“And as an illustration to this, I may share with the committee that even last evening we were looking at two case reports of allergic reactions. We know from the very extensive clinical trials that this wasn’t a feature. But if we need to strengthen our advice…. we get that advice to the field immediately.”
Tag: Vaccine
WHO looks at giving Covid-19 to healthy people to speed up vaccine trials
RFK, Jr. Urges FDA to Slow Down COVID Vaccine Approval Process
RFK, Jr. Urges FDA to Slow Down COVID Vaccine Approval Process
In a letter to Peter Marks, director of the Center for Biologics Evaluation and Research, Robert F. Kennedy, Jr. asks the U.S. Food and Drug Administration to take a cautious approach in approving COVID-19 vaccines that have been developed at “warp speed.”
Palantir will soon help the FDA evaluate drugs, including COVID-19 treatments
Palantir will soon help the FDA evaluate drugs, including COVID-19 treatments
Although it isn’t clear if the Biden administration will continue to expand federal work with Palantir, the process of distributing vaccines provides another logistical opportunity for the controversial company. Tracking which individuals have received both doses of a vaccine is work that sounds very much in Palantir’s wheelhouse.
People who get injured from COVID-19 vaccines could have a hard time getting compensated
People who get injured from COVID-19 vaccines could have a hard time getting compensated
Not only does CICP deny compensation for pain and suffering and attorney’s fees, and the right to appeals, it prohibits litigants from holding hearings and introducing evidence and expert testimony. Another CICP disadvantage, Pop said, is that the only the government’s own expert can form the basis for what constitutes a permissible claim. Therefore, he said, under the CICP program, it seems highly unlikely that any individual with a reaction that’s not “open and notorious, even though rare,” could ever get any kind of compensation.
Can your boss make you get a COVID vaccine? Probably
Can your boss make you get a COVID vaccine? Probably
The advent of the vaccines is great news for the country. But it also creates a quandary for employers who are already navigating tricky legal issues related to COVID, such as whether they can require workers to come into the office. In the case of the vaccines, can companies force employees to get a shot?
The short answer is yes. According to Jonathan Segal, a partner at Duane Morris who specializes in employment law, the legal bar for mandatory vaccinations requires showing a “strong business necessity.” And given the nature of the pandemic, companies should be able to clear that bar.
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There is also the question of who should pay for am employee to get a COVID vaccine. According to Segal, if the coming vaccine is not free, the law does not obligate employers to pay for the cost of a mandatory shot. Nonetheless, he argues they should do so, both because it is the ethical thing to do and since it will make it easier to ensure compliance. (Meanwhile, some politicians argue the U.S. should pay Americans $1,500 to get one).
Related:
Employers start preparing for the coronavirus vaccine with a question: Can we require it?
Wall Street and finance workers could get COVID vaccines before most Americans
Wall Street and finance workers could get COVID vaccines before most Americans
Let the bankers be the guinea pigs!
MIT machine learning models find gaps in coverage by Moderna, Pfizer, other Warp Speed COVID-19 vaccines
Vaccines to block COVID-19 that are in development by Moderna, Pfizer, AstraZeneca and others, and that are currently in Phase III clinical trials, may not do as well covering people of Black or Asian genetic ancestry as they do for white people, a study released Wednesday by the Massachusetts Institute of Technology indicated.
EU criticises ‘hasty’ UK approval of COVID-19 vaccine
EU criticises ‘hasty’ UK approval of COVID-19 vaccine
European Medicines Agency says its approval process is more appropriate, as German politician calls UK move ‘problematic’.
Emergency approval of coronavirus vaccines is not guaranteed, FDA commissioner says
Emergency approval of coronavirus vaccines is not guaranteed, FDA commissioner says
Career scientists at the FDA are reviewing raw data from the Pfizer and Moderna trials for the first time, investigating any adverse events or side effects that transpired over the course of the trials, different levels of effectiveness among populations and age groups, and whether individuals who were already infected by the coronavirus might have had any unexpected reactions to the vaccine doses.
Hahn said they will also be looking for evidence that the vaccines lead to increased respiratory infections – a concern with vaccines produced for other coronaviruses, such as SARS and MERS – and whether the use of a relatively new method of vaccine development, known as messenger RNA technology, poses any significant risks.
Ms. Cat’s Chronicles 
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