Results
Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).
Discussion
The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.
Coalition for Epidemic Preparedness Innovations
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THE influence of the Bill & Melinda Gates Foundation (GF) extends right into the heart of the British medical and science establishment. It has been funding British companies, charities, universities and public bodies for almost 25 years.
Drugs are a risky business and, for equity investors hoping to eventually share in the profits, each stage of development presents an escalated risk. Lo reasoned that substantially lowering the risks, even if it meant correspondingly lowering the rewards, could attract investment instead from ordinary bond markets—that is, from managers of pension funds, university endowments, and sovereign-wealth funds, who control a great deal of money and generally invest in low-risk, low-return assets.
Given how uncertain vaccine markets are, the paper notes, governments (“public-sector interventions,” and so forth), would need to guarantee a vaccine bond by committing in advance to purchase and stockpile vaccines. The paper’s most creative suggestion is for a subscription model, a kind of vaccine Netflix, where governments would pay an annual fee to a new international-development fund, one that could perhaps be managed by the G7. The fund could float a bond to both advance vaccine biotechs and to make market commitments to Big Pharma. The virus, the markets, and the science are global.
…it would be much better for the government to say that the money is not from taxpayers. “We’re borrowing it from the rest of the world. And if and when you succeed, or any of the other hundred and fifty projects—that could have been funded, but aren’t being funded right now—succeeds, all the bond holders will get paid. That would be great. Everybody earns a return.”