With nearly one million deaths worldwide from Covid-19, all countries with advanced pharma are working on a vaccine – competitively. Who will get the vaccine first? Will it work? And there is a dangerous trade-off between speed and safety, writes Victor Hill.

The quest for a vaccine

There are an estimated 176 coronavirus vaccines currently under development across the world, of ten different types; and there are likely to be at least 50 undergoing human trials by the end of 2020. This is much more than a scientific challenge: vaccinology in the coronavirus pandemic has become political. National leaders know that the swift delivery of a vaccination programme will yield political dividends at home. And, internationally, there is a race to see which country can succeed first and thereby reap the most national esteem.

President Putin has claimed that Russia has already won that race with its Sputnik V vaccine – the very name of which recalls the space race between the USSR and the USA. But there are serious doubts about the safety and efficacy of the Russian vaccine, which is still untested. German Health Minister, Jens Spahn, has said he is very sceptical about it. The fear in Germany and elsewhere is that if the Russian vaccine turns out to be injurious to human health then that could inhibit the take-up of any new vaccine globally[i]. Sputnik is currently being administered to 40,000 people (including Mr Putin’s daughter) but the first definitive results will not be available until October.

And what if President Trump could convince Americans, more than 200,000 of whom have already died of the virus, before 03 November, that they will be saved from the scourge of Covid-19? America’s programme is named Operation Warp Speed – a reference to Star Trek. This has as its stated objective to produce 300 million doses of safe vaccine by January next year. The key vaccine developers in the US are Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE) and Johnson & Johnson (NYSE:JNJ). What would be inimical to Mr Trump would be if China gets there first.

This week, Wu Guizhen, chief bio-safety expert at The Chinese Centre for Disease Control and Prevention, announced that a vaccine developed in China could be available as early as November[ii]. China has been testing its vaccine on health workers and border officials since July. China’s two leading vaccine candidates use inactivated vaccine technology – a technique widely used for flu and measles vaccines. President Xi has said that a Chinese vaccine will be a global public good.

In Britain, the programme jointly undertaken by Oxford University’s Jenner Institute and AstraZeneca (LON:AZN)stumbled in early September when tests were suspended after a patient exhibited an unexplained illness. This was later diagnosed as transverse myelitis, a rare neurological condition which can cause paralysis, sensory problems and digestive disfunction. AstraZeneca’s share price tumbled on this news; however, the trial has now resumed, and their share price has recovered.

The British vaccine, like the Russian one, uses a modified adenovirus which prevents the spike protein in Sars-CoV-2 from replicating. Reports of a hacking attack on the Jenner Institute in June were blamed on the Russians – but definitive proof of that has not been forthcoming. AstraZeneca has said their vaccine will be released at the cost of production – below $5 a shot according to one source – though Goldman Sachs thinks a realistic market price would be $50-$60. This would generate much goodwill for the pharma giant – which will do no harm to the share price – but little profit.

On 07 September the Health Secretary, Matt Hancock, announced that the UK government had pre-ordered 30 million doses of the AZD1222 vaccine from AstraZeneca. Apparently, these are already being manufactured and stored prior to regulatory approval.

In Germany, the frontrunner is BioNTech (NASDAQ:BNTX), which is developing a vaccine based on mRNA (crude DNA). Reportedly, this can be developed faster. And a French vaccine developed by Valneva (EPA:VLA) or Sanofi (EPA:SAN) might even restore President Macron’s flagging popularity.

Meanwhile, the World Health Organisation (WHO) has been encouraging countries to cooperate with one another – with limited success, though Canada and Norway have been exchanging expertise.

Practicalities

It normally takes about ten years to develop, test, trial and commercialise a vaccine – 4-6 years in lab research, then 3-5 of human trials, and then a few years to secure regulatory approval. Developers need to know firstly that a vaccine will produce an immune response; secondly that that immune response is sufficient to protect people; and thirdly that the vaccine is safe and does not generate severe adverse reactions. Finally, the production specialists have to figure out how to produce the vaccine in sufficient quantities. It took roughly 20 years to develop the polio vaccine – one of the most successful ever, as this terrible disease has now been eradicated.

Then there is the problem that some immune responses are induced by vaccines indefinitely (as is the case with the polio vaccine) and some for just a few months. A study by the Swedish Public Health Agency in July concluded that those who recover from Covid-19 carry immunity for six months. A more recent study carried out by Nanjing University in China      suggested that coronavirus antibodies fade after just one month. If that is the case, then regular booster vaccinations may be required which will make the vaccination programme much more costly.

The candidate vaccines under development in the USA and Germany need to be stored at extremely low temperatures. This begs the question of whether the world has enough super-freezers. The Oxford Jenner-AstraZeneca vaccine, in contrast, requires a temperature of 2-8C. Pfizer and Moderna are developing mRNA vaccines which need to be stored at minus 70C and minus 24C respectively to ensure that their chemical structure remains stable. It is unlikely that such vaccines could be administered in hot developing countries.

And how best to administer the vaccine? Imperial College, London, is working on a vaccine that can be inhaled directly through the lungs using an inhaler. By targeting the cells that line the airways – the point at which Covid-19 takes root – the aerosolised vaccine might induce a more effective immune response than that generated by an injection. Another variant is to use a nasal spray.

And could a vaccine ever be rolled out globally rather than in a series of national programmes? Information technology will have to play a critical role. Nandan Nilekani, co-founder of Indian tech giant Infosys (NSE:INFY) believes that what is needed is a global biometric ID system which will issue digital immunity certificates to determine who has been vaccinated and who is still at risk. India has unique experience in this realm, having rolled out a biometric identity card scheme verified by iris and fingerprint scans for all its 1.35 billion citizens.

Anti-vaxxers

There are already movements active in many countries opposed to mandatory vaccinations. The grounds advanced are, firstly, civil liberties – everybody should be free to choose how to safeguard their own health; and, secondly, safety – since many anti-vaxxers regards all forms of vaccination as inherently dangerous, especially for children. Many parents seem to think that vaccines can cause autism. Anti-vaxxers are often people who should know better such as Piers Corbyn (brother of Jeremy) and top tennis player Novak Djokovic. It is acknowledged, however, by the scientific community that some side-effects of vaccination only show up months or years later.

In the UK, childcare.co.uk conducted a survey last month. Out of 5,000 people polled, about half declared they would not vaccinate their child when a vaccine becomes available. Some vaccine experts claim that we shall need a 70 percent take-up to render the vaccination programme effective, so this is worrying. The WHO draws a distinction between vaccine refusers and vaccine deniers, the latter being more extreme in their opinions than the former. The problem is that the deniers augment the anxiety of the refusers. The medical establishment clearly believes that the risks of vaccination have been maliciously overestimated.

Some Americans will remember that, back in 1976, the US Federal government rushed out a flu vaccine in response to a localised outbreak at Fort Dix military base, New Jersey. The vaccine supposedly resulted in the death of over 30 patients by inducing Guillain-Barré syndrome, a neurological condition that can cause paralysis. There was huge political fallout from this – indeed Gerald Ford lost the presidential election to Jimmy Carter on 02 November 1976.

Will a vaccine be a panacea?

Earlier this week Professor Peter Openshaw of Imperial College London, a member of the government’s SAGE committee, warned that he did not expect a tried-and-tested vaccine to be rolled out in the UK until September 2021. That is probably more realistic.

An efficacious vaccine might boost GDP by re-opening theatres and welcoming football fans; but even the medical optimists recognise that a Covid-19 vaccine will not stop the virus altogether. Elderly and vulnerable folk might still succumb to Covid-19-induced flu-like symptoms, and some could still die. Professor Sarah Gilbert of the Jenner Institute thinks that multiple vaccines will be required to do the job. There will undoubtedly be problems in rolling out a vaccine even if it works beyond expectations.

Some investors anticipate a windfall from a Covid-19 vaccine. That may be overly sanguine; but post-Covid, the status of big pharma – and its umbilical link with big government – will be reinforced. That means less restrictive regulation going forward.

***

Brexit’s bitter endgame

The Law Society has asked its members to write to their MPs to support the rule of law. BBC commentators regularly enounce that legislation is passing through the House of Commons which will breach international law. William (Lord) Hague as well as five ex-prime ministers exalt Mr Johnson’s government not to make Britain an international pariah. All this is confused and confusing – and entirely misses the point of what is really in play.

The Internal Market Bill in no way breaches international law. It would however, if enacted (which is in doubt because it may well be held up by the House of Lords), empower the Secretary of State for Northern Ireland to make regulations which would be in conflict with the UK-EU Withdrawal Agreement, ratified last January.

Specifically, if there were no trade deal and the UK began to trade with the EU on 01 January on WTO terms, then tariffs will apply on goods traded between the two. Under the Withdrawal Agreement, Northern Ireland remains part of the EU single market though it is recognised as part of the UK’s customs territory. So, the risk that the EU may require tariffs on goods passing from Northern Ireland to Great Britain (i.e. the rest of the UK) is tangible. The Internal Market Bill empowers the Secretary of State to over-rule such tariffs.

There is legal justification for this – quite apart from the fact that I cannot think of any historical precedent of an international treaty which requires one party to impose tariffs on goods crossing an internal border. The UK could argue that the EU has breached Article 5 of the Withdrawal Agreement which enjoins the EU to assist Britain “in full mutual respect and good faith”. Is threatening to block all UK food exports – even though the UK is 100 percent compliant with all EU food regulations – an exhibition of good faith?

Moreover, the northern Ireland protocol within the Withdrawal Agreement recognises that cooperation between the Republic of Ireland and Northern Ireland is a central part of the 1998 [Good Friday] Agreement; and it also recognises Northern Ireland’s integral place in the UK’s internal market. Article 1 also states that the EU respects the territorial integrity of the UK. If the EU were to breach these principles, then unilateral action by the UK government might be deemed both legal and necessary under international arbitration.

In retrospect, it does seem that Mr Johnson’s “oven-ready” deal with the EU – much vaunted in the December general election – offered a hostage to fortune; though historians might judge that his room to manoeuvre had been excessively restrained by the Remainer cabal that characterised the last months of the Rotten Parliament of 2017-19. Now, in the bitter Brexit endgame, the EU is using the Northern Ireland Protocol within the Withdrawal Agreement to force Britain to submit to its state aid rules (even though they have been grievously flouted during the pandemic, not least by France and Germany) and to open its waters to European fishermen, in return for a free trade deal.

I cannot imagine the international law argument being made against the national interest in France or Germany. As Sherelle Jacobs wrote last week in the Daily Telegraph “international law is only valid to the extent that it does not subordinate the principle of sovereign will”[iii]. Countries break trade rules (international law, at a stretch) all the time – which is why the WTO specifically permits contraventions where appropriate compensation is offered. Ms Jacobs enumerates instances of where the EU itself has flagrantly violated international law. That the French navy is now actively assisting illegal migrant boats to enter British waters is arguably a breach of international law – but I don’t hear any howls of moral outrage from the UK’s Remainer establishment about that.

As for Mr Biden and Ms Pelosi threatening to stymie any US-UK trade deal if Britain breaks the Good Friday Agreement: they should get their facts right. That agreement specifically states that the constitutional status of Northern Ireland cannot be changed without the full consent of both communities. The imposition of tariffs between Northern Ireland and Great Britain would be tantamount to a change of status. It is the EU which is threatening the Good Friday Agreement.

Lord Hague et al should calm down. It’s not as if we have just invaded Poland. I have expressed the view in these pages that the Johnson government – especially in so far as the handling of the pandemic is concerned – has been lacklustre, even vacillating. But Mr Johnson is right to stand up to Brussels’s bullying – even if the downside risks, short-term, are considerable. At this rate we are heading, not just for the hard Brexit that I have always envisaged, but for a full-scale trade war next year to compound the coronavirus recession.

Expect early pandemic-style panic shopping in Q4. But at least we shall prospectively be self-sufficient in fish.

[i] See: https://www.businessinsider.com.au/germany-warns-putin-russia-coronavirus-vaccine-has-not-been-fully-tested-2020-8

[ii] See: https://www.businessinsider.com.au/coronavirus-vaccine-in-china-could-be-ready-by-november-say-officials-2020-9?utm_source=Business+Insider+Australia+-+10+things+you+need+to+know+in+the+morning+in+Australia&utm_campaign=b4f0c43f0a-businessinsider_2020_09_16&utm_medium=email&utm_term=0_8a990bd96b-b4f0c43f0a-280737397

[iii] See: https://www.telegraph.co.uk/politics/2020/09/10/no-10-must-stand-firm-flouting-international-law-face-eu-expansionism/