2021-1-25 法国巴斯德研究所1月25日表示，由于临床试验结果不如预期，终止与美国默克药厂合作研发对抗新冠的疫苗。
巴斯德研究所（Pasteur Institute）与默克药厂（Merck & Co.）是在去年5月宣布，合作研发以现有麻疹疫苗为基础的注射剂，并且在去年8月展开首阶段的临床试验。
巴斯德研究所发表声明指出：“在最初的人体试验中，这种有潜力疫苗的耐受性佳，但产生的免疫效果却不如自然康复的患者和经核准的疫苗。”
这项宣布使法国主导研发出疫苗的希望又受打击，最近才有报导指出，法国制药大厂赛诺菲（Sanofi）也难以让研发的候选疫苗进军市场。
不过巴斯德研究所表示，放弃这个以麻疹疫苗为基础的注射剂，“不影响巴斯德继续研究其他两款以不同方式发展的候选疫苗”。
Olika problem som debuterar efter coronavaccinationen kommer att skyllas på vaccinet. Det kommer att ta forskningen lång tid att utvärdera sådana misstankar. Det behövs en ovaccinerad kontrollgrupp att jämföra med, men även då kan det vara svårt att påvisa en sällsynt biverkan.
När en oväntad negativ händelse inträffar är det mänskligt att söka efter en förklaring. Våra hjärnor letar hela tiden efter mönster, efter möjliga orsakssamband; vi försöker göra den röriga värld vi ser mer begriplig.
I Sverige kommer vi inledningsvis att se fler negativa händelser efter massvaccinerandet, av den enkla anledningen att vi valt att börja vaccinera den del av befolkningen som har allra störst risk att få stroke, hjärtinfarkt, cancerdiagnos, svår lunginflammation, kallbrand, kort sagt alla de sjukdomar som oftare drabbar i hög ålder (vilket är majoriteten av allvarliga sjukdomar). En hel del åldringar kommer ofrånkomligen att dö kort tid efter att ha vaccinerats, även om de inte dör av själva vaccinet. Att som Expressen (med flera medier) göra en nyhetsartikel av sådana förväntade dödsfall framstår därför som inkompetent.
Finland börjar i stället vaccinera sjukvårdspersonalen som frivilligt utsätter sig för smittorisk genom att vårda covidpatienter. Dessa arbetsföra individer har faktiskt lägre risk för att drabbas av en – i förhållande till vaccinet – slumpmässig negativ händelse än jämnåriga som är arbetslösa (det kallas inom epidemiologin för ”healthy worker effect”), och de är förstås nästan osårbara jämfört med en genomsnittlig person på äldreboendet.
Jämfört med i Finland kommer det därför i Sverige sannolikt att väckas betydligt fler misstankar om allvarliga biverkningar av coronavaccinerna.
Hur kan man utesluta att vaccinet orsakat en misstänkt biverkan? I det enskilda fallet är det åtminstone i teorin omöjligt; man kan inte bevisa frånvaron av något, man kan bara visa att man misslyckats med att hitta det samband man letat efter. Det behövs en ovaccinerad kontrollgrupp att jämföra med, men även då kan det vara svårt att påvisa en sällsynt biverkan, och ännu svårare att utesluta en något ökad risk för sjukdomar som redan är vanliga.
När massmedia i Storbritannien under det sena 1990-talet skrämde småbarnsföräldrar genom att sprida vanföreställningen att mässlingvaccin kunde orsaka autism, då hade inte Sverige något centralt vaccinregister som kunde användas för att pröva hypotesen. Danskarna hade bättre ordning på sina data och kunde visa att autism inte var vanligare bland de 82 procenten barn som fått vaccinet (en tråkigt nog låg vaccintäckning i Danmark på 1990-talet) än hos de drygt en halv miljon barn som inte fått det.
Det glöms ofta bort att tidssambandet var en viktig orsak till att MPR-vaccinet (mot mässling, påssjuka och röda hund) av en del föräldrar misstänktes vara orsaken till deras barns autism; MPR ges i regel vid 18 månader och symtomen på klassisk autism noteras ofta strax efter denna ålder. Det finns ett tidssamband, men det är inte något orsakssamband.
Av samma anledning riskerar vi att olika problem som debuterar efter coronavaccinationen kommer att skyllas på vaccinet. Det kommer att ta forskningen lång tid att utvärdera sådana misstankar. Men det finns en klar risk att särskilt unga människor, med låg risk att bli allvarligt sjuka i covid-19, väljer att avstå från det nya vaccinet. De borde förstås vaccinera sig i solidaritet med äldre generationer, men från ett självcentrerat perspektiv är det säkrast om alla andra tar vaccinet. Jag misstänker att många länder framöver kommer att kräva vaccinationsintyg för inresa. Lusten att resa kommer att vara en säkrare drivkraft för att vaccinera sig än solidaritet.
Sydney, Australia: Australia’s medical regulator has formally approved the Pfizer Covid-19 vaccine, with the first doses expected to be administered in late February, Prime Minister Scott Morrison announced Monday.
The Therapeutic Goods Administration (TGA) granted provisional approval for the Pfizer product, making it the first Covid-19 vaccine to get the green light in Australia.
“I note this is not an emergency approval, as has been done in some other jurisdictions around the world,” Morrison told reporters.
“This is a formal approval under the ordinary processes of the TGA and we are one of the first countries… to have gone through that comprehensive and thorough process here in Australia to ensure the approval of that vaccine.”
Australia has secured 10 million doses from Pfizer — enough to vaccinate five million people — with healthcare workers and the elderly expected to receive the first jabs.
Morrison cautioned that the rollout would start with “very small beginnings” in late February, instead of the mid-February timetable his government had promised, due to production and delivery challenges globally.
He said the vaccination programme should be complete by October.
It means Australia will begin inoculating its citizens months after the United States and United Kingdom, despite Morrison’s boast earlier in the pandemic that his country would be “at the front of the queue”.
Largely virus-free Australia has fared comparatively well in its Covid-19 response, with 909 deaths from about 28,700 cases in a population of 25 million.
The country has also secured more than 50 million doses of the Oxford/AstraZeneca vaccine, with the majority set to be manufactured locally, but the TGA is yet to grant approval.
The German government has purchased 200,000 doses of the drug which was used to treat then-President Donald Trump during his brief stint at a hospital in the wake of a positive Covid-19 test.
“Starting next week, the monoclonal antibodies will be used in Germany as the first country in the EU. Initially in university clinics,” German Health Minister Jens Spahn said in an interview with Bild am Sonntag, which was published on Sunday.
The drug is produced by the biotech lab Regeneron, which is based in the state of New York, from proteins produced by mice bioengineered to mimic a human immune system. It helps neutralize viral particles in a body, helping the organism beat the infection.
It is supposed to be used for emergency intervention, protecting high-risk patients from serious symptoms and administered after a Covid-19 case is confirmed. Trump was arguably the most famous recipient of the treatment, which he received at the Walter Reed Hospital after testing positive.
The drug called REGN-COV2 remains experimental and quite costly. The US media estimated that the doses supplied under a contract with the US government would cost anywhere between $1,500 and $6,500 per treatment. Spahn said Germany paid €400 million for 200,000 doses, which translates into a price tag of $2,400 per dose.
The news comes as the German government is being criticized for the slower-than-expected rollout of Covid-19 vaccines. The minister suggested that the Germans “should be careful that 2021 does not become the year of blame” and said politicians and the public shared responsibility for the high infection rates the country experiences today.
As of Saturday, the country has some 275,800 active cases. The total death toll from the disease stands at 51,521.
The daughter of an elderly woman in Montreal, Canada has expressed outrage after her mother was accidentally injected with two different jabs, breaching guidelines that forbid mixing vaccines unless absolutely necessary.
Antonietta Pollice inadvertently became the first person in the province of Quebec to receive two doses of the Covid-19 jab, but the mixture of drugs has raised safety concerns, as well as questions about whether care home residents who receive the vaccine fully understand and consent to the medical procedure.
The 97-year-old took the Moderna jab on January 7 while living at a seniors’ home in a suburb of Montreal. Days later, the facility closed and she was transferred to a different residence. Apparently unaware that she had already been immunized, staff at Pollice’s new home injected her with another dose – but this time, with the Pfizer/BioNTech one.
Her daughter, Patrizia Di Biase, told the CBC that her mother suffers from dementia and didn’t understand what was being done to her.
“Shocked. I was upset,” she said. “How can that happen? ‘Mistakes happen,’ well, it’s not a small mistake.” She described the situation as “unacceptable” and demanded accountability from healthcare workers and officials.
“I don’t want this to happen again. It’s happened now, we can’t go back for my mom, but we need to go forward and have everybody know,” Di Biase added. She said that she had contacted Quebec Public Health demanding answers. Regional health authorities are currently probing the case, the CBC reported.
The decision to jab Pollice, apparently without her full understanding of the procedure, is particularly worrying, since the elderly woman reportedly contracted Covid-19 last spring and would presumably already have antibodies.
It is unclear whether she experienced any adverse reactions after being administered the second jab.
The safety and efficacy of mixing the two vaccines has yet to be established. Although both drugs are two-dose mRNA vaccines, no data exists on their interchangeability. Previously, medics suggested the use of different vaccines should happen only where there is no other option to administrate the patient with the second dose of the same type.
The recommended wait between receiving the first and second dose of each drug is also different. The second Pfizer/BioNTech shot should be administered three weeks after the first dose, while the wait time between Moderna injections is one month.
The accidental shot also goes against Quebec’s own vaccination scheme. The province’s premier, Francois Legault, decreed earlier this month that all second doses of the Covid-19 vaccine should be delayed so that more people can be immunized. According to the guidance, people should wait 90 days before taking the second shot.