Britain, we learned this morning, has become the first country in the world to approve the Pfizer/BioNTech vaccine, which is likely to be deployed from Monday onwards. Is Britain being reckless, or are other countries dragging their heels?
The first point to make is that, however tempting though it may be to think so, it is not a case of Britain taking advantage of new-found freedoms enabled by Brexit. It may be in the future that Britain develops a more nimble regulatory system than the EU, and that British patients can benefit for the earlier administration of drugs, but the UK will remain under the European Medicines Agency’s regulatory system until the end of the transition period in a month’s time.
Today’s decision has been possible thanks to the Human Medicines Regulations 2012, which allow Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) to grant temporary emergency use authorisation in circumstances such as this.
Even so, eyebrows have been raised at the speed of the MHRA’s decision. In a briefing this lunchtime, Berkeley Phillips, medical director of Pfizer, suggested that regulatory bodies had all the data they needed, but that the MHRA had been prepared to ‘read the individual chapters of a book’ rather than wait for the whole book to be written. The full, published results are still in preparation. As Britain will be the first country to administer the vaccine, Phillips said, it will work on any problems associated with the rollout. We will have to hope we don’t suffer the curse of the early adopter.
What we do now know is that of the 41,135 participants in the study, 170 went on to catch Covid-19. Of these, 162 were in the control group given the placebo and just eight had been given the vaccine. Pfizer says that the study deliberately recruited people who were especially vulnerable to the disease, and 45 per cent were over the age of 56. The overall efficacy rates of 95 per cent was observed across the range of ages and ethnic groups – it was judged to be over 94 per cent among the over 65s.
But there are two important issues we don’t yet know. While the trials have proved that the vaccine can provide immunity against Covid-19 for the person who has been vaccinated, they were not designed to show whether the vaccine stops someone transmitting the virus to others. Nor do we know how long immunity might last.
The phase three trials only began in July, so have not been able to study immunity effects for longer than that. The participants will be monitored for the next two years, so more data will emerge in time – and we will eventually discover whether this is a vaccine which needs to be administered only once, or whether it needs to be boosted every few years, or even every few months.