Never before, in the history of vaccinology, have so many scientists in so many countries spent so much time developing a vaccine against any single known virus, and never before have so many vaccines been produced at such breakneck speed. But we live in challenging times. The devastating impact of Covid-19 has mandated extraordinary measures to come up with a vaccine, aimed at containing the unfettered spread of the new coronavirus. As the race to achieve mass vaccination hots up, the UK government has displayed uncharacteristic decisiveness, approving a Covid-19 vaccine for general public use and in the process becoming the first Western nation to do so.
At 7 am on 1 December 2020, the Department of Health and Social Care issued a press release, confirming the fast-tracked approval, following a rolling review, of the two-dose Pfizer-BioNTech vaccine by the Medicines and Healthcare products Regulatory Agency (MHRA)- a decision further confirmed by the independent Commission on Human Medicines. The MHRA granted temporary authorisation for the vaccine under regulation 174 of the Human Medicine Regulations Act 2012, which permits emergency use of an unlicensed medicine under certain special and pressing circumstances. The vaccine manufacturer, Pfizer, was simultaneously ensured legal indemnity against any possible civil legal action in the event of unforeseeable harm caused by the vaccine, which was added to the list of vaccines covered by the Vaccine Damages Payment Scheme. Shortly thereafter, the Joint Committee Vaccinations and Immunisations published a ranked list of target groups of people prioritised to receive the vaccine, including care home residents, frontline health and social care workers, the elderly and the clinically vulnerable.
The Pfizer vaccine was one of three candidate vaccines being considered by the MHRA at the time of its approval. Phase 3 clinical trials, involving 43, 538 people, have confirmed the vaccine to be around 95% effective when the active vaccine was compared with inactive placebo, and it has been shown to work in all age groups. The vaccine is the product of a collaboration between American pharmaceutical giant Pfizer and a German biotechnology firm, BioNTech, which was set up in 2008 in the city of Mainz by Ugur Sahin (chief executive) and Ozlem Tureci, a husband-and-wife scientist team, along with Christoph Huber, a cancer specialist. They have developed an mRNA vaccine, which triggers an immune response without requiring the use of entire virus particles to generate a protective antibody response. The mRNA incorporates the genetic code for the spike protein of the coronavirus, which is responsible for the propensity of the virus to cause disease in humans. Making such vaccines relies on newer technologies, making the Pfizer vaccine the first mRNA vaccine to have been made available for unrestricted general use.
Following the announcement, several UK government ministers gloated in public over the speedy actions of the MHRA, which had responded within ten days of receiving the trial data from Pfizer. They even proclaimed a British lead over Europe and the US, which were allegedly disadvantaged by their less efficient regulators, in the form of the Emergency Medicines Agency and Food and Drugs Administration, respectively, and attested yet again to the looming benefits of Brexit. One minister summed it up when he said Britain is ‘a much better country’. But then the UK’s detractors soon hit back with some force, citing a possible lack of due diligence and inadequate scrutiny of Pfizer’s data in an unseemly rush to proceed with mass vaccination. It’s all part of a political point-scoring game, with little relevance to the actual fight against Covid-19.
The first batch of vaccines was flown in to the UK from Belgium on 3 December. Each dose of the vaccine is currently priced at £15. Mass vaccination hubs are being set up in a variety of venues throughout the UK, starting with 50 hospital hubs in England. It is possible that GP surgeries, leisure centres, sport halls and stadiums may also be used as vaccination centres when the vaccine is offered to the wider general public. But many logistical challenges lie ahead, including all-important supply chain issues that may impede delivery of the vaccine. First of all, the vaccine needs to be stored at -70C, although it can be transported at 2C to 8C for up to six hours. Secondly, two doses have to be given, with a 21-day interval in between doses. The whole process of identifying target populations and then ensuring that they receive the vaccine in a timely manner has to be streamlined.
The next few weeks are crucial, as the vaccine-hesitant and the anti-vaxxers actively look out for any emerging problems, including unanticipated side-effects, that will undoubtedly feed into their many anxieties and narratives when it comes to vaccines. If the vaccine does turn out to be safe and effective as promised, at least 70 per cent of the population will need to be immunised in due course to provide so-called herd immunity. It is too early to predict exactly how things will turn out, but we have to remain optimistic, as this seems to be the best chance for us to beat Covid-19 at its own game.
Ashis Banerjee
PS: On the historic occasion of “V-Day”, on 8 December 2020, Margaret Keenan, 90, and William Shakespeare (his real name!), 81, received the Pfizer BioNTech vaccine at University Hospital Coventry. In so doing, they became the world’s first and second recipients, respectively, of the vaccine as part of a mass vaccination programme.