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Pfizer may seek US green light to use COVID vaccine in late Nov

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But that makes it unlikely a vaccine will be available before the US election which President Trump has promised.

Pfizer Inc said on Friday it may file for United States authorisation of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before the US election as President Donald Trump has promised.

Pfizer said that it may say if the vaccine is effective as soon as this month based on its 40,000-person clinical trial but that it also needs safety data that will not be available until November at the earliest.

The Pfizer news, published in a letter from its chief executive on its website, lifted the US stock market and the company’s shares. Shares were up slightly in rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said.

Trump has said repeatedly that there would be a vaccine available before the election, but health officials and companies had only said that data might be available this month. The possibility of further delays was raised after trials for two rival vaccines were put on hold in the US this fall (autumn).

The president’s rush to a vaccine has also raised concerns that the US Food and Drug Administration, acting in haste, might not conduct an adequate review of the vaccine.

US health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on. Earlier this month, the FDA formalised a requirement that the vaccine makers collect two months of safety data on one-half of trial participants.

Pfizer’s comments on its timeline raise the possibility of US authorisation of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

Moderna could also apply for an emergency use authorisation (EUA) this year. It has said that it may have interim data on its 30,000-person trial as soon as November.

Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC. AstraZeneca’s US trial has been on hold since September.

After the FDA announced the two-month requirement on October 6, which was approved by the White House but undercut the likelihood of a vaccine before voters go to polls on November 3, Trump called the move a “political hit job”.

In addition to safety and efficacy, the FDA will also examine Pfizer’s manufacturing operations for the vaccine.

Bourla said the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.

He said the company plans to share efficacy data with the public as soon as practical.

A BioNTech spokeswoman confirmed the timeframe for the possible EUA application to the FDA.

Pfizer’s shares rose 2.1 percent in premarket trading, while BioNTech’s US-listed shares were up 4 percent before the opening bell. Moderna was unchanged and US futures were higher.

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American Voter: Nile Blass

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US President Donald Trump and his Democratic challenger Joe Biden are battling for the presidency in a sharply divided United States.

Trump has been focusing on “law and order”; Biden has been trying to strike a conciliatory note. The Black Lives Matter movement – and whether Trump will release his taxes – are among the many issues Americans will consider when choosing their president.

As the hotly contested election approaches, Al Jazeera has been speaking to voters across the US asking nine questions to understand who they are supporting and why.

Nile Blass

[Courtesy of Nile Blass]

Age: 20

Occupation: Production Assistant for Feral Films 

Residence: Prince George’s County, Maryland 

Voted in 2016 for: N/A

Will Vote in 2020 for: Joe Biden

Top Election Issue: Racial Equity 

Will you vote? Why or why not?

“I will be [voting]! I think that there’s a lot of conversation about reformation, or really like the deconstruction of the political system right now, and I agree with those things, but I always like to think about the interim. So, if we want to be put in a position wherein we can actually move forward and change the systems, we have to have an administration that’s receptive to opinion and perspective into science, and I don’t necessarily think that’s what we have right now.

“I think the only option is to vote … there’s work that needs to be done before and after an election, in terms of social justice and change, and the support of different communities. But right now, the most impactful thing I can do is participate in this national and local election, since judges and sheriffs will be on the ballot as well.”

What is your number one issue?

“I would have [to say] racial equity. Only because in every other issue — like if we talk about climate change, for example — that’s going to impact everyone. But if we look at the communities that are going to be immediately impacted, who’s going to be harmed first is going to be Black and brown communities, impoverished communities who are on coastlines, the states that are going to be flooding first — if oceans levels continue to rise in the next few decades— are black and brown communities. I think that when you’re looking at economics and unemployment rates, everything that is a national issue — when looked at on a more microscopic level— [it] becomes very clear who’s being harmed at an accelerated rate.

“And also, just because of how we’re dealing with race right now. The vice president of the United States said that he does not believe in systematic racism. And when you have the CIA and FBI talking about an imminent threat of white supremacy, that’s not a great narrative. So I think that’s the issue that I feel is central to what this country needs to deal with. And I feel like dealing with that allows us to deal with a lot of these other issues that stem from it — at least [those] with disproportionate impact.”

Who will you vote for?

“I will be voting for Joe Biden.”

Is there a main reason you chose your candidate?

“I understand the disappointment in Joe Biden. I’m more set on the left side of politics, so in terms of the candidate that was most progressive, and who would take a more immediate and strong stance on a lot of these issues, I don’t necessarily think he was that. I’m a proponent for the Green New Deal — [Joe Biden] is not. He stated as such on several different occasions. But when we’re talking about his climate change coalition – of committees of politicians, historians, scientists, who he is bringing together, who he wants to put on this issue and suggestion of policy – the authors of the Green New Deal are there.

“So that communicates to me that there’s a level of societal engagement and perspective and opinion that he’s willing to be receptive to and understand that I don’t necessarily think the other candidate is going to be doing. I don’t think he’s a perfect option, I don’t think that we can go back on autopilot like a lot of people were with Obama and that, ‘OK, we elected a competent person, and now we can have our hands off the wheel.’ I think we’re always going to have to be engaged. But I think that Joe Biden is the opportunity to do better, whereas the opposition is just — I don’t know. I don’t personally view there being a positive end.”

Are you happy with the state of the country?

“No, not at all. But I also think it’s important that a lot of people are discussing ‘Oh, back in 2015, 2016’ — I think the beautiful thing about America, at least on a conceptual level, is that it’s not being satisfied with where we are. Because at any given point, if you name a year, it’s when a certain group of people are going to be marginalised, disenfranchised or oppressed.

“Like there are people who are like, ‘Oh, I [miss] 2015, 2016.’ But for Black Americans, that was Ferguson, and for Indigenous people, that was the pipeline. So you’re going further back, there’s the fact that there was a point in time when we didn’t have handicap-accessible buildings or streets.

“And so there’s an obsession of nostalgia — that I don’t like the state of the country now, but there was a point in time where things were good. And it’s, ‘Well, things were good for you.’ So I don’t necessarily believe in ever being satisfied with the state of the nation. I think it’s understanding that we make progress, but the point is to continue making progress, because if we stand right here, and we congratulate ourselves on where we are now, it’s ignoring how much further we have to go. You’re never going to have a perfect union, but the point is to get as close as possible, and that just requires constant movement, and not an obsession with ‘I’m happy we’re here’.”

What would you like to see change?

“Everything. There’s so many issues that we have to deal with … I feel like we’re in a position where if we can, we address issues in terms of allocating resources, teams of researchers, of legislators, of local government and national government working together. We have to deal with the Black maternity death rate, we need to deal with the federal response to the coronavirus, we need to deal with voter suppression and whether or not we can have federal regulation that mandates ‘Hey, if you have a county with a certain amount of population, then for this amount of citizens, you have to have this amount of poll centres’. There’s so many different issues that are kind of intersecting that we can deal with.

“But the issue is everything — nothing right now is good. You have to deal with Black unemployment, we have to deal with Indigenous women going missing. There’s a lot of things from a legislative standpoint and a cultural standpoint that we need to be dealing with. So everything is a very – a cop-out answer – but it’s my legitimate stance that we have a lot of different areas of improvement, and not necessarily a big amount of time to start addressing those issues.”

Do you think the election will change anything?

“Not inherently. I think a lot of people who were disconnected during Obama and even during Bush, the thing they say is that ‘I trusted this leader to be reliable and consistent with their decision-making. So day to day, or even month to month, I did not feel that I as a citizen needed to be actively participating and paying attention to what they’re doing.’ I think that’s a failure.

“This current administration has shown a lot of people that engagement is before and after the election. So Joe Biden, to me, is an opportunity to make progress. But nothing’s promised, because he has a platform and you can argue as to whether or not you think he’s going to stick to that platform, or if he can be moved past that point, but if we elect him, and we stand back, then easily nothing can be done. And we can just either have a repeat of the last four years or just no significant progress past the last four years. So that’s what I would describe it as — an opportunity. But it’s not a promise. Nothing’s inherent in politics, unfortunately.”

What is your biggest concern for the US?

“My biggest concern is time. I tend to be an optimist. I can’t remember the exact wording, but there’s this James Baldwin quote, that’s essentially that ‘I’m an optimist, because I’m alive and being a pessimist makes life an academic matter.’ So I have to believe that we can get through this.

“I like to believe that we have the resources and the people available and willing to deal with all these issues. I think that the biggest problem to me is the time. I don’t know if we have a lot of time to still be discussing climate change, or to still be discussing white supremacy. I think we’re in the realm where we actually have to start doing really tangible things on a federal, local, [and] state level with consistent speed and dedication, and follow through. Because I don’t think that we can’t deal with these problems, but at some point, it’s going to be out of our hands if we don’t start. It can’t always be a conversation or a judiciary committee where we’re asking people to give us information that we already have. I think my biggest problem is time. We’ve got to start doing things a little bit.”

Is there anything we haven’t asked about the election that you want to share?

“The really important thing is a lot of people feel dissatisfied with the political system, including myself — I’m much more interested in the abolition of certain systems than I am [in] whether or not these systems can be reformed effectively.

“If you’re upset with a political system that puts two people forth, and you have to choose and you feel like neither of these people are my choice, then the work doesn’t start 20 days from the election, or even January 1, the work that it takes to reform and abolish systems is years in advance.

“So voting is an important part, but ultimately, a very small part in what can be done to make things better. And it’s [not] just waiting until November, to be mad and to express your issues, when you could have actively been doing something about it — in whatever way, because I understand economics and privilege and I’m a college student, so it’s very easy for me with like, where I am societally going to Georgetown [University] [to] be like, ‘you should do something.’ There are people who have to raise several children on minimum wage, and it’s like, ‘You know what, I’m not in a position to march in the streets.’ But I think that what people can do, they should do. And I think that if everyone does that to the capacity that they can do — like across different cultural, racial and economic standpoints — we’ll be in a much better place by next year.

“And then our future won’t just be on whether or not a Supreme Court justice dies at the right time, which is a weird conversation to have, or if the Russian roulette of our political process ends with two people that we find bearable.”

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AU, ECOWAS monitors say Guinea election conducted properly

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Monitors from the African Union and the West African regional bloc have said Guinea’s recent presidential election was conducted properly, amid rising tensions ahead of the release of official results.

Tuesday’s announcement came a day after leading opposition challenger Cellou Dalein Diallo said he had won the first round on Sunday after suggesting the poll was rigged, comments that set a showdown with incumbent President Alpha Conde. Diallo’s claim was swiftly rejected by the electoral commission, which called it “premature” and “void”.

Addressing reporters in the capital, Conakry, Augustin Matata Ponyo, the AU’s head of mission in Guinea, said on Tuesday the ballot took place “in transparency”.

Jose Maria Neves, the head of the monitoring mission of the Economic Community of West African States (ECOWAS) regional bloc, agreed the voting process was lawful and urged candidates to “use legal channels to settle election disputes”.

Guinean opposition leader Cellou Dalein Diallo, centre, walks with supporters at his headquarters in Conakry, Guinea [Sadak Souici/AP]

The government rejected allegations of rigging and said only the official electoral authority can declare the results, which are due within a week.

The commission will announce provisional results within three days of receiving the last polling-station tally. The Constitutional Court will then have eight days to declare a winner. A second round of voting, if needed, is scheduled for November 24.

‘Regrettable’

The government said in a statement on Monday that the opposition “clearly intended to create chaos and to call into question the real results”.

Meanwhile, the United Nations, AU and the 15-nation ECOWAS called the premature declaration of results “regrettable”.

“This state of affairs is not conducive to preserving calm,” they said in a joint statement.

Diallo, 68, on Monday had called on “fellow citizens who love peace and justice … to defend this democratic victory”.

But joyous celebrations from opposition supporters in Conakry quickly descended into violent clashes with security forces.

Diallo tweeted on Monday night that security forces had shot dead “three boys” and wounded several people. He blamed Conde for the “crimes”. Guinea’s government did not confirm the deaths. An AFP news agency journalist saw three injured people and heard gunfire in a Conakry suburb on Monday night.

Incumbent Alpha Conde, 82, is seeking a controversial third presidential term, a move that has triggered months of deadly unrest in Guinea [Sadak Souici/Reuters]

Conde, 82, is seeking a controversial third presidential term, a move that has triggered months of deadly unrest in the country.

In March, the president pushed through a new constitution which he argued would modernise the country – but also allowed him to bypass a two-term limit for presidents.

The revamped constitution was overwhelmingly supported by voters in a referendum, although that vote was boycotted by the opposition.

At least 50 people have been killed over the past year during demonstrations against the new constitution amid a harsh crackdown by security forces, according to Amnesty International.

Rising tensions

After decades as an opposition activist, Conde became Guinea’s first democratically elected president in 2010 and was re-elected five years later, but rights groups now accuse him of veering towards authoritarianism.

Diallo was formerly a prime minister under authoritarian leader Lansana Conte. He unsuccessfully challenged Conde in both 2010 and 2015, in elections his party activists are convinced were rigged.

Before vote counting began on Sunday, Diallo’s activists said their observers had been obstructed at polling stations and alleged ballot-box stuffing.

Polling day was mostly calm after an acrimonious political campaign that saw Conde and Diallo trade insults, and was marked by violent incidents in some parts of the country.

The rising tensions had also raised the spectre of ethnic strife, with Conde accused of exploiting divisions for electoral ends – a charge he denies.

Guinea’s politics are mainly drawn along ethnic lines: the president’s base is mostly from the ethnic Malinke community and Diallo’s from the Fulani people.

In the run-up to the vote, the UN had urged candidates to curb ethnically charged hate speech, warning the situation is “extremely dangerous” and may lead to violence.

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NFL announces 8 positive tests among players

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Sixth grade students at the Max Planck School in Kiel, Germany sit in their classroom during their first lesson after the autumn holidays on October 19.
Sixth grade students at the Max Planck School in Kiel, Germany sit in their classroom during their first lesson after the autumn holidays on October 19. Gregor Fischer/picture alliance/Getty Images

Ventilation and student placement can affect how coronavirus particles move around a classroom, according to a study published on Tuesday in the journal Physics of Fluids. The study also found that removing some seats, opening windows, placing glass barriers on desks and focusing on hand hygiene may help to reduce spread of the virus.

The authors conducted 20 computer simulations of how particles could spread based on a classroom including nine students and an instructor and desks with and without glass screens on the front.

Each student’s placement went beyond the typical recommendation of 6 feet of separation – instead there was 7 feet and 10 inches between each person. The model’s floor plan consisted of three rows of three desks with an instructor at the front corner. 

“Aerosol distribution in the room is not uniform and is strongly influenced by air conditioning layout,” said the authors, from the University of New Mexico. 

Based on the simulation, the authors suggest removing the middle seat to reduce potential spread. Students in the back corners received two to three times fewer particles on average than other students, so those may be better positions for students at risk for Covid-19 complications, the study said.

The authors said opening windows while the air conditioning was on increased the particles exiting the room and decreased particles deposited on those in the room. 

The study emphasizes the need for “efficient filtering in the air conditioning systems.”

Ventilation from air conditioning systems reduces the number of particles in the air. However, since air flow is often recycled, the authors said particles exiting the classroom “may pose greater risk to individuals in other rooms.” 

Even with only nine students and distance between them, aerosol “is transmitted in significant quantities between students and from one student other students’ desks,” the study said, highlighting the need for hand sanitization.

In the simulations, glass screens on desks reduced the spread of small particles from one student to another, and the authors said they should be used. But effectiveness will vary depending on air conditioning and the source of the aerosol.

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