7 April 2021

• EMA announces that rare cases of blood clots combined with low levels of blood platelets occurring within two weeks of vaccination should be listed as a very rare side effect from the AstraZeneca coronavirus vaccine. As of 4 April 2021, a total of 169 cases of blood clots in the brain and 53 cases of blood clots in the abdomen (among 34 million people who received the vaccine in the UK and the EU) were reported to  EudraVigilance. People should seek immediate medical assistance if they experience shortness of breath, chest pain, swelling in your leg, persistent abdominal (belly) pain, neurological symptoms, including severe and persistent headaches or blurred vision and tiny blood spots under the skin beyond the site of injection after vaccination. The vaccine may trigger an immune response that leads to an atypical heparin-induced-thrombocytopenia-like disorder. Most cases have occurred in women under age 60 years, although specific risk factors have not been identified. For people under 60, the risk is one in 100,000, according to Emer Cooke, EMA director. Source

• The University of Oxford, which co-developed the coronavirus vaccine with AstraZeneca, announces that it has suspended a UK trial of the vaccine in children and teenagers while waiting for regulators to issue guidance. AstraZeneca did not comment. Source

• The AstraZeneca vaccine may be causing an immune response causing antibodies to bind to platelets – triggering blood clots in veins that drain blood from the brain – which can lead to strokes. Germany and the Netherlands are not giving the AstraZeneca vaccine to people under age 60 years, while Canada and France have suspended use of the vaccine in young people and Norway and Denmark have stopped giving the vaccine to anyone while they continue investigations. Source

• A pre-print case-control study in Manaus reported that a single dose of Sinovac’s CoronaVac was 49.6 percent effective after 14 days in preventing symptomatic illness from the P.1 variant among healthcare workers. Notably, the study was conducted at the epicentre of the emergence of the P.1 variant – and in the context of an epidemic – but SARS-CoV-2 samples from healthcare workers were not routinely genotyped. Source

• A New York Times investigation of Emergent Biosolutions, the US government contractor who mixed ingredients of the J & J and AstraZeneca coronavirus vaccines, reports that the facility threw out ten to fifteen million doses of the AstraZeneca vaccine  because of suspected or actual contamination, and that workers had suffocated used to make the J & J vaccines. The Baltimore plant did not follow basic industry standards for disinfection and preventing contamination. Additional audits and investigations revealed persistent mold in areas where cell cultures were grown, bacteria on inadequately disinfected equipment, reports monitoring bacteria and other contamination were filed four to six months after they were due, staff were poorly trained and raw vaccine materials were approved before being fully tested. A former company official stated that a senior manufacturing supervisor responded to quality  errors by saying ““Do you want me to make drugs or fix issues? I don’t have time to do both.” Although Emergent  failed pressure-test deadlines, the Trump administration  still awarded it a $628 million contract to make coronavirus vaccines. Emergent also made its own deals with J & J and AstraZeneca. Source

• Britain  and Australia announce that people under age 30 years should not receive the AstraZeneca coronavirus vaccine; Italy, the Philippines and South Korea suspend use of the vaccine in people under age 60. Source

• South Korea  grants conditional approval for the J & J single-dose coronavirus vaccine. Source

• For the first time, Brazil’s daily coronavirus death toll exceeds 4,000. Nonetheless, President Jair Bolsonaro announces that There will be no nationwide lockdown. Our army will not go out on to the streets to keep people in their homes. Freedom is priceless.” Source

• Despite a dramatic decrease in new coronavirus infections and deaths from COVID-19, the UK death toll has exceeded 150,000. Source

• The MHRA – which is conducting a comprehensive review of the possible link between AstraZeneca’s vaccine and rare blood clots announced that people under age 30 should not receive it, noting that as of 31 March 2021, the risk of blood clots among the 20,2 million people  given the AstraZeneca vaccine was approximately four people in one million.  Source

• The NIH announces Systemic Allergic Reactions to SARS-CoV-2 Vaccination, a 3,400-person phase II clinical trial  looking at the incidence and possible causes of systemic allergic reactions to the Pfizer/BioNTech and Moderna coronavirus vaccines in people with and without a history of allergic reactions. Results are expected in Q3of 2021. Source

• COVAX delivers 62,400 of 100,800 doses of AstraZeneca’s coronavirus vaccine to Barbados. Source

• COVAX delivers 43,200 of 218,400 doses of AstraZeneca’s coronavirus vaccine to Costa Rica. Source

• Pending EMA approval, Germany plans to purchase the Sputnik V coronavirus vaccine. Source

• The Financial Times reports that the EMA plans to launch an investigation next week to see whether the Sputnik V vaccine meets “good clinical practice” (GCP) standards; staff were pressured to volunteer for, and recruit  people into clinical trials of the vaccine.  over concerns about unethical practices during its clinical trials. Source


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