Clarity must be ensured about expectations relating to Covid-19 vaccines so that there are no scientific or ethical compromises
If only the Covid-19 vaccine story was a fairy tale with a beginning, a middle and a happily-ever-after ending. Development, testing, manufacturing, and distribution of vaccines is an exact science. Given that we have no effective treatment in sight, and preventive measures such as lockdowns and physical distancing are unsustainable, the world is looking towards a magical vaccine that will confer immunity from the dreaded virus.
Even though, no effective vaccine has been developed for any other coronavirus so far, given the massive global effort, it seems the big question is not whether such a vaccine will become available, but when.
Will it work?
Researchers are using a number of approaches to make the vaccine and studies in animal models suggest that vaccines have promise, but concerns regarding safety and efficacy remain. Previous research with MERS and SARS demonstrated that although vaccines generated antibodies in some cases they caused a more severe form of disease. We cannot have a vaccine that will cause a more severe disease in those vaccinated than those not vaccinated.
Data in humans, although scant, suggests that Covid-19 vaccines prompt production of antibodies. What isn’t yet clear is whether levels of these antibodies is high enough to stop new infections and how long they last.
Analysis of safety and efficacy of vaccines is normally done over several years, in clinical trials that are inflexible, standardised, and intensely regulated to maximise safety and efficacy. A flawed vaccine may not only offer no defence from Covid-19, but may also expose the vaccinated individual to other potentially disastrous outcomes. The history of vaccine production has many examples of unintended outcomes directly related to a vaccine.
One particular challenge in Covid-19 is that prior experience indicates that vaccines generally do not work as well in the elderly, like in influenza vaccine, and it is the elderly who are actually at the greatest risk of Covid-19.
Warp Speed Ahead
Several countries including the US, China and India have pledged fast track delivery of a vaccine, and already serious scientific and ethical concerns have emerged.
To achieve high speed delivery of an anti-Covid-19 vaccine, we require novel vaccine development paradigms, innovative regulatory processes, and scaling manufacturing capacity. None of these innovations must, however, involve scientific or ethical compromises.
The US government’s Operation Warp Speed programme is expected to name five or more vaccine projects to receive billions of dollars in federal funding even before there is proof that the vaccines work. The idea is that this will enable new production lines, capable of generating billions of doses in a few months. At present, this capacity will be reached with difficulty and will represent an unprecedented effort.
China and India have also announced their efforts recently, with the Chinese vaccine already in Phase III clinical trials. China has already waved through an emergency authorisation to allow its armed forces to use the vaccine that remains incompletely tested. One can only hope that military personnel were chosen as trial candidates not because, unable to refuse, they formed a convenient cohort to experiment on. There are plans to test the Chinese vaccine in Pakistan also.
The initiative by the Indian Council for Medical Research is also raising eyebrows. Their candidate vaccine, just commencing Phase 1 and Phase 2 trials, has already been declared available for use by August 15 – the Indian Independence Day. This has prompted a strong backlash by scientists and bioethicists, concerned about the safety and efficacy of the vaccine, over the process that reeks of shortcuts. India has also partnered with the University of Oxford for the production of one billion doses of the Oxford vaccine for India and other low- and middle-income countries by the end of the year, with a strong statement from scientists at the Serum Institute of India that they will “not rush” anything, and want to produce a safe and effective vaccine.
For Covid-19 to accelerate vaccine development sequential studies in each phase have been shortened and partially overlapped. But it will be necessary that thousands of vaccinated people are followed for several months before the general-purpose vaccine is approved – global collaboration for clinical trial recruiting people is an advantage. The ideal place to test a vaccine is where we are still seeing high level of transmission and cases.
Even when a vaccine is available, it will initially be in short supply considering the entire global population is a candidate. Prioritisation will have to be done raising ethical challenges. If, for instance, a global consensus is reached for protecting the elderly, with an initial age cut off at say 70, Pakistani population will be at a disadvantage since only 3 percent of our population is over 70. Similar challenges abound in its initial disbursement. If access is limited and granted to a select group, we may witness what happened in Pakistan for various experimental therapies being sold on the black market. This will again shift the balance of access to those who can afford it, adding to the current economic, social, and cultural divides in our country.
In Britain, the Joint Committee on Vaccination and Immunisation, which advises the government, has recommended that front-line health- and social-care workers, then the most vulnerable, should be the first in the queue. As yet we have not formulated our Covid-19 vaccination strategy.
For the vaccine, to be practically suitable, it must ideally be stable at room temperature with a long shelf life, easily transportable and simple to administer. Additionally, in order to meet global demand, many sites must be enabled to produce it. When the polio vaccine was initially mass produced, a mishap in the production line led to a polio outbreak with children being crippled and dying.
We must also remember that there are over a hundred vaccine trials being developed or run at this time, the vast majority of which are pharmaceutical or biotech industry sponsored. The industry will look for a quick return on investments, preferably before the virus mutates into something benign.
If anything, we are already witnessing aspects of corporate greed making the pandemic a business opportunity. The US government has bought more than 500,000 treatment courses of the antiviral drug Remdesivir – the manufacturers’ entire production capacity for the next three months – and effectively excluding other countries from accessing this drug.
However, during the Covid-19 pandemic we have observed an awakening and strengthening of the regulation, governance, and approval processes in Pakistan. This will need to continue when it comes to deciding which vaccine we will use and how it will be delivered to people.
Challenges of vaccination in Pakistan
We cannot afford Covid-19 entirely eclipsing production and administration of other vaccines. Pakistan already has a poor track record regarding vaccination, being third among countries with the most unvaccinated and under-vaccinated children.
While a vaccine may eventually appear and be acceptable to the rest of the world, we can just hope Pakistan can avoid another polio type trajectory.
Just the beginning
There must be clarity and transparency about the challenges of developing and delivering an effective and safe Covid-19 vaccine. Projections and expectations need to be navigated with care to ensure warp speed is not hyped speed.
We have little option but to pursue the scientific track forward, speeding things up as safely as possible without comprising efficacy, knowing full well that there are no shortcuts. A happily-ever-after ending may be a fairy tale affair, but that ought to be our aim.
Dr Natasha Anwar is a consultant molecular pathologist at the Aga Khan University Hospital Regional Lab in Lahore. Dr Aamir M Jafarey is a professor at the Centre of Biomedical Ethics and Culture, at SIUT in Karachicaption