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    'We were in the dark': why the US is far behind in tracking Covid-19 variants

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    As researchers around the world scramble to understand the dangers of several newly discovered variants of the deadly coronavirus, the US remains woefully behind in its ability to track the mutations, scientists say.
    The federal government has had its “head in the sand”, failing to develop a coordinated surveillance system for tracking the genetic footprints of the virus, according to academic researchers, scientific panelists and private entrepreneurs, who say they have been urging US officials for months to make better use of the hi-tech resources already sitting in labs around the country.
    Genomic sequencing looks at the entire genetic code – or genome – of viruses obtained from samples from infected patients. The technique allows researchers to watch for dangerous mutations and to track movements of specific variants, like detectives following footprints.
    Most genetic variations are inconsequential. But to discover those with functional differences, like more transmissible variants first identified in the UK (B117) and in South Africa (B1351), the research is essential. Yet by Friday the US had only plotted and shared the genetic sequences of 0.3% of its coronavirus cases, ranking 30th in the world, behind countries including Portugal, Latvia and Sierra Leone, according to a tracker developed by scientists at the Broad Institute of MIT and Harvard. Some US states have had virtually no surveillance at all.
    “We’re used to being No 1 and this technology is all over the country,” said Jeremy Kamil, a virologist at the Louisiana State University Health Sciences Center Shreveport, who heads a coronavirus sequencing effort there. Instead, he said, when alarms were raised about the new mutation spreading rapidly in the UK, “we were in the dark. With so few samples, the detective work becomes more like seeing a mirage in the desert.”
    ‘A failure of leadership’
    As viruses replicate, small copying errors lead to changes in their genetic material. These mutations are one of the central features of how viruses function, mutating as they infect more and more hosts. Following the different changes can be like tracking fingerprints or footprints for homicide detectives. By watching for a sudden increase in a certain version of the virus, researchers can raise an alarm if one particular variant appears to be more transmissible than the dominant strain, as happened in December with the variant discovered in the United Kingdom, known as B117.
    The UK has been a world leader in the field of genomic sequencing, budgeting £20m ($27m) at the beginning of the pandemic to fund and coordinate research by a large network of laboratories around the country. So far, it has examined 186,000 genetic samples of its coronavirus cases – more than twice as many as the US, despite a caseload that’s one-seventh the size of that of the US, according to data from the worldwide open repository of genetic information, known as Gisaid.
    The US offered its scientists no such budget and coordination.
    In December, as scientists around the world scrambled to understand the potential dangers of the new variant rapidly spreading around London, the US had no way of knowing whether it was also thriving there, as many states had done no genetic sampling at all. More

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    FDA chief reportedly urged by White House to approve Pfizer vaccine or quit

    The White House chief of staff, Mark Meadows, has reportedly told the head of the US Food and Drug Administration to authorize Pfizer’s coronavirus vaccine on Friday or prepare to resign.Meadows leaned on Hahn during a phone conversation on Friday, according to the Washington Post. It came after Donald Trump tweeted that the FDA was “a big, old, slow turtle”, and told FDA commissioner Stephen Hahn to “get the dam vaccines out NOW”.The warning from Meadows led the FDA to speed up its timetable for potential emergency approval of the Pfizer/BioNTech vaccine from Saturday morning to later on Friday, according to the Post. The vaccine would be the first to roll out across the US, after also being approved in the UK and Canada.An unnamed official told Reuters that Meadows’ comment about resigning “wasn’t a red line” but was more of a quip with the intention of urging “the FDA to act quickly and get the job done and stop the delays”.The White House declined to comment, although an administration official said Meadows does request regular updates on the progress toward a vaccine.“This is an untrue representation of the phone call with the chief of staff,” Hahn said in a statement. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”Earlier in the day, the health secretary, Alex Azar, said the FDA was “very close” to granting emergency use authorization for the vaccine and that vaccination of the first Americans outside clinical trials could begin on Monday.“I’ve got some good news for you here,” Azar told ABC’s Good Morning America on Friday. “Just a little bit ago the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine.“We will work with Pfizer and get that shipped out so we could be seeing people getting vaccinated Monday, Tuesday of next week.”The step followed a vote on Thursday by an outside panel of experts convened by the FDA to recommend authorization of the vaccine. The recommendation signaled that the first approval of a Covid-19 vaccine for use in the US was imminent.That would mark a major milestone in a pandemic that has killed more than 285,000 Americans and 1.5 million people globally. The US would become the third country in the world to have authorized the use of the Pfizer/BioNTech vaccine in the broader public behind the UK and Canada, and it will be the most populous country to do so.A similar advisory panel will review a second vaccine, developed by Moderna with the National Institute of Allergy and Infectious Diseases, on 17 December.The United States recorded more than 224,000 confirmed cases on Thursday and 2,768 deaths, slightly down from a record high 3,124 deaths a day earlier, according to the coronavirus resource center at Johns Hopkins University.“If we have a smooth vaccination program where everybody steps to the plate quickly, we could get back to some form of normality, reasonably quickly,” Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN. “Into the summer, and certainly into the fall.”But that was a distant promise for many communities with overtaxed healthcare systems struggling to handle the surge of patients. At least 200 US hospitals were at full capacity last week and in one-third of all hospitals, more than 90% of all ICU beds were occupied, according to a CNN review of weekly data released by the health department.A top coronavirus adviser to President-elect Joe Biden warned that Americans should plan “no Christmas parties”, with weeks of continued pressure on healthcare systems anticipated ahead.“The next three to six weeks at minimum … are our Covid weeks,” Dr Michael Osterholm, the director of the center for infectious disease research and policy in Minnesota and a member of Biden’s coronavirus advisory board, told CNN. “It won’t end after that, but that is the period right now where we could have a surge upon a surge upon a surge.”The US Congress failed again on Thursday to strike a deal on a new package for coronavirus relief, after the Senate majority leader, Mitch McConnell, torpedoed $160bn in state and local funds from what had been an emerging $900bn deal.The Senate adjourned until next week when legislators were expected to resume their efforts.The United Kingdom began administering the Pfizer/BioNTech vaccine earlier this week. Azar said that the FDA had reviewed a recommendation by UK health officials that people with a medical history of serious allergic reactions should avoid the vaccine, after two healthcare workers who suffer from severe allergies and carry epipens had allergic reactions to the vaccine, and had to be treated. They have since recovered.“There was really good discussion at the advisory committee yesterday, especially around these issues of the allergic reactions that we saw in the United Kingdom,” Azar said.As a last step before issuing the authorization, the regulator needs to finalize guidance for doctors about prescribing the vaccine and advising patients.“It’s very close, it’s really just the last dotting of Is and crossing of Ts,” Azar said.Azar said earlier this week that he had been in contact with members of the Joe Biden transition team to ensure a smooth rollout of the vaccines. Both the Pfizer and Moderna vaccines require two does for maximum efficacy. Hundreds of millions of Americans could be vaccinated over the next year.Jessica Glenza contributed to this report More

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    BioNTech chief rejects Trump claim it delayed Covid vaccine news

    The scientist behind the BioNTech/Pfizer coronavirus vaccine has defended his company from Donald Trump’s accusation that it deliberately delayed news of its rapid progress until after the election, saying “we don’t play politics”.
    BioNTech, a German company, and the US pharmaceutical giant Pfizer announced on Monday that their jointly developed vaccine candidate had exceeded expectations in the crucial phase 3 vaccine trials, proving 90% effective in protecting people from coronavirus infections.
    Quick guide Who in the UK will get the new Covid-19 vaccine first?
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    The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:
    1. All those 80 years of age and over and health and social care workers.
    2. All those 75 years of age and over.
    3. All those 70 years of age and over.
    4. All those 65 years of age and over.
    5. Adults under 65 years of age at high at risk of serious disease and mortality from Covid-19.
    6. Adults under 65 years of age at moderate risk of at risk of serious disease and mortality from Covid-19.
    7. All those 60 years of age and over.
    8. All those 55 years of age and over.
    9. All those 50 years of age and over.
    10. Rest of the population

    The US president criticised the timing of their press release. Trump accused the companies of holding back the good news until after the American elections “because they didn’t have the courage to do it before”.
    But BioNTech’s chief executive, Prof Uğur Şahin, told the Guardian in a wide-ranging interview he only was notified of the outcome of the interim trials on Sunday at 8pm in a call from the Pfizer CEO Albert Bourla, who himself had only been informed three minutes earlier by the independent monitoring board.
    “We want to develop this vaccine as quickly as possible, and we have our own system of coordinates,” Şahin said in response to Trump’s accusation. “Every day counts, and we were desperately waiting for the day of the trial results. It couldn’t come early enough.”
    “Pharmaceutical research should never be politicised. It’s a question of integrity. Withholding information would have been unethical. What’s important for us is that we are developing a vaccine and we don’t play politics.”
    Others have criticised the two companies for not holding on to their information long enough. Bourla raised eyebrows when he sold $5.6m (£4.2m) in stock as company shares soared on Monday night.
    Pfizer says the shares were sold via an automated system after they hit a certain price, under a plan set up in August. More

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    Global report: WHO says 'evidence emerging' of airborne coronavirus spread

    WHO bows to pressure from scientists about risk from aerosol transmission; Brazil’s Bolsonaro tests positive; Israel health chief resigns Coronavirus latest updatesUS still ‘knee-deep’ in pandemic says FauciBrazilian president Jair Bolsonaro tests positive for Covid-19 Play Video 1:11 ‘Evidence emerging’ of airborne Covid-19 spread, says WHO – video The World Health Organization has acknowledged new […] More