European Medicines Agency to review the Johnson and Johnson vaccine candidate data in real time to expedite the process towards approval. Not really sure what this means, but sure sounds like it screams "short cut", but what the hell do I know? EMA starts rolling review of J&J's COVID-19 vaccine candidate
Usually pharma companies review the data, and then submit it for approval. This way government agencies don't have to waste time evaluating data that's clearly negative. My guess is that they'll just be reviewing the data at the same time as the pharma companies.
Pfizer has approval in the UK This is the package insert https://assets.publishing.service.g...nCQcrL1s25y85A5zISE0rAMkutTGYU6QqxbSNE9eAI0Gk This medicinal product does not have a UK marketing authorisation but has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over. As with any new medicine in the UK, this product will be closely monitored to allow quick identification of new safety information. Healthcare professionals are asked to rep
Page 4..wow UAE says 86% efficacy for Chinese vaccine. This is good news Chinese Covid-19 vaccine has 86% efficacy, UAE says The United Arab Emirates said a Chinese coronavirus vaccine tested in the federation of sheikhdoms has 86% efficacy, in a statement that provided few details but marked the first public release of information on the performance of the shot. The announcement brought yet another contender into the worldwide race for a vaccine to end the pandemic, a scientific effort in which China and Russia are competing with western firms to develop an effective inoculation.
UK issues warning for Pfizer shot. Apparently 2 people who have a history of severe allergic reactions did indeed have severe allergic reactions. In a different story, in FDA review of the late stage trial data, 4 individuals who took the shot developed Bells Palsy, while 0 people in the control group developed such a facial paralysis. UK to refine allergy warning on Pfizer vaccine sparked by two adverse reactions
How large was the group? Bell's palsy has been associated with the flu shot as well (but in a very small number of individuals).
21,700. Here are more details.... Pfizer vaccine: UK regulator allays fears after 4 Bell's palsy cases in US trials
so the one vaccine that US heavily subsidized is the most expensive one.. The Oxford-AstraZeneca vaccine can be stored at regular refrigerator temperature. It is also cheaper than its peers, thought to cost around $4 per dose. Pfizer-BioNTech is reportedly charging around $20 per dose for its coronavirus vaccine. Moderna has said it is charging $32 to $37 per dose, and Johnson & Johnson has said its candidate will cost around $10 per dose.
Way out over my skis on this, so I am not going to make any kind of statement that makes it sound like I know what I am talking about (hint: I don't), but the fact that no vaccine based on an Adenovirus has ever been approved in the US for human use before is a bit concerning. Unlike the mRNA where no one has developed one previously, there have been some developed, but never approved in the US due to ineffectiveness or other problems. If I understood it correctly, even though the adenovirus is rendered harmless, in some people, the immune system still reacts to it as an invader, and potentially ignores the "spike protein" from the coronavirus that you want the immune system to react to. Here’s What You Need To Know About AstraZeneca’s Covid-19 Vaccine
Its done. Just a matter of time now before the FDA signs off on the Emergency Use Authorization. First 85,000 doses arrived in North Carolina today. By early next week, health care workers should start getting dosed. FDA advisory panel endorses Pfizer/BioNTech Covid-19 vaccine
Extremely positive results from UF Health in regards to Anti-Viral treatments..... Existing antihistamine drugs show effectiveness against COVID-19 virus in cell testing
I use azelastine for allergies as needed. Guess I need to refresh my prescription and start using it daily
First negative Vaccine story I have read so far. Glaxo and Sanofi in their Phase1/2 trials failed to produce a good immune response in those 50+. Additional new research from primates had predicted that the antigen concentration in their current vaccine candidate may have been too low. A newer formulation performed much better in primate testing. This will likely force Glaxo and Sanofi to restart their trials in the coming weeks. Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine
Five key genes linked to severe COVID-19 found, suggesting drug targets | Reuters Researchers who studied the DNA of 2,700 COVID-19 patients in 208 intensive care units across Britain found that five genes involving in two molecular processes - antiviral immunity and lung inflammation - were central to many severe cases. “Our results immediately highlight which drugs should be at the top of the list for clinical testing,” said Kenneth Baillie, an academic consultant in critical care medicine at Edinburgh University who co-led the research. The genes - called IFNAR2, TYK2, OAS1, DPP9 and CCR2 – partially explain why some people become desperately sick with COVID-19, while others are not affected, Baillie said.
Not a shock, but the FDA has granted Emergency Use Authorization tonight.... FDA approves Pfizer's coronavirus vaccine for EUA
