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in US PoliticsFDA 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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in US PoliticsTrump officials scramble to justify decision not to buy extra Pfizer vaccine doses
The Trump administration on Tuesday scrambled to justify a decision not to buy millions of backup doses of a Covid-19 vaccine developed by Pfizer as the vaccine appeared likely to become the first approved for use in the United States.Government regulators with the Food and Drug Administration (FDA) announced favorable preliminary findings on Tuesday from a review of Pfizer data, following approval for use in the UK and the first post-approval vaccination there.The Trump administration last spring made a deal for 100m doses of the Pfizer vaccine candidate, but the administration turned down an offer to reserve additional doses, Scott Gottlieb, a current Pfizer board member and former FDA commissioner, confirmed on Tuesday.“Pfizer did offer an additional allotment coming out of that plan, basically the second-quarter allotment, to the US government multiple times – and as recently as after the interim data came out and we knew this vaccine looked to be effective,” Gottlieb told CNBC.“I think they were betting that more than one vaccine is going to get authorized and there will be more vaccines on the market, and that perhaps could be why they didn’t take up that additional 100m option agreement.”With global demand for its vaccine soaring following successful trial results and approval in the United Kingdom, New York-based Pfizer cannot guarantee the United States additional doses before next June, the New York Times reported.The extent to which the decision not to acquire more of the Pfizer vaccine could impede the vaccination effort in the United States was unclear.The news came as the US was on the verge of surpassing 15 million coronavirus cases, the highest number in the world.A second vaccine candidate is currently up for emergency approval from the FDA, and multiple additional vaccine candidates – some of them easier to manage than the Pfizer vaccine, which must be stored at extremely cold temperatures – are in the final stages of clinical review.But Donald Trump and officials involved in the vaccine development program scrambled on Tuesday to head off the perception that the government had failed to get first in line for sufficient supplies of a vaccine produced by an American-based company. US-based Pfizer partnered and its German pharmaceutical partner, BioNTech, are on track to have the first vaccine approved in the US.To celebrate the good vaccine news and tout his role in it, Trump planned to host an event at the White House on Tuesday billed as a “vaccine summit”. He planned to unveil an executive order to prioritize vaccine shipments to “Americans before other nations,” but as with many headline-grabbing orders issued by Trump the decree did not appear to be impactful or enforceable, analysts said.Asked on ABC’s Good Morning America on Tuesday how the order would work, the official in charge of the government’s vaccine development program, Operation Warp Speed, Moncef Slaoui, said: “Frankly, I don’t know.”Health officials named by president-elect Joe Biden, who will lead the vaccine rollout effort after taking office next month, were not invited to the White House event, underscoring the risks of a lack of continuity in the effort.And executives from two drug companies, Pfizer and Moderna – whose own vaccine candidate is also up for approval from the FDA – were invited to the White House by Trump but declined, Stat News reported.Slaoui defended the administration’s decision not to buy more doses of the Pfizer vaccine, in his appearance Tuesday on ABC, saying they were looking at several different vaccines during the summer when it had the option to lock in additional Pfizer vaccine doses.“No one reasonably would buy more from any one of those vaccines because we didn’t know which one would work and which one would be better than the other,” said Slaoui. Before taking his current post, Slaoui resigned from the Moderna board.The US government has also contracted for 100m doses of the Moderna vaccine. Both vaccines require two doses per patient, although a preliminary report on the Pfizer vaccine issued on Tuesday by the FDA found some protection after just one dose.The report, which found “no specific safety concerns identified that would preclude issuance” of an emergency use authorization, accelerated the path to approval. “FDA has determined that [Pfizer] has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the report said.A spokeswoman for the Department of Health and Human Services told the Times that in addition to Pfizer and Moderna, the government had signed contracts for doses for other vaccine candidates that have not yet reached the stage of seeking regulatory approval.“We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna,” she said. More
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in US PoliticsAnti-vaccine doctor to testify at Senate committee hearing on Covid mandates
The doctor heading a controversial physician’s advocacy group opposing government involvement in medicine has been announced as a leading witness at a US Senate homeland security and governmental affairs committee hearing on Tuesday.Jane Orient has rejected any “anti-vaxxer” label but her criticism of coronavirus vaccines has drawn scathing rebukes from some senior politicians infuriated by her invitation to testify to Congress.“At such a crucial time, giving a platform to conspiracy theorists to spread myths and falsehoods about Covid vaccines is downright dangerous and one of the last things Senate Republicans should be doing right now,” the Senate minority leader and New York Democrat, Chuck Schumer, said in a statement released on Sunday.Critics have cited Orient’s promotion of the anti-malaria drug hydroxychloroquine as a Covid-19 treatment as well as her organization’s view that federal vaccine mandates are a violation of human rights.In a statement provided to the Senate last year, Orient called vaccine mandates “a serious intrusion into individual liberty, autonomy and parental decisions”.“The regulation of medical practice is a state function, not a federal one,” she wrote. “Governmental pre-emption of patients’ or parents’ decisions about accepting drugs or other medical interventions is a serious intrusion into individual liberty, autonomy, and parental decisions about child-rearing.”Orient is one of four medical professionals set to testify in the hearing in which federal health officials will weigh vaccine mandates and other initiatives to combat a worsening coronavirus pandemic that, so far, has killed more than 282,000 Americans.The Association of American Physicians and Surgeons is a fringe group of fewer than 5,000 doctors that offers advice experts say isn’t “consistent with evidence-based medicine”. It had even been cited by Donald Trump’s former campaign manager Brad Parscale when explaining why the president had taken hydroxychloroquine as a preventive measure.At that time, Orient told the Guardian she believed the drug “should be prescribed more often”, and in a statement claimed the drug offered “about 90% chance of helping Covid-19 patients”.That claim was based on a flawed database.As infections surge towards 15m confirmed cases, Orient has opposed government plans for all Americans to be vaccinated, noting that those emerging vaccines currently awaiting approval by US regulators, one made by the Pfizer and BioNTech partnership and the other by Moderna – use a new scientific method.There is currently no plan for a federal mandate that Americans be inoculated against Covid-19.In a phone interview on Sunday with the New York Times, she called it “reckless to be pushing people to take risks”.“People’s rights should be respected. Where is ‘my body, my choice’ when it comes to this?” Orient said, adding she would not get a coronavirus vaccine, telling the Times that she has an autoimmune condition.Republicans have presented mixed messages on support for government vaccine mandates, with many expressing concerns about the legality of businesses requiring them and infringements on individual liberties.Meanwhile, even as some Republicans questioned the CDC on the safety of the vaccine, Ivanka Trump – White House adviser and daughter of the president – as well as former Republican president George Bush have both confirmed they would publicly take the vaccine. More
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in ElectionsIt's only fake-believe: how to deal with a conspiracy theorist
Unless you’ve been on a silent retreat for the past year, you will have almost certainly heard the rumours – that the pandemic is an elaborate hoax, or that the virus was created as a Chinese weapon, or that dangerous elites are trying to kill off the elderly and to establish a new world order, or that the symptoms are caused by 5G.It is troubling enough to see these ideas on social media. But when you are hearing them from your family, your friends, or a casual acquaintance, it is even harder to know how to respond. You are going to struggle to convince the most committed believers, of course, but what about people who are only flirting with the ideas?These difficult conversations are only set to increase now that a new vaccine is on the horizon. Certain niches of internet are already rife with the “plandemic” theory, which alleges that the spread of the virus has been designed to create big bucks for pharmaceutical companies and the philanthropist Bill Gates (whose charity is funding many of the efforts). The idea has been debunked numerous times, whereas there is good evidence that conspiracy theorists such as David Icke are themselves reaping huge profits from spreading misinformation. The danger, of course, is that their ideas will discourage people from taking the vaccine, leaving them vulnerable to the actual disease. More
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in ElectionsG20 leaders pledge to distribute Covid vaccines fairly around world
G20 leaders meeting remotely pledged on Sunday to “spare no effort” to ensure the fair distribution of coronavirus vaccines worldwide, but offered no specific new funding to meet that goal. The virtual summit hosted by Saudi Arabia was an awkward swan song for Donald Trump, who skipped some sessions on Saturday to play golf, paid little attention to other leaders’ speeches and claimed the Paris climate agreement was designed not to save the planet but to the kill the US economy.Joe Biden has promised to rejoin the accord on day one of his presidency, giving other world leaders hope that the UN climate change conference at the end of next year will see more ambitious pledges, including from China, to cut carbon emissions by 2050.Trump’s isolationist diplomacy has allowed China to escape some scrutiny both on its climate and debt forgiveness measures. “To protect American workers, I withdrew the country from the unjust Paris agreement,” Trump told the G20. “I refuse to surrender millions of American jobs and send trillions of American dollars to the world’s worst polluters and environmental offenders, and that’s what would have happened.”The bulk of the summit focused on ensuring that the coronavirus vaccines expected to hit the market imminently are available for distribution at affordable prices in poorer countries.The EU and the UN say there is a £4.5bn funding shortfall this year that the G20 nations should fill. Countries have so far invested $10bn in the Access to Covid-19 Tools (ACT) Accelerator and its vaccine pillar, the Covax Facility. The two schemes are designed to ensure the vaccines do not remain the preserve of the wealthiest economies.The UN secretary general, António Guterres, said: “The recent breakthroughs on Covid-19 vaccines offer a ray of hope. But that ray of hope needs to reach everyone. That means ensuring that vaccines are treated as a global public good, a people’s vaccine accessible and affordable to everyone, everywhere,” he said.“This is not a ‘do-good’ exercise. It is the only way to stop the pandemic dead in its tracks. Solidarity is indeed survival.”The final G20 communique simply said: “We have mobilised resources to address the immediate financing needs in global health to support the research, development, manufacturing and distribution of safe and effective Covid-19 diagnostics, therapeutics and vaccines.“We will spare no effort to ensure their affordable and equitable access for all people, consistent with members’ commitments to incentivise innovation.” It gave no supporting evidence or statistics.In a sign of the competition for access to vaccines and national prestige, Russia said its Sputnik V would be much cheaper than those offered by Pfizer and Moderna. More
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in US PoliticsTrump bids to take credit for Moderna vaccine while Biden offers cautious optimism
Donald Trump and Joe Biden offered sharply contrasting reactions on Monday to news of a coronavirus vaccine that proved nearly 95% effective in trials.
In a press conference the president-elect called the vaccine news “really encouraging” but warned “more people may die” unless the Trump administration starts cooperating with the incoming Democratic administration. “We are going into a very dark winter. Things are going to get much tougher before they get easier,” he said.
Rather than working to combat the virus, which is spreading faster than ever and on average killing more than 1,000 Americans a day, Trump has stayed focused on unsubstantiated claims that the presidential election was stolen.
Pharmaceutical giant Moderna said on Monday its experimental vaccine was 94.5% effective, based on interim data from a late-stage clinical trial.
“Another vaccine just announced,” Trump tweeted, seeking to claim credit. “This time by Moderna, 95% effective. For those great ‘historians’, please remember that these great discoveries, which will end the China Plague, all took place on my watch!”
Critics say Trump has all but surrendered to the pandemic, which has killed more than 244,000 people in the US and is averaging more than 100,000 cases per day. Michael Osterholm, an adviser to Biden, told NBC on Sunday: “We are in a very dangerous period – the most dangerous public health period since 1918.”
Yet Trump has not attended a taskforce meeting in “at least five months”, public health expert Dr Anthony Fauci said on Sunday, and seems to have bet everything on a vaccine. Trump appeared consumed instead by the election – and now by denying its outcome.
Biden beat him by the same 306-232 margin in the electoral college Trump described as a “landslide” when he won in 2016. The Democrat is also ahead in the popular vote by 5.5m votes, or 3.6%, with ballots still being counted.
The Trump administration has not recognised Biden as president-elect, preventing his team from gaining access to government office space and funding. Democrats and some Republicans have warned that refusal to give Biden access to intelligence poses a risk to national security and hampers the battle against the virus, including vaccine distribution planning.
Biden said the delay was “more embarrassing than debilitating” and that he was continuing to put in place his team and plans to deal with the pandemic and its economic fallout.
The pandemic is the most pressing crisis facing the incoming president. Ron Klain, who will be White House chief of staff, said Biden advisers would meet Pfizer and other drugmakers this week.
White House officials and Republicans in Congress are outnumbered by world leaders in acknowledging Biden’s win. On Monday Robert O’Brien, Trump’s national security adviser, noted that a transition would only take place “if the current lawsuits don’t work out for the president”.
But speaking at the Global Security Forum, O’Brien acknowledged: “If there is a new administration, they deserve some time to come in and implement their policies.
“We may have policy disagreements but look, if the Biden-Harris ticket is determined to be the winner – and obviously things look that way now – we’ll have a very professional transition from the National Security Council. There’s no question about it.”
The president appeared on Sunday to publicly acknowledge that Biden had won the election, but then backtracked and reiterated his false claim the vote was rigged.
Trump, who has put Rudy Giuliani, the former New York mayor, in charge of his legal offensive, tweeted on Sunday that he would soon file “big cases” challenging election results. However, his campaign has already lost numerous court battles and dropped a major part of a suit seeking to prevent Pennsylvania from certifying its results, narrowing the case to a small number of ballots. Biden won the state by more than 68,000 votes.
On Monday Trump tweeted: “The Radical Left Democrats, working with their partner, the Fake News Media, are trying to STEAL this Election. We won’t let them!”
In a statement issued last week by the lead US cybersecurity agency, federal election security officials dismissed such “unfounded claims” and expressed “utmost confidence” in the integrity of the elections. Officials from both parties have said there is no evidence of major irregularities.
Biden has called Trump’s refusal to concede “an embarrassment” and is pressing ahead with the transition. On Monday afternoon he and running mate Kamala Harris were due to speak “on the economic recovery and building back better in the long term”, in their first speech addressing the economic situation since their victory.
Biden outlined a $7.3tn plan ahead of the election that among other goals would bolster crumbling infrastructure, build a clean energy economy and support domestic manufacturing with cash for research and development.
His first aim is to pass a new stimulus plan. But it is unclear how likely he is to pass any deal while Republicans control the Senate, which will hinge on runoff elections in Georgia in January. Talks about a new stimulus package have been deadlocked for months.
The economic situation has improved but remains on a knife edge. Unemployment has dropped dramatically since a high of 14.7% in April but worrying signs remain.
By October the unemployment rate had fallen to 6.9% but the number of long-term unemployed – those jobless for 27 weeks or more – increased by 1.2 million to 3.6 million. Almost a third of the total number of people out of work are now long-term unemployed, black and latino Americans suffering far higher rates of unemployment than their white neighbors.
Jobs growth has continued to slow and each week people are filing unemployment claims at a rate still more than three times as high as before the pandemic.
Elise Gould, senior economist at the Economics Policy Institute, said: “If this drags on and the pace of jobs growth continues to slow, it will take years before we get back to a pre-pandemic economy. Americans can not afford the political games that are being played.” More125 Shares149 Views
in US PoliticsBioNTech 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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HideThe 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 populationThe 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