Covid-19 roundup: Blood clot risk much higher from disease than vaccines — study; Brazil OKs Inovio PhIII trial
Researchers in the UK have published a new paper showing that the risk of blood clots is much higher after a Covid-19 infection than following vaccination.
In one of the largest studies of its kind, the scientists looked at data from more than 29 million individuals in the UK comparing the Pfizer/BioNTech and AstraZeneca vaccines to Covid-19 cases. They found that for every 10 million people who receive their first AstraZeneca shot, there were 107 more cases of low platelet counts than one would normally expect, another 66 developed blood clots and seven had CVST, or blood clotting in the brain. And for those who received the Pfizer/BioNTech shot, there were an extra 143 cases of ischemic stroke.
Each figure rose sharply when looking at Covid-19 patients, the analysis found. There were an estimated 934 “excess” cases of low platelets, 12,614 incidents of blood clots, 1699 of ischemic stroke and 20 of CVST.
“This is crucial not only for the present and future safety of Covid-19 vaccines, but also will hopefully pave the way more broadly for future international harmonisation and collaboration in drug safety monitoring,” researchers wrote in a linked editorial, discussing the effort to further understand vaccines’ benefit-risk profile.
The data come from a nearly five-month period starting at the beginning of December 2020 through April 24, 2021. Researchers tracked 19.6 million people who got the AstraZeneca shot, 9.6 million who received Pfizer/BioNTech and 1.8 million Covid-19 patients.
AstraZeneca’s vaccine in particular had been dogged by safety concerns during its large-scale Phase III trial in 2020 and into 2021. Reports of blood clotting events first emerged earlier this year and the shot has yet to be authorized or approved by the FDA. The Pfizer/BioNTech vaccine was tagged with a safety warning in June as well, though this stemmed from a risk of heart inflammation.
But the UK researchers are outlining — building on more and more evidence — that contracting Covid-19 is far more dangerous than getting vaccinated. Individuals are nine times more likely to suffer from low platelet counts and 191 times more likely to develop blood clots, per the incidence rate numbers.
Inovio receives OK from Brazil to start Phase III study
Inovio ran into a significant setback in 2020 when its Covid-19 vaccine ran into an FDA hold, and then another earlier this year trying to secure funding for its Phase III Covid-19 vaccine trial. But the biotech is one step closer to getting it off the ground.
The company announced Thursday that it has received the go-ahead from Brazil’s health regulator to start the Phase III segment of its Phase II/III study. Pending further clearance, Inovio plans to run the trial in several countries in Latin America, Asia and the African continent.
“With many countries in the world experiencing low vaccination rates and seeing an increase in infections, we feel the urgency to advance INO-4800 globally,” CEO Joseph Kim said in a statement.
Thursday’s green light comes a few weeks after Inovio got approval to test its DNA vaccine as a booster in China with Chinese biotech Sinovac.
Inovio previously had funding from the Department of Defense to test its vaccine candidate, but the Pentagon scrapped funding for the Phase III segment of its study back in April. At the time, Inovio said the move was due to the growing availability of other Covid-19 vaccines and that it was not, it asserted, related to the partial clinical hold in place since September 2020.
And in a 10-K filing at the time, Inovio was unsure whether it would ever be able to get its Phase III launched, writing, “We do not know whether our planned Phase 3 clinical trial will begin on time or be completed on schedule, if at all.”
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