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Putin and Trump are fast-tracking vaccine trials – with potentially perilous consequences

Inflicting a defective vaccine on millions would damage the immunisation campaign, and gift ammunition to anti-vaxxers.   

By Phil Whitaker

Immunisation against Covid-19 offers the swiftest path out of the pandemic. So why, in recent weeks, have influential publications such as the British Medical Journal been calling for the race to develop a vaccine to be slowed down?

There are around 160 candidate vaccines worldwide, employing a wide variety of methods. Traditionally, vaccine development takes years. The initial small-scale human trials seek to demonstrate two things: that the vaccine stimulates an immune response against the pathogen; and that in doing so it appears to be safe. Many potential products prove flawed during these first two stages. The minority that succeed go into phase three: human trials involving tens of thousands of participants, in which the vaccine is pitted against a placebo to establish whether its immune response translates into meaningful protection against infection – by no means a given – and to further assess for adverse effects, the rarest of which would only become apparent at scale.

The World Health Organisation (WHO) is seeking to bring cohesion to the global effort. It has compiled a register of initiatives, and is fostering exchanges between researchers so that problems and solutions can be shared. Furthermore, in anticipation that the 160 vaccines in development will yield several with proven efficacy and safety, the WHO has designed an international study to compare them. The logistics of manufacturing, distributing and administering billions of doses worldwide are mind-boggling. To set that in train with a vaccine that has demonstrated, say, 50 per cent efficacy, only to find a short while later that a different product offers 90 per cent protection, would be a huge missed opportunity.

While the WHO aims to ensure that the best vaccines are selected for global rollout, the body has no powers to compel cooperation. Cracks have begun to appear. Earlier this month, Russia announced that it had granted regulatory approval to the world’s first Covid-19 vaccine, and plans to commence large-scale immunisation in the coming weeks. The vaccine, named Sputnik V, has reportedly only been through phase one and two, and trialled on 76 healthy volunteers, with the results as yet unpublished. Vladimir Putin assured the world that Sputnik V produces “strong immunity” and has “passed all the necessary tests”. In a move reminiscent of John Gummer’s efforts to bolster British beef during the BSE crisis in the 1990s, Putin announced that his own daughter had been given a dose.

Denis Logunov, the deputy research director at the Gamaleya Research Centre in Moscow, which developed Sputnik V, has defended the accelerated pace. The genetic tools they are using have been employed in several other vaccines previously with no safety concerns. But until subjected to phase three studies, there is simply no way of knowing whether a new immunisation will actually prevent infection, prove useless, or even cause harm.

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The history of vaccination is punctuated with instances where a new inoculation has caused worse outcomes. Logunov is dismissive of one potential complication, in which antibodies raised by a vaccine actually facilitate viral entry into host cells. And he is silent on the more concerning possibility. Severe Covid-19 – the illness that sends patients into hospital and on to ventilators – is caused by an unbalanced immune response (commonly triggered among patients in “at risk” groups) more than by the direct effects of the virus. Any Covid-19 vaccine has the potential to skew the delicate equipoise between the different arms of our highly complex immune system. Until assessed in phase three trials, no one can be sure that a new vaccine won’t provoke more severe disease when some patients encounter coronavirus.

Putin’s announcement has been followed by hasty clarification. Regulatory approval is, it turns out, actually “temporary registration”, a way of allowing phase three trials to be conducted not on young, fit people, as would be standard practice, but on real-world volunteers, including those in established Covid-19 risk groups. There is sense in this, as long as consent is truly informed: including them will give important information about how at-risk patients will fare.

There are domestic pay-offs in being the first country to immunise its citizens, but Putin also has an eye on international influence. Russia has reached agreements to allow volunteers from Brazil, Saudi Arabia, the Philippines and the United Arab Emirates to participate in its phase three studies, and worldwide orders for a billion doses are said to have been signed. Russia stands to cement a lot of friendships among countries it chooses preferentially to supply – assuming that Putin’s gamble pays off and that phase three proves both efficacy and safety.

Putin is far from the only leader seeking to capitalise on an early vaccine. In May Donald Trump launched Operation Warp Speed, the US’s initiative to create a vaccine in record time. For Trump, the imperative is primarily domestic. Announcing a breakthrough ahead of 3 November would offer him a precious opportunity to improve his electoral fortunes, which have been rocked by his otherwise disastrous response to the pandemic. Judging by Trump’s recent accusations that the Food and Drug Administration is deliberately delaying vaccine trials in order to frustrate his re-election, it must now be getting very tight for him to be able to claim success ahead of polling day.

The fear of the science community is that in their haste, Russia or the US might launch a dud – or far worse, a killer. Inflicting a defective vaccine on millions would cause untold damage to the immunisation campaign, and would gift ammunition to anti-vaxxers. But pleas to slow the race seem to have fallen on ears deafened by clamant political noise. 

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