VAKCINA

Kirko Skaddeng wrote:Verovatno autor misli da duvamo jedni drugima u nos sasušenu sluz virusnih žrtava, i to jadni zovemo vakcinacijom.

Fascinating piece. Apparently, the UK was battening down early on vaccine delivery commitment in order to avoid possible US measures. Unlike EU, UK decided early what its basic priority was & stuck to it. Strategy is about achieving aims, not about ticking boxes. UK was strategic https://t.co/7LDQQqCtVk

— François Heisbourg (@FHeisbourg) February 1, 2021

Mór Thököly wrote:Da jbt.

Kako li smo se mi provukli bog zna

ćaća wrote:Odradila ih korporacija kao majmune, što i jesu.

https://www.politico.eu/article/europe-coronavirus-vaccine-struggle-pfizer-biontech-astrazeneca/

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When it came to vaccines, the Commission proposed doing something that would turn the tables.

On June 17, Health Commissioner Stella Kyriakides presented what would become the EU’s new vaccine plan. Rather than going back and forth to gather approvals from each EU country, the Commission repurposed a mechanism called the Emergency Support Instrument. The rarely used tool gave Brussels the ability to directly purchase vaccines — with some €2.1 billion initially allocated for the task. Once approved by regulators, the jabs would be distributed to EU countries according to their populations.

All that was left to do was convince the Inclusive Vaccine Alliance to give up its head start.

In addition to making the case that both altruism and self-interest would be best served by empowering the Commission, von der Leyen also added firepower to DG SANTE — the relatively sleepy department with little real authority that would be charged with negotiating with the drugmakers.

Hours after Kyriakides debuted her strategy came the quieter announcement that Sandra Gallina, deputy director general in the Commission’s trade department, would take charge of DG SANTE’s health division. Granted, she didn’t have a health background, but she was fresh off a bravura performance as the EU’s top haggler for the Mercosur trade accord.

Von der Leyen’s team also sweetened the pot for the members of the Alliance: Each of the four countries scored seats on the seven-member negotiating team. (The remaining three spots went to Spain, Portugal and Poland.)

IN ITS VACCINE NEGOTIATIONS, Gallina and her team put great importance on three things: a wide selection of potential vaccines, low prices for each jab, and that drugmakers would bear legal responsibility if anything went wrong.

They tackled the latter point, liability, from the get-go. “We knew already that that was likely to prove a difficult subject,” said the Commission official close to the negotiations.

Immediately, the big multinational pharma players launched what looked to the EU negotiators like a coordinated effort to secure protections in case something unexpected went wrong with their vaccines after they hit the market.

A 15-year-old American law, known as the PREP Act, shields manufacturers from being taken to court in the U.S. if something goes wrong with a vaccine or medicine they make to respond to an emergency — and other U.S. programs limit and cover potential damages.
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Both sides tried to use Europe’s vaccine skepticism to their advantage. Lobbyists and lawyers for Big Pharma argued that public lawsuits for every accusation would only fuel concerns about vaccines. Instead, they urged a no-fault compensation system that would pay damages without a fuss.

The lobbying backfired. A memo circulated by the industry group Vaccines Europe calling for liability protection made its way to the Financial Times on August 26. Gallina was soon called into the European Parliament, where she repeatedly promised that drugmakers would remain responsible for any problems, even though the issue was proving a sticking point.

“Perhaps some others — not the EU, but some others — have done other approaches on liability,” she told members of Parliament. “But we knew that vaccines are an emotional issue. Nobody can trust the vaccines when you have cut the corners.”

The Commission was willing to compromise, by covering some of the legal bills and damages to drugmakers if unexpected problems emerged. But hashing out those terms dragged out the process, and in the end, each agreement was bespoke. For companies that agreed to sell vaccines at cost, the so-called indemnity protections were fairly generous. Those seeking a profit would have to fend more for themselves.
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Tensions were building between the countries who had vaccine producers “on their shores,” including France, Germany, Italy, Sweden and the Netherlands, and “those who just pay for it” as one diplomat put it. The latter — generally in the east — questioned the motives of countries with big pharma industries, assuming they were eager to spend more because their companies would benefit from taxpayer dollars.

When the Commission asked for another €750 million on September 4 to finalize deals and add another vaccine from Novavax, several countries balked and called for the Commission to better justify its choices. Although capitals ultimately agreed to the boost in the end, it took months for them to send their money to Brussels.

Meanwhile, the Commission’s negotiations with producers of mRNA vaccines were dragging on. COVID-19 didn’t just lend urgency to the negotiations: Talks were held virtually, adding an intangible complication. Austria’s Clemens Martin Auer, the chair of the member country steering board for the negotiations, remarked in late August that he had still never actually met Gallina in person — though he was by then a committed fan.

Talks with American companies, especially Pfizer and Moderna, proved especially thorny: Both reopened aspects of the contracts that had already been determined when the companies, in the view of the Commission official close to the negotiations, thought they had a bit more leverage.

In an interview with AFP in November, Moderna CEO Stéphane Bancel griped that dealing with 27 member countries was slowing everything down. By contrast, he said the American company had wrapped a deal with Canadian authorities two weeks after starting talks. A delayed order, Bancel said, “is not going to limit the total amount, but it is going to slow down delivery."
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If there’s only one thing that industry, national governments and the Commission agree on, it’s that Gallina “played a decisive role in the EU vaccines’ deals success,” as the lobbyist Antoine Mialhe put it.

Gallina “managed to keep member states happy while being sometimes harsh with companies,” said Mialhe, head of healthcare at FTI Brussels, a consulting firm that had several vaccine manufacturers, including Moderna, as clients during the pandemic.

The terms of the Commission’s procurement contracts are confidential (to the chagrin of many in the European Parliament). Only one deal has been made public, and key details have been redacted. But the available information points to a robust defense of European consumers and their pocketbooks: A leaked price list suggests Gallina was able to drive down prices lower than her counterparts in Washington.
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WHERE THE EU DIDN'T PERFORM AS WELL as the U.S. and the U.K. was speed.

The Commission had offered to let the U.K. join its vaccine purchasing program, but London — with the reality of Brexit in its sights — had declined. Instead, the U.K. proceeded to ink its own deals. Beyond its homegrown Oxford/AstraZeneca jab, the government also inked deals for shots from BioNTech/Pfizer and — shortly after preliminary data came out — Moderna.
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“Generally you go to the U.S. first as that’s where you start earning back your investment,” said Schulthess. Approval in the EU involves interactions with 27 different health ministries. In the U.S., “it’s faster to get revenue, the prices are generally higher, and these applications are large and very technical.”

European politicians around the Continent were up in arms about the longer wait before vaccinations could begin.

“We need to be as quick as we can,” said German Health Minister Jens Spahn. Malta’s Chris Fearne said it might be helpful for the EMA to “explain to us, and more importantly to the wider European general public” why Europe had been slower to approve the vaccine. Other health ministers and EU leaders pushed out of the public eye, phoning the Berlaymont instead. At a Council summit on December 10, Polish Prime Minister Mateusz Morawiecki urged the Commission to hurry up.

Meanwhile, European citizens weren’t getting the jabs that could slow the epidemic and save their lives.

Vaccinations in the EU began on December 26, after three countries — Hungary, Germany and Slovakia — jumped the gun on the Commission’s proposal to start on December 27.

IT DIDN'T TAKE LONG for the recriminations to start.

Von der Leyen was quick to claim the coordinated rollout as “a true European success story,” but some diplomats rolled their eyes at her attempt to make countries join hands and vaccinate together. One chalked it up to von der Leyen not missing a photo-op for the Commission.
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The head of the team that developed Sputnik V is Denis Logunov, a fortytwo-year-old microbiologistwith a fuzzy beard,the shoulders of a defensive lineman, and the demeanor of a researcher who would prefer to busy himself with experiments rather than to boast of the results. He and I walked across the snow-mottled campus of the institute to hislaboratory,where he had overseen the development of the vaccines for Ebola and MERS, in addition to Sputnik V. There, we put on lab coats and disposable plastic covers for our shoes. A sign on the door read “Caution! Biological Hazard!”

In 2014, after the outbreak of Ebola in West Africa, Logunov and other Gamaleya scientists had set out to create a vector vaccine using a modified form of the human adenovirus, which causes the common cold. That year, Chumakov, the
virologist from the Global Virus Network, visited Logunov and his team, and was impressed. “I have no questions about
their professional qualities and abilities,” he told me. “They are certainly not worse than any of the many other people involved in vaccine development.” In the summer of 2017, the Gamaleya scientists sent two thousand doses of the vaccine to Guinea for a Phase III trial. By then, the country’s epidemic had largely petered out, so it wasn’t possible to gauge its efficacy in a clinicalsetting as planned. All the same, Putin claimed that the Gamaleya vaccine had “proved to be the most effective in the world.” (It was approved in Russia, but it has yet to be licensed by an international regulatory body. An Ebola vaccine developed by Merck was approved by the W.H.O. in 2019, and one by Johnson & Johnson won the European Commission’s market authorization last July.) In 2018,Gamaleya developed a vaccine for MERS, but that outbreak also subsided, and the vaccine prototype did not reach a Phase III trial or feature in scientific journals abroad. As Ilya Yasny, the head of scientific research at Inbio Ventures, an investment fund in Moscow, put it, describing the two earlier would-be successes of the institute’s scientists, “We have to take them at their word.”
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Johnson & Johnson uses adenovirus-26, a rare variant of cold virus to which most recipients would be unlikely to mount a robust immune response.The Oxford-AstraZeneca vaccine uses an adenovirus strain that infects chimpanzees, and to which humans presumably do not have preëxisting immunity. The researchers at Gamaleya decided to use two separate vectors, as they had done with their Ebola and MERS vaccines. In the first dose, the vector would be adenovirus-26; for the second shot, which is meant to help induce long-lasting immunity by activating T cells, they chose adenovirus-5, a more common strain.

Jerome Kim,the director of the International Vaccine Institute, told me that the two-vector approach, known to scientists as “heterologous prime boosting,” is grounded in sound theory. “It’s a way to confuse the immune system so that it focusses on the COVID-19 protein,”he said.But, he added, “we need to see the data before we can say whether this particular vaccine is ready for prime time.” Chumakov expressed similar reservations, saying that,until the long-term efficacy of the various vectors has been proved, the arguments for and against each approach remain “entirely theoretical, and thus equally valid or bogus.” In assembling the vaccine, Gamaleya’sscientists used an enzyme to stitch togethe rthe vectors’ DNA and the gene that codes for the spike protein of SARSCoV-2. In less than twoweeks, and even before Moscow went into lockdown, a prototype vaccine was ready. Logunov showed me his laboratory’s vivarium, a small room with dozens of plastic cages of live mice stacked nearly to the ceiling. In March, researchers vaccinated mice and analyzed their blood for an immune response. Next came hamsters and guinea pigs, followed by macaques and marmosets. All produced high levels of antibodies, and the vaccinated animals did not become ill.
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In early September, Logunov and his colleagues published the results from Sputnik V’s combined Phase I and II trials in The Lancet. There were only seventy-six participants—aboutthe same number as in the equivalent trials by Pfizer, but fewer than in Moderna’s, which had several hundred volunteers, or in Oxford-AstraZeneca’s, which had more than a  thousand. All the participants had produced large quantities of antibodies and infection-fightingT cells, and no one had become infected or developed seriousside effects.The authors wrote that the vaccine was “safe, well tolerated, and induces strong humoral and cellular immune responses.”

Three days later,an open letter, which has since been signed by almost forty scientists,mostly from prominent Western research centers,pointed out a number of supposed irregularities with the data. Most significant,the reported antibody levels of participants looked strangely similar. “On the ground of simple probabilistic evaluations the fact of observing so many data points preserved among different experiments is highly unlikely,”the letter read. One of its signatories, a Russian-born molecular biologist at Northwestern University named Konstantin Andreev, told me, “We  eren’t saying whether the vaccine is good or bad, safe or unsafe. Our objection wasn’t really to the vaccine per se but to how the researchers carried out their study.At minimum,it was sloppy; at most, it was manipulated.”The signers ofthe letter requested the raw data from the trials so that they could draw their own conclusions. Logunov and his co-authors replied in The Lancet, saying that any repetitive figures were the result of simple coincidence, the small number of participants, and lab instruments that distribute values into discrete clusters. They declined to provide the raw data. Logunov told me that to give such information to anyone who asked for it would be a distraction, and a violation of the norms and practices of modern pharmaceutical development. “There are seven billion people on earth, and it’s impossible to present every data point to everyone,” he said. “No one works this way.”
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In mid-December, on the basis of data collected from some twenty-three thousand participants in its Phase III trial, Gamaleya issued its final determination of the vaccine’s efficacy: 91.4 per cent.“I don’t expect everyone to  immediately love me and believe in my product,” Logunov said.“There’s no need to trust me.Just look at the numbers—the serological results of those vaccinated, the antibody titers they produce, their rates of infection.”Nearly five hundred participants in the Phase III trial shared early global vaccine bonanza.A September report from Oxfam revealed that nations representing thirteen per cent of the world’s population have purchased fifty-one per cent of all anticipated vaccine supplies. The U.K. and E.U. member states have secured orders for enough doses to vaccinate their entire populations nearly three times over. Covax, a program led by the W.H.O.to insure an equitable global vaccine supply, has said that it will likely be able to inoculate only twenty per cent of the populations of developing countries this year; as yet, none of those doses have been distributed.
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Recently, international researchers have raised concerns about new strains of the coronavirus,particularly the South African variant,which carries a mutated spike protein that may help the virus bypass immune protection. Moderna  announced that it was testing a “booster shot.”Gushchin told me that Sputnik V’s “protective efficacy may be reduced, but likely only by a little bit.” Even if the virus did manage to get past a vaccinated person’s antibodies, he explained, the T cell immune response should prevent that person from getting sick. “We’re looking into it,” he said.
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Marius Lăcătuș wrote:Natrag u realnost. Vest dana je da Srbija testira kinesku vakcinu na Hrvaticama:

http://www.rudan.info/evropljanka-u-beogradu/