…and certainly not a Cold War Space Race, argues Daniel Altmann
When we hear that the Russian “SPUTNIK” vaccine has “won” the covid-19 vaccine race, any scientists, policy makers, or journalists who have been complicit in allowing the endeavor to be talked up as a competitive race of vaccine nationalism should pause for reflection. This was never intended to be the Eurovision Song Contest or the World Cup, but rather, a serious, life and death piece of translational medicine.
There are more than 160 vaccines in trial in the world in many countries, several in the final, phase 3 trials. We are in desperate need of the best, safest, most durably protective vaccines. We can’t possibly identify these for the common good unless we have a transparent, peer reviewed, scientific protocol for comparing and evaluating safety, immunogenicity, and protection side by side in an objective way. Anything less than this risks poor choices that we can ill afford.
Many vaccine teams have already published detailed data and protocols from phase 2 vaccine trials in sizeable human cohorts of several hundred people, including the UK, US, China, and Germany. The major bottleneck is to accrue compelling data on phase 3 trials—the long term trial on thousands of people given vaccine or placebo, then looking in a setting which still has a high infection rate if there is significant protection from infection without “adverse events”—these would only be seen if you follow thousands of people through to the infection phase.
The report from Russia seems to comprise a very small, unpublished, phase 2 trial in 38 volunteers of a basic, human adenovirus (common cold) vaccine platform, like many others already published, including from the US and China. While statements refer to “strong immunity,” the levels of binding and neutralizing antibodies appear to be somewhere between one third and one eighth of those previously published by others. Other parameters that have been key in the peer reviewed, published studies, such as CD4 T cell frequencies and the potential confounder of pre-formed antibodies to the adenovirus (blocking vaccine uptake and limiting its function), are not mentioned.
The key safety concern in all the tests is not just or mainly about initial “reactogenicity”, though this seems to have been rather high, but more about whether there are adverse events down the line, when the immunised person subsequently meets the virus. All platforms have strengths and weaknesses: this particular approach tends to have a moderately good safety profile, but may be poorly effective in people who have pre-formed antibodies against the adenovirus.
Approval for the vaccine has been granted locally, having dispensed with the phase 3 trial that would normally be a prerequisite for licensure (from the FDA, EMA, or MHRA) through robust demonstration of efficacy and safety in the field. To briefly revisit the disallowed “race” metaphor, this is entering the marathon, running the first few metres, then unilaterally crowning yourself the winner as all the others run on ahead.
Just sour grapes? Why should we care if countries seek separate solutions?
Well, first, any negative publicity at all about vaccine efficacy or safety would muddy the waters and undermine confidence in one of the most significant missions humankind has ever faced. Also, we’re all in this together and need to resolve it together: as we saw with global spread of the virus in early 2020, the virus spreads fast with no respect for borders, so there’s no benefit in some countries racing into suboptimal vaccines—we need joined up approaches with the help of bodies such as CEPI, WHO, Gates Foundation, and Wellcome Trust.
Most of all, this cannot be turned into a Cold War arms race for political gain. The arbiters here must be antibody titres, T cell frequencies, and lung CT scans, not popularity ratings of regional politicians. We simply need good research to find the vaccine candidates that save the most lives. There has been much discussion of the undesirability of “vaccine nationalism”—something which should be strongly resisted by the medical profession in all engagement with policy makers. This cannot be devalued into a race in which politicians seek to strong-arm a path past robust regulatory protocols which are there for good reasons.
Rolling out the manufacture, quality control, transport, administering, and monitoring of billions of vaccine doses globally will be a challenge to medical infrastructure like none before—think space mission logistics, and then some. Then imagine if we had made poor, rushed, vaccine choices and, at best, had to repeat the exercise a year later, or at worst, had eroded public confidence in vaccines as an answer.
Daniel M Altmann, professor at the Department of Immunology and Inflammation, Hammersmith Hospital, Imperial College, London. Daniel has served 20-years as editor at several immunology journals, including many years as associate-editor at ‘Vaccine.’ He also spent time in charge of infection and immunity strategy at the Wellcome Trust. He has been one of the contributors to the Immunology Task Force feeding into SAGE.
Conflicts of interest: DA receives an honorarium as an Editor at ‘Vaccine.’ No other conflicts to declare.