Barron, senior medical director of infection prevention and control at Colorado’s UCHealth said research from China suggests the Delta variant replicates much faster and generates 1,000 times more virus in the body compared to the original coronavirus strain, highlighting the biggest danger of this new wave.

“This is like a wildfire, this is not a smoldering campfire. It is full-on flames right now,” Barron said.

Other doctors said patients infected with Delta appeared to become ill faster, and sometimes showed more severe symptoms, than those they treated earlier in the pandemic.

“We are seeing more patients requiring oxygen sooner,” said Dr. Benjamin Barlow, chief medical officer at American Family Care, a 28-state chain of urgent care clinics.


Click to play video: 'Delta COVID-19 variant ‘greatest threat’ to U.S. pandemic response: Fauci'



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Delta COVID-19 variant ‘greatest threat’ to U.S. pandemic response: Fauci


Delta COVID-19 variant ‘greatest threat’ to U.S. pandemic response: Fauci – Jun 22, 2021

At his clinic in Birmingham, Alabama, Barlow recorded 20 per cent of the patients testing positive for COVID-19, compared with the two-to-three per cent a few weeks ago.

David Montefiori, director of the Laboratory for AIDS Vaccine Research and Development at Duke University Medical Center, said the Delta variant is more infectious and leads to faster onset of illness.

“Frankly there’s a severity that comes from this variant that is a little more severe,” Montefiori said on a webcast last week. “It’s not just easier to transmit, it makes you sicker.”

Fauci reiterated the same.

“It’s just a very dominant variant,” he told Global News. “It’s already in over one hundred and twelve countries. So the horse is out of the barn, as it were.”

“Wherever Delta has been, it invariably is so efficient in transmitting from person to person that it always seems to push out the other variants and become dominant,” Fauci explained. “We’ve seen that in the United States. A few months ago it was two, three or so percent. Then it went up to 20, then 50, then 80, and now it’s close to 90 percent.”

Read more:
Canada’s Delta-driven 4th wave of COVID-19 will be ‘different’ amid vaccinations: experts

Nevertheless, Fauci is optimistic.

He said adaption is key when it comes to dealing with this ever-evolving virus.

“[As] the science evolves, the evidence evolves,” he said. “Your approach and your guidelines and your recommendations need to evolve. And that’s exactly what happened in the United States with the change in the CDC guidelines.”

Canadian experts too are optimistic. However, they don’t think that a Delta-driven 4th wave would be as big as the previous ones given Canada’s current vaccinations rates.

Even with the country’s rise in cases, Dr. Gerald Evans, chair of the Division of Infectious Diseases at Queen’s University said that the virus would primarily affect unvaccinated communities, highlighting the fact that over 97 per cent of all new cases in Canada were among those who did not get a jab.

Canada added at least another 218 cases of COVID-19 on Sunday, bringing its total infections to 1,431,219. Two additional deaths were reported as well, with the country’s overall death toll now standing at 26,600. Over 1.39 million people have recovered from the coronavirus and more than 49.5 million vaccinations have been doled out so far.

Read more:
CDC now recommends fully vaccinated Americans wear masks indoors in some places

Dr. Ronald St John, former WHO director for the Americas and national manager for Canada’s response to SARS, also expressed caution when interpreting the findings of the internal CDC report.

Speaking on the Roy Green show, he mentioned that the data in the report was not peer-reviewed or published in a scientific journal.

“How often [the Delta variants] spread, the frequency of spread — that’s what’s not clear to me in the data that’s been presented so far,” he said. “I think it’s just been an internal document that’s been spread around. So I’m waiting to see a little more data.”

-With files from Global News’ David Lao and Reuters

© 2021 Global News, a division of Corus Entertainment Inc.

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Study Will Test Different Time Intervals for COVID-19 Vaccines in Pregnant Individuals – Technology Networks

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A new UK-based clinical trial will test the most appropriate time interval between two doses of an mRNA COVID-19 vaccine in pregnant individuals. 

COVID-19 vaccines and pregnancy


In 2020, clinical trials of COVID-19 vaccines now authorized for human use did not include pregnant or breastfeeding individuals. This approach is typical for the clinical study of a new investigational medicinal product and is enforced by regulatory bodies such as the US Food and Drug Administration (FDA) to protect both mothers and pregnancies.

As the global rollout of several COVID-19 vaccines commenced, many pregnant individuals opted to be immunized against SARS-CoV-2 regardless. This enabled scientists to gather real-world retrospective data on the safety and efficacy of the different types of vaccines in this population. Based on the growing data supply, in April, the UK’s Joint Committee on Vaccination and Immunisation (JCVI) advised that pregnant persons in the UK should be offered two doses of mRNA-based vaccines (Pfizer–BioNTech’s BNT162b2 or Moderna’s mRNA-1273) where available.

However, data gaps remain,  Professor of Pediatric Infectious Diseases Paul Heath from St George’s University of London explained in a recent press release: “Tens of thousands of pregnant women have now been vaccinated in both the US and the UK with no safety concerns reported, but we still lack robust, prospective clinical trial data on COVID-19 vaccines in pregnant women.”

More information is required to determine the best time schedule for administering the two mRNA COVID-19 vaccine doses in pregnant individuals in order to achieve the optimum immune response. A new study led by Heath – known as Preg-Cov – will provide this vital clinical information.

Vaccine dose intervals in pregnancy


Preg-Cov will recruit over 600 low-risk pregnant women aged 18-45-years-old across a number of sites in the UK. All participants will receive two doses of an mRNA-based COVID-19 vaccine (either Pfizer–BioNTech’s BNT162b2 or Moderna’s mRNA-1273). The eligibility criteria permits the inclusion of individuals that have received their first dose prior to enrolling in the trial. Speaking to Technology Networks, Heath said: “All will be blinded to the COVID-19 vaccine they receive except for the group that have received a dose before pregnancy – as they obviously know what they had already.”

Participants must be between 13 and 34 weeks pregnant on the date of the first COVID-19 vaccination, and will be divided into two groups: short interval and long interval dosing. The short interval group will receive their second COVID-19 vaccine between four to six weeks after their first dose, whereas the long interval group will receive their second dose between 8 and 12 weeks after their first. Consequently, some individuals will receive their second dose after delivering their baby. The study will follow all recruits for a period of one year.

“It’s important to highlight that all participants in this study will receive a COVID-19 vaccine. This is particularly important with the rising number of cases, the easing of restrictions and low vaccine uptake among pregnant women,” Professor Asma Khalil, lead obstetrician for the trial said.

Throughout the duration of the trial, various data will be collected. Recruits will be asked to maintain a symptom diary and blood samples will be obtained from the mother. In some instances, cord blood will also be extracted. “The blood samples are taken from all mothers but cord blood only from mothers at certain sites. This is because we don’t actually need to take as many samples to address the question about transfer of antibody from mother to baby in the cord blood,” Heath told Technology Networks.

The trial – which is now open for enrollment – is supported by £7.5 million worth of funding from the UK government. “Pregnant women are more likely to get seriously ill from COVID-19 and we know that vaccines are safe for them and make a huge difference – in fact no pregnant woman with two jabs has required hospitalisation with COVID-19,” said the Minister for Covid-19 Vaccine Deployment, Nadhim Zahawi. “This government-backed trial will provide more data about how we can best protect pregnant women and their babies, and we can use this evidence to inform future vaccination programmes.”

Professor Paul Heath was speaking to Molly Campbell, Science Writer for Technology Networks. 

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Delta variant spreads 'like wildfire' as doctors study whether it makes patients sicker – CP24 Toronto's Breaking News

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LOS ANGELES, Aug 2 (Reuters) – With a new wave of COVID-19 infections fueled by the Delta variant striking countries worldwide, disease experts are scrambling to learn whether the latest version of coronavirus is making people – mainly the unvaccinated – sicker than before.

The U.S. Centers for Disease Control and Prevention warned that Delta, first identified in India and now dominant worldwide, is “likely more severe” than earlier versions of the virus, according to an internal report made public on Friday.

The agency cited research in Canada, Singapore and Scotland showing that people infected with the Delta variant were more likely to be hospitalized than patients earlier in the pandemic.

In interviews with Reuters, disease experts said the three papers suggest a greater risk from the variant, but the study populations are limited and the findings have not yet been reviewed by outside experts. Doctors treating patients infected with Delta described a more rapid onset of COVID-19 symptoms, and in many regions an overall increase serious cases.

But the experts said more work is needed to compare outcomes among larger numbers of individuals in epidemiologic studies to sort out whether one variant causes more severe disease than another.

“It’s difficult to pin down increase in severity and population bias,” said Lawrence Young, a virologist at the UK’s Warwick Medical School.

In addition, it is likely that the extraordinary rate of Delta transmission is also contributing to a greater number of severe cases arriving at hospitals, the experts said.

Delta is as contagious as chickenpox and far more contagious than the common cold or flu, according to the CDC report.

Shane Crotty, a virologist at the La Jolla Institute for Immunology in San Diego, said the clearest indication that the variant may cause more severe disease comes from the Scotland study, which found that Delta roughly doubled the risk of hospitalization compared to an earlier version.

The majority of hospitalizations and deaths from coronavirus in the United States are occurring in people who have not been vaccinated. But there is evidence that the shots are less effective in people with compromised immune systems, including the elderly.

For vaccinated, otherwise healthy individuals, the odds are that if they contract COVID-19 they will only experience asymptomatic or mild disease, said Dr. Gregory Poland, infectious disease expert at the Mayo Clinic.

“But they can pass it on to family members and others who may not be so lucky,” Poland said. “We have to be vaccinated and masked or we will, for the fourth time now, endure another surge and out of that will come worse variants.”

‘FULL-ON FLAMES’

The rate of severe illness, especially in regions where vaccination rates are low, is again straining healthcare workers on the front lines of the pandemic.

“This is like a wildfire, this is not a smoldering campfire. It is full-on flames right now,” said Dr. Michelle Barron, senior medical director of infection prevention and control at Colorado’s UCHealth.

Research from China suggesting that the Delta variant replicates much faster and generates 1,000 times more virus in the body compared to the original strain highlights the biggest danger of this new wave, Barron said.

“It is hard to tell if they are more sick because of the Delta variant or if they would have been more sick anyway,” she said.

Other doctors said patients infected with Delta appear to become ill more quickly, and in some cases with more severe symptoms, than those they treated earlier in the pandemic.

“We are seeing more patients requiring oxygen sooner,” said Dr. Benjamin Barlow, chief medical officer at American Family Care, a 28-state chain of urgent care clinics.

At his clinic in Birmingham, Alabama, Barlow said that around 20% of patients are testing positive for COVID-19, compared with 2-3% a few weeks ago. Patients are assessed at that time for potential hospital admission and oxygen support.

David Montefiori, director of the Laboratory for AIDS Vaccine Research and Development at Duke University Medical Center, said the Delta variant is more infectious and leads to faster onset of illness – particularly for the unvaccinated.

“Frankly there’s a severity that comes from this variant that is a little more severe,” Montefiori said on a webcast last week. “It’s not just easier to transmit, it makes you sicker.” (Reporting by Deena Beasley in Los Angeles, Josephine Mason in London and Julie Steenhuysen in Chicago; Editing by Michele Gershberg and Daniel Wallis)

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