THE FIRST fully-tested covid-19 vaccine is expected to be approved imminently in Britain. The drug regulator, the Medicines and Healthcare products Regulatory Agency , is believed to be about to grant emergency authorisation to the vaccine made by Pfizer, an American pharmaceutical giant, and BioNTech, a smaller German firm. Trials have shown that the vaccine has an efficacy of 95%, a response consistently found in people of different ages, sexes and ethnicities.
Even so, Britain has moved remarkably quickly. Earlier today, the head of America’s Food and Drug Administration was summoned to the White House to answer questions on why his agency has not moved faster to approve BNT162b2. The move will also fuel concern that Britain’s rapid movement is political, and might even be an example of “regulatory nationalism”—ie, countries moving quickly to approve vaccines in order to jump ahead of the queue for deliveries.
Although a large number of patients have been tested, health authorities have already constructed safety follow-up plans, says Penny Ward, chair of the education and standards committee of the Faculty of Pharmaceutical Medicine, a charity. These include a system for following up adverse reactions, and using anonymised healthcare records to see how the incidence of disease varies between those who have been vaccinated and those who have not.
Fully tested? Even Government acknowledges there will be extremely high rates of ADRs - Adverse Drug Reactions. If you take it, I think we can be forgiven for using the term Darwinism.
Fully tested - well, the trial continues for another 2 years. Somewhat below your normal standards. What is being proposed is emergency or temporary authorisation for use on results so far while trials continue.
And Trump is wanting USA to agree to Pfizer vaccine first, before Britain ... without getting CDC approval yet, so Trump can proclaim he came up with the first vaccine. Never mind it still needs CDC approval so we know it doesn’t harm people.
thanks for this news
Can a vaccine that has been rushed to development really be considered 'fully tested'?
No they are applying the Emergency Use in the US, that means it is still an experimental vaccine. The Safety trial still hasn’t completed.
Fast tracked is not fully tested.
Haberin başlığını “Pfizer Bitcoin” diye okuyorsam GSMH nın yüksek çıkmasına rağmen kişi başına düşen gelirin malum kişi/kişiler tarafından çalınması yüzündendir
We don’t need it, do we?
thank you very much for your work
Let’s mention that most pharm giants got liability waivers similar to this
Hooray! Some good news from 2020!
lara__wo
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