Garage "Pfizer"
What happens when biohackers take up the creation of a vaccine
Polina Loseva, N+1
Almost a year has passed from the beginning of the development of anti-coronavirus vaccines to the first person vaccinated outside of clinical trials. For the creators of vaccines, this is incredibly fast, but for ordinary people locked in quarantine, the wait has long become unbearable. Among those who would like to get vaccinated as soon as possible, there were three biohackers. In a month and a half, they created their own alternative vaccine, injected it themselves, found antibodies to the coronavirus in their blood – and solemnly declared that science had lost. We are looking into whether this is so – and what it costs to repeat their route.
"I know it sounds a little pathetic, but we are actually having a class war," biohacker Josiah Zayner wrote in his blog on December 11, on the eve of the approval of the first vaccine in the United States. – When the covid vaccine appears, 99 percent of people will not receive it first. Those who will receive it are the same people who can sit out the pandemic in the comfort of their home."
"Your life," continues Zeiner, "the life of your child, mother, loved one depends on how much you earn. And considering that if you're reading this, there's a 99 percent chance you're not at the top of the 1 percent, I ask you: why do we let the rich and powerful behave like this?"
However, Zeiner is going to fight against stratification in society exclusively by peaceful means. He does not call for taking the vaccine away from the exploiters – on the contrary, he offers the oppressed class to make the vaccine itself.
Three against the system
Anyone who has followed the anti-coronavirus vaccine race with at least one eye could notice that ethical problems arise as much as technical ones as they develop. As soon as a company reports that their drug has caused the necessary immune response from a bunch of volunteers, it is immediately flooded with questions. Why are there so few women in the sample? Where are the old people? What about pregnant women and allergy sufferers? What should those who have already been ill or are ill right now do?
But every time science slips on ethical issues and spends time on reinsurance and rechecking, there are those who are willing to take the risk and do the same, but faster. This was the case, for example, with Elizabeth Perish, who injected herself with an adenoviral vector with the telomerase gene – without waiting for this method of prolonging life to be tested on any mammals other than mice. This was the case with George Lopez – he, having been diagnosed with Parkinson's disease, found scientists who developed a turnkey experimental stem cell treatment for him. It is not surprising that there were also "normal heroes" for the coronavirus vaccine who chose the road bypassing clinical trials.
A biologist by training, Josiah Zeiner is not the first time challenging science "in a tie". Since he left the NASA research center, he has made some bold experiments on himself: in 2016 he transplanted intestinal bacteria from one of his friends, and in 2017 he injected himself with CRISPR/Cas9 "molecular scissors" to build more powerful muscles (whether he succeeded or not, by the way, we still don't know).
This time, Zeiner decided to act not alone, but together with colleagues on the Central Dogma Collective project (abbreviated to CDC, as one of the agencies of the US Department of Health): American David Ishee and Ukrainian Daria Dantseva. Like Zeiner, Dantseva is a biotechnologist by education. But Aishi is self–taught: he learned everything he knows about molecular biology and medicine in practice while he was looking for a way to "improve" pedigreed dogs that he breeds for sale.
At the end of June 2020, the rebellious trinity launched an open online course on creating a vaccine against SARS-CoV-2 with their own hands. In two months, biohackers promised to take students through the whole process: from scientific results to a shot in the shoulder. "The problem now is, – wrote in Zeiner wrote in his blog that there are not enough people educated enough and crazy enough to conduct such experiments. I want everyone who has access to the Internet to have access to knowledge sufficient for biomedical research. What if we can pull this off with any other medicine?"
Anatomy of the knee
Biohackers had little choice. They could not afford to work with a weakened or inactivated virus – this requires a specially equipped laboratory with a safety certificate. An adenovirus vaccine is also not easy to assemble – a reactor would be needed to "dilute" viral vectors. Therefore, Zeiner and his colleagues opted for a DNA vaccine: like mRNA vaccine technology, it has not yet been widely used in humans, but has long been used in veterinary medicine. In addition, in May, preliminary results of tests of a DNA vaccine against coronavirus on monkeys appeared (they were published later in a peer-reviewed journal) – at that time, mRNA vaccines could not boast of such success.
Every week, Zeiner, Aisha and Dantseva went on the air from their home labs. As befits biohackers, everyone equipped the workplace according to their capabilities – Zainer right in the bedroom of his own apartment, Aisha took a wooden shed for his experiments. Every week they posted one training video and a video where they shared their experiences and discussed their experiments – each conducted them independently.
The whole path of biohackers to the vaccine can be divided into three parts: creation, confirmation and self-testing. The first stage didn't actually require them to do any handwork. Since a DNA vaccine is, in essence, a ring DNA (plasmid) for delivering a viral gene to human cells, its assembly can be ordered from any company that deals with synthetic nucleic acids. You just need to know which gene is required.
But the coronavirus genome has long been deciphered and published, so Zeiner only has to show his viewers how to find it, where to look for the right gene in it and how to make it more similar to ordinary human genes so that cells do not suspect a trick. Next, the biohacker sent an order – and soon received the vaccine itself: the SARS-CoV-2 S-protein gene, packaged in a plasmid, which was originally designed to work in human cells.
At the second stage, it was finally time for laboratory work. To understand whether they had collected the right plasmid, biohackers undertook to test it on human cells. They used a ready-made HEK293 culture (embryonic kidney cells) for this, which Zeiner often worked with in his CRISPR projects. They treated the cells with the resulting vaccine, and then, using electrophoresis, checked that they really produce large quantities of a protein similar in size to the S-protein of the coronavirus.
After that, the third stage began – experiments on yourself. All three injected themselves with two doses of the vaccine with an interval of 16-17 days (like many other coronavirus vaccines, it was supposed to work in two sets – first to start the immune response, and then "disperse" it) and began searching for antibodies in their blood. They also carried out these tests independently, having bought a commercial kit for enzyme immunoassay.
They managed to find some antibodies to the S-protein of the coronavirus even before vaccination: Zeiner had IgG antibodies, and Dantseva had IgM antibodies (although tests in an independent laboratory gave both a negative result). And only Aisha did not have either one or the other in significant quantities. After vaccination, they noticed serious changes only in Zeiner: he had five times more IgM.
But all three – according to their report – found neutralizing antibodies (they do not indicate the concentration). This is a subspecies of antibodies that not only bind to the coronavirus, but also prevent it from attaching to the ACE2 receptor on the cell surface. It is believed that neutralizing antibodies form the main line of defense against infection, so they are used as an indicator of the effectiveness of the immune response (for example, their concentration was separately tested in tests of the Sputnik vaccine). However, most laboratories have not yet conducted such tests in the summer – in the USA, for example, the first such test system for widespread use was approved only in November. Therefore, biohackers had to check it on their own – and it was the presence of neutralizing antibodies that they declared an indicator of their success.
What should we do
Is it really a success? Let's see what the CDC has actually achieved during its experiment.
Did they manage to make the vaccine faster than Big Pharma? At first glance, it seems that yes: apart from the preparation stage, the whole process – from the beginning of the course to the first injection – took biohackers about 40 days (of which clean laboratory work is two weeks less). This seems to be a good result against the background of other developments: for example, BioNTech, whose vaccine is now distributed by Pfizer, began its development in January, and the first volunteers received an injection in May.
But biohackers were not engaged in a vaccine from scratch. They took the developed vaccine, which their predecessors, who published their report in Science, had already tested on primates. Thus, they saved on the preclinical phase of research. The work they talk about on the online course is actually a small fragment of the 1/2 phase of trials: when researchers check on a small group of volunteers that their vaccine causes an immune response and does not cause side effects (biohackers, by the way, complained of slight malaise after the injection - like many participants in clinical trials of other vaccines). And for a fragment of 1/2 phase, 40 days is not such a small period.
Was it possible to make the vaccine inexpensive? This question is also not easy to answer. Biohackers have been collecting their home laboratories for a long time, so their expenses were limited to the purchase of antibody detection kits and the synthesis of a vaccine. The latter, by the way, is not so cheap: Zeiner gave a little more than $ 2,200 for his plasmid (in Russia such an order can cost even more – several hundred thousand rubles).
An outsider – if he decides to go all the way side by side with biohackers – will have to spend much more. To assemble his "laboratory on his knee", he will also need cell culture, reagents and plastic, electrophoresis equipment, as well as a centrifuge and a spectrophotometer. Some of these devices can cost tens of thousands of rubles. These are, of course, not the amounts that pharmaceutical giants operate on – but also not those that 99 percent of the population deprived of the vaccine can easily afford.
However, those who want to get the coveted injection cheaper can also find where to save money here. For example, it is absolutely not necessary to confirm the effectiveness of the vaccine on cells – if you trust the manufacturing company. In addition, you can do without a spectrophotometer – and pass all the tests in a commercial laboratory. Strictly speaking, you can not even take tests – if you are convinced by the evidence of Zeiner and his team that their method is effective. In this case, all you need is to order a plasmid in a specialized office, buy two syringes for intramuscular injections at a pharmacy and believe that everything will work out.
The idea of injecting yourself with any kind of drug without checking in any way that it works and will not harm you sounds risky. However, this is exactly how biohackers act – neglecting the standards of clinical trials and not bothering with unnecessary evidence. In the end, the only thing we know about the effectiveness of the "vaccine-on-the–knee" is that its creators themselves have found an unknown amount of neutralizing antibodies, while their data on other antibodies (obtained by the same method) differ from the results of commercial tests.
What was that
The road bypassing traditional standards does not always lead its heroes to unequivocal success. Some really manage to contribute to the development of their field. For example, the story of George Lopez and his experimental stem cell treatment has been published in a prestigious medical journal – which means it can serve as an example and support for other researchers and doctors.
But Elizabeth Perish's performance with the telomerase gene, apparently, ended in nothing. Despite the fact that Perish later said that her telomeres had become longer, and she herself, therefore, was younger, this story did not receive any scientific continuation. Perish founded her own company, which offers experimental gene therapy to clients – but neither the clinical trials that she would conduct, nor the specific results, were ever known.
The crusade of Zeiner, Aisha and Dantseva is also unlikely to be a biotechnological breakthrough – as well as an argument in the fight against pharmaceutical giants with their seemingly unreasonably long and expensive trials. Rather, this example shows quite clearly what it takes time to develop and test vaccines and what unexpected difficulties can be encountered in the process. And now it is much easier for us to talk about why such thorough tests are needed: at least so that later it does not turn out that the output result is not obvious, different analyses give different answers, and you can only believe in success.
As for the rescue of drowning people by the hands of drowning people themselves, even here we do not know whether the biohackers have achieved their goal. In his manifesto, Zeiner wrote: "if we can teach people to do it on their own, we will regain power" – implying that now all power is in the hands of official science and big pharma. However, it is still unclear whether anyone has learned how to develop vaccines during the online course and whether they have tested them on themselves - at least, no one admits this in the comments to the videos.
Therefore, today we can only say that the three biohackers just had fun, because their "mini-1/2 phase of trials" says nothing about the effectiveness of the vaccine (strictly speaking, now it cannot even be called a vaccine, while it is just a plasmid encoding the S-protein of the coronavirus). It is possible that there will be more subjects for the "hacked" vaccine – now Zeiner offers to leave an application for receiving his vaccine by mail. In a note to the application, he clarifies: he will send the first thousand doses for free. For subsequent doses, the oppressed 99 percent will probably have to pay – but it is still unclear how much he will ask.
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