For those who remember the Cold War and the Space Race between the then Soviet Union and the USA, there are striking parallels to be drawn as world leaders now race, not for weapons or moon landings, but to be first with a vaccine for COVID-19. The desire to be the first nation to manufacture a vaccine is setting an alarming precedent whereby the usual safety trials are being circumnavigated and decisions to roll out a vaccine to entire populations are being made on the basis of dubious, unpublished data. (1)
There are currently more than 160 vaccine trials worldwide and some, including the UK’s trial, are in the final, phase III trials. You can read more about the background to vaccine development and the different trial phases here and more about the Oxford trial here.
Phase III trials are a vital stage in vaccine production that determine overall safety of a vaccine and how well it is or isn’t working. Crucially phase III trials test vaccines in people with pre-existing health conditions who may react differently to the vaccine compared with healthy volunteers.
Different countries are at different stages of their vaccine development with some abandoning phase III trials altogether. Although bodies including the WHO (World Health Organisation) and the ICMRA (International Coalition of Medicine Regulatory Authorities) provide regulatory guidance on vaccine production, individual countries can choose to act independently.
The UK
The most promising vaccine in the UK is being developed by the University of Oxford. Their combined phase I and II trials recruited over 1,000 healthy people. They found that the vaccine induced a good immune response with some mild side effects but no serious adverse reactions. Their phase III trials are now underway in the UK and also in South Africa and Brazil. The US announced in May 2020 it had partnered with Oxford University and as a result a further trial of the Oxford vaccine is due to start in the US in the autumn. The aim is to recruit over 50,000 volunteers for the phase III trials. (2) (3)
Whilst the Oxford vaccine continues to look promising, England’s Chief Medical Officer Professor Chris Whitty has said that, whilst he is optimistic we will eventually have a vaccine, it is unlikely to be ready for the winter of 2020 citing the fact that a vaccine must be proven both safe and efficacious before it is rolled out to the population. (4)
The USA
In mid-May the US announced “Operation Warp Speed”, its plan to have 300 million doses of vaccine by January 2021. (5)
The US has said it will not partner with any Chinese vaccine development but somewhat surprisingly has also announced it will not partner with the WHO, the European Commission or The Coalition for Epidemic Preparedness Innovations, all of which are co-ordinating international vaccine development programmes. Of note is that the US chose not to submit Operation Warp Speed to the international Solidarity Trial on vaccine development organized by the WHO. Concerns have also been raised about the fact that the head of Operation Warp Speed, Moncef Slaoui, had been a board member of the US vaccine developer Moderna. Although he resigned from the Moderna board when appointed to Operation Warp Speed he is estimated to have made a financial personal gain of $10 million from his Moderna shares. (6)
Meanwhile Moderna is now conducting phase III trials of its vaccine. (More can be found here on the Moderna Vaccine.) (7)
The US has also signed contracts for a potential vaccine with the companies Pfizer and the German firm BioNTech who have partnered with each other and are in the phase III trial stage of their vaccine development. (8)
Since the initial Operation Warp Speed announcement US President Donald Trump has declared he wants to fast-track approval of the Oxford University vaccine for use in October 2020 in a move seen by many as politically motivated in view of the forth coming Presidential elections in November. The goal of October 2020 has been criticised both within and outside the US with experts pointing out that coronavirus vaccines are notoriously difficult to manufacture and there are major safety implications of rushing through vaccine development. (9) (10)
Trump wants the US FDA (Food And Drug Administration) to authorise its emergency use, a so-called EUA (Emergency Use Authorisation) but AstraZeneca (the drug company working in partnership with Oxford University) have said they have had no discussions with the US about this. Several senior figures at the FDA have said they will resign if an EUA is issued. (11)
Dr Anthony Fauci, the top US virus expert, has also warned that a vaccine should not be rushed out until it is proven safe and effective. (12)
Speaking with Reuters news agency, Dr Fauci said, “The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy. One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enrol people in their trial.”
Dr Fauci also explained that EUAs have never been used to fast track any vaccine and usually apply to treatments for life-threatening diseases where benefit outweighs risk, a very different scenario to administering a vaccine to the general population. (13)
Previously the FDA issued an EUA for the drug hydroxychloroquine to be used for COVID-19 which it had to reverse in July 2020 when studies showed it was not effective and may cause harm. Stephen Hann, the Commissioner of the FDA, has said in interview that all decisions on the vaccine will be guided by science and not politics. (14) (15)
Russia
The Russian government has approved a vaccine, Sputnik V, developed by the Gamaleya Institute in Moscow, for widespread use and is claiming it is safe and effective. On 11 August President Vladimir Putin announced on Russian television that the vaccine had passed all necessary checks and claimed it had been given to one of his daughters. (16) (17)
The vaccine has only gone through two phase II trials, each with just 38 participants, the results of which have not been published. Although Russia have said they will start Phase III trials in August, given the fact the average length of a phase III trial is one to three years, it is hard to marry this with the announcement that the vaccine will be rolled out to the whole population in September. (18)
Experts worldwide have been critical of the Russian approach. Professor of Immunology Daniel Altmann from Imperial College, London said in a statement, “The collateral damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably...”
He criticised the fact no data has been released by Russia saying, “I have spent a long time trying to track all the candidate vaccines through the evidence that’s been published and preprints. What has been noticeably unusual is that there’s been almost no information, and none that’s been peer reviewed, on this Russian vaccine apart from on the clinical test website.”
Professor Francois Balloux at University College London, described the move by Russia as “a reckless and foolish decision”. (19)
Concerns have also been raised by the fact a financial incentive was offered for people to volunteer for the Russian trials, a move considered unethical by many although it should be acknowledged that such payments happen around the world and are not unique to Russia. (20) (21) (22)
China
The Chinese currently are conducting three of the six trials which have reached the stage III phase. (The other three being Oxford, Moderna and the combined BioTECH/Pfiezer trials.) The trials use different technologies and the testing is being carried out on the Chinese military. (23)
Although commentators have questioned the ethics of testing those who cannot refuse to co-operate, it is common practice in China where the combining of military and civilian technologies has been actively pursued. China is not alone in this, in the US the Defense Advanced Research Projects Agency is working alongside the Department of Health and Human Services in vaccine development. (24) (25)
There are also reports that some key workers in China have been given the vaccine. (26)
The initial findings of the Chinese researchers have been published in the Lancet. Stimulation of the immune response was seen but it is not yet known if it is at the level needed to afford protection against the virus. (27)
China also appears to be making diplomatic overtures to some countries by offering priority access to its vaccine amidst its deteriorating relationships with many Western nations including the US and the UK. (28)
In Conclusion
Scientists are right to be alarmed at the political race to be first with a vaccine for COVID-19. Negative publicity about a vaccine will undermine people’s confidence not just in a potential COVID-19 vaccine but in vaccination in general, especially in countries where trust over vaccination programmes is still being built.
If ever there is a time when countries need to work together, it is in the face of a worldwide pandemic. The protocols for vaccine development are there for a reason – to ensure vaccines are safe and that they work. Politicians cannot be allowed to circumvent established and scientifically sound procedures for their own political gain. The race to be first with a vaccine risks losing it altogether.
(2) https://www.nationalgeographic.co.uk/science-and-technology/2020/07/oxford-vaccine-enters-final-phase-of-covid-19-trials-heres-what
(3) https://www.cnbc.com/2020/05/21/coronavirus-us-gives-astrazenena-1-billion-for-oxford-vaccine.html
(26) https://news.sky.com/story/coronavirus-china-has-been-vaccinating-key-workers-since-july-12055441
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