Israel's rapid rollout provides the first real-world proof that COVID vaccination works as well as promised https://www.yahoo.com/news/israels-...tion-works-as-well-as-promised-152103525.html When it comes to vaccinating people against COVID-19 as quickly as possible, Israel is the undisputed world champion so far. In per capita terms, the country has administered more than 55 doses of either the Pfizer or the Moderna vaccine for every 100 residents. A full third of its population has already received at least the first of the two required doses. No other nation comes close. In fourth and sixth place, respectively, the United Kingdom (15 doses per 100 residents) and the United States (10 doses per 100 residents) trail far behind. The main driver of Israel’s rapid rollout — an efficient nationalized health system in which all 9 million citizens hold identity cards and register their electronic medical files with one of the country’s four national health maintenance organizations (HMOs) — is not something other nations can emulate on the fly. And Israel’s refusal to vaccinate all but a handful of Palestinians has been deeply controversial for both ethical and medical reasons. Yet the rest of the world can still learn a lot from what’s happening there. Now that such a huge share of Israelis have been vaccinated, experts are looking at the country’s experience as a kind of real-world, real-time experiment, with far more participants than any clinical trial and unique data that could start to answer some of our most pressing questions about the power of vaccines to curb the pandemic. Here are four key takeaways from Israel’s latest numbers: The vaccines look like they’re as effective as promised — even against the U.K. variant The launch of Israel’s vaccination campaign on Dec. 20 coincided with the start of its third — and largest — wave of infections. Two weeks later, the country reentered its version of strict lockdown, and even today it’s averaging as many cases as it did during the peak of its previous surge in September. This has caused some confusion. If the Pfizer and Moderna vaccines work so well, onlookers have wondered, then why is Israel’s outbreak still raging? Adding to concerns were comments late last month from the country’s coronavirus czar claiming that a single dose of the Pfizer vaccine appeared “less effective than we had thought,” based on preliminary data. (Israel struck a deal with Pfizer for a stable pipeline of doses in exchange for patient data.) But these fears about effectiveness may finally be put to rest with the release of results from the world’s first big controlled investigation into how a COVID-19 vaccine performs outside of clinical trials. Of 163,000 Israelis given both doses of the Pfizer vaccine by Maccabi Healthcare Services, the nation’s second-largest HMO, just 31 were diagnosed with COVID-19 during their first 10 days of full-strength protection, the Times of Israel reported late last week. Maccabi then compared that number to the number of infections over the same period among an equivalent sample of Israelis with similar age and health profiles who hadn’t been vaccinated — and found that members of the control group were 11 times more likely to test positive. The upshot? According to Maccabi’s calculations, the Pfizer vaccine is 92 percent effective at preventing infection starting seven days after the second dose — a result that’s right in line with Pfizer’s own clinical data. Subsequent waves of real-world data this week have continued to confirm the 92 percent number. “This is very, very good news,” Anat Ekka Zohar, Maccabi’s top vaccine statistics analyst, told the Times of Israel. “It is the first study in the world that looks at such a large number of fully vaccinated patients.” And the good news doesn’t stop there. Of the 31 fully vaccinated Maccabi members who did test positive, not a single person needed to be hospitalized. “They have very, very light symptoms,” Ekka Zohar reported. “We are talking about headache and a mild feeling of sickness, and they are almost completely without fever. It’s really a very light illness.” In other words, full vaccination seems to make any COVID-19 infection that slips past the body’s bolstered defenses even less risky, on an individual level, than the flu. This is an incredible level of protection. Clinical trials have also shown that all five vaccines with public results can prevent deaths and nearly eliminate hospitalizations. What’s more, Israel’s latest surge has been supercharged by the U.K. variant known as B.1.1.7, which is significantly more transmissible than earlier versions of the virus and now accounts for about 70 percent of all cases there — yet the Pfizer vaccine doesn’t seem to be any less effective because of it. Again, clinical trials previously suggested that B.1.1.7 wouldn’t be able to evade the vaccines. But real-world data is reassuring. Israel’s rapid vaccination rollout may finally be starting to reverse its winter surge It’s one thing for a vaccine to protect an individual person; the data from clinical trials has consistently been very encouraging on that front. But it’s another thing for vaccination to start to protect a population — and turn the tide of a pandemic. No clinical trial can predict when or how that will happen. Yet it may be starting to happen in Israel. Beyond health care workers, the first big group of Israelis eligible for vaccination were residents over 60. Today, about 72 percent of them have already received their second dose. The result, according to Eran Segal, a computational biologist at Israel’s Weizmann Institute, is that over the past two weeks cases in this age group have fallen 41 percent, hospitalizations have fallen 32 percent and critical illness has fallen 27 percent — trend lines not seen during any previous, pre-immunization lockdown, and not seen today in any other (read: less vaccinated) age group. In addition, such declines were most pronounced in cities that vaccinated the most residents early on. “We say with caution, the magic has started,” Segal tweeted Monday. All real-world data comes with caveats. In Israel’s case, the precise (and likely conflicting) impact of the lockdowns and new strains is hard to quantify, and people who get vaccinated and tested for COVID-19 are not necessarily representative of an entire population. Still, Segal’s numbers suggest that even as more transmissible variants increase infections across other age groups, a population that is largely vaccinated will start to be immune, so to speak, from that spread. Which is exactly the sort of shift in the dynamics of the pandemic that everyone is hoping mass vaccination can trigger. The side effects have been minor This week, researchers from Israel’s Health Ministry released a report that should also calm the nerves of anyone who’s anxious about the risks of vaccination. In the world’s most detailed data yet on how the Pfizer vaccine makes people feel, the Health Ministry reported Tuesday that just 6,575 of nearly 2.8 million Israelis sought medical assistance for side effects after their first shot, or less than a quarter of 1 percent. The figure after the second shot, which is said to pack more of a punch, was nearly identical at 0.26 percent (or 3,592 of nearly 1.4 million recipients), suggesting that even more uncomfortable side effects almost never escalated to formal medical complaints. According to researchers, any symptoms were “similar in frequency and character to symptoms reported after other vaccines given to the population” — both “mild” and “soon [to] pass.” Arm pain accounted for 50 percent of first-shot complaints and 22 percent of second-shot complaints. Some 41 percent of first-shot and 73 percent of second-shot complainers reported feeling generally unwell. An average of just 17 patients per million sought hospitalization after the first shot; that number fell to just three patients per million after the second shot. “People around the world should feel reassured,” Yoav Yehezkelli, a physician and Tel Aviv University public health expert who was not involved in the study, told the Times of Israel. In the future, demand could be more of an issue than supply Israel’s vaccination campaign has been moving so quickly, in fact, that health care providers are finding it increasingly difficult to get people to come in and be vaccinated, with the Health Ministry reporting Monday that the country’s daily rate of vaccinations had fallen by nearly half from two weeks earlier, even as eligibility was recently extended to anyone over 35 as well as students ages 16 to 18. As a result, local providers have discarded thousands of thawed but unused doses and invited younger, technically ineligible residents to get inoculated. Israel is expected to officially open its vaccination campaign to all ages nationwide by next week. It’s a problem that seems utterly alien to Americans, who’ve grown accustomed to supply shortages and crashing appointment websites. But the U.S. could eventually find itself in a similar position. Like Israel, the U.S. has already reserved enough doses of various vaccines to immunize its entire population (and then some). And like Israel, where the vaccination rate is much lower among Arabs and ultra-Orthodox citizens than among other groups, vaccine hesitancy may eventually pose a challenge in the U.S. too. According to a recent CNN poll, 30 percent of U.S. adults say they won’t even “try” to get vaccinated once they’re eligible. That number climbs to 43 percent among 18- to 34-year-olds and soars to 56 percent among Americans who approve of former President Donald Trump, who spent much of the 2020 election downplaying the virus’s severity. It remains to be seen how durable this resistance is and what threat it poses to achieving population-wide herd immunity, which experts define as the point when so many people gain protection through either vaccination or prior infection that the virus can no longer easily spread from host to host. The gold standard, they say, will be getting about 75 percent of Americans (or 240 million people) fully vaccinated. But given that no vaccines have been approved for the 25 percent or so of Americans who are under 16, hitting that 75-percent mark in 2021 would effectively mean vaccinating 100 percent of eligible adults. That’s hard to do when 30 percent of them say they aren’t even willing to try. Israel’s experience should serve as a valuable preview of how declining demand might affect vaccine uptake — not to mention how (and whether) the problem can be solved.
It shows you how smart younger healthy people are. Its the flu for them. Why would they get vaccinated with an experimental vaccine if the manufacturers are not even sure it will help prevent them from spreading the virus. Especially women who might be concerned about getting pregnant. Give the vaccine a few years of success and tolerable side effects and I am sure the uptake in younger groups will rise with Covid is still around and mutating.
(Re-posted from the other thread) Single Pfizer shot 90 percent effective after 21 days: study https://medicalxpress.com/news/2021-02-pfizer-shot-percent-effective-days.html A single dose of the Pfizer vaccine provides "very high" protection from COVID-19 after 21 days—without a 'top up' dose in the recommended time frame, according to a new study from the University of East Anglia. Researchers looked at data from Israel, where the vaccine has been rolled out. They found that the Pfizer vaccine becomes 90 percent effective after 21 days—supporting UK plans to delay the timing of a second injection. But they warn that people's risk of infection doubled in the first eight days after vaccination—possibly because people become less cautious. Due to the rapid response nature of this research it has not yet been peer reviewed. Lead researcher and COVID-19 expert Prof Paul Hunter, from UEA's Norwich Medical School, said: "A second dose of the Pfizer vaccine would normally be given 21 days or more after the first to top up and lengthen the effect of the first dose. "But here in the UK, the decision was made to delay the timing of the second injection until 12 weeks after the first. "The logic behind this is to protect more people sooner and so reduce the total number of severe infections, hospitalisations, and deaths. "But this decision caused criticism from some quarters due in part to a belief that a single injection may not give adequate immunity. "A recent non peer-reviewed pre-print paper based on Israel's experience looked at data from 500,000 people who had been given the Pfizer vaccine. It reported that a single dose may not provide adequate protection. "But we saw a number of flaws in how they looked at the data including the fact that they did not attempt to estimate the effectiveness of the vaccine from day 18 onwards. This would have given a better indication of how effective a single dose of the vaccine could be if the second dose was delayed by up to 12 weeks." The research team set out to estimate the effectiveness of the Pfizer vaccine after a single dose—by reanalysing real-world outcomes from Israel. They used the data to see how the Israeli vaccination programme impacted case numbers, and went on to estimate vaccine effectiveness over time. They found that after the initial vaccination—case numbers increased for eight days before declining to low levels by day 21. Prof Hunter said: "Surprisingly, the daily incidence of cases increased strongly after vaccination till about day eight—approximately doubling. We don't know why there was this initial surge in infection risk but it may be related to people being less cautious about maintaining protective behaviours as soon as they have the injection. "We found that the vaccine effectiveness was still pretty much zero until about 14 days after people were vaccinated. But then after day 14 immunity rose gradually day by day to about 90 percent at day 21 and then didn't improve any further. All the observed improvement was before any second injection. "This shows that a single dose of vaccine is highly protective, although it can take up to 21 days to achieve this. "And it supports the UK policy of extending the gap between doses by showing that a single dose can give a high level of protection. "Whilst we do not know how long this immunity will last beyond 21 days without a second booster, we are unlikely to see any major decline during the following nine weeks," he added. Prof Hunter and Dr. Brainard were funded by the National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Emergency Preparedness and Response at King's College London in partnership with Public Health England (PHE) in collaboration with the University of East Anglia. "Estimating the effectiveness of the Pfizer COVID-19 BNT162b2 vaccine after a single dose. A reanalysis of a study of 'real-world' vaccination outcomes from Israel" is published on the medRxiv pre-print server: www.medrxiv.org/content/10.110 … 021.02.01.21250957v1
"Hey... I got an idea... let's inject them with any ole shiat we can get our hands on." Covid trial in UK examines mixing different vaccines BBC - https://tinyurl.com/2lytwpbb A UK trial has been launched to see if giving people different Covid vaccines for their first and second doses works as well as the current approach of using the same type of vaccine twice. The idea is to provide more flexibility with vaccine rollout and help deal with any potential disruption to supplies. Scientists say mixing jabs could also possibly give even better protection. The vaccines minister said no changes would be made to the UK's current approach until at least the summer. Currently, official guidance from the Joint Committee on Vaccination and Immunisation (JCVI) says anyone already given the Pfizer-BioNTech or Oxford-AstraZeneca jab as part of the UK's approved immunisation programme should get the same vaccine for both doses. There is no suggestion this will change, although in very rare circumstances a different vaccine can be used - if only one vaccine is available, or it's not known which was given for the first dose. Vaccines Minister Nadhim Zahawi said the government's taskforce had given about £7m to fund the study, but that findings would not be available until the summer and therefore "at the moment, we're not changing anything at all". Previous experience suggests mixing vaccines could be a beneficial approach - some Ebola immunisation programmes involve mixing different jabs to improve protection, for example. And Mr Zahawi told BBC Breakfast that this has been done with other vaccines such as jabs for hepatitis, polio and measles, mumps and rubella. The Com-Cov study, run by the National Immunisation Schedule Evaluation Consortium, will involve more than 800 volunteers. The study will be recruiting people aged 50 or older, who have not yet received a Covid vaccine, in London, Birmingham, Liverpool, Nottingham, Bristol, Oxford and Southampton. Some will receive the Oxford jab followed by the Pfizer vaccine or vice versa, four or 12 weeks apart. Other vaccines may be added as they are approved by regulators. (More at above url)
Summary: India is promoting the two internal COVID vaccines it has developed which are much cheaper. They kept delaying emergency approval for Pfizer demanding large amounts of additional paperwork. Pfizer basically said "enough of this bullshiat" and left the market. This is not an issue about the Pfizer vaccine being safe and effective. Pfizer withdraws application for emergency use of its Covid-19 vaccine in India https://www.cnbc.com/2021/02/05/pfi...ncy-use-of-its-covid-19-vaccine-in-india.html Pfizer has withdrawn an application for emergency-use authorization of its Covid-19 vaccine in India that it has developed with Germany’s BioNTech, the company told Reuters on Friday. The U.S. company was the first drugmaker to apply for emergency use authorization of its Covid-19 vaccine in India. Pfizer had sought authorization for its vaccine in India late last year, but the government in January approved two much cheaper shots. Pfizer has withdrawn an application for emergency-use authorization of its Covid-19 vaccine in India that it has developed with Germany’s BioNTech, the company told Reuters on Friday. The U.S. company, which was the first drugmaker to apply for emergency use authorization of its Covid-19 vaccine in India, had a meeting with the country’s drugs regulator on Wednesday and the decision was made after that, the company said. “Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” it said in a statement to Reuters. “Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.” Pfizer had sought authorization for its vaccine in India late last year, but the government in January approved two much cheaper shots — one from Oxford University/AstraZeneca and another developed at home by Bharat Biotech with the Indian Council of Medical Research. Both companies had applied for approval of their vaccines after Pfizer. India’s Central Drugs Standard Control Organization had declined to accept Pfizer’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters has reported. Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in Western nations. There are, however, provisions under India’s New Drugs and Clinical Trial Rules, 2019, to waive such trials in certain conditions. Pfizer earlier told Reuters its application was supported by data from a global study that showed an overall efficacy rate of 95% with no vaccine-related, serious safety concerns.
Johnson & Johnson requests FDA authorization for its one-dose COVID-19 vaccine https://www.usatoday.com/story/news...uthorization-its-covid-19-vaccine/4331329001/ Johnson & Johnson submitted paperwork Thursday requesting that the U.S. Food and Drug Administration authorize its COVID-19 vaccine for use in adults. The FDA announced later in the evening that its advisory committee will meet Feb. 26 to discuss the application. The agency is expected to authorize the vaccine within a few days of that meeting, making it the third available to the American public. J&J announced last week that its vaccine was 72% effective in a U.S. trial, though it was less effective among people in Latin America and South Africa, bringing overall effectiveness down to 66%. That compares to findings last year that vaccines from Pfizer-BioNTech and Moderna that their vaccines would be more than 94% effective. Federal officials have said, however, that the trials are not directly comparable because they were conducted at different points in the COVID-19 pandemic. Safety of vaccines holding: The first 22M Americans have been vaccinated for COVID-19, and initial safety data shows everything is going well, CDC says It's possible J&J's vaccine would have shown equal effectiveness if its trial had been conducted last summer and fall as the other two were. Now, there are multiple different variants of the virus that causes COVID-19, which might weaken the vaccine's effectiveness. Still, NIH director Dr. Francis Collins and America's top infectious disease expert Dr. Anthony Fauci, said last week that the J&J vaccine would provide a profound benefit to the fight against the pandemic. The J&J vaccine is meant to be delivered as a single dose, though the company is running a separate trial to determine if a second dose is worthwhile. The vaccine can also be stored at refrigerator temperatures, so it will be easier to distribute than the Pfizer-BioNTech and Moderna vaccines, both of which must be kept frozen much of the time. All the vaccines appear to protect against severe disease and prevent deaths from COVID-19. "Today's submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic," Dr. Paul Stoffels, J&J's chief scientific officer said in a prepared statement. The company expects to have product available upon authorization. "With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible," Stoffels said. Before authorization, an FDA advisory committee must review the vaccine's data and application in a public hearing that must be announced two weeks ahead of time. That hearing has not been scheduled. Last year, the federal government spent $1 billion to pre-purchase 100 million doses of J&J vaccine, in addition to nearly $500 million to help develop the vaccine. The government also holds an option to purchase enough doses to vaccine 300 million more people. Because the J&J vaccine requires only one shot instead of the two required of the other two authorized vaccines, people will be considered protected within two weeks of receiving their injection. It's not clear whether people will be able to choose which vaccine they receive, or whether different vaccines will be prioritized to different groups. Some have suggested that it may make sense to continue vaccinating older, more vulnerable people with the Pfizer-BioNTech and Moderna vaccines that showed 94% effectiveness, reserving the J&J vaccine for people at lower risk from COVID-19. An advisory committee to the Centers for Disease Control and Prevention would make any such recommendation for use before the latest vaccine is authorized. There are two more candidate vaccines that could be available in the coming months. One from AstraZeneca and Oxford University has completed a large trial in the United States and is expected to have effectiveness data available later this monthor early next, with authorization likely next month. In earlier trials in other countries, effectiveness data was muddied by dosing differences, but it appeared to be about 60% effective overall. Gaithersburg, Maryland-based biotech company Novavax is currently recruiting for a large-scale trial in the United States. As of last week, it had recruited 13,000 people out of a desired 30,000. This vaccine was shown to be 90% effective in a trial in the U.K., though just 50% effective in South Africa, where a variant has taken hold, and where high rates of people immunocompromised with HIV also reduced effectiveness. Both the AstraZeneca-Oxford vaccine and the one from Novavax are to be given in two doses and both can be stored in refrigerators, making them relatively easy to distribute.
Why wait three weeks (2/26) to meet? All we hear is the lack of vaccine, not getting it fast enough. Why are we waiting?
Why the FDA is taking 22 days to look over J&J’s data https://www.theverge.com/2021/2/6/22269580/fda-johnson-and-johnson-vaccine-covid-review-antivirus A billion years ago last summer, people were getting antsy about vaccines. They wanted things to move faster, maybe skip a few steps in clinical trials to speed things up. This was, at the time, generally considered a bad idea that would result in less accurate data and cause people to lose trust in the vaccines. Now, exactly 1.589 trillion years later, recklessly speeding things up for speed’s sake remains a poor choice, but some people on Twitter like journalist Nate Silver, seem to think we should do it anyways. They take particular issue with the fact that while Johnson and Johnson submitted their data from their giant clinical trial this week, the Food and Drug Administration will take until February 26th to review the data. Three weeks can feel like an eternity during the pandemic, with hospitals crowded and deaths still climbing. It’s easy to be flip about the process and want things to Just. Go. Faster. But the 22 days is not that much longer than the 20 days the agency took to review data for Pfizer/BioNTech’s vaccine or the 17 days for Moderna’s candidate. Here’s what’s going to happen during those days. Researchers at the FDA will have to review the data from the 43,783 people who participated in the trial. This will entail looking at the cases across all study sites — here in the US, in Latin America and in South Africa, where a new coronavirus variant is dominant. The typical review process for a vaccine can take months. Instead, it will happen in a few weeks. If the process is anything like what the FDA planned for the earlier vaccine candidates, those weeks will be filled with a lot of late nights and workers doing everything that they can to reasonably speed things up. “Groups have been working in shifts, nights and weekends, looking in parallel at issues of clinical effectiveness and safety, and of levels of antibodies to confirm the way the vaccine is working.” the Wall Street Journal reported in December. Why do all that work? Right now, the information that we have about the vaccine comes from the company. That information is promising, and shows that it will probably be a good vaccine. But there are reasons that the FDA doesn’t just take a company at its word. Let’s turn to noted scientific historian Billy Joel, and the “children of thalidomide.” Thalidomide was a sedative that was given to pregnant people in the 1960’s as a cure for morning sickness. It caused birth defects in thousands of children across the world. In the US, pregnant women were given the drug in clinical trials, but unlike other countries, it wasn’t approved for sale at the time, thanks to Frances Kelsey. Kelsey was a drug reviewer at the FDA who looked over data from the company trying to sell the drug and found it unconvincing. The incident led to new laws that let the FDA determine a drug’s safety and effectiveness. Taking the time to review a vaccine during a pandemic might seem like rearranging deck chairs on the Titanic — but it’s actually inspecting the lifeboats before you leave port. We have procedures and protocols for a reason. When we launch something big, like a rocket, engineers don’t just push a button and send it soaring. They go through detailed pre-flight checklists, making sure that every bit of a spaceship is sound. We’ve learned the hard way that disregarding safety procedures can cost lives. Pushing out a third vaccine quickly might help save lives, yes. But only if people are willing to take it. Some healthcare workers are already hesitant to take the vaccine. They worry that the process is rushed. Rushing the process more isn’t likely to convince them — people who generally are not opposed to vaccines — that the process is safe and secure. I get it. Waiting sucks. But when you’re injecting people with a new treatment and the trust of billions of people is on the line, sometimes it’s worth taking the time to double-check your work.
"Confidential European Commission documents seen by a German media team show a majority of EU member states wanted "traditional" vaccines and were "very little interested" in new-type jabs from BioNTech-Pfizer and Moderna." Now EU countries are eating their words and frothing at the mouth demanding doses of very effective Pfizer and Moderna vaccines. The "traditional" vaccines desired by EU countries have proven to be delayed in delivery or nearly ineffective -- at minimum the mRNA vaccines have proven to have much better effectiveness than "traditional" vaccines. The EU is now eating its words as the Europe faces a vaccine shortage crisis after they refused to pre-order a significant number of doses of Pfizer or Moderna vaccines. This is -- of course -- after they spent months bad mouthing the Pfizer & Moderna vaccines on the basis of pricing, liability, and cold storage requirements -- all as a basis to push "traditional" vaccines. Well now the birds have come home to roost. The EU placed its bets on "traditional" horses and lost -- now they are complaining about it. COVID vaccines largely unwanted at first, slowed EU talks: report The race in Brussels last year to find COVID-19 vaccines was fraught by wrangling among many EU states over the type of inoculation, liability issues and price, a German media report has revealed. https://www.dw.com/en/covid-vaccine...GK_RSS_SmartNews_Volltext_ENG-20051-xml-media Confidential European Commission documents seen by a German media team show a majority of EU member states wanted "traditional" vaccines and were "very little interested" in new-type jabs from BioNTech-Pfizer and Moderna. The novel messenger RNA vaccines from these firms interested "only a small minority of member states" as initial buyers, reported the team, comprising German public broadcasters NDR and WDR, as well as Munich's Süddeutsche Zeitung newspaper. The report coincided Saturday with a YouGov survey showing 50% of Germans were satisfied by the government's management of the crisis, down from 67% last April and 57% in October. On Friday, a Reuters' retrospective article depicted a EU Commission in "panic" last month as vaccine delays became public, with Europe already mourning more than 700,000 dead and Brussels having promised 70% adult vaccinations across the EU by the third quarter of 2021. 'Quick' talks slowed Saturday's report, however, depicts EU negotiators aiming for quick results as talks began last June. That changed when German developer BioNTech was joined by its American partner Pfizer with liability lawyers. Numerous EU states were also against the new mRNA vaccines because they — and BioNTech's especially — require subzero cooling during transport. Furthermore, scientific experts advising the EU executive were — until October — "very skeptical" toward all forms of mRNA usage, intended to immunize human cells against the SARS-CoV-2 virus which causes COVID-19. A further argument touted in Germany was that compared to jabs from Britain's AstraZeneca, the other mRNA vaccines were priced higher. Senior German official 'involved' And, contrary to disclaimers, a German ministry director — a medicines expert reporting to Health Minister Jens Spahn — was involved from June in those negotiations, led by an EU "steering board" chaired by the Commission's director general for health, Sandra Gallina of Italy, and Austria's Clemens Auer. Members of the steering group were constantly in contact via the WhatsApp messaging service and consulted every Friday at midday on the latest status of the talks, the media team learned from an inside source. Blocking a quick agreement, said Auer, were demands from pharmaceutical firms that the Commission free them largely from liability — a key factor in medication development, given tragedies such as Thalidomide scandal in the 1960s, which caused birth defects. "We started negotiating with BioNTech, and at some point Pfizer got involved, and then all of a sudden there were American lawyers at the table," Auer is quoted as saying in the report. "That didn't make it any easier." Pricing, liability One firm, unnamed in Saturday's report, argued that given its planned delivery at near-cost and little profit, then liability risk should be considered in the pricing. Another firm wanted the EU to at least cover legal costs if future lawsuits from claimants proved to be unjustified. As this became known, lead negotiator Gallina was quizzed on liability at a European Parliament hearing in mid-January and promised patient rights would not be trimmed. Gallina rejects accusations Earlier this week, Gallina rejected accusations that EU citizens are now having to wait longer for vaccines because the Commission had opted to save on expenditure or insisted on compliance with existing law. Firms like BioNTech and AstraZeneca had already received hundreds of millions of euros to ramp up production before contracts were signed, she noted. More doses would not have been received had the EU paid more, she insisted, apparently borne out Saturday in a magazine report in Der Spiegel citing BioNTech's financial chief Sierk Poetting: "More money wouldn't have helped us last year." "We had to set up the production process, by and large," he told Spiegel, adding: "But now money would help, especially if we are supposed to anticipate a capacity of 3 billion doses, as was requested this week." Reuters in its analysis said January's "two weeks of confusion" over the EU's initial vaccine supplies amounted to the 27-nation bloc's "deepest crisis" since Ursula von der Leyen became president of the European Commission just over a year ago.