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      Johnson & Johnson one-shot Covid vaccine gets nod from FDA advisory panel

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      The battle against Covid-19 took a major step forward on Friday as the US moved closer to distributing its first one-shot Covid-19 vaccine, after an independent expert advisory panel recommended drug regulators authorize the Johnson & Johnson vaccine for emergency use.The authorization would be a significant boost to the Biden administration’s vaccination plans, making Johnson & Johnson’s vaccine the third available to the public. Janssen, Johnson & Johnson’s vaccine subsidiary, told a congressional hearing this week that it expects to deliver 20m doses by March and a total of 100m doses before the end of June.The Johnson & Johnson vaccine, along with those from Pfizer and Moderna, should provide the US with more than enough supply to vaccinate every vaccine-eligible person.“We’re still in the midst of this deadly pandemic,” said Dr Archana Chatterjee, a voting member of the panel and an infectious disease pediatrician at Chicago Medical School, as she explained her vote in favor of recommending the vaccine. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”While regulators at the US Food and Drug Administration (FDA) do not always take the advice of their advisory panels, the agency is expected to authorize the vaccine for emergency use.“We urgently need more vaccines [authorized] to protect the millions of Americans who remain at risk” of Covid-19 infection, said Dr Greg Poland, the editor-in-chief of the medical journal Vaccine and leader of the Vaccine Research Group at the Mayo Clinic.“Today, we have seen clear and compelling evidence that the Janssen vaccine candidate is well tolerated, has an acceptable safety profile and most importantly is highly efficacious against Covid-19,” he said. “To me, it is clear that the known benefits vastly outweigh the known risks.”The recommendation comes soon after the US marks 500,000 deaths from Covid-19, a toll that comes as cases decline in the US and across many countries worldwide. More than 28 million Americans have been infected by Covid-19.“We are seeing positive trends in terms of declining cases,” said Dr Adam MacNeil, a member of the Covid-19 epidemiology taskforce with the US Centers for Disease Control and Prevention. He later added: “We are certainly not out of the woods yet.”Importantly, Johnson & Johnson’s vaccine would also be the easiest to distribute. Unlike vaccines from Pfizer and Moderna, which require sub-zero storage, Johnson & Johnson’s vaccine can be stored at common refrigerator temperatures for up to three months. When frozen it has a shelf life of three years.The convenience of the Johnson & Johnson vaccine comes with caveats. The company’s clinical trials were the first to show the potential impacts of Covid-19 variants, or evolutionary changes in the virus.The vaccine was found to 85% effective at preventing severe disease and to provide complete protection against Covid-19-related hospitalization and death after 28 days. Johnson & Johnson’s vaccine was found to be 72% effective in clinical trials in the US, but only 57% effective in South Africa, where a variant called B1351 originated.However, vaccination remains a powerful weapon, even with threats posed by variants. “Even with decreased effectiveness, vaccination may still provide partial protection against variants,” said MacNeil. Like the Moderna vaccine, Johnson & Johnson’s product will only be available to people 18 and older. Pfizer’s vaccine is available to teenagers older than 16. Also, as with other vaccines, researchers are uncertain how long the vaccine protects against Covid-19, and whether it reduces asymptomatic transmission of the virus, although studies are promising.Johnson & Johnson’s vaccine uses different technology from the two vaccines currently available in the US. The new vaccine uses “viral vector” technology, which introduces the body to the genetic code for the spike protein covering the outside of the coronavirus. This code is transmitted by a second, weakened virus called an adenovirus.Immunity is provoked when the body’s immune system then recognizes the coronavirus by this key structure. Vaccines developed by Pfizer and Moderna also prompt the body to recognize spike proteins on the outside of the coronavirus, but deliver the genetic code through lipid nanoparticles, or tiny molecules of fatty acids.Because scientists are still researching the degree to which any of the authorized vaccines prevent people from spreading Covid-19 to other people, public health authorities recommend people continue to social distance and wear masks after being vaccinated. In theory, a vaccinated person could still spread the SARS-CoV-2 virus, even if they do not experience any symptoms of the disease Covid-19.Johnson & Johnson’s vaccines and the doses already scheduled to be delivered by Moderna and Pfizer, the makers of the two vaccines currently authorized in the US, mean there could be enough supply to vaccinate 400 million people by July. Roughly 267 million people in the US are eligible for a vaccine.This ease of storage and one-dose regime is likely to increase pressure on the US government to pledge doses to low- and middle-income countries, which often lack the cold chain infrastructure needed to distribute the Pfizer or Moderna vaccines. Currently, dozens of low- and middle-income countries do not expect to begin broadly distributing vaccine doses until 2022.Activists, many of whom also worked to expand access to Aids medications, have described this as “vaccine apartheid”, and a threat to the “project of global population immunity”. More

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      BioNTech chief rejects Trump claim it delayed Covid vaccine news

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      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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      Demand surges for Regeneron drug that Trump claims ‘cures’ Covid-19

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      Doctors are reporting a spike in enquiries by patients for an experimental Covid-19 drug cocktail after Donald Trump called the Regeneron Pharmaceuticals drug “a blessing from God” that is a “cure” for the virus.Two doctors involved in the trial of the drug told Reuters that more patients are asking to participate in the drug’s trials, though medical experts have pointed out the drug, REGN-COV2, is still too early in its trial period to confirm that it can help treat Covid-19.On Wednesday, just hours after Trump praised the drug as the “cure” for the virus, Regeneron announced that it submitted an application to the Food and Drug Administration’s (FDA) for an emergency use authorization of the drug, which is a cocktail mix of two antibodies meant to aid the immune system in fighting the virus.Regeneron’s stock, and the stock of Eli Lilly, another pharmaceutical company conducting drug trials for an anti-body treatment, soared Thursday after Trump touted the treatment.“The politics of the situation would suggest to me that the story could be Trump gets Covid … then American technology fostered by the Trump administration cures Covid,” said Dr Dirk Sostman, head of research network at Houston Methodist Hospital, a trial site for Regeneron’s antibody program, who told Reuters that more patients were seeking to take part in the trial. “I would think there would be pressure on regulators [to approve the drug],” he said.Though Trump said that “hundreds of thousands” of doses were ready for use, Regeneron said that it actually has enough doses for 50,000 patients and would have enough for 300,000 patients in the coming months. The company has said 275 patients participated in the first phase of the drug trial.The US has more than 7.5m confirmed cases of Covid-19 and over 212,000 people have died of the disease, according to Johns Hopkins University.Because the drug is in clinical trials, it is only available to patients who are accepted into the trial. With approval from the FDA, drug companies can offer a treatment to patients not participating in trials under “compassionate use” rules, which are meant to make treatments accessible to patients with a life-threatening condition that has no alternative therapies available. Regeneron said that under 10 people have been given its drug under the rules.Doctors on Twitter have been voicing their concerns about promises of a cure when the treatment is still nascent.“We don’t know if it works. We don’t know about patient outcomes because it hasn’t been studied enough. Frankly, [Trump] is an anecdote,” said Dr Rob Davidson, an emergency room physician in Michigan and executive director of the Committee to Protect Medicine, in a video on Twitter.Regeneron’s drug is just the latest treatment that Trump is touting as the cure to the virus without the evidence medical experts say is necessary to actual confirm a treatment is safe and effective. In the spring, Trump infamously announced he was taking anti-malaria drug hydroxychloroquine in an attempt to prevent Covid-19, though the FDA warned against using the drug for that reason. Just a month later, the FDA revoked its emergency authorization for the drug citing growing evidence that it did not work to prevent the virus and that it had serious side effects. More

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      Katie Porter lambasts big pharma over cancer drug price hike using whiteboard calculations – video

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      3:02

      US representative Katie Porter used her now-signature whiteboard as she questioned former Celgene CEO Mark Alles over the connection between the significant price hike for Revlimid, a common cancer drug, and his personal bonus.
      The Democratic congresswoman for California presented her argument during a House oversight and reform committee hearing that centred on an 18-month investigation into pharmaceutical price gouging. The drug makers defended the price rises as the cost of doing research and development and talked about price-reduction programmes their companies offer
      Congresswoman Katie Porter secures free coronavirus testing for all Americans – video

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      Oleandrin: Trump allies pitch extract from poisonous plant to fight Covid

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      Allies of Donald Trump have promoted a plant extract called oleandrin to people seeking to ward off Covid-19. The plant the extract is derived from, oleander, is poisonous and there is no proof the compound is either safe or effective to treat or prevent Covid-19, experts say.But unlike other unproven and potentially dangerous Covid-19 “cures” pitched by Donald Trump and his supporters, including the prescription antimalarial hydroxychloroquine, experts fear this compound could easily reach the public as a dietary supplement.“Supplements are like snake oil, in the sense they are not regulated by the FDA,” said Martin Ronis, a professor in Louisiana State University’s department of pharmacology and experimental therapeutics, referring to the US Food and Drug Administration.While pharmaceutical companies must show the FDA drugs are safe before they go to market, dietary supplements are considered “food” in the US and thus must be proven unsafe before they are removed from the market. Because of this regulatory structure, Ronis said it would be possible for the company behind the plant compound – Texas-based Phoenix Biotechnology – to bring the extract to market.“You can essentially make all kinds of apocryphal claims about supplements,” said Ronis. One of Phoenix’s board members is Mike Lindell, a prominent Trump backer, pitchman, and CEO of MyPillow. Lindell chairs Trump’s re-election effort in Minnesota.While Lindell has pitched Phoenix’s plant extract as a coronavirus cure on TV and to the president’s coronavirus taskforce, the company also quietly received $5m in funding from an undisclosed investor, patented its extract for use in Covid-19, and promoted an early study in monkey cells as proof of efficacy – an assertion one of the study’s own authors denies.Lindell told the TV host Greg Kelly, an anchor on the conservative Newsmax network: “I started using it myself and giving it to friends and family who tested positive.”The interview was one of several television appearances about oleandrin and is prominently displayed on the company’s website. “Is he allowed to do that?” Kelly laughed as he asked his other guest, Andrew Whitney, the vice-chairman and fellow director of Phoenix Biotechnology.“Well, I’m doing it as well,” Whitney replied, “and so is everyone else at the company, because we believe in the product, Greg. We know it works.” Phoenix Biotechnology did not respond to an emailed request for an interview.The Washington Post has reported that Whitney has visited Trump in the White House and pitched oleandrin to him.Oleandrin has not been approved to treat any medical disorder. The supplements industry has also opposed introducing oleandrin to the market.“The unanimous opinion is that this is a stupid idea and no one should allow an oleander supplement to get close to their mouth,” ​said Loren Israelsen, president of the United Natural Products Alliance, in a statement to a trade publication.Phoenix Biotechnology has released only one study on oleandrin’s use against Covid-19. The study was published in what is called a “pre-print”, which means it is not peer-reviewed. Two of the authors had a financial stake in Phoenix Biotechnology. The study, called an “in vitro” study, examined oleandrin’s effect on monkey cells in the laboratory.Pharmaceutical companies looking for FDA approval typically take drugs through a long pipeline of testing including in pre-clinical trials, in non-human primates, and then in a series of clinical trials testing for safety and dosing, leading up to a double-blind, placebo-controlled randomized trial for efficacy.If Phoenix sought approval for its product, the pre-print it published would represent a concept for potential study at the very beginning of this pipeline. The median cost of bringing a drug to market is $985m, according to a recent study in the Journal of the American Medical Association. Most new drugs fail.Phoenix has conducted two clinical trials for safety of oleandrin in cancer treatment, but both were small. Phoenix proposed providing oleandrin in what appears to be a liquid, according to its website.Although Whitney said in his interview with Kelly that Phoenix has researched oleandrin for “25 years”, the earliest research related to the company appears to be from 2002. Phoenix was incorporated in 2003, according to a press release.Phoenix received a patent for its extraction process in 2005, and in that time it has sponsored research at several institutions, including University of Texas San Antonio, the MD Anderson Cancer Center and Duke University.The company appears to be moving ahead in its efforts to monetize oleandrin. The “pre-print” was published on 15 July. The company filed for patents in the US on 18 July and earlier in Australia. The American patent was reportedly granted on 29 July, and Phoenix told the US Securities and Exchange Commission it received $5m from a single, unnamed investor on 7 August. More

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      US buys up world stock of key Covid-19 drug remdesivir

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      No other country will be able to buy remdesivir, which can help recovery from Covid-19, for next three months at least Coronavirus – latest US updates Coronavirus – latest updates See all our coronavirus coverage Remdesivir is patented by California-based Gilead. Photograph: Mike Blake/Reuters The US has bought up virtually all the stocks for the […] More