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Both #China & #Russia approved #COVID19 #coronavirus #vaccines for use outside of clinical trials before #phaseIII was completed. This is quite an unusual move; many think the #US will follow suit. So, what do we know about how this #prematureapproval process went so far? 1/n
Let’s start with the #Russian #vaccine #SputnikV/Gam-COVID-Vac by the Gamaleya Research Inst. Two clinical trials have been registered: both phase I/II trials https://clinicaltrials.gov/ct2/show/NCT04436471 & https://clinicaltrials.gov/ct2/show/NCT04437875?term=vaccine&cond=covid-19&draw=4 (same design, one is for a lyophilized (freeze-dried) version). 2/n
What is the main take home message based on these trial registration records? At the time of approval for use outside of clinical trials, the #Russian #Vaccine #SputnikV or “Gam-COVID-Vac” had been tested in ONLY 76 PEOPLE. 3/n
No matter how positive the results were in those early trials, it is not possible to rigorously establish the safety & efficacy of any vaccine after testing it in less than 100 people. Remember, phase III trials are often tested in TENS OF THOUSANDS of participants. 4/n
#Prematureapproval of a #vaccine prior to establishing safety & before determining whether it protects (only phase III trials assess whether the vaccine protects against infection/disease) can severely compromise public trust in vaccines & willingness to be vaccinated. 5/n
So, what is happening now that the #vaccine is being used outside of clinical trials in #Russia? Check out this very interesting @nytimes article which captures a lot of the critical issues: 6/n https://www.nytimes.com/2020/08/23/world/europe/russia-coronavirus-vaccine.html
For one, vaccine researchers have expressed concern about skipping phase III clinical trials from the beginning, & rightfully so! Many vaccines that look promising in early trials do not turn out to be safe & effective when tested on a broader scale. 7/n https://www.nytimes.com/2020/08/11/health/russia-covid-19-vaccine-safety.html
Also noted in the @nytimes piece, in a recent survey, 76% of #Russian physicians reported that they would not take the vaccine, which is not at all surprising given the limited evidence available & the lack of rigorous testing. 8/n https://www.nytimes.com/2020/08/23/world/europe/russia-coronavirus-vaccine.html
This kind of #prematureapproval, skipping from an early trial to approval, raises more questions than it answers & compromises trust the process of assessing vaccines rigorously. For example, systematic documentation of adverse events is standard in all clinical trial stages. 9/n
What processes have been put in place to monitor #SputnikV #vaccine #safety now that it is being used outside of clinical trials? How will those results be reported? What is the degree of transparency? There is no clarity on if/how the vaccine will be evaluated going forward 10/n
These questions are really important not only for the use of the vaccine in Russia but also because more than 20 countries have reportedly expressed interest in gaining access to the vaccine. Will those countries have access to any evidence at all before taking this step? 11/n
The success of any #covid19 #coronavirus vaccination program fully depends on the willingness of individuals to be vaccinated. Concerns about safety/efficacy are top reasons for vaccine hesitancy. Providing no evidence for a vaccine is dangerous and a recipe for disaster. 12/n
We should all be watching this process very closely. We cannot compromise on the safety/efficacy of a vaccine during this #pandemic. For #COVID19 vaccines, the rigorous evidence we need doesn't exist yet, as @nataliexdean wrote earlier 13/n https://www.nytimes.com/2020/08/03/opinion/sunday/coronavirus-vaccine-efficacy-trials.html
As I noted at the beginning, #China also recently approved a #COVID19 #coronavirus #vaccine for use outside of clinical trials & has been giving this vaccine to the military and certain groups including doctors. More on this vaccine a bit later! 14/n https://www.cnn.com/2020/08/24/asia/china-vaccine-doctors-workers-intl/index.html
