https://thehill.com/homenews/admini...-pressures-fda-to-approve-coronavirus-vaccine Trump pressures FDA to approve coronavirus vaccine President Trump on Friday publicly pressured the Food and Drug Administration (FDA) to move more quickly in approving a coronavirus vaccine, lamenting that the organization was acting like a “big, old, slow turtle.” “While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!” Trump tweeted early Friday, tagging FDA Commissioner Stephen Hahn in the message. The tweet came hours after a federal panel of outside experts voted to recommend the FDA grant emergency use authorization to the vaccine produced by Pfizer and BioNTech, saying that the safety and efficacy of the vaccine outweigh the risks. The FDA is widely expected to follow the recommendation, and a decision could be made within days.
They can just use a vaccine from another manufacturer which does not have possible adverse allergic effects.
Crisis-Actor Grandmas, Chimps, and Boris-Branded Microchips: Britain’s Anti-Vaxxers Lose It as Rollout Begins As the British government rolls out the Pfizer vaccine, it’s also battling false claims that it’s hiring 90-year-old crisis actors and that shots will turn people into chimps. https://www.thedailybeast.com/anti-...ists-sent-crazy-by-vaccine-rollout-in-britain Ninety-year-old granny Margaret Keenan became the world’s most unlikely megastar this week when she became the first person to receive a fully-approved coronavirus vaccine in the Western world. The sweet old lady told reporters that she was so happy to get the jab as it meant she might see her family after being on her own for nearly a year. To some, however, the soon-to-be-91-year-old, who wore a penguin-themed charity Christmas t-shirt as she gamely received her vaccine, was the purest manifestation of their very darkest fears. Keenan, some conspiracy theorists alleged, is a crisis actor employed by the government to trick people into taking the vaccine. Others went further, claiming that Keenan is actually dead and an imposter sat in her place. It wasn’t explained what the exact point of that ruse would be. Of course, there is no evidence to support any of the conspiracy theories around Keenan, who is just a seemingly nice, and definitely alive lady who was the right age and lived in the right place to get the jab first. But, as Britain was the first Western nation to grant emergency use authorization for a coronavirus vaccine, it’s also the first to contend with rampant anti-vaxx disinformation during an unprecedentedly huge COVID-19 immunization rollout. Right now, anti-vaxx views in Britain aren’t quite as prevalent as in the United States. According to the latest polling figures, just one in five Brits said they were unlikely to take the vaccine if they’re offered it—a number which has shrunk in recent weeks. By comparison, polling released by Pew Research last week showed that around 39 percent of Americans are either unlikely or definitely not going to take a vaccine when it’s offered. But that doesn’t mean that there aren’t underlying fears ready to be exploited by opportunistic conspiracy theorists. The same polling showed that 48 percent of people in Britain are worried that the vaccine won’t be safe, and over half are worried about its possible side-effects. Other research showed, when exposed to specific bits of vaccine disinformation, less than half of Brits say they’ll definitely take the jab. Experts have said that around 70 percent the population will need to be vaccinated before COVID-19 can be considered to no longer be a threat—a target that could easily be undermined by anti-vaxxers. “I hope that enough people take these vaccines, but I think it is going to be much more of a challenge than is recognized,” Prof. Heidi Larson, director of the Vaccine Confidence Project, told the Financial Times last week. The University of Cambridge’s Dr Jon Roozenbeek, who has carried out research into COVID-19 conspiracy theories, told The Daily Beast: “I’d say the anti-vaccination movement is a pretty significant problem in terms of its potential to reduce trust in vaccinations, and by extension vaccination rates, in both [Britain and the United States].” The theories in Britain largely mimic the trusty old classics pushed in the U.S.—microchips, fetal tissue, 5G and so on—but they are occasionally given a decidedly British twist. For example, instead of Bill Gates installing microchips in grannies for unspecified reasons, one theory accuses Boris Johnson of carrying out the scheme instead. Earlier this year, a letter claiming to be from the PM went viral on Facebook. It said: “I am personally writing to you in order to alert you to a new government policy, in which we are proposing that all U.K. residents will be required to wear a RFID [radio-frequency identification] microchip from January 1st 2021.” If the absurd nature of the suggestion itself wasn’t the giveaway, the creators didn’t even use Johnson’s real signature. Another theory suggested that, because Johnson’s dad Stanley wrote a book called The Virus in the early 1980s, it proves that the pandemic was all part of a decades-long family plan. Perhaps the most absurd false claim that has been spread is one, reportedly pushed by Russia, that says the British-made Oxford vaccine could turn people into chimpanzees. While in the United States, anti-vaxxing is usually associated with freedom-loving, mask-hating, Trumpist conservatives, protests in Britain have had a more leftist anti-authoritarian flavor. In fact, one of the most prominent anti-vaccination protesters is Piers Corbyn, brother of former leader of the opposition Labour party Jeremy Corbyn. Piers Corbyn has called COVID-19 a hoax to install a new world order, using the term “plandemic,” and was charged for his role in anti-lockdown protests this month. Britain is also home to king of the conspiracy theory David Icke, who has been banned from some social media platforms for pushing ridiculous yet pervasive theories about the virus. But the focus on loud and eccentric oddballs like Icke and Corbyn risks overlooking much more dangerous and legitimate-looking sources of disinformation, which are much more likely to push people who are undecided about the vaccine to the dark side. Over the summer, The Guardian found that engagement with anti-vaxx posts on British Facebook pages had trebled—with one of the largest sources being an alternative medicine business, with two million likes, which has pumped out dozens of viral vaccine-sceptic posts. ITV News reported research Friday showing that there are some 5.4 million U.K. followers of anti-vaccination accounts across social media. The theories have also reportedly infected the country’s National Health Service, which has a central role in the vaccine rollout. According to the Times of London, a Facebook group containing hundreds of NHS staff was home to posts saying that the Pfizer-BioNTech coronavirus vaccine was a new virus, similar to smallpox, to be “unleashed” on the world. It’s sources like these that can sway people who are undecided about getting the vaccine towards avoiding it. A paper published in Nature earlier this year warned: “Anti-vaccination clusters manage to become highly entangled with undecided clusters in the main online network, whereas pro-vaccination clusters are more peripheral.” Those experts predict that anti-vaxx voices will drown out pro-vaccination voices online in the coming months and years. However, Britain’s health secretary Matt Hancock has insisted that the government is doing everything it can to stop the anti-vaxx movement from threatening the rollout of the COVID-19 immunization program. Last month, the government agreed with tech companies that it would flag misinformation and would expect a “timely response” for removal. Ministers are also said to get a weekly round-up of new COVID conspiracy theories to help coordinate the effort to neutralize them. “The good news is that it’s not growing,” Hancock said of the anti-vaxx movement last week on LBC radio, without explaining what he was basing that statement on. “We monitor this very carefully and actually the number of people who want to have the vaccine is increasing, and that’s good because obviously that’s the right thing to do.” If the government is looking for a vaccine cheerleader to fight back against disinformation, they could do worse than 90-year-old Keenan. After she took her historic shot Tuesday, she said: “My advice to anyone offered the vaccine is to take it. If I can have it at 90, then you can have it too.”
Germany shows the world the proper way to prepare for a mass vaccination rollout... As Germany awaits vaccine, mass vaccination centers are built in less than a week https://www.washingtonpost.com/worl...db9b08-3951-11eb-aad9-8959227280c4_story.html Under the curved brick-and-glass roof of the Arena Berlin, which began its life as a 1920s bus depot, workers raced to lay flooring and rig wiring for the building's newest metamorphosis: a mass vaccination center. The 70,000-square-foot space on Berlin’s River Spree is one of scores of vaccination sites German authorities were scrambling to finish before a Tuesday deadline. Albrecht Broemmer is in charge of getting six in Berlin ready, and it’s tight. “That’s my duty, but it’s hard work to get to it,” he said. The string of vaccination centers being built across the country come before Germany even has a vaccine to distribute.European approval of the Pfizer vaccine is expected sometime this month. The German approach could be watched closely by the United States and other countries around the world as they eye ways to vaccinate their populations as speedily as possible. Time constraints are particularly pressing with the Pfizer vaccine — developed by the German firm BioNTech with German government funding — because of its cold storage requirements. Members of the Federal Agency for Technical Relief help set up a center for vaccinations in a converted gymnasium in Eschwege. Germany’s federal states have scrambled to procure the deep freezers necessary for vaccine storage. The vaccine can survive for only about five days after being defrosted from minus-94 degrees, and it comes in trays of just under 1,000 doses, so experts say it makes sense for people to come to a central location that can get as many people in and out as possible. Britain, which began giving its first vaccines through hospitals this past week, is also expected to open mass vaccination centers next year. “We asked the federal states to be ready by Dec. 15. And we are confident they will be,” said Hanno Kautz, a spokesman for Germany’s Health Ministry. Vaccination centers are being constructed because “you want to be quick,” he said, and there simply isn’t the space at hospitals, he said. Construction is underway in all 16 German states. The central state of Hessen has said it will have 28 centers ready before the week is out, with the capacity to vaccinate 28,000 a day. Michael Schaich, a spokesman for the Interior Ministry, said that operations have been tested, including a “seamless logistics chain.” “We are well prepared,” he said. The western state of Baden-Württemberg is setting up nine large centers for its 11 million people, with 44 more community vaccination points to be added in January. “It’s better to have [vaccination centers] ready and there are delays than the other way around: having the vaccine and no vaccination centers ready to go,” Health Minister Jens Spahn told reporters last week as he visited a new vaccination center in a Düsseldorf soccer ground set up to give 2,800 shots a day. The Health Ministry did not provide numbers on how many vaccination centers it expects to be ready by Tuesday. The cost of Berlin’s six centers will range from about $70 million to $95 million, according to Broemmer, with other federal states outlining similar investments. At Arena Berlin, where Broemmer was overseeing the work, there are 80 small cubicles planned for the center, which is designed to vaccinate 4,000 people a day. The aim is to vaccinate 450,000 people in Berlin — about 10 percent of the population — within three months. But that will depend on supplies, and little is certain. Broemmer sketched out his plans for the space with a Lego brick model before handing them to architects. Centers will have a waiting area where patients will be monitored for a half-hour for side effects before they are allowed to leave. About 20 doctors will oversee the center at any one time, with about 150 staff members and volunteers. Those administering shots will be drawn from organizations such as the International Committee of the Red Cross, and Broemmer said the city also was in discussions with airlines including Lufthansa and easyJet about using flight attendants who have first aid training. Europe has purchased an initial 200 million doses of the vaccine, double the initial order from the United States. But Germany has also secured an additional 40 million outside the European Union contract. Germany’s federal states have scrambled to procure the deep freezers necessary for vaccine storage. That was a challenge, Broemmer said. “The problem is to find these fridges,” he said. “We ordered them two months ago, and we got them.” There are three for all of Berlin, enough to store the 900,000 doses of the Pfizer-BioNTech vaccine that it hopes to initially receive. In Hessen, Schaich said that his state had also made an “early effort” to get freezers, without giving specifics. “There are only a few suppliers for this ultra-freezing,” he said. Berlin’s three freezers will be kept at a central location in the city, one of 27 “distribution hubs” across the country, the location of which won’t be made public for security reasons. There are concerns that the centers could be targets for anti-vaxxers and followers of conspiracy theories. Germany has a vociferous anti-lockdown movement that has been becoming increasingly radicalized, with police still investigating an arson attack on the building of the federal agency for infectious-disease control in late October. On Wednesday, the domestic intelligence agency in Baden-Württemberg, home to some of the largest demonstrations, said it would put the main protest organizers — a group called Querdenken 711 —under observation. “We never know what happens around, what happens at night,” Broemmer said. “There might be arson or something like this. There might be some people that want to make trouble.” Throughout the pandemic, Germany has been quick to put in motion practical measures such as contact tracing, which took other countries months to roll out. However, now it’s struggling to bring down the number of new cases, as daily deaths reach a record high. Broemmer was also responsible for overseeing the construction of an overspill hospital in an exhibition center in Berlin during the first wave of the pandemic in the spring, which cost around $4 million but has not taken in a single patient. Still, Broemmer said, it’s better to be prepared. (More pictures in article)
Peru suspends Sinopharm COVID-19 vaccine trial after 'adverse event' https://www.smh.com.au/world/south-...rial-after-adverse-event-20201213-p56n22.html Peru has suspended trials for China's Sinopharm COVID-19 vaccine due to a "serious adverse event" that occurred with one of the volunteers for the study, the Peruvian government has said in a statement. The health ministry said the event is "under investigation to determine if it is related to the vaccine or if there is another explanation". Sinopharm Group Co Ltd, which is conducting its trials in Peru with some 12,000 volunteers, was about to complete the first stage of the trials in the next few days. Some 36,544 people have died so far in Peru from the coronavirus pandemic. "The decision to temporarily suspend clinical trials is a safety measure contemplated in the regulations for clinical trials and protocols established to protect the health of research subjects, the health ministry said in the statement. German Malaga, chief researcher at the local Cayetano Heredia University, which is involved with the study, said one volunteer had experienced decreased strength in his legs among other symptoms, and the condition could be related to Guillain-Barré syndrome. The Brazilian government has meanwhile unveiled its long-awaited national vaccination plan against COVID-19, with an initial goal of vaccinating 51 million people, or about a quarter of the population, in the first half of 2021. In a document sent to the Supreme Court, which had given the government a deadline to draw up the plan, the Health Ministry said 108 million doses will be available for priority vaccination of vulnerable groups that include health workers, elderly people and indigenous communities. The plan says 70 per cent of the population - or about 148 million of Brazil's 212 million people - need to be immunised to stop the virus spreading. The current plan covers just about one third of that goal. Researchers said the plan was hastily drawn up and had mistaken details about the potential vaccines. The plan, which says each person will need two doses, does not mention a starting date for vaccination of the population nor does it detail the supplies of vaccines that it will need. Brazil is in the midst of the world's second-deadliest coronavirus outbreak after the United States, with more than 180,000 deaths. On Thursday, Health Minister Eduardo Pazuello pledged to vaccinate Brazil's entire population against COVID-19 next year. The government of right-wing President Jair Bolsonaro has been under pressure from state governors and city mayors for failing to prepare in time for mass immunisation or secure a diverse enough supply of vaccines. Brazil reported 43,900 additional confirmed coronavirus cases in the past 24 hours and 686 fatalities from COVID-19, bringing total cases to 6,880,127 and the death toll to 181,123, the ministry said on Saturday. Although Brazil has an enviable record for national vaccination campaigns and a strong public health system, Bolsonaro has repeatedly denied the gravity of the virus and is a vaccine sceptic who has said he will not take a COVID-19 shot. He has also said his government will not buy the vaccine made by China's Sinovac Biotech Ltd that will likely be the first to complete late stage trials in Brazil. AstraZeneca , Pfizer Inc, and Johnson & Johnson's pharmaceutical subsidiary Janssen also have vaccines in Phase 3 trials in Brazil. Microbiologist Natalia Pasternak, a critic of the government's handling of the pandemic, tweeted that there was no provision for extreme cold-storage required by Pfizer's vaccine and China's CoronVac was ignored in the plan. Epidemiologist Ethel Maciel said that she and other scientist who were advising the government said they had not seen the plan before it was published and learned about it in the media. Bolsonaro's government is planning to set aside 20 billion reais ($5.3 billion) from its budget to buy COVID-19 vaccines. A poll by DataFolha published on Saturday showed that a growing number of Brazilians - 22 per cent - say they are unwilling to take any COVID-19 vaccine, and most said they would not accept one made by China, as Bolsonaro's comments stoke scepticism.